  July 1, 2020

      Title 40
      Protection of Environment
      Parts 150 to 189
      Revised as of July 1, 2020
      Containing a codification of documents of general applicability and future effect
      As of July 1, 2020

        Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register

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      Table of Contents
      Page

        Explanation
        v

        Title 40:

          Chapter I—Environmental Protection Agency (Continued)
          3

        Finding Aids:
        Table of CFR Titles and Chapters
        835
        Alphabetical List of Agencies Appearing in the CFR
        855
        List of CFR Sections Affected
        865

      Cite this Code: CFR

      To cite the regulations in this volume use title, part and section number. Thus, 40 CFR 150.17 refers to title 40, part 150, section 17.

      Explanation
      The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
      Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:

        Title 1 through Title 16
        as of January 1
        Title 17 through Title 27
        as of April 1
        Title 28 through Title 41
        as of July 1
        Title 42 through Title 50
        as of October 1

      The appropriate revision date is printed on the cover of each volume.

        LEGAL STATUS
        The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510).

        HOW TO USE THE CODE OF FEDERAL REGULATIONS
        The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule.
        To determine whether a Code volume has been amended since its revision date (in this case, July 1, 2020), consult the “List of CFR Sections Affected (LSA),” which is issued monthly, and the “Cumulative List of Parts Affected,” which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule.

        EFFECTIVE AND EXPIRATION DATES
        Each volume of the Code contains amendments published in the Federal Register since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut-off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text.

        OMB CONTROL NUMBERS

        The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agencies to display an OMB control number with their information collection request. Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements.

        PAST PROVISIONS OF THE CODE
        Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appropriate List of CFR Sections Affected (LSA). For the convenience of the reader, a “List of CFR Sections Affected” is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

        “[RESERVED]” TERMINOLOGY
        The term “[Reserved]” is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a “[Reserved]” location at any time. Occasionally “[Reserved]” is used editorially to indicate that a portion of the CFR was left vacant and not dropped in error.

        INCORPORATION BY REFERENCE

          What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law.

          What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are:
        (a) The incorporation will substantially reduce the volume of material published in the Federal Register.
        (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process.
        (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51.

          What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010.

        CFR INDEXES AND TABULAR GUIDES

        A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR Index and Finding Aids. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.

        An index to the text of “Title 3—The President” is carried within that volume.

        The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the “Contents” entries in the daily Federal Register.
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        REPUBLICATION OF MATERIAL
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        INQUIRIES
        For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency's name appears at the top of odd-numbered pages.

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        ELECTRONIC SERVICES

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        The Office of the Federal Register also offers a free service on the National Archives and Records Administration's (NARA) website for public law numbers, Federal Register finding aids, and related information. Connect to NARA's website at www.archives.gov/federal-register.

        The e-CFR is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments, produced by the Office of the Federal Register and the Government Publishing Office. It is available at www.ecfr.gov.

          Oliver A. Potts,

          Director,

          Office of the Federal Register

          July 1, 2020

      THIS TITLE
      Title 40—Protection of Environment is composed of thirty-seven volumes. The parts in these volumes are arranged in the following order: Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-60.499), part 60 (60.500-end of part 60, sections), part 60 (Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63 (63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts 72-79, part 80, part 81, parts 82-86, parts 87-95, parts 96-99, parts 100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-265, parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts 700-722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to end. The contents of these volumes represent all current regulations codified under this title of the CFR as of July 1, 2020.
      Chapter I—Environmental Protection Agency appears in all thirty-seven volumes. OMB control numbers for title 40 appear in § 9.1 of this chapter.
      Chapters IV-VIII—Regulations issued by the Environmental Protection Agency and Department of Justice, Council on Environmental Quality, Chemical Safety and Hazard Investigation Board, Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces, and the Gulf Coast Ecosystem Restoration Council appear in volume thirty seven.
      For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of Federal Regulations publication program is under the direction of John Hyrum Martinez, assisted by Stephen J. Frattini.

    40 CFR Ch. I (7-1-20 Edition)
    Environmental Protection Agency

        Title 40—Protection of Environment
        (This book contains parts 150 to 189)

        Part

            chapter i—Environmental Protection Agency (Continued)
          150

          CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

          Editorial Note:
          Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2, 2000, and at 66 FR 34375, 34376, June 28, 2001.

          SUBCHAPTER E—PESTICIDE PROGRAMS

        Part
        Page

          150
          General
          5
          151
          [Reserved]
          152
          Pesticide registration and classification procedures
          5
          153
          Registration policies and interpretations
          49
          154
          Special review procedures
          50
          155
          Registration standards and registration review
          58
          156
          Labeling requirements for pesticides and devices
          66
          157
          Packaging requirements for pesticides and devices
          88
          158
          Data requirements for pesticides
          93
          159
          Statements of policies and interpretations
          200
          160
          Good laboratory practice standards
          214
          162
          State registration of pesticide products
          226
          164
          Rules of practice governing hearings, under the Federal Insecticide, Fungicide, and Rodenticide Act, arising from refusals to register, cancellations of registrations, changes of classifications, suspensions of registrations and other hearings called pursuant to section 6 of the Act
          234
          165
          Pesticide management and disposal
          252
          166
          Exemption of Federal and State agencies for use of pesticides under emergency conditions
          278
          167
          Registration of pesticide and active ingredient producing establishments, submission of pesticide reports
          288
          168
          Statements of enforcement policies and interpretations
          291
          169
          Books and records of pesticide production and distribution
          300
          170
          Worker protection standard
          303
          171
          Certification of pesticide applicators
          360

          172
          Experimental use permits
          399
          173
          Procedures governing the rescission of State primary enforcement responsibility for pesticide use violations
          415
          174
          Procedures and requirements for plant-incorporated protectants
          418
          176
          Time-limited tolerances for emergency exemptions
          428
          178
          Objections and requests for hearings
          429
          179
          Formal evidentiary public hearing
          433
          180
          Tolerances and exemptions for pesticide chemical residues in food
          445
          181-189
          [Reserved]

        SUBCHAPTER E—PESTICIDE PROGRAMS

          Pt. 150
          PART 150—GENERAL

            Authority:
            Reorganization Plan No. 3 of 1970 (5 U.S.C. App.).

            § 150.17
            Addresses for the Office of Pesticide Programs.
            The official addresses, unless otherwise noted, are as follows:
            (a) Applications, correspondence, and non-docket materials—(1) United States Postal Service mailing address. Office of Pesticide Programs (7510P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
            (2) Hand/courier delivery address. Office of Pesticide Programs, Environmental Protection Agency, 2777 S. Crystal Dr., Arlington, VA 22202-4501. This is not a mailing address. You must make arrangements with the person receiving your delivery.
            (b) Office of Pesticide Programs Regulatory Public Docket (OPP Docket)—(1) Electronic docket address. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov. Although listed in the docket index at regulations.gov, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only at the OPP Docket.
            (2) Physical location. Environmental Protection Agency Docket Center (EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. This is not a mailing address. For instructions on visiting the docket, go to http://www.epa.gov/dockets/contacts.htm.

            (3) United States Postal Service mailing address. Office of Pesticide Programs Regulatory Public Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
            (4) Hand/courier delivery. For hand/courier delivery or to make special arrangements for deliveries of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

            [77 FR 46291, Aug. 3, 2012]

          PART 151 [RESERVED]

          Pt. 152
          PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES

              Subpart A—General Provisions
              Sec.
              152.1
              Scope.
              152.3
              Definitions.
              152.5
              Pests.
              152.6
              Substances excluded from regulation by FIFRA.
              152.8
              Products that are not pesticides because they are not for use against pests.
              152.10
              Products that are not pesticides because they are not intended for a pesticidal purpose.
              152.15
              Pesticide products required to be registered.

              Subpart B—Exemptions
              152.20
              Exemptions for pesticides adequately regulated by another Federal agency.
              152.25
              Exemptions for pesticides of a character not requiring FIFRA regulation.
              152.30
              Pesticides that may be transferred, sold, or distributed without registration.

              Subpart C—Registration Procedures
              152.40
              Who may apply.
              152.42
              Application for new registration.
              152.43
              Alternate formulations.
              152.44
              Application for amended registration.
              152.46
              Notification and non-notification changes to registrations.
              152.50
              Contents of application.
              152.55
              Where to send applications and correspondence.

              Subpart D [Reserved]

              Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights
              152.80
              General.
              152.81
              Applicability.
              152.82
              Definitions.
              152.83
              Definition of exclusive use study.
              152.84

              When materials must be submitted to the Agency.

              152.85
              Formulators' exemption.
              152.86
              The cite-all method.
              152.90
              The selective method.
              152.91
              Waiver of a data requirement.
              152.92
              Submission of a new valid study.
              152.93
              Citation of a previously submitted valid study.
              152.94
              Citation of a public literature study or study generated at government expense.
              152.95
              Citation of all studies in the Agency's files pertinent to a specific data requirement.
              152.96
              Claim of data gap.
              152.97
              Rights and obligations regarding the Data Submitters List.
              152.98
              Procedures for transfer of exclusive use or compensation rights to another person.
              152.99
              Petitions to cancel registration.

              Subpart F—Agency Review of Applications
              152.100
              Scope.
              152.102
              Publication.
              152.104
              Completeness of applications.
              152.105
              Incomplete applications.
              152.107
              Review of data.
              152.108
              Review of labeling.
              152.110
              Time for agency review.
              152.111
              Choice of standards for review of applications.
              152.112
              Approval of registration under FIFRA sec. 3(c)(5).
              152.113
              Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient.
              152.114
              Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient.
              152.115
              Conditions of registration.
              152.116
              Notice of intent to register to original submitters of exclusive use data.
              152.117
              Notification to applicant.
              152.118
              Denial of application.
              152.119
              Availability of material submitted in support of registration.

              Subpart G—Obligations and Rights of Registrants
              152.122
              Currency of address of record and authorized agent.
              152.125
              Submission of information pertaining to adverse effects.
              152.130
              Distribution under approved labeling.
              152.132
              Supplemental distribution.
              152.135
              Transfer of registration.

              Subpart H [Reserved]

              Subpart I—Classification of Pesticides
              152.160
              Scope.
              152.161
              Definitions.
              152.164
              Classification procedures.
              152.166
              Labeling of restricted use products.
              152.167
              Distribution and sale of restricted use products.
              152.168
              Advertising of restricted use products.
              152.170
              Criteria for restriction to use by certified applicators.
              152.171
              Restrictions other than those relating to use by certified applicators.
              152.175
              Pesticides classified for restricted use.

              Subparts J-T [Reserved]

              Subpart U—Registration Fees
              152.400
              Purpose.
              152.401
              Inapplicability of fee provisions to applications filed prior to October 1, 1997.
              152.403
              Definitions of fee categories.
              152.404
              Fee amounts.
              152.406
              Submission of supplementary data.
              152.408
              Special considerations.
              152.410
              Adjustment of fees.
              152.412
              Waivers and refunds.
              152.414
              Procedures.

              Subparts V-Y [Reserved]

              Subpart Z—Devices
              152.500
              Requirements for devices.

            Authority:
            7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

            Subpart A—General Provisions

              Source:
              53 FR 15975, May 4, 1988, unless otherwise noted.

              § 152.1
              Scope.
              (a) Part 152 sets forth procedures, requirements and criteria concerning the registration of pesticide products under FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the regulations in part 152 apply to PIPs.
              (b) Part 152 also describes associated regulatory activities affecting registration, as described in this paragraph.
              (1) Data compensation and exclusive use of data in support of registration. Refer to subpart E of this part.
              (2) Rights and obligations of registrants. Refer to subpart G of this part.
              (3) Classification of pesticide uses. Refer to subpart I of this part.
              (4) Fees. Refer to subpart U of this part.

              (5) Requirements pertaining to pesticide devices. Refer to subpart Z of this part.
              [73 FR 75594, Dec. 12, 2008]

              § 152.3
              Definitions.
              Terms used in this part have the same meaning as in the Act. In addition, the following terms have the meanings set forth in this section.

                Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-136y).

                Active ingredient means any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in § 174.3 of this chapter.

                Acute dermal LD
                50 means a statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions.

                Acute inhalation LC
                50 means a statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population under specified conditions.

                Acute oral LD
                50 means a statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions.

                Administrator means the Administrator of the United States Environmental Protection Agency or his delegate.

                Agency means the United States Environmental Protection Agency (EPA), unless otherwise specified.

                Applicant means a person who applies for a registration or amended registration under FIFRA sec. 3.

                Biological control agent means any living organism applied to or introduced into the environment that is intended to function as a pesticide against another organism declared to be a pest by the Administrator.

                Distribute or sell and other grammatical variations of the term such as “distributed or sold” and “distribution or sale,” means the acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any State.

                End use product means a pesticide product whose labeling
              (1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating, or regulating the growth of plants, and
              (2) Does not state that the product may be used to manufacture or formulate other pesticide products.

                Final printed labeling means the label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.

                Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product, except as provided by § 174.3 of this chapter.

                Institutional use means any application of a pesticide in or around any property or facility that functions to provide a service to the general public or to public or private organizations, including but not limited to:
              (1) Hospitals and nursing homes.
              (2) Schools other than preschools and day care facilities.
              (3) Museums and libraries.
              (4) Sports facilities.
              (5) Office buildings.

                Living plant means a plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.

                Manufacturing use product means any pesticide product that is not an end-use product.

                New use, when used with respect to a product containing a particular active ingredient, means:

              (1) Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of a tolerance or food additive regulation under section 408 of the Federal Food, Drug and Cosmetic Act;

              (2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
              (3) Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.

                Operated by the same producer, when used with respect to two establishments, means that each such establishment is either owned by, or leased for operation by and under the control of, the same person. The term does not include establishments owned or operated by different persons, regardless of contractural agreement between such persons.

                Package or packaging means the immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.

                Pesticide means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any article that:
              (1) Is a new animal drug under FFDCA sec. 201(w), or
              (2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or
              (3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s) (1) or (2) of this section.

                Pesticide product means a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.

                Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.

                Released for shipment. A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent activities, such as relabeling or repackaging, constitute production.

                Residential use means use of a pesticide directly:
              (1) On humans or pets,
              (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or
              (3) In any preschool or day care facility.
              [53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 73 FR 64224, Oct. 29, 2008; 73 FR 75594, Dec. 12, 2008]

              § 152.5
              Pests.
              An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is:
              (a) Any vertebrate animal other than man;
              (b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals;
              (c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root; or

              (d) Any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA section 201(i)).
              [53 FR 15975, May 4, 1988, as amended at 78 FR 13507, Feb. 28, 2013]

              § 152.6
              Substances excluded from regulation by FIFRA.
              Products and substances listed in this section are excluded from FIFRA regulation if they meet the specified conditions or criteria.
              (a) Liquid chemical sterilants. A liquid chemical sterilant product is not a pesticide under section 2(u) of FIFRA if it meets all of the following criteria. Excluded products are regulated by the Food and Drug Administration (FDA). Products excluded are those meeting all of the following criteria:
              (1) Composition. The product must be in liquid form as sold or distributed. Pressurized gases or products in dry or semi-solid form are not excluded by this provision. Ethylene oxide products are not liquid products and are not excluded by this provision.
              (2) Claims. The product must bear a sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims solely at a level less than “sterilant” are not excluded and are jointly regulated by EPA and FDA.
              (3) Use site. (i) The product must be intended and labeled only for use on “critical or semi-critical devices.” A “critical device” is any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body. A semi-critical device is any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
              (ii) Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.
              (iii) Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.
              (b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation under FIFRA if it is a substance (or mixture of substances), meeting all of the following criteria:
              (1) The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes. For purposes of this section, living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a substance is deemed to be a nitrogen stabilizer.
              (2) The substance was in “commercial agronomic use” in the United States before January 1, 1992. EPA considers a substance to be in commercial agronomic use if it is available for sale or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.
              (3) The substance was not registered under FIFRA before January 1, 1992.
              (4) Since January 1, 1992, the distributor or seller has made no claim that the product prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease production. EPA considers any of the following claims (or their equivalents) to be a claim that the product prevents or hinders nitrification, denitrification, ammonia volatilization or urease production:
              (i) Improves crop utilization of applied nitrogen.
              (ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen contamination.
              (iii) Prevents nitrogen loss.
              (iv) Prolongs availability of nitrogen.
              (v) Increases nitrogen uptake, availability, usage, or efficiency.
              (5) A product will be considered to have met the criterion of paragraph (b)(4) of this section that no nitrogen stabilization claim has been made if:

              (i) The nitrogen stabilization claim, in whatever terms expressed, is made solely in compliance with a State requirement to include the claim in materials required to be submitted to a State legislative or regulatory authority, or in the labeling or other literature accompanying the product; and

              (ii) The State requirement to include the claim was in effect both before the product bearing the claim was introduced into commercial agronomic use, and before the effective date of this rule.
              (6) A product that meets all of the criteria of this paragraph with respect to one State is not thereby excluded from FIFRA regulation if distributed and sold in another State whose nitrogen stabilization statement requirement does not meet the requirements of paragraph (b)(5)(ii) of this section.
              (c) Human drugs. Fungi, bacteria, viruses or other microorganisms in or on living man are not “pests” as defined in section 2(t) of FIFRA. Products intended and labeled for use against such organisms are human drugs subject to regulation by the FDA under the FFDCA.
              (d) Animal drugs. (1) Fungi, viruses, bacteria or other microorganisms on or in living animals are not “pests” under section 2(t) of FIFRA. Products intended for use against such organisms are “animal drugs” regulated by the FDA under the FFDCA.
              (2) A “new animal drug” as defined in section 201(w) of the FFDCA, or an animal drug that FDA has determined is not a “new animal drug” is not a pesticide under section 2(u) of FIFRA. Animal drugs are regulated by the FDA under the FFDCA.
              (e) Animal feeds. An animal feed containing a new animal drug is not a pesticide under section 2(u) of FIFRA. An animal feed containing a new animal drug is subject to regulation by the FDA under the FFDCA.
              (f) Vitamin hormone products. A product consisting of a mixture of plant hormones, plant nutrients, inoculants, or soil amendments is not a “plant regulator” under section 2(v) of FIFRA, provided it meets the following criteria:
              (1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.62 of this chapter for Toxicity Category III or IV; and
              (2) The product is not intended for use on food crop sites, and is labeled accordingly.
              (g) Products intended to aid the growth of desirable plants. A product of any of the following types, intended only to aid the growth of desirable plants, is not a “plant regulator” under section 2(v) of FIFRA, and therefore is not a pesticide:
              (1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily usable by plants.
              (2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system.
              (3) A soil amendment product containing a substance or substances intended for the purpose of improving soil characteristics favorable for plant growth.
              [66 FR 64763, Dec. 14, 2001, as amended at 73 FR 75594, Dec. 12, 2008]

              § 152.8
              Products that are not pesticides because they are not for use against pests.
              A substance or article is not a pesticide, because it is not intended for use against “pests” as defined in § 152.5, if it is:
              (a) A fertilizer product not containing a pesticide.
              (b) A product intended to force bees from hives for the collection of honey crops.
              [53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001]

              § 152.10
              Products that are not pesticides because they are not intended for a pesticidal purpose.
              A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants, is not considered to be a pesticide. The following types of products or articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in connection with their sale and distribution:
              (a) Deodorizers, bleaches, and cleaning agents;

              (b) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly;

              (c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.

              § 152.15
              Pesticide products required to be registered.

              No person may distribute or sell any pesticide product that is not registered under the Act, except as provided in §§ 152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances) intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
              (a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise):
              (1) That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or
              (2) That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or
              (b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or
              (c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.

            Subpart B—Exemptions

              Source:
              53 FR 15977, May 4, 1988, unless otherwise noted.

              § 152.20
              Exemptions for pesticides adequately regulated by another Federal agency.
              The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA. The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal agency.
              (a) Certain biological control agents. (1) Except as provided by paragraphs (a)(3) and (a)(4) of this section, all biological control agents are exempt from FIFRA requirements.
              (2) If the Agency determines that an individual biological control agent or class of biological control agents is no longer adequately regulated by another Federal agency, and that it should not otherwise be exempted from the requirements of FIFRA, the Agency will revoke this exemption by amending paragraph (a)(3) of this section.
              (3) The following biological control agents are not exempt from FIFRA requirements:
              (i) A eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
              (ii) A procaryotic microorganism including, but not limited to, Eubacteria and Archaebacteria; or
              (iii) A parasitically-replicating microscopic element, including, but not limited to, viruses.
              (4) All living plants intended for use as biological control agents are exempt from the requirements of FIFRA. However, plant-incorporated protectants are not exempt pursuant to this section. Regulations, including exemptions, for plant-incorporated protectants are addressed in part 174 of this chapter.
              (b) Non-liquid chemical sterilants. A non-liquid chemical sterilant, except ethylene oxide, that meets the criteria of § 152.6(a)(2) with respect to its claims and § 152.6(a)(3) with respect to its use sites is exempted from regulation under FIFRA.
              [53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 FR 64764, Dec. 14, 2001; 72 FR 61027, Oct. 26, 2007]

              § 152.25
              Exemptions for pesticides of a character not requiring FIFRA regulation.

              The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified.

              (a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such use.
              (b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which the Administrator determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in which those compounds are the sole active ingredient(s).
              (1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.
              (2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only when their molecular structures are identical, or when the only differences between the molecular structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic compound found to have toxicological properties significantly different from a pheromone is not identical.
              (3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar compound.
              (4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical or substantially similar compound used for the sole purpose of attracting, and trapping or killing, target arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms from their natural environment and do not result in increased levels of pheromones or identical or substantially similar compounds over a significant fraction of the treated area.
              (c) Preservatives for biological specimens. (1) Embalming fluids.
              (2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.
              (3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.
              (d) Foods. Products consisting of foods and containing no active ingredients, which are used to attract pests.
              (e) Natural cedar. (1) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that meet all of the following criteria:
              (i) The product consists totally of cedarwood or natural cedar.
              (ii) The product is not treated, combined, or impregnated with any additional substance(s).
              (iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as “arthropods,” “insects,” “bugs,” or any other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to repel ticks.
              (2) The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture.
              (f) Minimum risk pesticides—(1) Exempted products. Products containing the following active ingredients, alone or in combination with other substances listed in table 1 of this paragraph, are exempt from the requirements of FIFRA provided that all of the criteria of this section are met. All listed active ingredients may be used in non-food use products. Under section 408 of the Federal Food, Drug, and Cosmetic Act and EPA (FFDCA) implementing regulations at part 180 of this chapter, food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter. Such tolerances or exemptions may be found, for example, in §§ 180.950, 180.1071, 180.1087, 180.1233, and 180.1251 of this chapter.

                Table 1—Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products

                  Label display name
                  Chemical name
                  Specifications
                  CAS No.

                  Castor oil
                  Castor oil
                  United States Pharmacopeia (U.S.P.) or equivalent
                  8001-79-4

                  Cedarwood oil
                  Cedarwood oil (China)

                  85085-29-6

                  Cedarwood oil
                  Cedarwood oil (Texas)

                  68990-83-0

                  Cedarwood oil
                  Cedarwood oil (Virginia)

                  8000-27-9

                  Cinnamon
                  Cinnamon

                  N/A

                  Cinnamon oil
                  Cinnamon oil

                  8015-91-6

                  Citric acid
                  2-Hydroxypropane-1,2,3-tricarboxylic acid

                  77-92-9

                  Citronella
                  Citronella

                  N/A

                  Citronella oil
                  Citronella oil

                  8000-29-1

                  Cloves
                  Cloves

                  N/A

                  Clove oil
                  Clove oil

                  8000-34-8

                  Corn gluten meal
                  Corn gluten meal

                  66071-96-3

                  Corn oil
                  Corn oil

                  8001-30-7

                  Cornmint
                  Cornmint

                  N/A

                  Cornmint oil
                  Cornmint oil

                  68917-18-0

                  Cottonseed oil
                  Cottonseed oil

                  8001-29-4

                  Dried blood
                  Dried blood

                  68991-49-9

                  Eugenol
                  4-Allyl-2-methoxyphenol

                  97-53-0

                  Garlic
                  Garlic

                  N/A

                  Garlic oil
                  Garlic oil

                  8000-78-0

                  Geraniol
                  (2E)-3,7-Dimethylocta-2,6-dien-1-ol

                  106-24-1

                  Geranium oil
                  Geranium oil

                  8000-46-2

                  Lauryl sulfate
                  Lauryl sulfate

                  151-41-7

                  Lemongrass oil
                  Lemongrass oil

                  8007-02-1

                  Linseed oil
                  Linseed oil

                  8001-26-1

                  Malic acid
                  2-Hydroxybutanedioic acid

                  6915-15-7

                  Peppermint
                  Peppermint

                  N/A

                  Peppermint oil
                  Peppermint oil

                  8006-90-4

                  2-Phenylethyl propionate
                  2-Phenylethyl propionate

                  122-70-3

                  Potassium sorbate
                  Potassium (2E,4E)-hexa-2,4-dienoate

                  24634-61-5

                  Putrescent whole egg solids
                  Putrescent whole egg solids

                  51609-52-0

                  Rosemary
                  Rosemary

                  N/A

                  Rosemary oil
                  Rosemary oil

                  8000-25-7

                  Sesame
                  Sesame
                  Includes ground sesame plant
                  N/A

                  Sesame oil
                  Sesame oil

                  8008-74-0

                  Sodium chloride
                  Sodium chloride

                  7647-14-5

                  Sodium lauryl sulfate
                  Sulfuric acid monododecyl ester, sodium salt

                  151-21-3

                  Soybean oil
                  Soybean oil

                  8001-22-7

                  Spearmint
                  Spearmint

                  N/A

                  Spearmint oil
                  Spearmint oil

                  8008-79-5

                  Thyme
                  Thyme

                  N/A

                  Thyme oil
                  Thyme oil

                  8007-46-3

                  White pepper
                  White pepper

                  N/A

                  Zinc
                  Zinc
                  Zinc metal strips (consisting solely of zinc metal and impurities)
                  7440-66-6

              (2) Permitted inert ingredients. A pesticide product exempt under paragraph (f)(1) of this section may only include the inert ingredients listed in paragraphs (f)(2)(i) through (iv) of this section. All listed inert ingredients may be used in non-food use products. Under FFDCA section 408 and EPA implementing regulations at part 180 of this chapter, food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter. Such tolerances or exemptions may be found, for example, in §§ 180.910, 180.920. 180.930, 180.940, 180.950, and 180.1071 of this chapter.
              (i) Commonly consumed food commodities, as described in § 180.950(a) of this chapter.
              (ii) Animal feed items, as described in § 180.950(b) of this chapter.
              (iii) Edible fats and oils, as described in § 180.950(c) of this chapter.
              (iv) Specific chemical substances, as listed in the following table.

                Table 2—Inert Ingredients Permitted in Minimum Risk Pesticide Products

                  Label display name
                  Chemical name
                  CAS No.

                  Acetyl tributyl citrate
                  Citric acid, 2-(acetyloxy)-, tributyl ester
                  77-90-7

                  Agar
                  Agar
                  9002-18-0

                  Almond hulls
                  Almond hulls
                  N/A

                  Almond oil
                  Oils, almond
                  8007-69-0

                  Almond shells
                  Almond shells
                  N/A

                  alpha-Cyclodextrin
                  alpha-Cyclodextrin
                  10016-20-3

                  Aluminatesilicate
                  Aluminatesilicate
                  1327-36-2

                  Aluminum magnesium silicate
                  Silicic acid, aluminum magnesium salt
                  1327-43-1

                  Aluminum potassium sodium silicate
                  Silicic acid, aluminum potassium sodium salt
                  12736-96-8

                  Aluminum silicate
                  Aluminum silicate
                  1335-30-4

                  Aluminum sodium silicate
                  Silicic acid, aluminum sodium salt
                  1344-00-9

                  Aluminum sodium silicate
                  Silicic acid (H4 SiO4), aluminum sodium salt (1:1:1)
                  12003-51-9

                  Ammonium benzoate
                  Benzoic acid, ammonium salt
                  1863-63-4

                  Ammonium stearate
                  Octadecanoic acid, ammonium salt
                  1002-89-7

                  Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate
                  Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate
                  113894-85-2

                  Amylopectin, hydrogen 1-octadecenylbutanedioate
                  Amylopectin, hydrogen 1-octadecenylbutanedioate
                  125109-81-1

                  Animal glue
                  Animal glue
                  N/A

                  Ascorbyl palmitate
                  Ascorbyl palmitate
                  137-66-6

                  Attapulgite-type clay
                  Attapulgite-type clay
                  12174-11-7

                  Beeswax
                  Beeswax
                  8012-89-3

                  Bentonite
                  Bentonite
                  1302-78-9

                  Bentonite, sodian
                  Bentonite, sodian
                  85049-30-5

                  beta-Cyclodextrin
                  beta-Cyclodextrin
                  7585-39-9

                  Bone meal
                  Bone meal
                  68409-75-6

                  Bran
                  Bran
                  N/A

                  Bread crumbs
                  Bread crumbs
                  N/A

                  (+)-Butyl lactate
                  Lactic acid, n-butyl ester, (S)
                  34451-19-9

                  Butyl lactate
                  Lactic acid, n-butyl ester
                  138-22-7

                  Butyl stearate
                  Octadecanoic acid, butyl ester
                  123-95-5

                  Calcareous shale
                  Calcareous shale
                  N/A

                  Calcite
                  Calcite (Ca(CO3))
                  13397-26-7

                  Calcium acetate
                  Calcium acetate
                  62-54-4

                  Calcium acetate monohydrate
                  Acetic acid, calcium salt, monohydrate
                  5743-26-0

                  Calcium benzoate
                  Benzoic acid, calcium salt
                  2090-05-3

                  Calcium carbonate
                  Calcium carbonate
                  471-34-1

                  Calcium citrate
                  Citric acid, calcium salt
                  7693-13-2

                  Calcium octanoate
                  Calcium octanoate
                  6107-56-8

                  Calcium oxide silicate
                  Calcium oxide silicate (Ca3 O(SiO4))
                  12168-85-3

                  Calcium silicate
                  Silicic acid, calcium salt
                  1344-95-2

                  Calcium stearate
                  Octadecanoic acid, calcium salt
                  1592-23-0

                  Calcium sulfate
                  Calcium sulfate
                  7778-18-9

                  Calcium sulfate dihydrate
                  Calcium sulfate dihydrate
                  10101-41-4

                  Calcium sulfate hemihydrate
                  Calcium sulfate hemihydrate
                  10034-76-1

                  Canary seed
                  Canary seed
                  N/A

                  Carbon
                  Carbon
                  7440-44-0

                  Carbon dioxide
                  Carbon dioxide
                  124-38-9

                  Carboxymethyl cellulose
                  Cellulose, carboxymethyl ether
                  9000-11-7

                  Cardboard
                  Cardboard
                  N/A

                  Carnauba wax
                  Carnauba wax
                  8015-86-9

                  Carob gum
                  Locust bean gum
                  9000-40-2

                  Carrageenan
                  Carrageenan
                  9000-07-1

                  Caseins
                  Caseins
                  9000-71-9

                  Castor oil
                  Castor oil
                  8001-79-4

                  Castor oil, hydrogenated
                  Castor oil, hydrogenated
                  8001-78-3

                  Cat food
                  Cat food
                  N/A

                  Cellulose
                  Cellulose
                  9004-34-6

                  Cellulose acetate
                  Cellulose acetate
                  9004-35-7

                  Cellulose, mixture with cellulose carboxymethyl ether, sodium salt
                  Cellulose, mixture with cellulose carboxymethyl ether, sodium salt
                  51395-75-6

                  Cellulose, pulp
                  Cellulose, pulp
                  65996-61-4

                  Cellulose, regenerated
                  Cellulose, regenerated
                  68442-85-3

                  Cheese
                  Cheese
                  N/A

                  Chlorophyll a
                  Chlorophyll a
                  479-61-8

                  Chlorophyll b
                  Chlorophyll b
                  519-62-0

                  Citric acid
                  Citric acid
                  77-92-9

                  Citric acid, monohydrate
                  Citric acid, monohydrate
                  5949-29-1

                  Citrus meal
                  Citrus meal
                  N/A

                  Citrus pectin
                  Citrus pectin
                  9000-69-5

                  Citrus pulp
                  Citrus pulp
                  68514-76-1

                  Clam shells
                  Clam shells
                  N/A

                  Cocoa
                  Cocoa
                  8002-31-1

                  Cocoa shell flour
                  Cocoa shell flour
                  N/A

                  Cocoa shells
                  Cocoa shells
                  N/A

                  Cod-liver oil
                  Cod-liver oil
                  8001-69-2

                  Coffee grounds
                  Coffee grounds
                  68916-18-7

                  Cookies
                  Cookies
                  N/A

                  Cork
                  Cork
                  61789-98-8

                  Corn cobs
                  Corn cobs
                  N/A

                  Cotton
                  Cotton
                  N/A

                  Cottonseed meal
                  Cottonseed meal
                  68424-10-2

                  Cracked wheat
                  Cracked wheat
                  N/A

                  Decanoic acid, monoester with 1,2,3-propanetriol
                  Decanoic acid, monoester with 1,2,3-propanetriol
                  26402-22-2

                  Dextrins
                  Dextrins
                  9004-53-9

                  Diglyceryl monooleate
                  9-Octadecenoic acid, ester with 1,2,3-propanetriol
                  49553-76-6

                  Diglyceryl monostearate
                  9-Octadecanoic acid, monoester with oxybis(propanediol)
                  12694-22-3

                  Dilaurin
                  Dodecanoic acid, diester with 1,2,3-propanetriol
                  27638-00-2

                  Dipalmitin
                  Hexadecanoic acid, diester with 1,2,3-propanetriol
                  26657-95-4

                  Dipotassium citrate
                  Citric acid, dipotassium salt
                  3609-96-9

                  Disodium citrate
                  Citric acid, disodium salt
                  144-33-2

                  Disodium sulfate decahydrate
                  Disodium sulfate decahydrate
                  7727-73-3

                  Diatomaceous earth
                  Kieselguhr; Diatomite (less than 1% crystalline silica)
                  61790-53-2

                  Dodecanoic acid, monoester with 1,2,3-propanetriol
                  Dodecanoic acid, monoester with 1,2,3-propanetriol
                  27215-38-9

                  Dolomite
                  Dolomite
                  16389-88-1

                  Douglas fir bark
                  Douglas fir bark
                  N/A

                  Egg shells
                  Egg shells
                  N/A

                  Eggs
                  Eggs
                  N/A

                  (+)-Ethyl lactate
                  Lactic acid, ethyl ester, (S)
                  687-47-8

                  Ethyl lactate
                  Lactic acid, ethyl ester
                  97-64-3

                  Feldspar
                  Feldspar
                  68476-25-5

                  Ferric oxide
                  Iron oxide (Fe2O3)
                  1309-37-1

                  Ferrous oxide
                  Iron oxide (FeO)
                  1345-25-1

                  Fish meal
                  Fish meal
                  N/A

                  Fish oil
                  Fish oil
                  8016-13-5

                  Fuller's earth
                  Fuller's earth
                  8031-18-3

                  Fumaric acid
                  Fumaric acid
                  110-17-8

                  gamma-Cyclodextrin
                  gamma-Cyclodextrin
                  17465-86-0

                  Gelatins
                  Gelatins
                  9000-70-8

                  Gellan gum
                  Gellan gum
                  71010-52-1

                  Glue
                  Glue (as depolymd. animal collagen)
                  68476-37-9

                  Glycerin
                  1,2,3-Propanetriol
                  56-81-5

                  Glycerol monooleate
                  9-Octadecenoic acid (Z)-, 2,3-dihydroxypropyl ester
                  111-03-5

                  Glyceryl dicaprylate
                  Octanoic acid, diester with 1,2,3-propanetriol
                  36354-80-0

                  Glyceryl dimyristate
                  Tetradecanoic acid, diester with 1,2,3-propanetriol
                  53563-63-6

                  Glyceryl dioleate
                  9-Octadecenoic acid (9Z)-, diester with 1,2,3-propanetriol
                  25637-84-7

                  Glyceryl distearate
                  Octadecanoic acid, diester with 1,2,3-propanetriol
                  1323-83-7

                  Glyceryl monomyristate
                  Tetradecanoic acid, monoester with 1,2,3-propanetriol
                  27214-38-6

                  Glyceryl monooctanoate
                  Octanoic acid, monoester with 1,2,3-propanetriol
                  26402-26-6

                  Glyceryl monooleate
                  9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol
                  25496-72-4

                  Glyceryl monostearate
                  Octadecanoic acid, monoester with 1,2,3-propanetriol
                  31566-31-1

                  Glyceryl stearate
                  Octadecanoic acid, ester with 1,2,3-propanetriol
                  11099-07-3

                  Granite
                  Granite
                  N/A

                  Graphite
                  Graphite
                  7782-42-5

                  Guar gum
                  Guar gum
                  9000-30-0

                  Gum Arabic
                  Gum arabic
                  9000-01-5

                  Gum tragacanth
                  Gum tragacanth
                  9000-65-1

                  Gypsum
                  Gypsum
                  13397-24-5

                  Hematite
                  Hematite (Fe2O3)
                  1317-60-8

                  Humic acid
                  Humic acid
                  1415-93-6

                  Hydrogenated cottonseed oil
                  Hydrogenated cottonseed oil
                  68334-00-9

                  Hydrogenated rapeseed oil
                  Hydrogenated rapeseed oil
                  84681-71-0

                  Hydrogenated soybean oil
                  Hydrogenated soybean oil
                  8016-70-4

                  Hydroxyethyl cellulose
                  Cellulose, 2-hydroxyethyl ether
                  9004-62-0

                  Hydroxypropyl cellulose
                  Cellulose, 2-hydroxypropyl ether
                  9004-64-2

                  Hydroxypropyl methyl cellulose
                  Cellulose, 2-hydroxypropyl methyl ether
                  9004-65-3

                  Iron magnesium oxide
                  Iron magnesium oxide (Fe2MgO4)
                  12068-86-9

                  Iron oxide, hydrate
                  Iron oxide (Fe2O3), hydrate
                  12259-21-1

                  Iron oxide
                  Iron oxide (Fe3O4)
                  1317-61-9

                  Isopropyl alcohol
                  2-Propanol
                  67-63-0

                  Isopropyl myristate
                  Isopropyl myristate
                  110-27-0

                  Kaolin
                  Kaolin
                  1332-58-7

                  Lactose
                  Lactose
                  63-42-3

                  Lactose monohydrate
                  Lactose monohydrate
                  64044-51-5

                  Lanolin
                  Lanolin
                  8006-54-0

                  Latex rubber
                  Latex rubber
                  N/A

                  Lauric acid
                  Lauric acid
                  143-07-7

                  Lecithins
                  Lecithins
                  8002-43-5

                  Licorice extract
                  Licorice extract
                  68916-91-6

                  Lime dolomitic
                  Lime (chemical) dolomitic
                  12001-27-3

                  Limestone
                  Limestone
                  1317-65-3

                  Linseed oil
                  Linseed oil
                  8001-26-1

                  Magnesium carbonate
                  Carbonic acid, magnesium salt (1:1)
                  546-93-0

                  Magnesium benzoate
                  Magnesium benzoate
                  553-70-8

                  Magnesium oxide
                  Magnesium oxide
                  1309-48-4

                  Magnesium oxide silicate
                  Magnesium oxide silicate (Mg3O(Si2O5)2), monohydrate
                  12207-97-5

                  Magnesium silicate
                  Magnesium silicate
                  1343-88-0

                  Magnesium silicate hydrate
                  Magnesium silicate hydrate
                  1343-90-4

                  Magnesium silicon oxide
                  Magnesium silicon oxide (Mg2Si3O8)
                  14987-04-3

                  Magnesium stearate
                  Octadecanoic acid, magnesium salt
                  557-04-0

                  Magnesium sulfate
                  Magnesium sulfate
                  7487-88-9

                  Magnesium sulfate heptahydrate
                  Magnesium sulfate heptahydrate
                  10034-99-8

                  Malic acid
                  Malic acid
                  6915-15-7

                  Malt extract
                  Malt extract
                  8002-48-0

                  Malt flavor
                  Malt flavor
                  N/A

                  Maltodextrin
                  Maltodextrin
                  9050-36-6

                  Methylcellulose
                  Cellulose, methyl ether
                  9004-67-5

                  Mica
                  Mica
                  12003-38-2

                  Mica-group minerals
                  Mica-group minerals
                  12001-26-2

                  Milk
                  Milk
                  8049-98-7

                  Millet seed
                  Millet seed
                  N/A

                  Mineral oil
                  Mineral oil (U.S.P.)
                  8012-95-1

                  1-Monolaurin
                  Dodecanoic acid, 2,3-dihydroxypropyl ester
                  142-18-7

                  1-Monomyristin
                  Tetradecanoic acid, 2,3-dihydroxypropyl ester
                  589-68-4

                  Monomyristin
                  Decanoic acid, diester with 1,2,3-propanetriol
                  53998-07-1

                  Monopalmitin
                  Hexadecanoic acid, monoester with 1,2,3-propanetriol
                  26657-96-5

                  Monopotassium citrate
                  Citric acid, monopotassium salt
                  866-83-1

                  Monosodium citrate
                  Citric acid, monosodium salt
                  18996-35-5

                  Montmorillonite
                  Montmorillonite
                  1318-93-0

                  Myristic acid
                  Myristic acid
                  544-63-8

                  Nepheline syenite
                  Nepheline syenite
                  37244-96-5

                  Nitrogen
                  Nitrogen
                  7727-37-9

                  Nutria meat
                  Nutria meat
                  N/A

                  Nylon
                  Nylon
                  N/A

                  Octanoic acid, potassium salt
                  Octanoic acid, potassium salt
                  764-71-6

                  Octanoic acid, sodium salt
                  Octanoic acid, sodium salt
                  1984-06-1

                  Oleic acid
                  Oleic acid
                  112-80-1

                  Oyster shells
                  Oyster shells
                  N/A

                  Palm oil
                  Palm oil
                  8002-75-3

                  Palm oil, hydrogenated
                  Palm oil, hydrogenated
                  68514-74-9

                  Palmitic acid
                  Hexadecanoic acid
                  57-10-3

                  Paper
                  Paper
                  N/A

                  Paraffin wax
                  Paraffin wax
                  8002-74-2

                  Peanut butter
                  Peanut butter
                  N/A

                  Peanut shells
                  Peanut shells
                  N/A

                  Peanuts
                  Peanuts
                  N/A

                  Peat moss
                  Peat moss
                  N/A

                  Pectin
                  Pectin
                  9000-69-5

                  Perlite
                  Perlite
                  130885-09-5

                  Perlite, expanded
                  Perlite, expanded
                  93763-70-3

                  Plaster of paris
                  Plaster of paris
                  26499-65-0

                  Polyethylene
                  Polyethylene
                  9002-88-4

                  Polyglyceryl oleate
                  Polyglyceryl oleate
                  9007-48-1

                  Polyglyceryl stearate
                  Polyglyceryl stearate
                  9009-32-9

                  Potassium acetate
                  Acetic acid, potassium salt
                  127-08-2

                  Potassium aluminum silicate, anhydrous
                  Potassium aluminum silicate, anhydrous
                  1327-44-2

                  Potassium benzoate
                  Benzoic acid, potassium salt
                  582-25-2

                  Potassium bicarbonate
                  Carbonic acid, monopotassium salt
                  298-14-6

                  Potassium chloride
                  Potassium chloride
                  7447-40-7

                  Potassium citrate
                  Citric acid, potassium salt
                  7778-49-6

                  Potassium humate
                  Humic acids, potassium salts
                  68514-28-3

                  Potassium myristate
                  Tetradecanoic acid, potassium salt
                  13429-27-1

                  Potassium oleate
                  9-Octadecenoic acid (9Z)-, potassium salt
                  143-18-0

                  Potassium ricinoleate
                  9-Octadecenoic acid, 12-hydroxy-, monopotassium salt, (9Z, 12R)-
                  7492-30-0

                  Potassium sorbate
                  Sorbic acid, potassium salt
                  24634-61-5

                  Potassium stearate
                  Octadecanoic acid, potassium salt
                  593-29-3

                  Potassium sulfate
                  Potassium sulfate
                  7778-80-5

                  Potassium sulfate
                  Sulfuric acid, monopotassium salt
                  7646-93-7

                  1,2-Propylene carbonate
                  1,3-Dioxolan-2-one, 4-methyl-
                  108-32-7

                  Pumice
                  Pumice
                  1332-09-8

                  Red cabbage color
                  Red cabbage color (expressed from edible red cabbage heads via a pressing process using only acidified water)
                  N/A

                  Red cedar chips
                  Red cedar chips
                  N/A

                  Red dog flour
                  Red dog flour
                  N/A

                  Rubber
                  Rubber
                  9006-04-6

                  Sawdust
                  Sawdust
                  N/A

                  Shale
                  Shale
                  N/A

                  Silica, amorphous, fumed
                  Silica, amorphous, fumed (crystalline free)
                  112945-52-5

                  Silica, amorphous, precipitate and gel
                  Silica, amorphous, precipitate and gel
                  7699-41-4

                  Silica
                  Silica (crystalline free)
                  7631-86-9

                  Silica gel
                  Silica gel
                  63231-67-4

                  Silica gel, precipitated, crystalline-free
                  Silica gel, precipitated, crystalline-free
                  112926-00-8

                  Silica, hydrate
                  Silica, hydrate
                  10279-57-9

                  Silica, vitreous
                  Silica, vitreous
                  60676-86-0

                  Silicic acid, magnesium salt
                  Silicic acid (H2SiO3), magnesium salt (1:1)
                  13776-74-4

                  Soap
                  Soap (The water soluble sodium or potassium salts of fatty acids produced by either the saponification of fats and oils, or the neutralization of fatty acid)
                  N/A

                  Soapbark
                  Quillaja saponin
                  1393-03-9

                  Soapstone
                  Soapstone
                  308076-02-0

                  Sodium acetate
                  Acetic acid, sodium salt
                  127-09-3

                  Sodium alginate
                  Sodium alginate
                  9005-38-3

                  Sodium benzoate
                  Benzoic acid, sodium salt
                  532-32-1

                  Sodium bicarbonate
                  Sodium bicarbonate
                  144-55-8

                  Sodium carboxymethyl cellulose
                  Cellulose, carboxymethyl ether, sodium salt
                  9004-32-4

                  Sodium chloride
                  Sodium chloride
                  7647-14-5

                  Sodium citrate
                  Sodium citrate
                  994-36-5

                  Sodium humate
                  Humic acids, sodium salts
                  68131-04-4

                  Sodium oleate
                  Sodium oleate
                  143-19-1

                  Sodium ricinoleate
                  9-Octadecenoic acid, 12-hydroxy-, monosodium salt, (9Z,12R)-
                  5323-95-5

                  Sodium stearate
                  Octadecanoic acid, sodium salt
                  822-16-2

                  Sodium sulfate
                  Sodium sulfate
                  7757-82-6

                  Sorbitol
                  D-glucitol
                  50-70-4

                  Soy protein
                  Soy protein
                  N/A

                  Soya lecithins
                  Lecithins, soya
                  8030-76-0

                  Soybean hulls
                  Soybean hulls
                  N/A

                  Soybean meal
                  Soybean meal
                  68308-36-1

                  Soybean, flour
                  Soybean, flour
                  68513-95-1

                  Stearic acid
                  Octadecanoic acid
                  57-11-4

                  Sulfur
                  Sulfur
                  7704-34-9

                  Syrups, hydrolyzed starch, hydrogenated
                  Syrups, hydrolyzed starch, hydrogenated
                  68425-17-2

                  Tetraglyceryl monooleate
                  9-Octadecenoic acid (9Z)-, monoester with tetraglycerol
                  71012-10-7

                  Tricalcium citrate
                  Citric acid, calcium salt (2:3)
                  813-94-5

                  Triethyl citrate
                  Citric acid, triethyl ester
                  77-93-0

                  Tripotassium citrate
                  Citric acid, tripotassium salt
                  866-84-2

                  Tripotassium citrate monohydrate
                  Citric acid, tripotassium salt, monohydrate
                  6100-05-6

                  Trisodium citrate
                  Citric acid, trisodium salt
                  68-04-2

                  Trisodium citrate dehydrate
                  Citric acid, trisodium salt, dehydrate
                  6132-04-3

                  Trisodium citrate pentahydrate
                  Citric acid, trisodium salt, pentahydrate
                  6858-44-2

                  Ultramarine blue
                  C.I. Pigment Blue 29
                  57455-37-5

                  Urea
                  Urea
                  57-13-6

                  Vanillin
                  Benzaldehyde, 4-hydroxy-3-methoxy-
                  121-33-5

                  Vermiculite
                  Vermiculite
                  1318-00-9

                  Vinegar
                  Vinegar (maximum 8% acetic acid in solution)
                  8028-52-2

                  Vitamin C
                  L-Ascorbic acid
                  50-81-7

                  Vitamin E
                  Vitamin E
                  1406-18-4

                  Walnut flour
                  Walnut flour
                  N/A

                  Walnut shells
                  Walnut shells
                  N/A

                  Wheat
                  Wheat
                  N/A

                  Wheat flour
                  Wheat flour
                  N/A

                  Wheat germ oil
                  Wheat germ oil
                  8006-95-9

                  Wheat oil
                  Oils, wheat
                  68917-73-7

                  Whey
                  Whey
                  92129-90-3

                  White mineral oil
                  White mineral oil (petroleum)
                  8042-47-5

                  Wintergreen oil
                  Wintergreen oil
                  68917-75-9

                  Wollastonite
                  Wollastonite (Ca(SiO3))
                  13983-17-0

                  Wool
                  Wool
                  N/A

                  Xanthan gum
                  Xanthan gum
                  11138-66-2

                  Yeast
                  Yeast
                  68876-77-7

                  Zeolites
                  Zeolites (excluding erionite (CAS Reg. No. 66733-21-9))
                  1318-02-1

                  Zeolites, NaA
                  Zeolites, NaA
                  68989-22-0

                  Zinc iron oxide
                  Zinc iron oxide
                  12063-19-3

                  Zinc oxide
                  Zinc oxide (ZnO)
                  1314-13-2

                  Zinc stearate
                  Octadecanoic acid, zinc salt
                  557-05-1

              (3) Other conditions of exemption. All of the following conditions must be met for products to be exempted under this section:
              (i) Each product containing the substance must bear a label identifying the label display name and percentage (by weight) of each active ingredient as listed in table 1 in paragraph (f)(1) of this section. Each product must also list all inert ingredients by the label display name listed in table 2 in paragraph (f)(2)(iv) of this section.
              (ii) The product must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.
              (iii) Company name and contact information.
              (A) The name of the producer or the company for whom the product was produced must appear on the product label. If the company whose name appears on the label in accordance with this paragraph is not the producer, the company name must be qualified by appropriate wording such as “Packed for [insert name],” “Distributed by [insert name], or “Sold by [insert name]” to show that the name is not that of the producer.
              (B) Contact information for the company specified in accordance with paragraph (f)(3)(iii)(A) of this section must appear on the product label including the street address plus ZIP code and the telephone phone number of the location at which the company may be reached.
              (C) The company name and contact information must be displayed prominently on the product label.
              (iv) The product must not include any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).
              (4) Providing guidance. Guidance on minimum risk pesticides is available at http://www2.epa.gov/minimum-risk-pesticides or successor Web pages.
              [53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61 FR 8878, Mar. 6, 1996; 66 FR 64764, Dec. 14, 2001; 71 FR 35545, June 21, 2006; 80 FR 80660, Dec. 28, 2015]

              § 152.30
              Pesticides that may be transferred, sold, or distributed without registration.
              An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be dis-tributed or sold, or otherwise transferred, to the extent described by this section.
              (a) A pesticide transferred between registered establishments operated by the same producer. An unregistered pesticide may be transferred between registered establishments operated by the same producer. The pesticide as transferred must be labeled in accordance with part 156 of this chapter.
              (b) A pesticide transferred between registered establishments not operated by the same producer. An unregistered pesticide may be transferred between registered establishments not operated by the same producer if:

              (1) The transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered;
              (2) Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either:
              (i) A registered product; or
              (ii) A pesticide that is produced by the registrant of the final product; and
              (3) The product as transferred is labeled in accordance with part 156 of this chapter.
              (c) A pesticide distributed or sold under an experimental use permit. (1) An unregistered pesticide may be distributed or sold in accordance with the terms of an experimental use permit issued under FIFRA sec. 5, if the product is labeled in accordance with § 172.6 of this chapter.
              (2) An unregistered pesticide may be distributed or sold in accordance with the provisions of § 172.3 of this chapter, pertaining to use of a pesticide for which an experimental use permit is not required, provided the product is labeled in accordance with part 156 of this chapter.
              (d) A pesticide transferred solely for export. An unregistered pesticide may be transferred within the United States solely for export if it meets the following conditions:
              (1) The product is prepared and packaged according to the specifications of the foreign purchaser; and
              (2) The product is labeled in accordance with part 156 of this chapter.
              (e) A pesticide distributed or sold under an emergency exemption. An unregistered pesticide may be distributed or sold in accordance with the terms of an emergency exemption under FIFRA sec. 18, if the product is labeled in accordance with part 156 of this chapter.
              (f) A pesticide transferred for purposes of disposal. An unregistered, suspended, or cancelled pesticide may be transferred solely for disposal in accordance with FIFRA sec. 19 or an applicable Administrator's order. The product must be labeled in accordance with part 156 of this chapter.
              (g) Existing stocks of a formerly registered product. A cancelled or suspended pesticide may be distributed or sold to the extent and in the manner specified in an order issued by the Administrator concerning existing stocks of the pecticide.

            Subpart C—Registration Procedures

              Source:
              53 FR 15978, May 4, 1988, unless otherwise noted.

              § 152.40
              Who may apply.
              Any person may apply for new registration of a pesticide product. Any registrant may apply for amendment of the registration of his product.

              § 152.42
              Application for new registration.
              Any person seeking to obtain a registration for a new pesticide product must submit an application for registration, containing the information specified in § 152.50. An application for new registration must be approved by the Agency before the product may legally be distributed or sold, except as provided by § 152.30.

              § 152.43
              Alternate formulations.
              (a) A product proposed for registration must have a single, defined composition, except that EPA may approve a basic formulation and one or more alternate formulations for a single product.
              (b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section. The Agency may require the submission of data to determine whether the criteria have been met.
              (1) The alternate formulation must have the same certified limits for each active ingredient as the basic formulation.
              (2) If the alternate formulation contains an inert ingredient or impurity of toxicological significance, the formulation must have the same upper certified limit for that substance as the basic formulation;
              (3) The label text of the alternate formulation product must be identical to that of the basic formulation.

              (4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation.

              (c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number.
              [53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]

              § 152.44
              Application for amended registration.
              (a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.
              (b) In its discretion, the Agency may:
              (1) Waive the requirement for submission of an application for amended registration;
              (2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or
              (3) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.
              (c) A registrant may at any time submit identical minor labeling amendments affecting a number of products as a single application if no data are required for EPA to approve the amendment (for example, a change in the wording of a storage statement for designated residential use products). A consolidated application must clearly identify the labeling modification(s) to be made (which must be identical for all products included in the application), list the registration number of each product for which the modification is requested, and provide required supporting materials (for example, labeling) for each affected product.
              [53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 FR 64764, Dec. 14, 2001]

              § 152.46
              Notification and non-notification changes to registrations.
              (a) Changes permitted by notification. (1) EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of modifications permitted by notification and any conditions and procedures for submitting notifications.
              (2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any procedures issued thereunder and distribute or sell the modified product as soon as the Agency has received the notification. Based upon the notification, the Agency may require that the registrant submit an application for amended registration. If it does so, the Agency will notify the registrant and state its reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit an application the Agency may determine that the product is not in compliance with the requirements of the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of FIFRA section 12(a)(2)(M).
              (b) Changes permitted without notification. EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished without notification to or approval by the Agency. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of amendments permitted without notification (also known as non-notification). A registrant may distribute or sell a product changed in a manner consistent with such procedures without notification to or approval by the Agency.
              (c) Effect of non-compliance. Notwithstanding any other provision of this section, if the Agency determines that a product has been modified through notification or without notification in a manner inconsistent with paragraphs (a) or (b) of this section and any procedures issued thereunder, the Agency may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application for amended registration.
              [61 FR 33041, June 26, 1996]

              § 152.50
              Contents of application.
              Each application for registration or amended registration must include the following information, as applicable:
              (a) Application form. An application form must be completed and submitted to the Agency. Application forms are provided by the Agency, with instructions as to the number of copies required and proper completion.
              (b) Identity of the applicant—(1) Name. The applicant must identify himself. An applicant not residing in the United States must also designate an agent in accordance with paragraph (b)(3) of this section to act on behalf of the applicant on all registration matters.
              (2) Address of record. The applicant must provide an address in the United States for correspondence purposes. The U.S. address provided will be considered the applicant's address of record, and EPA will send all correspondence concerning the application and any subsequent registration to that address. It is the responsibility of the applicant and any registrant under § 152.122 to ensure that the Agency has a current and accurate address.
              (3) Authorized agent. An applicant may designate a person residing in the United States to act as his agent. If an applicant wishes to designate an agent, he must send the Agency a letter stating the name and United States address of his agent. The applicant must notify the Agency if he changes his designated agent. This relationship may be terminated at any time by the applicant by notifying the Agency in writing.
              (4) Company number. If an applicant has been assigned a company number by the Agency, the application must reference that number.
              (c) Summary of the application. Each application must include a list of the data submitted with the application, together with a brief description of the results of the studies. The list of data submitted may be the same as the list required by § 158.32 or § 161.32, as applicable, of this chapter. The summary must state that it is releasable to the public after registration in accordance with § 152.119.
              (d) Identity of the product. The product for which application is being submitted must be identified. The following information is required:
              (1) The product name;
              (2) The trade name(s) (if different); and
              (3) The EPA Registration Number, if currently registered.
              (e) Draft labeling. Each application for new registration must be accompanied by five legible copies of draft labeling (typescript or mock-up). Each application for amended registration that proposes to make any changes in the product labeling must be accompanied by five legible copies of draft labeling incorporating the proposed labeling changes. If the proposed labeling change affects only a portion of the labeling, such as the use directions, the applicant may submit five copies of that portion of the label which is the subject of the amendment. Upon request, an applicant for amended registration must submit a complete label to consolidate amendments.
              (f) Registration data requirements. (1) An applicant must submit materials to demonstrate that he has complied with the FIFRA sec. 3(c)(1)(F) and subpart E of this part with respect to satisfaction of data requirements, to enable the Agency to make the determination required by FIFRA sec. 3(c)(5)(B). Required items are described in subpart E of this part.

              (2) An applicant must furnish any data specified in part 158 or part 161 of this chapter, as applicable, of this chapter which are required by the Agency to determine that the product meets the registration standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
              (i) Section 158.32 of this chapter, with respect to format of data submission.
              (ii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made.
              (iii) Section 158.34 of this chapter, with respect to flagging for potential adverse effects.
              (iv) Section 160.12 of this chapter, with respect to a statement whether studies were conducted in accordance with Good Laboratory Practices of part 160.
              (3) An applicant shall furnish with his application any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on man or the environment, which would be required to be reported under FIFRA sec. 6(a)(2) if the product were registered.
              (g) Certification relating to child-resistant packaging. If the product meets the criteria for child-resistant packaging, the applicant must submit a certification that the product will be distributed or sold only in child-resistant packaging. Refer to part 157 of this chapter for the criteria and certification requirements.
              (h) Request for classification. If an applicant wishes to request a classification different from that established by the Agency, he must submit a request for such classification and information supporting the request.
              (i) Statement concerning tolerances. (1) If the proposed labeling bears instructions for use of the pesticide on food or feed crops, or if the intended use of the pesticide results or may be expected to result, directly or indirectly, in pesticide chemical residues in or on food or feed (including residues of any active ingredient, inert ingredient, metabolite, or degradation product), the applicant must submit a statement indicating whether such residues are authorized by a tolerance or exemption from the requirement of a tolerance issued under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA).
              (2) If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances or exemptions from the requirement of a tolerance, in accordance with part 180 of this chapter.
              (j) Fees. (1) The applicant shall identify the appropriate fee category in the schedule provided for by FIFRA sec. 33, and shall submit the fee for that category as prescribed by the latest EPA notice of section 33 fees.
              (2) If FIFRA sec. 33 is not in effect, the applicant shall submit any fees required by subpart U of this part, if applicable.
              [53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 FR 32096, June 19, 1995; 72 FR 61027, Oct. 26, 2007; 73 FR 75594, Dec. 12, 2008]

              § 152.55
              Where to send applications and correspondence.
              Applications and correspondence relating to registration should be sent to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              [71 FR 35545, June 21, 2006]

            Subpart D [Reserved]

            Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights

              Source:
              49 FR 30903, Aug. 1, 1984, unless otherwise noted.

              § 152.80
              General.

              This subpart E describes the information that an applicant must submit with his application for registration or amended registration to comply (and for the Agency to determine compliance) with the provisions of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with these procedures. If the Agency determines that an applicant has failed to comply with the requirements and procedures in this subpart, the application may be denied. If the Agency determines, after registration has been issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice of intent to cancel the product's registration.
              [73 FR 75594, Dec. 12, 2008]

              § 152.81
              Applicability.
              (a) Except as provided in paragraph (b) of this section, the requirements of this subpart apply to:
              (1) Each application for registration of a new product.
              (2) Each application for amended registration of a currently registered product.
              (3) Each submission in response to a Data Call-In under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B) for an existing registration, including but not limited to, a product subject to reregistration under FIFRA section 4 or registration review under FIFRA section 3(g). If the Data Call-In establishes procedures for protection of data submitters' rights, recipients must comply with the specific requirements of the Data Call-In rather than the generic procedures set forth in §§ 152.85 through 152.96.
              (b) This subpart does not apply to any of the following:
              (1) An application for registration submitted to a State under FIFRA section 24(c).
              (2) An application for an experimental use permit (EUP) under FIFRA section 5.
              (3) An application for an emergency exemption under FIFRA section 18.
              (4) A request for cancellation of a registration, or a request for deletion of one or more existing uses, under FIFRA section 6(f).
              (5) A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification.
              (6) Any type of amendment if the Administrator determines, by written finding, that Agency consideration of data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5).
              (7) Compliance with Agency regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or canceled, or that a hearing will be held under FIFRA section 6. However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.
              [79 FR 6824, Feb. 5, 2014]

              § 152.82
              Definitions.
              For the purposes of this subpart, the definitions set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in § 152.3, and in this section apply. In addition, the term “exclusive use study” shall have the meaning set forth in § 152.83.

                Data gap means the absence of any valid study or studies in the Agency's files which would satisfy a specific data requirement for a particular pesticide product.

                Data Submitters List means the current Agency list, entitled “Pesticide Data Submitters by Chemical,” of persons who have submitted data to the Agency.

                Original data submitter means the person who possesses all rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) in a study originally submitted in support of an application for registration, amended registration, reregistration, or experimental use permit, or to maintain an existing registration in effect. The term includes the person who originally submitted the study, any person to whom the rights under FIFRA section 3(c)(1)(F) have been transferred, or the authorized representative of a group of joint data developers.

                Valid study means a study that has been conducted in accordance with the Good Laboratory Practice standards of 40 CFR part 160 or generally accepted scientific methodology and that EPA has not determined to be invalid.
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008. Redesignated and amended at 79 FR 6825, Feb. 5, 2014]

              § 152.83
              Definition of exclusive use study.
              A study is an exclusive use study if it meets the conditions of either paragraph (a) or paragraph (b) of this section.
              (a) Initial exclusive use period. A study submitted to support the registration of a product containing a new active ingredient (new chemical) or a new combination of active ingredients (new combination) is an exclusive use study if all the following conditions are met:
              (1) The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new combination) first registered after September 30, 1978.
              (2) The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration of a product containing such new chemical or new combination, or an application to amend such registration to add a new use.
              (3) Less than 10 years have passed (or up to 13 years, if the period of exclusive use protection has been extended under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(1)(F)(ii)) since the issuance of the registration for which the data were submitted.
              (4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).
              (b) Exclusive use period for certain minor use data. A study submitted by an applicant or registrant to support an amendment adding a new minor use to an existing registration that does not retain any period of exclusive use under paragraph (b)(1) of this section is an exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following conditions are met:
              (1) The study relates solely to a minor use of a pesticide.
              (2) The applicant or registrant at the time the new use is requested has notified the Administrator that any exclusive use period for the pesticide has expired and that the study is eligible for exclusive use treatment.
              (3) Less than 10 years have passed since the study was submitted to EPA.
              (4) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).
              (5) The minor use supported by the data has not been voluntarily canceled nor have such data been used to support a non-minor use.
              [79 FR 6825, Feb. 5, 2014]

              § 152.84
              When materials must be submitted to the Agency.
              Information and materials required by this subpart must be submitted at the time of application, unless the application is determined not to be subject to the requirements of this subpart.
              [79 FR 6825, Feb. 5, 2014]

              § 152.85
              Formulators' exemption.
              (a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to any pesticide contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another person. This provision is commonly referred to as the formulators' exemption.
              (b) Applicability of the formulators' exemption. (1) The formulators' exemption applies only to data concerning the purchased product or its ingredients. These data may include, but are not limited to, product chemistry, toxicology, residue chemistry, exposure, environmental fate, and ecological effects.

              (2) The data to which the formulators' exemption applies usually will concern the safety of one or more of the product's active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators' exemption.

              (3) The formulators' exemption generally does not apply to data on the applicant's product itself, including the safety or efficacy of the product, unless the composition of the product is identical to the purchased product. In general, data for which the required test substance is the product proposed for registration are not eligible for the formulators' exemption.
              (c) Limitation of the formulators' exemption. EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant to use the formulators' exemption with respect to data concerning an ingredient of his product only if:
              (1) The application indicates that the ingredient's presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and
              (2) The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant's product will be labeled; or
              (3) The purchased product is a registered end-use product labeled for each use for which the applicant's product will be labeled.
              (d) Claiming eligibility for the exemption. (1) If the product contains one or more ingredients eligible for the formulators' exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirement pertaining to such ingredient, provided that he submits to the Agency a certification statement containing the following information (a form for this purpose is available from the Agency):
              (i) Identification of the applicant, and of the product by EPA registration number or file symbol.
              (ii) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient.
              (iii) A statement that the listed ingredients meet the requirements for the formulators' exemption.
              (iv) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.
              (v) The name, title and signature of the applicant or his authorized representative and the date of signature.
              (2) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.
              (e) Approval of registration. Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an application unless there are available to EPA for its review all data that are necessary to make the required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).
              [72 FR 61027, Oct. 26, 2007]

              § 152.86
              The cite-all method.
              An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.
              (a) Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each person listed on the Data Submitters List as an exclusive use data submitter for the chemical in question, a written authorization that contains at least the following information:
              (1) Identification of the applicant to whom the authorization is granted;
              (2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the application in question; and
              (3) The signature and title of the original data submitter or his authorized representative and date of the authorization.
              If the Agency identifies any exclusive use data submitter not on the Data Submitters List, the applicant will be required prior to registration to obtain the necessary written authorization from such person.
              (b) Other studies. The applicant must certify to the Agency that, with respect to each other person on the Data Submitters List for the chemical in question:

              (1) He has obtained from that person a written authorization that contains the information required by paragraphs (a) (1) through (3) of this section; or
              (2) He has furnished to that person:
              (i) A notification of his intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
              (ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F) for any data on which the application relies;
              (iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and
              (iv) The applicant's name, address, and contact information, including telephone number and email address.
              (c) General offer to pay statement. The applicant must submit to the Agency the following general offer to pay statement:

                [Name of applicant] hereby offers and agrees to pay compensation to other persons, with regard to the approval of this application, to the extent required by FIFRA section 3(c)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act.

              (d) Acknowledgement of reliance on data. Each application filed under this section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) the application relies on the following data:
              (1) All data submitted with or specifically cited in the application; and
              (2) Each other item of data in the Agency's files which:
              (i) Concerns the properties or effects of the applicant's product, of any product which is identical or substantially similar to the applicant's product, or of one or more of the active ingredients in the applicant's product; and
              (ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant's product, under the data requirements in effect on the date EPA approves the applicant's present application.
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

              § 152.90
              The selective method.
              An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or claiming a data gap.
              (a) List of data requirements. (1) Each applicant must submit a list of the data requirements that would apply to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) for the first time.
              (2) The applicant must list the applicable requirements, as prescribed by part 158 of this chapter, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant need not list data requirements pertaining to any ingredient which qualifies for the formulators' exemption.
              (b) Methods of demonstrating compliance. The applicant must state for each data requirement on the list required by paragraph (a) of this section which of the following methods of compliance with the requirement he is using, and shall provide the supporting documentation specified in the referenced section.
              (1) Existence of or granting of a data waiver. Refer to § 152.91.
              (2) Submission of a new valid study. Refer to § 152.92.
              (3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93.
              (4) Citation of a public literature study. Refer to § 152.94.

              (5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95.
              (6) Claim of data gap. Refer to § 152.96.
              [49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

              § 152.91
              Waiver of a data requirement.
              The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in accordance with paragraph (b) of this section.
              (a) Request for an extension of an existing waiver. An applicant may claim that a waiver previously granted by the Agency also applies to a data requirement for the product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Reregistration Eligibility Decision (RED) document or registration review decision document, and explain why that waiver should apply to the product.
              (b) Request for a new waiver. An applicant who requests a waiver to satisfy a data requirement must submit the information specified in 40 CFR 158.45 or 40 CFR 161.45.
              (c) Effect of denial of waiver request. A decision by the Agency to deny a written request for a new waiver or an extension of an existing waiver is a final Agency action. Following denial, the applicant must choose another method of satisfying the data requirement.
              [49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

              § 152.92
              Submission of a new valid study.
              An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency. A study previously submitted to the Agency should not be resubmitted but should be cited in accordance with § 152.93.

              § 152.93
              Citation of a previously submitted valid study.
              An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application.
              (a) Study originally submitted by the applicant. If the applicant certifies that he is the original data submitter, no documentation other than the citation is necessary.
              (b) Study previously submitted by another person. If the applicant is not the original data submitter, the applicant may cite the study only in accordance with paragraphs (b) (1) through (3) of this section.
              (1) Citation with authorization of original data submitter. The applicant may cite any valid study for which he has obtained the written authorization of the original data submitter. The applicant must obtain written authorization to cite any study that is an exclusive use study. The applicant must certify that he has obtained from the original data submitter a written authorization that contains at least the following information:
              (i) Identification of the applicant to whom the authorization is granted;
              (ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of submission, of the study or studies for which the authorization is granted;
              (iii) Authorization to the applicant to use the specified study in satisfaction of the data requirement for the application in question; and
              (iv) The signature and title of the original data submitter or his authorized representative, and date of the authorization.
              (2) Citation with offer to pay compensation to the original data submitter. The applicant may cite any valid study that is not subject to the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without written authorization from the original data submitter if the applicant certifies to the Agency that he has furnished to the original data submitter:

              (i) A notification of the applicant's intent to apply for registration, including the proposed product name and a list of the product's active ingredients;
              (ii) Identification of the specific data requirement involved and of the study for which the offer to pay is made (by title, EPA Accession Number or Master Record Identification Number, and date of submission, if possible);
              (iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);
              (iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study; and
              (v) The applicant's name, address, and contact information, including a telephone number and email address.
              (3) Citation without authorization or offer to pay. The applicant may cite any valid study without written authorization from, or offer to pay to, the original data submitter if the study was originally submitted to the Agency on or before the date that is 15 years before the date of the application for which it is cited, and the study is not an exclusive use study, as defined in § 152.83(c).
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

              § 152.94
              Citation of a public literature study or study generated at government expense.
              (a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following:
              (1) A valid study from the public literature.
              (2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.
              (b) In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(F).
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

              § 152.95
              Citation of all studies in the Agency's files pertinent to a specific data requirement.
              An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent to that data requirement. The applicant who selects this cite-all option must submit to the Agency:
              (a) A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;
              (b) A certification that:
              (1) For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and
              (2) For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:
              (i) A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
              (ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made;
              (iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);
              (iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and
              (v) The applicant's name, address, and contact information, including a telephone number and email address.

              (c) An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected.
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

              § 152.96
              Claim of data gap.
              (a) When a data gap may be claimed. Except as provided in paragraph (b) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requires the data if no other person has previously submitted to the Agency a valid study that would satisfy the data requirement in question.
              (b) When a data gap may not be claimed—(1) Product containing a new active ingredient. An applicant for registration of a product containing a new active ingredient may not defer his obligation by claiming a data gap unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).
              (2) Product not containing a new active ingredient. An applicant for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a product not containing a new active ingredient) may not defer his obligation by claiming a data gap if the data are:
              (i) Data needed to determine whether the product is identical or substantially similar to another currently registered product or differs only in ways that would substantially increase the risk of unreasonable adverse effects on the environment.
              (ii) Efficacy data specific to the product, if required to be submitted to the Agency.
              (iii) If a new use is proposed for a product that is identical or substantially similar to an existing product, data to demonstrate whether the new use would substantially increase the risk of unreasonable adverse effects on the environment.
              (c) Approval of application with a data gap claim—(1) In accordance with § 152.115(a), any registration that is approved based upon a data gap claim shall be conditioned on the submission of the data no later than the time that the data are required to be submitted for similar products already registered.
              (2) Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7).
              [79 FR 6826, Feb. 5, 2014]

              § 152.97
              Rights and obligations regarding the Data Submitters List.
              (a) Each original data submitter shall have the right to be included on the Agency's Data Submitters List.
              (b) Each original data submitter who wishes to have his name added to the current Data Submitters List must submit to the Agency the following information:
              (1) Name and current address.
              (2) Chemical name, common name (if any) and Chemical Abstracts Service (CAS) number (if any) of the active ingredients(s), with respect to which he is an original data submitter.
              (3) For each such active ingredient, the type(s) of study he has previously submitted (identified by reference to data/information requirements listed in part 158 of this chapter), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted.
              (c) Each applicant not already included on the Data Submitters List for a particular active ingredient must inform the Agency at the time of the submission of a relevant study whether he wishes to be included on the Data Submitters List for that pesticide.
              [79 FR 6826, Feb. 5, 2014]

              § 152.98
              Procedures for transfer of exclusive use or compensation rights to another person.

              A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with this section.

              (a) The original data submitter must submit to the Agency a transfer document that contains the following information:
              (1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);
              (2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee);
              (3) Identification of each item of data transferred including:
              (i) The name of the study or item of data;
              (ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires;
              (iii) The name of the person or laboratory that conducted the study;
              (iv) The date the study was submitted to the Agency;
              (v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data.
              (vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named;
              (vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and
              (viii) The names, signatures and titles of the transferor and transferee, and the date signed.
              (b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that:
              (1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter;
              (2) No court order prohibits the transfer, and any required court approvals have been obtained; and
              (3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements.
              (c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement is submitted to the Agency.
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

              § 152.99
              Petitions to cancel registration.
              An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy.
              (a) Grounds for petition. (1) If an applicant has offered to pay compensation to an original data submitter of a study (either specifically or by filing a general offer to pay statement), the original data submitter may petition the Agency to deny or cancel the registration to which the offer related on any of the following grounds:
              (i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure and describe the applicant's failure to participate in the procedure.
              (ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the agreement.
              (iii) The applicant has failed to participate in an arbitration proceeding. The petitioner shall submit evidence of such failure.
              (iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall submit a copy of the arbitration decision, and describe how the applicant has failed to comply with the decision.

              (2) When no offer to pay has been made, the petitioner shall state in his petition the basis for the challenge, and describe how the failure of the applicant to comply with the procedures of this subpart has deprived him of the rights accorded him under FIFRA section 3(c)(1)(F). Possible grounds for challenge include, but are not limited to, the following:
              (i) The applicant has failed to list a data requirement applicable to his product, or has failed to demonstrate compliance with all applicable data requirements.
              (ii) The applicant has submitted or cited a study that is not valid.
              (iii) The applicant has submitted or cited a study that does not satisfy the data requirement for which it was submitted or cited.
              (iv) The applicant has falsely or improperly claimed that a data gap existed at the time of his application.
              (v) The applicant has submitted or cited a study originally submitted by the petitioner, without the required authorization or offer to pay.
              (b) Procedure for petition to the Agency—(1) Time for filing. A petition under paragraph (a)(1) of this section may be filed at any time that the circumstances warrant. A petition under paragraph (a)(2) of this section must be filed within one year after the Agency makes public the issuance of the registration.
              (2) Notice to affected registrant. At the same time that the petitioner files his petition with the Agency, the petitioner shall send a copy to the affected applicant or registrant by certified mail or by any other method that provides evidence of delivery. The affected applicant or registrant shall have 60 days from the date of receipt of the petition to submit written comments to the Agency.
              (c) Disposition of petitions. The Agency will consider the material submitted by the petitioner and the response, if any, by the affected applicant or registrant.
              (1) If the Agency determines that the petition is without merit, it will inform the petitioner and the affected applicant or registrant that the petition is denied. Denial of a petition is a final Agency action.
              (2) If the Agency determines that an applicant has acted in any way described by paragraph (a)(1) of this section, the Agency will notify the petitioner and the affected applicant or registrant that it intends to deny or cancel the registration of the product in support of which the data were cited. The affected applicant or registrant will have 15 days from the date of delivery of this notice to respond. If the Agency determines, after considering any response, that the affected applicant or registrant has acted in the ways described by paragraph (a)(1) of this section, the Agency will deny or cancel the registration without further hearing. Refer to FIFRA section 3(c)(1)(F)(ii). Denial or cancellation of a registration is a final Agency action.
              (3) Except as provided in paragraph (c)(2) of this section, if the Agency determines that an applicant for registration of a product has acted in any way that deprives an original data submitter of rights under FIFRA section 3(c)(1)(F), the Agency will take steps to deny the application or cancel the registration, as appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or cancellation is a final Agency action.
              (d) Hearing. Any hearing will be conducted in accordance with the procedures in 40 CFR part 164. The only matter for resolution at the hearing shall be whether the registrant failed to comply with the requirements and procedures of FIFRA section 3(c)(1)(F) or of this subpart, in the manner described by the petitioner. A decision following a hearing shall be final.
              [49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6826, Feb. 5, 2014]

            Subpart F—Agency Review of Applications

              Source:
              53 FR 15980, May 4, 1988, unless otherwise noted.

              § 152.100
              Scope.
              (a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide that has been the subject of a previous Agency cancellation or suspension notice under FIFRA sec. 6.

              (b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a suspension or cancellation order, to the extent required by subpart D of part 164.

              § 152.102
              Publication.
              The Agency will issue in the Federal Register a notice of receipt of each application for registration of a product that contains a new active ingredient or that proposes a new use. After registration of the product, the Agency will issue in the Federal Register a notice of issuance. The notice of issuance will describe the new chemical or new use, summarize the Agency's regulatory conclusions, list missing data and the conditions for their submission, and respond to comments received on the notice of application.

              § 152.104
              Completeness of applications.
              The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).
              [72 FR 61028, Oct. 26, 2007]

              § 152.105
              Incomplete applications.
              The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application.

              § 152.107
              Review of data.
              (a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency.
              (b) The Agency normally will review other data submitted or cited by an applicant only:
              (1) As part of the process of reregistering currently registered products;
              (2) When acting on an application for registration of a product containing a new active ingredient;
              (3) If such data have been flagged in accordance with § 158.34 or 161.34 of this chapter; or
              (4) When the Agency determines that it would otherwise serve the public interest.
              (c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process.
              [53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]

              § 152.108
              Review of labeling.
              The Agency will review all draft labeling submitted with the application. If an applicant for amended registration submits only that portion of the labeling proposed for amendment, the Agency may review the entire label, as revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve final printed labeling, but will selectively review it for compliance.

              § 152.110
              Time for agency review.

              The Agency will complete its review of applications as expeditiously as possible. Applications subject to specific timeframes under the fee schedule established by FIFRA section 33 will be reviewed within the timeframes established for the application or action type.
              [73 FR 75595, Dec. 12, 2008]

              § 152.111
              Choice of standards for review of applications.
              The Agency has discretion to review applications under either the unconditional registration criteria of FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for completeness and scientific validity. EPA conducts data reviews needed to support unconditional registrations on a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of a new active ingredient or in special cases where it finds immediate review to be warranted, the Agency will not commence a complete review of the existing data base on a given chemical in response to receipt of an application for registration. Instead the Agency will review the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).

              § 152.112
              Approval of registration under FIFRA sec. 3(c)(5).
              EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:
              (a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part;
              (b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111);
              (c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application;
              (d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable.
              (e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment;
              (f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter;
              (g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and
              (h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA.
              [53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 FR 75595, Dec. 12, 2008]

              § 152.113
              Approval of registration under FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient.
              (a) Except as provided in paragraph (b) of this section, the Agency may approve an application for registration or amended registration of a pesticide product, each of whose active ingredients is contained in one or more other registered peticide products, only if the Agency has determined that:

              (1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);
              (2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment; and
              (3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied.
              (b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined that the applicant's product and its proposed use are identical or substantially similar to a currently registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
              (c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
              (1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure; and
              (2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture.

              § 152.114
              Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient.
              An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a period of time sufficient for the generation and submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that:
              (a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been developed;
              (b) All other required test data and materials have been submitted to the Agency;
              (c) The criteria in § 152.112(a), (b), (d), and (f) through (h) have been satisfied;
              (d) The use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and
              (e) The registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest.

              § 152.115
              Conditions of registration.
              (a) Substantially similar products and new uses. Each registration issued under § 152.113 shall be conditioned upon the submission or citation by the registrant of all data which are required for unconditional registration of his product under FIFRA sec. 3(c)(5), but which have not yet been submitted, no later than the time such data are required to be submitted for similar pesticide products already registered. If a notice requiring submission of such data has been issued under FIFRA sec. 3(c)(2)(B) prior to the date of approval of the application, the applicant must submit or cite the data described by that notice at the time specified by that notice. The applicant must agree to these conditions before the application may be approved.
              (b) New active ingredients. Each registration issued under § 152.114 shall be conditioned upon the applicant's agreement to each of the following conditions:
              (1) The applicant will submit remaining required data (and interim reports if required) in accordance with a schedule approved by the Agency.

              (2) The registration will expire upon a date established by the Agency, if the registrant fails to submit data as required by the Agency. The expiration date will be established based upon the length of time necessary to generate and submit the required data. If the studies are submitted in a timely manner, the registration will be cancelled if the Agency determines, based on the data (alone, or in conjuction with other data), that the product or one or more of its uses meets or exceeds any of the risk criteria established by the Agency to initiate a special review. If the Agency so determines, it will issue to the registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will specify any provisions for sale and distribution of existing stocks of the pesticide product.
              (3) The applicant will submit an annual report of the production of the product.
              (c) Other conditions. The Agency may establish, on a case-by-case basis, other conditions applicable to registrations to be issued under FIFRA sec. 3(c)(7).
              (d) Cancellation if condition is not satisfied. If any condition of the registration of the product is not satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action towards fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA sec. 6(e).
              [53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

              § 152.116
              Notice of intent to register to original submitters of exclusive use data.
              (a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product containing an active ingredient for which a previously submitted study is eligible for exclusive use under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original submitter of the exclusive use study of the intended registration of the product. If requested by the exclusive use data submitter within 30 days, the Agency will also provide the applicant's list of data requirements and method of demonstrating compliance with each data requirement.
              (b) Within 30 days after receipt of the Agency's notice, or of the applicant's list of data requirements, whichever is later, the exclusive use data submitter may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit, it will issue a notice of denial of the application. The applicant may then avail himself of the hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will deny the petition and register the applicant's product. Denial of the petition is a final Agency action.
              (c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that he is aware of the applicant's application for registration, and does not object to the issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section to that exclusive use data submitter.
              [53 FR 15980, May 4, 1988, as amended at 73 FR 75595, Dec. 12, 2008]

              § 152.117
              Notification to applicant.
              The Agency will notify the applicant of the approval of his application by a Notice of Registration for new registration, or by a letter in the case of an amended registration.

              § 152.118
              Denial of application.
              (a) Basis for denial. The Agency may deny an application for registration if the Agency determines that the pesticide product does not meet the criteria for registration under either FIFRA sec. 3(c)(5) or (7), as specified in §§ 152.112 through 152.114.
              (b) Notification of applicant. If the Agency determines that an application should be denied, it will notify the applicant by certified letter. The letter will set forth the reasons and factual basis for the determination with conditions, if any, which must be fulfilled in order for the registration to be approved.
              (c) Opportunity for remedy by the applicant. The applicant will have 30 days from the date of receipt of the certified letter to take the specified corrective action. During this time the applicant may request that his application be withdrawn.
              (d) Notice of denial. If the applicant fails to correct the deficiencies within the 30-day period, the Agency may issue a notice of denial, which will be published in the Federal Register, and which will set forth the reasons and the factual basis for the denial.
              (e) Hearing rights. Within 30 days following the publication of the notice of denial, an applicant, or any interested person with written authorization of the applicant, may request a hearing in accordance with FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164 of this chapter.

              § 152.119
              Availability of material in support of registration.
              (a) The information submitted to support a registration application shall be part of the official Agency file for that registration.
              (b) Within 30 days after registration, the Agency will make available for public inspection, upon request, the materials required by subpart E to be submitted with an application. Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable.
              (c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency based its decision to register the product will be made available for public inspection, upon request, in accordance with the procedures in 40 CFR part 2.

            Subpart G—Obligations and Rights of Registrants

              Source:
              53 FR 15983, May 4, 1988, unless otherwise noted.

              § 152.122
              Currency of address of record and authorized agent.

              (a) The registrant must keep the Agency informed of his current name and address of record. If the Agency's good faith attempts to contact the registrant are not successful, the Agency will issue in the Federal Register a notice of intent to cancel all products of the registrant under FIFRA sec. 6(b). The registrant must respond within 30 days requesting that the registrations be maintained in effect, and providing his name and address of record. If no response is received, the cancellations will become effective at the end of 30 days without further notice to the registrant. The Agency may make provision for the sale and distribution of existing stocks of such products after the effective date of cancellation.
              (b) The registrant must also notify the Agency if he changes his authorized agent.

              § 152.125
              Submission of information pertaining to adverse effects.
              If at any time the registrant receives or becomes aware of any factual information regarding unreasonable adverse effects of the pesticide on the environment that has not previously been submitted to the Agency, the registrant shall, in accordance with FIFRA section 6(a)(2) and the requirements of part 159, subpart D of this chapter, provide such information to the Agency, clearly identified as FIFRA 6(a)(2) data.
              [73 FR 75595, Dec. 12, 2008]

              § 152.130
              Distribution under approved labeling.
              (a) A registrant may distribute or sell a registered product with the composition, packaging and labeling currently approved by the Agency.
              (b) A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in precautionary statements, use classification, or packaging of the product.
              (c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section applies to the registrant's product, the time frames established by the Agency in accordance with that paragraph shall take precedence.

              (d) If a product's labeling is required to be revised as a result of the issuance of a Registration Standard, a Label Improvement Program notice, or a notice concluding a special review process, the Agency will specify in the notice to the registrant the period of time that previously approved labeling may be used. In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency may establish dates as follows governing when label changes must appear on labels:
              (1) The Agency may establish a date after which all product distributed or sold by the registrant must bear revised labeling.
              (2) The Agency may also establish a date after which no product may be distributed or sold by any person unless it bears revised labeling. This date will provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise disposed of.

              § 152.132
              Supplemental distribution.
              The registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is termed “supplemental distribution” and the product is referred to as a “distributor product.” The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon notification to the Agency if all the following conditions are met:
              (a) The registrant has submitted to the Agency for each distributor product a statement signed by both the registrant and the distributor listing the names and addresses of the registrant and the distributor, the distributor's company number, the additional brand name(s) to be used, and the registration number of the registered product.
              (b) The distributor product is produced, packaged and labeled in a registered establishment operated by the same producer (or under contract in accordance with § 152.30) who produces, packages, and labels the registered product.
              (c) The distributor product is not repackaged (remains in the producer's unopened container).
              (d) The label of the distributor product is the same as that of the registered product, except that:
              (1) The product name of the distributor product may be different (but may not be misleading);
              (2) The name and address of the distributor may appear instead of that of the registrant;
              (3) The registration number of the registered product must be followed by a dash, followed by the distributor's company number (obtainable from the Agency upon request);
              (4) The establishment number must be that of the final establishment at which the product was produced; and
              (5) Specific claims may be deleted, provided that no other changes are necessary.
              (e) Voluntary cancellation of a product applies to the registered product and all distributor products distributed or sold under that registration number. The registrant is responsible for ensuring that distributors under his cancelled registration are notified and comply with the terms of the cancellation.
              [53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

              § 152.135
              Transfer of registration.
              (a) A registrant may transfer the registration of a product to another person, and the registered product may be distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section, and receive Agency approval as described in paragraph (d) of this section.
              (b) Persons seeking approval of a transfer of registration must provide a document signed by the authorized representative of the registrant (the transferor) and of the person to whom the registration is transferred (the transferee) that contains the following information:
              (1) The name, address and State of incorporation (if any) of the transferor;
              (2) The name, address and State of incorporation of the transferee;
              (3) The name(s) and EPA registration number(s) of the product(s) being transferred;

              (4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed in the document;
              (5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency;
              (6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed);
              (7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and
              (8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved.
              (c) In addition, the transferor must submit to the Agency a notarized statement affirming that:
              (1) The person signing the transfer agreement is authorized by the registrant to bind the transferor;
              (2) No court order prohibits the transfer, and that any required court approvals have been obtained; and
              (3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements.
              (d) If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration. The Agency will notify the transferor and transferee of its approval.
              (e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be regarded as the registrant for all purposes under FIFRA.
              (f) Rights to exclusive use of data or compensation under FIFRA section 3(c)(1)(F) are separate from the registration itself and may be retained by the transferor, or may be transferred independently in accordance with the provisions of § 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data.
              [53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 73 FR 75595, Dec. 12, 2008]

            Subpart H [Reserved]

            Subpart I—Classification of Pesticides

              Source:
              53 FR 15986, May 4, 1988, unless otherwise noted.

              § 152.160
              Scope.
              (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for general use. The Agency does not normally classify products for general use; products that are not restricted remain unclassified.
              (b) Kinds of restrictions. The Agency may restrict a product or its uses to use by a certified applicator, or by or under the direct supervision of a certified applicator, as described in FIFRA sec. 3(d)(1)(C). The Agency may also, by regulation, prescribe restrictions relating to the product's composition, labeling, packaging, uses, or distribution and sale, or to the status or qualifications of the user.

              § 152.161
              Definitions.
              In addition to the definitions in § 152.3, the following terms are defined for the purposes of this subpart:
              (a) Dietary LC
                50 means a statistically derived estimate of the concentration of a test substance in the diet that would cause 50 percent mortality to the test population under specified conditions.
              (b) Outdoor use means any pesticide application that occurs outside enclosed manmade structures or the consequences of which extend beyond enclosed manmade structures, including, but not limited to, pulp and paper mill water treatments and industrial cooling water treatments.

              § 152.164
              Classification procedures.
              (a) Grouping of products for classification purposes. In its discretion, the Agency may identify a group of products having common characteristics or uses and may classify for restricted use same or all of the products or uses included in that group. Such a group may be comprised of, but is not limited to, products that:
              (1) Contain the same active ingredients.
              (2) Contain the same active ingredients in a particular concentration range, formulation type, or combination of concentration range and formulation type.
              (3) Have uses in common.
              (4) Have other characteristics, such as toxicity, flammability, or physical properties, in common.
              (b) Classification reviews. The Agency may conduct classification reviews and classify products at any time, if it determines that a restriction on the use of a pesticide product is necessary to avoid unreasonable adverse effects on the environment. However, classification reviews normally will be conducted and products classified only in the following circumstances:
              (1) As part of the review of an application for new registration of a product containing an active ingredient not contained in any currently registered product.
              (2) As part of the review of an application for a new use of a product, if existing uses of that product previously have been classified for restricted use. Review of a restricted use product at this time is for the purpose of determining whether the new use should also be classified for restricted use. Normally the Agency will not conduct initial classification reviews for existing uses of individual products in conjunction with an application for amended registration.
              (3) As part of the process of developing or amending a registration standard for a pesticide. The Agency normally will conduct classification reviews of all uses of a currently registered pesticide at this time.
              (4) As part of any special review of a pesticide, in accordance with the procedures of 40 CFR part 154.
              (c) Classification procedures. (1) If the Agency determines that a product or one or more of its uses should be classified for restricted use, the Agency initially may classify the product by regulation. In this case, within 60 days after the effective date of a final rule, each registrant of a product subject to the rule must submit to the Agency one of the following, as directed in the final rule:
              (i) A copy of the amended label and any supplemental labeling to be used as an interim compliance measure.
              (ii) A statement, which the Agency considers a report under the Act, that the registrant will comply with the labeling requirements prescribed by the Agency within the timeframes prescribed by the regulation.
              (iii) An application for amended registration to delete the uses which have been restricted, or to “split” the registration into two registrations, one including only restricted or all uses, and the other including only uses that have not been classified.
              (2) Alternatively, EPA may notify the applicant or registrant of the classification decision and require that he submit the information required by paragraph (c)(1) of this section. The Agency may deny registration or initiate cancellation proceedings if the registrant fails to comply within the timeframes established by the Agency in its notification.

              § 152.166
              Labeling of restricted use products.
              (a) Products intended for end use. A product whose labeling bears directions for end use and that has been classified for restricted use must be labeled in accordance with the requirements of § 156.10 of this chapter or other Agency instructions. The Agency will permit the use of stickers or supplemental labeling as an interim alternative to the use of an approved amended label, in accordance with § 152.167.
              (b) Products intended only for formulation. A product whose labeling does not bear directions for end use (a product that is intended and labeled solely for further formulation into other pesticide products) is not subject to the labeling requirements of this subpart.

              § 152.167
              Distribution and sale of restricted use products.
              Unless modified by the Agency, the compliance dates in this section shall apply to restricted use products.
              (a) Sale by registrant or producer. (1) No product with a use classified for restricted use may be distributed or sold by the registrant or producer after the 120th day after the effective date of such classification unless the product:
              (i) Bears an approved amended label which contains the terms of restricted use imposed by the Agency and otherwise complies with part 156 of this chapter;
              (ii) Bears a sticker containing the product name, EPA registration number, and any terms of restricted use imposed by the Agency; or
              (iii) Is accompanied by supplemental labeling bearing the information listed in paragraph (a)(1)(ii) of this section.
              (2) If the registrant chooses to delete the restricted uses from his product label, that product may not be distributed or sold after the 180th day after the effective date of classification unless the product bears amended labeling with the restricted uses deleted.
              (3) Notwithstanding paragraphs (a) (1) and (2) of this section, after the 270th day after the effective date of classification, no registrant or producer may distribute or sell a product that does not bear the approved amended label. After that date, stickers and supplemental labeling described in paragraph (a)(1) (ii) and (iii) are no longer acceptable.
              (b) Sale by retailer. No product with a use classified for restricted use by a regulation may be distributed or sold by a retailer or other person after the 270th day after the effective date of the final rule unless the product bears a label or labeling which complies with paragraph (a)(1) of this section.

              § 152.168
              Advertising of restricted use products.
              (a) Any product classified for restricted use shall not be advertised unless the advertisement contains a statement of its restricted use classification.
              (b) The requirement in paragraph (a) of this section applies to all advertisements of the product, including, but not limited, to:
              (1) Brochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by direct mail.
              (2) Newspapers, magazines, newsletters and other material in circulation or available to the public.
              (3) Broadcast media such as radio and television.
              (4) Telephone advertising.
              (5) Billboards and posters.
              (c) The requirement may be satisfied for printed material by inclusion of the statement “Restricted Use Pesticide,” or the terms of restriction, prominently in the advertisement. The requirement may be satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of the spoken words “Restricted use pesticide,” or a statement of the terms of restriction.
              (d) The requirements of this section shall be effective:
              (1) After 270 days after the effective date of restriction of a product that is currently registered, unless the Agency specifies a shorter time period;
              (2) Upon the effective date of registration of a product not currently registered.

              § 152.170
              Criteria for restriction to use by certified applicators.
              (a) General criteria. An end-use product will be restricted to use by certified applicators (or persons under their direct supervision) if the Agency determines that:
              (1) Its toxicity exceeds one or more of the specific hazard criteria in paragraph (b) or (c) of this section, or evidence described in paragraph (d) of this section substantiates that the product or use poses a serious hazard that may be mitigated by restricting its use;
              (2) Its labeling, when considered according to the factors in paragraph (e)(2) of this section, is not adequate to mitigate these hazard(s);

              (3) Restriction of the product would decrease the risk of adverse effects; and

              (4) The decrease in risks of the pesticide as a result of restriction would exceed the decrease in benefits.
              (b) Criteria for human hazard—(1) Residential and institutional uses. A pesticide product intended for residential or institutional use will be considered for restricted use classification if:

              (i) The pesticide, as diluted for use, has an acute oral LD50 of 1.5 g/kg or less;

              (ii) The pesticide, as formulated, has an acute dermal LD50 of 2000 mg/kg or less;

              (iii) The pesticide, as formulated, has an acute inhalation LC50 of 0.5 mg/liter or less, based upon a 4-hour exposure period;
              (iv) The pesticide, as formulated, is corrosive to the eye (causes irreversible destruction of ocular tissue) or results in corneal involvement or irritation persisting for more than 7 days;
              (v) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe irritation (severe erythema or edema) at 72 hours; or
              (vi) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of single or multiple exposures to the product ingredients or residues.
              (2) All other uses. A pesticide product intended for uses other than residential or institutional use will be considered for restricted use classification if:

              (i) The pesticide, as formulated, has an acute oral LD50 of 50 mg/kg or less;

              (ii) The pesticide, as formulated, has an acute dermal LD50 of 200 mg/kg or less;

              (iii) The pesticide, as diluted for use, has an acute dermal LD50 of 16 g/kg or less;

              (iv) The pesticide, as formulated, has an acute inhalation LC50 of 0.05 mg/liter or less, based upon a 4-hour exposure period;
              (v) The pesticide, as formulated, is corrosive to the eye or causes corneal involvement or irritation persisting for more than 21 days;
              (vi) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring); or
              (vii) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic toxicity, chronic toxicity, or delayed toxic effects on man, as a result of single or multiple exposures to the product ingredients or residues.
              (c) Criteria for hazard to non-target species—(1) All products. A pesticide product intended for outdoor use will be considered for restricted use classification if:
              (i) When used according to label directions, application results in residues of the pesticide, its metabolites, or its degradation products, in the diet of exposed mammalian wildlife, immediately after application, such that:

              (A) The level of such residues equals or exceeds one-fifth of the acute dietary LC50; or

              (B) The amount of pesticide consumed in one feeding day (mg/kg/day) equals or exceeds one-fifth of the mammalian acute oral LD50;

              (ii) When used according to label directions, application results, immediately after application, in residues of the pesticide, its metabolites or its degradation products, in the diet of exposed birds at levels that equal or exceed one-fifth of the avian subacute dietary LC50;

              (iii) When used according to label directions, application results in residues of the pesticide, its metabolites or its degradation products, in water that equal or exceed one-tenth of the acute LC50 for non-target aquatic organisms likely to be exposed; or
              (iv) Under conditions of label use or widespread and commonly recognized practice, the pesticide may cause discernible adverse effects on non-target organisms, such as significant mortality or effects on the physiology, growth, population levels or reproduction rates of such organisms, resulting from direct or indirect exposure to the pesticide, its metabolites or its degradation products.
              (2) Granular products. In addition to the criteria of paragraph (c)(1) of this section, a pesticide intended for outdoor use and formulated as a granular product will be considered for restricted use classification if:

              (i) The formulated product has an acute avian or mammalian oral LD50 of 50 mg/kg or less as determined by extrapolation from tests conducted with technical material or directly with the formulated product; and
              (ii) It is intended to be applied in such a manner that significant exposure to birds or mammals may occur.
              (d) Other evidence. The Agency may also consider evidence such as field studies, use history, accident data, monitoring data, or other pertinent evidence in deciding whether the product or use may pose a serious hazard to man or the environment that can reasonably be mitigated by restricted use classification.
              (e) Alternative labeling language. (1) If the Agency determines that a product meets one or more of the criteria of paragraphs (b) or (c) of this section, or if other evidence identified in paragraph (d) of this section leads the Agency to conclude that the product should be considered for restricted use classification, the Agency will then determine if additional labeling language would be adequate to mitigate the identified hazard(s) without restricted use classification. If the labeling language meets all the criteria specified in paragraph (e)(2) of this section, the product will not be classified for restricted use.
              (2) The labeling will be judged adequate if it meets all the following criteria:
              (i) The user, in order to follow label directions, would not be required to perform complex operations or procedures requiring specialized training and/or experience.
              (ii) The label directions do not call for specialized apparatus, protective equipment, or materials that reasonably would not be available to the general public.
              (iii) Failure to follow label directions in a minor way would result in few or no significant adverse effects.
              (iv) Following directions for use would result in few or no significant adverse effects of a delayed or indirect nature through bioaccumulation, persistence, or pesticide movement from the original application site.
              (v) Widespread and commonly recognized practices of use would not nullify or detract from label directions such that unreasonable adverse effects on the environment might occur.

              § 152.171
              Restrictions other than those relating to use by certified applicators.
              The Agency may by regulation impose restrictions on a product or class of products if it determines that:
              (a) Without such restrictions, the product when used in accordance with warnings, cautions and directions for use or in accordance with widespread and commonly recognized practices of use may cause unreasonable adverse effects on the environment; and
              (b) The decrease in risks as a result of restricted use would exceed the decrease in benefits as a result of restricted use.

              § 152.175
              Pesticides classified for restricted use.
              The following uses of pesticide products containing the active ingredients specified below have been classified for restricted use and are limited to use by or under the direct supervision of a certified applicator.

                  Active ingredient
                  Formulation
                  Use pattern
                  Classification 1

                  Criteria influencing restriction

                  Acrolein
                  As sole active ingredient. No mixtures registered
                  All uses
                  Restricted
                  Inhalation hazard to humans. Residue effects on avian species and aquatic organisms.

                  Aldicarb
                  As sole active ingredient
                  Ornamental uses (indoor and outdoor)
                  ......do
                  Other hazards—accident history.

                  No mixtures registered
                  Agricultural crop uses
                  Under further evaluation

                  Aluminum phosphide
                  As sole active ingredient. No mixtures registered
                  ......do
                  ......do
                  Inhalation hazard to humans.

                  Azinphos methyl
                  All liquids with a concentration greater than 13.5 pct
                  ......do
                  ......do
                    Do.

                  All other formulations
                  ......do
                  Under futher evaluation.

                  Carbofuran
                  All concentrate suspensions and wettable powders 40% and greater
                  ......do
                  ......do
                  Acute inhalation toxicity.

                  All granular formulations
                  Rice
                  Under evaluation

                  All granular and fertilizer formulations
                  All uses except rice
                  ......do

                  Chloropicrin
                  All formulations greater than 2%
                  All uses
                  ......do
                  Acute inhalation toxicity.

                  All formulations
                  Rodent control
                  ......do
                  Hazard to non-target organisms.

                  All formulations 2% and less
                  Outdoor uses (other than rodent control)
                  Unclassified

                  Clonitralid
                  All wettable powders 70% and greater
                  All uses
                  Restricted
                  Acute inhalation toxicity.

                  All granulars and wettable powders
                  Molluscide uses
                  Restricted
                  Effects on aquatic organisms.

                  Pressurized sprays 0.55% and less
                  Hospital antiseptics
                  Unclassified

                  Dicrotophos
                  All liquid formulations 8% and greater
                  All uses
                  Restricted
                  Acute dermal toxicity; residue effects on avian species (except for tree injections).

                  Disulfoton
                  All emulsifiable concentrates 65% and greater, all emulsifiable concentrates and concentrate solutions 21% and greater with fensulfothion 43% and greater, all emulsifiable concentrates 32% and greater in combination with 32% fensulfothion and greater
                  ......do
                  Restricted
                    Do.Acute inhalation toxicity.

                  Non-aqueous solution 95% and greater
                  Commercial seed treatment
                  Restricted
                  Acute dermal toxicity.

                  Granular formulations 10% and greater
                  Indoor uses (greenhouse)
                  ......do
                  Acute inhalation toxicity.

                  Ethoprop
                  Emulsifiable concentrates 40% and greater
                  Aquatic uses
                  ......do
                  Acute dermal toxicity.

                  All granular and fertilizer formulations
                  All uses
                  Under evaluation

                  Ethyl parathion
                  All granular and dust formulations greater than 2 pct, fertilizer formulations, wettable powders, emulsifiable concentrates, concentrated suspensions, concentrated solutions
                  ......do
                  Restricted
                  Inhalation hazard to humans. Acute dermal toxicity. Residue effects on mammalian, aquatic, avian species.

                  Smoke fumigants
                  ......do
                  ......do
                  Inhalation hazard to humans.

                  Dust and granular formulations 2 pct and below
                  ......do
                  ......do
                  Other hazards—accident history.

                  Fenamiphos
                  Emulsifiable concentrates 35% and greater
                  ......do
                  ......do
                  Acute dermal toxicity.

                  Fonofos
                  Emulsifiable concentrates 44% and greater
                  ......do
                  ......do
                  Acute dermal toxicity.

                  Emulsifiable concentrates 12.6% and less with pebulate 50.3% and less
                  Tobacco
                  Unclassified

                  Methamidophos
                  Liquid formulations 40% and greater
                  ......do
                  Restricted
                  Acute dermal toxicity; residue effects on avian species.

                  Dust formulations 2.5% and greater
                  ......do
                  ......do
                  Residue effects on avian species.

                  Methidathion
                  All formulations
                  All uses except nursery stock, safflower and sunflower
                  ......do
                    Do.

                  All formulations
                  Nursery stock, safflower and sunflower
                  Unclassified

                  Methomyl
                  As sole active ingredient in 1 pct to 2.5 baits (except 1 pct fly bait)
                  Nondomestic outdoors-agricultural crops, ornamental and turf. All other registered uses
                  Restricted
                  Residue effects on mammalian species.

                  All concentrated solution formulations
                  ......do
                  ......do
                  Other hazards-accident history.

                  90 pct wettable powder formulations (not in water soluble bags)
                  ......do
                  ......do
                    Do.

                  90 pct wettable powder formulation in water soluble bags
                  ......do
                  Unclassified

                  All granular formulations
                  ......do
                  ......do

                  25 pct wettable powder formulations
                  ......do
                  ......do

                  In 1.24 pct to 2.5 pct dusts as sole active ingredient and in mixtures with fungicides and chlorinated hydrocarbon, inorganic phosphate and biological insecticides
                  ......do
                  ......do

                  Methyl bromide
                  All formulations in containers greater than 1.5 lb
                  All uses
                  Restricted
                    Do.

                  Containers with not more than 1.5 lb of methyl bromide with 0.25 pct to 2.0 pct chloropicrin as an indicator
                  Single applications (nondomestic use) for soil treatment in closed systems
                  Unclassified

                  Container with not more than 1.5 lb having no indicator
                  All uses
                  Restricted
                    Do.

                  Methyl parathion
                  All dust and granular formulations less than 5 pct
                  ......do
                  ......do
                  Other hazards-accident history. All foliar applications restricted based on residue effects on mammalian and avian species.

                  Microencapsulated
                  ......do
                  ......do
                  Residue effects on avian species. Hazard to bees.

                  All dust and granular formulations 5 pct and greater and all wettable powders and liquids
                  ......do
                  ......do
                  Acute dermal toxicity. Residue effects on mammalian and avian species.

                  Nicotine (alkaloid)
                  Liquid and dry formulations 14% and above
                  Indoor (greenhouse)
                  ......do
                  Acute inhalation toxicity.

                  All formulations
                  Applications to cranberries
                  ......do
                  Effects on aquatic organisms.

                  Liquid and dry formulations 1.5% and less
                  All uses (domestic and nondomestic)
                  Unclassified

                  Paraquat (dichloride) and paraquat bis(methyl sulfate)
                  All formulations and concentrations except those listed below
                  All uses
                  Restricted
                  Other hazards. Use and accident history, human toxicological data.

                  Pressurized spray formulations containing 0.44 pct Paraquat bis(methyl sulfate) and 15 pct petroleum distillates as active ingredients
                  Spot weed and grass control
                  ......do

                  Liquid fertilizers containing concentrations of 0.025 pct paraquat dichloride and 0.03 percent atrazine; 0.03 pct paraquat dichloride and 0.37 pct atrazine, 0.04 pct paraquat dichloride and 0.49 pct atrazine
                  All uses
                  Unclassified

                  Phorate
                  Liquid formulations 65% and greater
                  ......do
                  Restricted
                  Acute dermal toxicity.Residue effects on avian species (applies to foliar applications only).
                    Residue effects on mammalian species (applies to foliar application only).

                  All granular formulations
                  Rice
                  ......do
                  Effects on aquatic organisms.

                  Phosphamidon
                  Liquid formulations 75% and greater
                  ......do
                  ......do
                  Acute dermal toxicity.Residue effects on mammalian species.
                    Residue effects on avian species.

                  Dust formulations 1.5% and greater
                  ......do
                  ......do
                    Do.Residue effects on mammalian species.

                  Picloram
                  All formulations and concentrations except tordon 101 R
                  ......do
                  ......do
                  Hazard to nontarget organisms (specifically nontarget plants both crop and noncrop).

                  Tordon 101 R forestry herbicide containing 5.4 pct picloram and 20.9 pct 2.4-D
                  Control of unwanted trees by cut surface treatment
                  Unclassified

                  Sodium cyanide 3

                  All capsules and ball formulations
                  All uses
                  Restricted
                  Inhalation hazard to humans.

                  Sodium fluoroacetate
                  All solutions and dry baits
                  ......do
                  ......do
                  Acute oral toxicity. Hazard to nontarget organisms. Use and accident history.

                  Strychnine
                  All dry baits, pellets and powder formulations greater than 0.5 pct
                  ......do
                  ......do
                  Acute oral toxicity. Hazard to nontarget avain species. Use and accident history.

                  All dry baits, pellets and powder formulations
                  All uses calling for burrow builders
                  ......do
                  Hazard to nontarget organisms.

                  All dry baits, pellets and powder formulations 0.5 pct and below
                  All uses except subsoil
                  ......do
                    Do.

                  ......do
                  All subsoil uses
                  Unclassified

                  Sulfotepp
                  Sprays and smoke generators
                  All uses
                  Restricted
                  Inhalation hazard to humans.

                  Zinc Phosphide
                  All formulations 2% and less
                  All domestic uses and non-domestic uses in and around buildings
                  Unclassified

                  All dry formulations 60% and greater.

                  All uses
                  Restricted
                  Acute inhalation toxicity.

                  All bait formulations
                  Non-domestic outdoor uses (other than around buildings)
                  ......do
                  Hazard to non-target organisms.

                  All dry formulations 10% and greater
                  Domestic uses
                  ......do
                  Acute oral toxicity.

                  1 “Under evaluation” means no classification decision has been made and the use/formulation in question is still under active review within EPA.

                  2 Percentages given are the total of dioxathion plus related compounds.

                  3 (Note—M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the required additional training.)

              [43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995]

            Subparts J-T [Reserved]

            Subpart U—Registration Fees

              Source:
              53 FR 19114, May 26, 1988, unless otherwise noted.

              § 152.400
              Purpose.
              Subpart U prescribes fees to be charged for the pesticide regulatory activities set forth in § 152.403 as performed by the Environmental Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) and provisions regarding their payment.

              § 152.401
              Inapplicability of fee provisions to applications filed prior to October 1, 1997.
              No fee required by this subpart U shall be levied with respect to any application filed during the period beginning on October 25, 1988, and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).
              [53 FR 11923, Mar. 22, 1989]

              § 152.403
              Definitions of fee categories.
              (a) New chemical registration review means review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained as an active ingredient in any other pesticide product that is registered under FIFRA at the time the application is made.
              (b) New biochemical and microbial registration review means review of an application for registration of a biochemical or microbial pesticide product containing a biochemical or microbial active ingredient not contained in any other pesticide product that is registered under FIFRA at the time the application is made. For purposes of this subpart, the definitions of biochemical and microbial pesticides contained in § 158.2000 and § 158.2100, respectively, shall apply.
              (c) New use pattern registration review means review of an application for registration, or for amendment of a registration entailing a major change to the use pattern of an active ingredient contained in a product registered under FIFRA or pending Agency decision on a prior application at the time of application. For purposes of this paragraph, examples of major changes include but are not limited to, changes from non-food to food use, outdoor to indoor use, ground to aerial application, terrestrial to aquatic use, and non-residential to residential use.
              (d) Old chemical registration review means review of an application for registration of a new product containing active ingredients and uses which are substantially similar or identical to those currently registered or for which an application is pending Agency decision.
              (e) Amendment review means review of any application requiring Agency approval to amend the registration of a currently registered product, or for which an application is pending Agency decision, not entailing a major change to the use pattern of an active ingredient.
              (f) Experimental use permit review means review of an application for a permit pursuant to section 5 of FIFRA to apply a limited quantity of a pesticide in order to accumulate information necessary to register the pesticide. The application may be for a new chemical or for a new use of an old chemical. The fee applies to such experimental uses of a single unregistered active ingredient (no limit on the number of other active ingredients, in a tank mix, already registered for the crops involved) and no more than three crops. This fee does not apply to experimental use permits required for small-scale field testing of microbial pest control agents (40 CFR 172.3).
              [53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007]

              § 152.404
              Fee amounts.
              The fee prescribed by the following table must be submitted with each application for registration, amended registration or experimental use permit. Fees will be adjusted annually in accordance with § 152.410. The Agency may waive or refund fees in accordance with § 152.412.

                Table—Registration Fees

                  Type of review
                  Fee

                  New chemical
                  $184,500

                  New biochemical or microbial
                  64,000

                  New use pattern
                  33,800

                  Experimental use permit
                  4,500

                  Old chemical
                  4,000

                  Amendment
                  700

              [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

              § 152.406
              Submission of supplementary data.
              Applicants may submit data to supplement pending applications without incurring additional charges if the proper fee was paid with submission of the original application and subsequent submissions of supplementary data do not constitute a change in the type of registration action requested.
              [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

              § 152.408
              Special considerations.

              (a) If two or more applicants apply for a new chemical registration for products having the same active ingredient and each applicant provides a set of data in support of the registration developed independently of the other applicants' data, then each applicant submitting an independent set of data shall be charged the full new chemical registration review fee.
              (b) If two or more applicants apply for a new chemical registration for products having the same active ingredient and the applicants have jointly developed or paid for the joint development of a common set of data to support their applications for registration, then each applicant shall be charged an equal share of the total fee for review of the applications for all of the subject products. The total fee will include the sum of the new chemical registration review fee for one product and one old chemical registration review fee for each additional product.
              (c) If an application is received for registration of a product that contains two or more new chemical active ingredients and a different set of generic data is required by the Agency for each new chemical for the purpose of registration, the applicant will be required to pay the full new chemical registration review fee for each active ingredient.

              § 152.410
              Adjustment of fees.

              (a) The fee schedule will be adjusted annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. Such adjustments will be published in the Federal Register as a final rule and will be effective 30 days or more after promulgation.

              (b) Processing costs and fees will be reviewed periodically and changes will be made to the schedule as necessary. Such adjustments will be published for notice and comment in the Federal Register.

              § 152.412
              Waivers and refunds.
              (a) Refunds. If an application is not accepted for processing because it is incomplete, the fee, less $1,200 for handling and initial review (or the amount of the fee, whichever is less), shall be returned. If an application is withdrawn by the applicant before significant Agency scientific review has begun, the fee, less $1,200, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be accompanied by the fee that would be required if it were submitted for the first time.
              (b) Waiver of fees for activities initiated by the Agency. The Agency may waive fees for amended registrations where the amendment has been initiated solely by the Agency. The Agency retains sole discretion in determining when this fee will be waived. The announcement of the fee waiver will accompany the EPA request for an amendment. The Agency will not approve any individual requests for waivers of EPA-initiated activity fees.
              (c) Waiver of fees for activities initiated by applicants. Upon request by an applicant, together with the supporting documentation or justification described in this paragraph, the Agency may waive or refund fees in whole or in part. A request for waiver must be submitted in accordance with § 152.414(a). An application for which a waiver of fees has been requested will not be accepted for review until the waiver has been granted, or until the waiver has been denied and thereafter the proper fee has been submitted.
              (1) Minor use. Fees may be waived for applications limited to minor uses that lack commercial feasibility for the pesticide applicant. An applicant requesting a waiver on this basis must provide supporting information that demonstrates that anticipated revenues from the uses that are the subject of the application would be insufficient to pay back the cost of the fee. The burden of proof of the reasonableness of this estimate rests with the applicant.
              (2) IR-4. Fees will be waived for registration actions that are determined to be specifically associated with tolerance petitions submitted by the Inter-Regional Research Project Number 4 (IR-4 program) when such waiver is deemed by the Agency to be in the public interest.
              (3) Severe economic impact. The Agency may waive two-thirds of any cumulative registration fee payment in a 12-month period following completion of the applicant's most recent fiscal year that exceeds 3 percent of the applicant's pesticide sales in its most recently completed fiscal year. An applicant requesting a waiver on this basis must provide documentation (e.g. copy of an annual report, or income tax forms filed with the Internal Revenue Service, or if needed, a notarized statement signed by a corporate officer regarding annual pesticide sales) demonstrating that:
              (i) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and a single fee would constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently completed fiscal year of operation, or
              (ii) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and the cumulative registration fees paid during the 12 months following the applicant's most recently completed fiscal year, including any registration fees paid for the applicant for which a waiver is requested, constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently concluded fiscal year of operation.
              (iii) The Agency will not grant such a waiver if it determines that the entity submitting the application has been formed or manipulated to qualify for such a waiver.
              (4) Public interest. The Agency, in its discretion, may waive in whole or in part any of the fees established herein in the public interest. Examples include, but are not limited to, pesticides offering unique advantages for reducing public health risks, those that significantly reduce a current environmental risk, or a product with extraordinary utility for use in Integrated Pest Management (IPM).
              [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]

              § 152.414
              Procedures.
              (a) Procedures for requesting a waiver. (1) A request for a waiver must be submitted in writing at the time the application is submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              (2) A payment of $1,200 for processing the waiver or the amount of the actual fee, whichever is less, must be submitted simultaneously to the address set forth in paragraph (b) of this section. This fee will be refunded (or applied to any resulting partial fee) if the waiver is granted. Payment of fees for the registration activities, in contrast to the waiver fee, shall not be required until the Agency makes a determination on the waiver request. Since the actual fee is submitted to an address different than the one to which the waiver request is submitted, a copy of the payment document must be submitted with the waiver request that is submitted to the Office of Pesticide Programs' Document Processing Desk as described in paragraph (a)(1) of this section. No fee is required from a person who has no financial interest in the application.
              (b) Procedures for payment of fees. All fees required by this section must be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All payment of fees must be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs (Registration Fees), P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be specifically labeled “Registration Fees” and should be accompanied only by a copy of the registration application form or the experimental use permit application form, as appropriate. An application will not be accepted for processing until the required fees have been submitted.
              (c) Procedures for submitting application and supporting data. The application, along with supporting data, shall be forwarded within 30 days of payment to the Washington DC address set forth in paragraph (a)(1) of this section.
              [53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

            Subparts V-Y [Reserved]

            Subpart Z—Devices

              § 152.500
              Requirements for devices.

              (a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.

              (b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy statement concerning its authority and activities with respect to devices, which was published in the Federal Register of November 19, 1976 (41 FR 51065). A device is subject to the requirements set forth in:
              (1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to labeling;
              (2) FIFRA sec. 7 and part 167 of this chapter, with respect to establishment registration and reporting;
              (3) FIFRA sec. 8 and part 169 of this chapter, with respect to books and records;
              (4) FIFRA sec. 9, with respect to inspection of establishments;
              (5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties;
              (6) FIFRA sec. 17, with respect to import and export of devices;
              (7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; and
              (8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to declare devices subject to certain provisions of the Act.
              [53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]

          Pt. 153
          PART 153—REGISTRATION POLICIES AND INTERPRETATIONS

              Subparts A-F [Reserved]

              Subpart G—Determination of Active and Inert Ingredients
              Sec.
              153.125
              Criteria for determination of pesticidal activity.

              Subpart H—Coloration and Discoloration of Pesticides
              153.140
              General.
              153.155
              Seed treatment products.

              Subparts I-M [Reserved]

            Authority:
            7 U.S.C. 136w.

            Subparts A-F [Reserved]

            Subpart G—Determination of Active and Inert Ingredients

              Source:
              53 FR 15989, May 4, 1988, unless otherwise noted.

              § 153.125
              Criteria for determination of pesticidal activity.
              (a) An ingredient will be considered an active ingredient if it is contained in a pesticide product and:
              (1) The ingredient has the capability by itself, and when used as directed at the proposed use dilution, to function as a pesticide; or
              (2) The ingredient has the ability to elicit or enhance a pesticidal effect in another compound whose pesticidal activity is substantially increased due to the interaction of the compounds. Compounds which function simply to enhance or prolong the activity of an active ingredient by physical action, such as stickers and other adjuvants, are not generally considered to be active ingredients.
              (b) Normally the applicant will determine and state in his application whether an ingredient is active or inert with respect to pesticidal activity. The Agency, as part of its review of an application for registration, or in conjunction with the Registration Standard or Special Review process, may require any ingredient, to be designated as an active ingredient if the Agency finds that it meets the criteria in paragraph (a) of this section. Conversely, the Agency may determine that any ingredient designated as active by an applicant is an inert ingredient if it fails to meet those criteria.
              (c) If an ingredient is designated as an active ingredient, it must be identified in the label ingredients statement. If an ingredient is designated as an inert ingredient, it must be included as part of the total inert ingredients in the label ingredients statement.

              (d) Designation of a substance as a pesticidally inert ingredient does not relieve the applicant or registrant of other requirements of FIFRA with respect to labeling of inert ingredients or submission of data, or from the requirements of the Federal Food, Drug, and Cosmetic Act with respect to tolerances or other clearance of ingredients.
              [53 FR 15989, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]

            Subpart H—Coloration and Discoloration of Pesticides

              Source:
              53 FR 15990, May 4, 1988, unless otherwise noted.

              § 153.140
              General.
              Section 25(c)(5) of the Act authorizes the Administrator to prescribe regulations requiring coloration or discoloration of any pesticide if the Administrator determines that such requirements are feasible and necessary for the protection of health and the environment. This subpart describes those pesticide products which must be colored or discolored.
              [60 FR 32096, June 19, 1995]

              § 153.155
              Seed treatment products.
              (a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to impart an unnatural color to the seed, unless appropriate tolerances or other clearances have been established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide.
              (b) The following products are exempt from the requirement of paragraph (a) of this section:
              (1) Products intended and labeled for use solely by commercial seed treaters, provided that the label bears a statement requiring the user to add an EPA-approved dye with the pesticide during the seed treatment process.
              (2) Products intended and labeled for use solely as at-planting or hopper box treatments.
              (3) Products which are gaseous in form or are used as fumigants.
              (c) EPA-approved dyes for seed treatment are listed in:
              (1) Sections 180.910, 180.920, and 180.950 if an exemption from the requirement of a tolerance has been established.
              (2) Section 180.2010 if EPA has determined that residues of the dye will be present, if at all, at levels that are below the threshold of regulation.
              (3) Section 180.2020 if it has been determined that no tolerance or exemption from the requirement of a tolerance is needed as a result of a determination by EPA that the use is unlikely to result in residues in food/feed.
              [53 FR 15990, May 4, 1988, as amended at 66 FR 66772, Dec. 27, 2001; 69 FR 23117, Apr. 28, 2004]

            Subparts I-M [Reserved]

          Pt. 154
          PART 154—SPECIAL REVIEW PROCEDURES

              Subpart A—General Provisions
              Sec.
              154.1
              Purpose and scope.
              154.3
              Definitions.
              154.5
              Burden of persuasion in determinations under this part.
              154.7
              Criteria for initiation of Special Review.
              154.10
              Petitions to begin the Special Review process.
              154.15
              Docket for the Special Review.

              Subpart B—Procedures
              154.21
              Preliminary notification to registrants and applicants for registration.
              154.23
              Proposed decision not to initiate a Special Review.
              154.25
              Public announcement of final decision whether to initiate a Special Review.
              154.26
              Comment opportunity.
              154.27
              Meetings with interested persons.
              154.29
              Informal public hearings.
              154.31
              Notices of Preliminary Determination.
              154.33
              Notice of Final Determination.
              154.34
              Expedited procedures.
              154.35
              Finality of determinations.

            Authority:
            7 U.S.C. 136a, d, and w.

            Source:
            50 FR 49015, Nov. 27, 1985, unless otherwise noted.

            Subpart A—General Provisions

              § 154.1
              Purpose and scope.
              (a) Purpose. The purpose of the Special Review process is to help the Agency determine whether to initiate procedures to cancel, deny, or reclassify registration of a pesticide product because uses of that product may cause unreasonable adverse effects on the environment, in accordance with sections 3(c)(6) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The process is intended to ensure that the Agency assesses risks that may be posed by pesticides, and the benefits of use of those pesticides, in an open and responsive manner. The issuance of a Notice of Special Review means that the Agency has determined that one or more uses of a pesticide may pose significant risks and that, following completion of the Special Review process, the Agency expects to initiate formal proceedings seeking to cancel, deny, reclassify, or require modifications to the registration of the product(s) in question unless it has been shown during the Special Review that the Agency's initial determination was erroneous, that the risks can be reduced to acceptable levels without the need for formal proceedings, or that the benefits of the pesticide's use outweigh the risks. Following completion of the Special Review process, a pesticide in question may be returned to the registration process.
              (b) Scope. This part sets forth the substantive standards for initiating a Special Review of a pesticide product and the procedures for initiating and conducting the Special Review.

              § 154.3
              Definitions.
              Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:

                Act or FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.

                Administrator means the Administrator of the Environmental Protection Agency or any officer or employee thereof to whom authority has been delegated to act for the Administrator.

                Confidential business information means trade secrets or confidential commercial or financial information under FIFRA section 10(b) or 5 U.S.C. 552(b)(3) or (4).

                Other significant evidence means factually significant information that relates to the uses of the pesticide and its adverse risk to man or to the environment but does not include evidence based only on misuse of the pesticide unless such misuse is widespread and commonly recognized practice.

                Person means an applicant, registrant, manufacturer, pesticide user, environmental group, labor union, or other individual or group of individuals interested in pesticide regulation.

                Pesticide use means a use of a pesticide (described in terms of the application site and other applicable identifying factors) that is included in the labeling of a pesticide product which is registered, or for which an application for registration is pending, and the terms and conditions (or proposed terms and conditions) of registration for the use.

                Terms and conditions of registration means the terms and conditions governing lawful sale, distribution, and use approved in conjunction with registration, including labeling, use classification, composition, and packaging.

                Validated test means a test determined by the Agency to have been conducted and evaluated in a manner consistent with accepted scientific procedures.
              [73 FR 75595, Dec. 12, 2008]

              § 154.5
              Burden of persuasion in determinations under this part.
              In making determinations under this part the Administrator shall be guided by the principle that the burden of persuasion that a pesticide product is entitled to registration or continued registration for any particular use or under any particular set of terms and conditions of registration is always on the proponent(s) of registration.

              § 154.7
              Criteria for initiation of Special Review.
              (a) The Administrator may conduct a Special Review of a pesticide use if he determines, based on a validated test or other significant evidence, that the use of the pesticide (taking into account the ingredients, impurities, metabolites, and degradation products of the pesticide):
              (1) May pose a risk of serious acute injury to humans or domestic animals.

              (2) May pose a risk of inducing in humans an oncogenic, heritable genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or delayed toxic effect, which risk is of concern in terms of either the degree of risk to individual humans or the number of humans at some risk, based upon:
              (i) Effects demonstrated in humans or experimental animals.
              (ii) Known or predicted levels of exposure of various groups of humans.
              (iii) The use of appropriate methods of evaluating data and relating such data to human risk.
              (3) May result in residues in the environment of nontarget organisms at levels which equal or exceed concentrations acutely or chronically toxic to such organisms, or at levels which produce adverse reproductive effects in such organisms, as determined from tests conducted on representative species or from other appropriate data.
              (4) May pose a risk to the continued existence of any endangered or threatened species designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act of 1973, as amended.
              (5) May result in the destruction or other adverse modification of any habitat designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act as a critical habitat for any endangered or threatened species.
              (6) May otherwise pose a risk to humans or to the environment which is of sufficient magnitude to merit a determination whether the use of the pesticide product offers offsetting social, economic, and environmental benefits that justify initial or continued registration.
              (b) In making any determination that a pesticide use satisfies one of the criteria for issuance of a Special Review specified by paragraph (a) of this section, the Administrator shall consider available evidence concerning both the adverse effect in question and the magnitude and scope of exposure of humans and nontarget organisms associated with use of the pesticide.

              § 154.10
              Petitions to begin the Special Review process.
              The Administrator may evaluate a pesticide use under the criteria of § 154.7 either on his own initiative, or at the suggestion of any interested person.

              § 154.15
              Docket for the Special Review.
              (a) Establishment of the docket. When the Agency first notifies registrants privately that it is considering issuance of a Notice of Special Review for a pesticide, it shall establish a docket concerning that particular pesticide.
              (b) Contents of the docket. For each pre-Special Review or Special Review, the docket shall contain:
              (1) The Notice of Special Review, any Notice of Preliminary Determination, and any Notice of Final Determination.
              (2) Any notice issued under § 154.21 or § 154.23.
              (3) Any documents (other than information claimed to be confidential business information) referred to by the Agency in those notices as relied upon by the Agency in reaching its determination.
              (4) Copies of all written comments or materials (other than information claimed to be confidential business information) responding to any notice furnished under § 154.21 or § 154.23 or submitted at any time during the Special Review process by any person outside of government.
              (5) Any written response to the Notice of Preliminary Determination from the Secretary of Agriculture or the Scientific Advisory Panel.
              (6) A transcript of all public meetings held by the Scientific Advisory Panel or conducted by the Agency for the purpose of gathering information.

              (7) A memorandum describing each meeting between Agency personnel and any person or party outside of government which concerns a pending pre-Special Review or Special Review decision. Each such memorandum shall be based on notes taken at the meeting and shall specify the date and time of the meeting, the participants and their affiliations, who requested the meeting, the subject matter of the meeting, and the person who prepared the memorandum. Except for information claimed to be confidential business information, each memorandum shall describe fully and accurately all significant positions taken, arguments made, and facts presented by each participant in the meeting, and shall identify all documents, proposals, or other materials distributed or exchanged at the meeting. Any discussion of claimed confidential business information shall be identified in meeting notes and referenced in the memorandum.
              (8) All comments, correspondence, or other materials concerning a pending pre-Special Review or Special Review decision provided to the Agency by a person or party outside of government (other than information claimed to be confidential business information).
              (9) All documents, proposals, or other materials concerning a pending pre-Special Review or Special Review decision, provided by the Agency to any person or party outside of government (other than information claimed to be confidential business information).
              (c) Assertion of confidential business information claims. (1) Information, comments, data, or other written material submitted to the Agency concerning a Special Review may be claimed by the submitter to be confidential business information. The burden of identifying claimed confidential business information rests with the submitter, or, in meetings, with the participants who wish to assert a claim of confidentiality.
              (2) To assert a claim of confidentiality for all or any part of a written submission concerning a Special Review, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the text. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.
              (3) Any written material concerning a Special Review received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.
              (d) Placement of materials in the docket. Any memorandum identified under paragraph (b)(7) of this section shall be placed in the docket within 10 working days of the subject meeting. Materials identified under paragraph (b)(8) of this section shall be placed in the docket within 10 working days of receipt by the Office of Pesticide Programs, or within 15 working days of receipt by the Office of Pesticide Programs if the submitter has asserted a confidential business information claim concerning the submittal. Materials identified under paragraph (b)(9) of this section shall be placed in the docket within 15 working days of transmittal to such person or party outside of government.
              (e) Index. The Agency shall prepare and maintain a current index of all materials included in the docket. The index will include a list identifying, for each meeting between Agency personnel and a person or party outside of government for which a memorandum has been prepared, the date, the subject, participants, and person who requested the meeting. The index will also list any document included in the docket by its title, its source, its recipient, and the date it was received or provided by the Agency.
              (f) Access to the docket. (1)(i) For each chemical in Special Review, the docket shall be available for public inspection and copying and its index kept current and made available to the public on request. The docket and index for any pesticide for which the Agency has issued a pre-Special Review notification under § 154.21 will only be made available for public inspection and copying following issuance of a proposed decision not to start a Special Review under § 154.23, a Notice of Special Review under § 154.25(c), or as otherwise specified in § 154.34.
              (ii) The docket and index will be available at the OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c).

              (2) Information contained in the docket shall not be disclosed to the public to the extent that FIFRA or any other statute or regulation (including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its disclosure.

              (3) The Agency will distribute a compendium of indices for new materials in the public docket by mail, on a monthly basis, to those members of the public who have specifically requested such material. The Agency will announce the availability of docket indices both annually in the Federal Register and in each Federal Register Notice concerning pre-Special Review or Special Review for specific pesticides. The Agency may also periodically require parties on the mailing list to renew their previous request for such materials.
              [50 FR 49015, Nov. 27, 1985, as amended at 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

            Subpart B—Procedures

              § 154.21
              Preliminary notification to registrants and applicants for registration.
              (a) Preliminary notification. If the Administrator decides that he may initiate a Special Review of a pesticide use, he shall send written notice by certified mail to the affected registrant(s) and applicant(s) setting forth his decision and a general description of the information which supports it.
              (b) Comment opportunity. Registrant(s) and applicant(s) will be allowed 30 days from the receipt of notification to respond in writing to dispute the validity of the Agency's conclusions or to present information in response to the notification.

              § 154.23
              Proposed decision not to initiate a Special Review.

              If the Administrator proposes not to initiate a Special Review after having given notice under § 154.21, he shall issue a proposed decision for publication in the Federal Register. The proposal shall include a description of the concerns which were the original basis for placement of the pesticide in pre-Special Review status and the Agency's rationale for its proposed decision, announce the availability of a public docket, and provide a period generally not less than 30 days for submission of comments. A notice under § 154.25(b) may not be published unless it has been preceded by a notice under this section. A proposal under this section shall not be based on the benefits of use of a pesticide product.

              § 154.25
              Public announcement of final decision whether to initiate a Special Review.

              (a) The Administrator shall evaluate the available information and the comments received in response to the notice under § 154.21 and any notice issued under § 154.23, and shall issue for publication in the Federal Register a notice under paragraph (b) or (c) of this section.

              (b) If the Administrator determines after having given notice under § 154.21 not to initiate a Special Review, he shall issue his decision for publication in the Federal Register with a statement of reasons.

              (c) If the Administrator determines after having given notice under § 154.21 that one or more of the risk criteria set forth in § 154.7 have been satisfied, the Agency shall issue a notice for publication in the Federal Register which shall include:
              (1) Identification of the pesticide uses for which a Special Review has been initiated and an identification of the criteria which have been satisfied.
              (2) A brief discussion of the Agency's reasons for determining that the criteria have been satisfied.
              (3) A statement indicating that EPA has established a docket for the Special Review, the contents of the docket, the location of the docket, and the times during which the docket will be available for inspection and copying.
              (4) An invitation to all interested persons to submit further information concerning the risks and benefits associated with each use of the pesticide subject to the Special Review.
              (5) A brief description of the Special Review process and a statement that registrants and applicants bear an affirmative burden of supporting registration of a pesticide product.
              (6) A date by which information in response to the Agency's request for further information must be submitted.
              (d) In his discretion, the Administrator may request that the Scientific Advisory Panel hold a public meeting to review the scientific issues related to the Special Review.

              § 154.26
              Comment opportunity.
              After issuance of a Notice of Special Review that applies to a use of a pesticide product (or category of products), any person may submit to the Agency any information, argument, or both, pertinent to:
              (a) Whether the use of a pesticide product satisfies any of the § 154.7 risk criteria, with respect to the composition, labeling, packaging, and restrictions on use of the product as currently registered.
              (b) Whether the use of a pesticide product would satisfy any of the § 154.7 risk criteria if its composition, labeling, packaging, and restrictions on use were approved in accordance with an application for registration or amended registration pending before the Agency. For further information see § 154.27(b).
              (c) Whether any risks posed by the use or proposed use of the product that satisfy the § 154.7 risk criteria are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product.
              (d) What regulatory action, if any, the Agency should take with respect to the use of the product.

              § 154.27
              Meetings with interested persons.
              (a) In the Special Review process, to assure openness and responsiveness, no person or party outside of government will be afforded special or preferential access to Agency Special Review decisionmakers or to the Agency's Special Review process. At the same time, however, Agency personnel are free to meet and otherwise communicate with persons or parties outside of government, including registrants and manufacturers, users, trade unions, environmental groups and other interested persons, to obtain information, exchange views, explore factual and substantive positions, or discuss regulatory options concerning Special Review decisions.
              (b) Meetings between EPA and any person or party outside of government will not result in undue delay in reaching Special Review decisions. During such meetings, the Agency will not commit to take any particular action concerning a pending decision. The Agency may receive and consider information and recommendations from persons or parties outside of government; however, the Agency will make the final administrative decision on a wholly independent basis and in accordance with law.
              (c) Any interested person may ask to meet with Agency officials to discuss factual information available to the Agency, to present any factual information, to respond to presentations by other persons, or to discuss what regulatory actions should be taken regarding a pesticide which is or may be the subject of a Special Review. If, at its discretion, the Agency holds such meetings with any person outside of government concerning a use of a pesticide product, the Agency will prepare and file in the docket a memorandum of such meeting, meeting the requirements specified in § 154.15(b)(7).
              (d) Meetings described in this section may include meetings held after issuance of a Notice of Special Review with any registrant who proposes to change voluntarily the composition, packaging, and labeling, or other terms and conditions of registration of his pesticide product in a way which he believes would reduce the risks of use of the product so that it would no longer meet or exceed the risk criteria of § 154.7. Meetings for this purpose will be most helpful and productive for both registrants and the Agency if they are requested by registrants shortly after the issuance of the Notice of Special Review.

              (e) If the Agency meets with any person or party outside of government concerning a pending Special Review decision, the Agency will not issue a final Special Review decision until 30 days after inclusion of a memorandum concerning that meeting in the public docket. During those 30 days, any person or party may submit written comments to the Agency regarding the subject matter of the meeting in question. The Agency may issue a final Special Review decision without allowing this 30-day period if expedited action is necessary to protect public health or the environment, or if the Agency has invited other parties with potentially opposing viewpoints to the meeting in question (e.g., registrants, users, labor, and environmental groups).
              (f) The Agency may decline to meet subsequently with any person or party who asserts unreasonable confidential business information claims pursuant to § 154.15(c) for the purpose of circumventing the docketing procedures described in § 154.15(b).

              § 154.29
              Informal public hearings.
              (a) Timing. At any time after issuance of a Notice of Special Review and prior to issuance of a Notice of Final Determination, the Administrator may conduct an informal public hearing to gather relevant information or otherwise assist Agency decisionmaking.
              (b) Federal Register notice. The Administrator shall issue a notice for publication in the Federal Register of any informal public hearing to be held under this section. The notice shall contain the following information:
              (1) The time, date, and place of the hearing.
              (2) A brief description of the procedures governing participation in the hearing by interested persons.
              (3) The issues to be considered at the hearing.
              (c) Transcript. A verbatim transcript of the hearing shall be prepared and filed in the public docket.

              § 154.31
              Notices of Preliminary Determination.
              The Administrator shall prepare a Notice of Preliminary Determination after the close of the comment period on a Notice of Special Review.
              (a) Contents of notice. The Notice of Preliminary Determination shall respond to all significant comments submitted in response to the Notice of Special Review. For each use of a pesticide product that was the subject of the Notice of Special Review, the Notice of Preliminary Determination shall also include, as appropriate:
              (1) A determination whether the use satisfies any of the risk criteria set forth in § 154.7, and a discussion of the reasons for the determination.
              (2) A determination of whether any changes in the composition, packaging, labeling, or restrictions on use of a pesticide product that were proposed in an application for new or amended registration submitted after issuance of the Notice of Special Review would reduce the risk so that the use no longer would satisfy any of the risk criteria in § 154.7.
              (3) If the use satisfies any of the risk criteria set forth in § 154.7, a determination of whether the adverse effects posed by the use are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product, and a discussion of reasons for the determination.
              (4) If the use is determined to pose an unreasonable adverse effect, a statement of the regulatory action, if any, which the Agency intends to initiate with respect to the use, and a discussion of the reasons for initiating that regulatory action.
              (5) A statement that the Administrator is requesting comments from the Secretary of Agriculture and the Scientific Advisory Panel on the notices and analysis specified in paragraph (b) of this section, and that the notices and analysis are available on request.
              (6) Instructions to interested persons on how to submit comments (including the deadline for submission of comments).
              (7) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.
              (b) Referral to Secretary of Agriculture and Scientific Advisory Panel. If the Administrator proposes to cancel, deny, or change the classification of the registration of a pesticide product which is the subject of a Special Review, or to hold a hearing under FIFRA section 6(b)(2) on whether to take any of those actions, he shall:
              (1) Prepare a proposed form of a Notice of Intent to Cancel, a Notice of Intent to Deny Registration, a Notice of Intent to Hold a Hearing, and/or a Notice of Intent to Change Classification, as appropriate.

              (2) Prepare an Agricultural Impact Analysis, analyzing the impact of the proposed action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy.

              (3) Send the proposed notices and analysis to the Secretary of Agriculture and the Scientific Advisory Panel for comment, as provided by the Act.
              (4) Send the Notice of Preliminary Determination and the other notices and analysis prepared under this section to all registrants and applicants for registration of products that are subject to the Special Review.
              (c) Publication. The Agency shall issue the Notice of Preliminary Determination for publication in the Federal Register.

              § 154.33
              Notice of Final Determination.
              (a) Publication and notice to registrants and applicants. The Administrator shall prepare a Notice of Final Determination after the close of the comment period on a Notice of Preliminary Determination. As necessary, the Administrator shall also prepare Notices of Intent to Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under FIFRA section 6(b)(2), or Notices of Intent to Change Classification.
              (b) Contents. The Notice of Final Determination shall include:
              (1) For each pesticide use subject to the Notice of Preliminary Determination, the Agency's final determination with respect to each use, along with a discussion of the reasons for the determination.
              (2) Any comments submitted by the Secretary of Agriculture or the Scientific Advisory Panel, and the responses of the Administrator to these comments.
              (3) The response of the Administrator to any significant public comments submitted on the Notice of Preliminary Determination.
              (4) Instructions to registrants, applicants for registration, and other interested persons concerning the procedures which will be used to implement any regulatory action which the Administrator has decided upon, including instructions concerning how to request hearings, if hearings are available as of right under the Act or have been made available by the Administrator under the Act.
              (5) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.
              (c) Publication and notification of registrants and applicants. The Notice of Final Determination and any Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification shall be published in the Federal Register. If the Administrator issues a Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification, such notice, along with the Notice of Final Determination, also shall be sent by certified mail to all affected registrants and applicants.

              § 154.34
              Expedited procedures.
              (a) The Agency may elect to issue a Notice of Special Review and a Notice of Preliminary Determination simultaneously; or, to initiate cancellation, suspension, or denial proceedings concerning a pesticide or any of its uses without first conducting a Special Review or issuing a Notice of Preliminary Determination.
              (b) If the Agency elects to issue a simultaneous Notice of Special Review and Notice of Preliminary Determination, the Agency will make the docket for that decision available for public inspection no more than 3 months after the Agency privately notifies the registrant of its risk concerns pursuant to § 154.21(a).

              § 154.35
              Finality of determinations.
              (a) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:
              (1) The application proposes registration of a product for a use which earlier had been the subject of a notice under § 154.21(a);

              (2) After the Administrator issued the notice, he determined not to initiate a Special Review, because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for a Special Review; and

              (3) The application for registration or amended registration now proposes that the terms and conditions which served as the basis of the earlier determination be eliminated, or be modified in a way which might increase the risk which was the subject of the notice under § 154.21(a).
              (b) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:
              (1) The application proposed registration of a product for a use which earlier had been the subject of a Notice of Special Review issued under § 154.25;
              (2) After the Administrator issued that Notice, he determined not to issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for issuance of a notice under FIFRA section 3(c)(6) or 6(b); and
              (3) The application for registration or amended registration now proposes that the terms and conditions of registration which served as the basis for the earlier determination now be eliminated or be modified in a way which might increase the risk which was the subject of the Notice of Special Review.
              (c) An application to which paragraph (a) or (b) of this section applies may not be approved until:

              (1) The Administrator issues a notice for publication in the Federal Register which describes why the application is subject to the provisions of this section, states that the Administrator proposes to approve the application and his reasons, solicits public comment on whether the application should be approved, and provides a period not less than 30 days for comments to be submitted; and

              (2) If any substantive comments are submitted in response to the notice, the Administrator issues a second notice for publication in the Federal Register responding to the comments.

          Pt. 155
          PART 155—REGISTRATION STANDARDS AND REGISTRATION REVIEW

              Subpart A [Reserved]

              Subpart B—Docketing and Public Participation Procedures
              Sec.
              155.23
              Definitions.
              155.25
              Schedule.
              155.27
              Agency review of data.
              155.30
              Meetings and communications.
              155.32
              Public docket.
              155.34
              Notice of availability.

              Subpart C—Registration Review Procedures
              155.40
              General.
              155.42
              Registration review cases.
              155.44
              Establish schedules for registration review.
              155.46
              Deciding that a registration review is complete and additional review is not needed.
              155.48
              Data Call-In.
              155.50
              Initiate a pesticide's registration review.
              155.52
              Stakeholder engagement.
              155.53
              Conduct of a pesticide's registration review.
              155.56
              Interim registration review decision.
              155.57
              Registration review decision.
              155.58
              Procedures for issuing a decision on a registration review case.

            Authority:
            7 U.S.C. 136a and 136w.

            Source:
            50 FR 49001, Nov. 27, 1985, unless otherwise noted.

            Subpart A [Reserved]

            Subpart B—Docketing and Public Participation Procedures

              § 155.23
              Definitions.
              For the purposes of this part, confidential business information means trade secrets or confidential commercial or financial information under FIFRA sec. 10(b) or 5 U.S.C. 552(b) (3) or (4).

              § 155.25
              Schedule.
              EPA will issue annually in the Federal Register a notice listing the pesticides (or groups of pesticides) for which Registration Standards are currently being developed. The list will include pesticides for which a Registration Standard is scheduled for issuance within the next year, and the approximate sequence of issuance. The list may also include pesticides for which a Registration Standard will be under development during the upcoming year, but which are not scheduled for issuance until the succeeding year. The notice will invite comment and submission of information on the individual pesticides on the list.

              § 155.27
              Agency review of data.
              EPA will independently (or using the services of disinterested contractors or consultants) review available data in preparation for the development of a Registration Standard, and will be responsible for the drafting of the Registration Standard based on such data reviews. The Agency will not permit registrants to prepare, or assist in the preparation of, data reviews or other Registration Standard documents. The Agency may, however, meet with registrants to discuss its pending reviews, decisions, or documents, in accordance with the meeting procedures in § 155.30, and the docketing procedures in § 155.32.

              § 155.30
              Meetings and communications.
              EPA personnel may, upon their own initiative or upon request of any interested person or party, meet or communicate with persons or parties outside of government concerning a Registration Standard under development. Such meetings or communications will conform to the following policies and procedures:
              (a) Purpose. Meetings and communications may be for the purpose of receiving and considering information, exchanging views, exploring factual and substantive positions, discussing regulatory options or for any other purpose deemed appropriate by the Agency in its deliberations concerning development of a Registration Standard. The Agency will not commit to take any particular action concerning a Registration Standard under development during discussions with any person or party outside of government. The Agency will make its final administrative decision on a wholly independent basis, and in accordance with law.
              (b) Meetings with persons or parties outside of government. Requests by responsible persons or parties outside of government to meet with Agency personnel concerning a Registration Standard under development should be directed in writing to the Registration Division. Reasonable requests will ordinarily be granted on a timely basis. EPA will decide the time and place of such meetings, and the Agency personnel who will attend. EPA may decline to meet with persons or parties who assert unreasonable claims of confidential business information for the purpose of circumventing the docketing procedures in § 155.32. EPA may also decline to meet if the number or frequency of meetings would delay unduly the issuance of the Registration Standard. Further, no person or party outside government will be accorded special or preferential access to Agency pesticide decisionmaking or to the Agency's decisional process.
              (c) Information submitted to the Agency concerning a Registration Standard under development. (1) Information, comments, data, or other written material submitted to the Agency at any time concerning a Registration Standard under development may be claimed by the submitter to be confidential business information. The burden of identifying claimed confidential business information rests with the submitter, or, in meetings, with the participants from outside of government who wish to assert a claim of confidentiality.

              (2) To assert a claim of confidentiality for all or any part of a written submission concerning a Registration Standard under development, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the document. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.
              (3) Any written material received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.
              (d) Memorandum of meeting. For each meeting with a person or party outside of government, the Agency will prepare, based on notes taken at the meeting, a memorandum of the meeting. The memorandum will be prepared within 10 working days of the meeting and will include all of the following information:
              (1) The date and time of the meeting.
              (2) The name of the person who requested the meeting.
              (3) The names and affiliations of the participants.
              (4) The subject matter of the meeting.
              (5) A full and accurate description of all significant positions taken, facts presented, and arguments made by each participant (except that any discussion of claimed confidential business information will be identified in meeting notes, and referenced in the memorandum).
              (6) Identification of all documents, proposals, or other materials (other than information claimed to be confidential business information) distributed or exchanged at the meeting.
              (7) The name of the person who prepared the memorandum.
              [50 FR 49001, Nov. 27, 1985, as amended at 58 FR 34203, June 23, 1993]

              § 155.32
              Public docket.
              (a) When created. (1) A docket will be created for each Registration Standard under development when the Agency begins review of data for the Registration Standard or upon publication of the notice described in § 155.25 setting out the list and sequence of Registration Standards, whichever is earlier. The Agency will announce in its annual schedule notice the dockets that are available for Registration Standards under development.
              (2) If the Agency notifies registrants privately in accordance with 40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7 (leading to a special review) may have been exceeded, that notification and any subsequent communications concerning that notification will be placed in a separate docket pertaining to possible special review in accordance with the provisions of § 154.15.
              (b) Contents of docket. The docket will contain, within the time frames indicated, all of the following documents and information (except that information claimed to be confidential business information will not be included):
              (1) An index of its contents (refer to paragraph (c) of this section).
              (2) A copy of each comment received in response to the notice described in § 155.25 that pertains to a pesticide for which the notice indicated a Registration Standard was under development (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).
              (3) A copy of each memorandum of a meeting between the Agency and persons or parties outside of government, prepared in accordance with § 155.30(d) (within 10 working days after the meeting).
              (4) A copy of each document, comment, item of correspondence or other written material concerning the Registration Standard submitted to the Agency by any person or party outside of government, whether in a meeting or separately (within 10 working days after receipt, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).
              (5) A copy of each document, proposal, or other item of written material concerning the Registration Standard provided by the Agency to any person or party outside of government (within 15 working days after the item is made available to such person or party).
              (6) A copy of the Registration Standard;

              (7) With respect to a Registration Standard for which the Agency has determined that a substantially complete chronic health and teratology data base exists, a copy of the Federal Register notice concerning availability of a proposed Registration Standard, and a copy of each comment received in response to that notice (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).
              (8) A copy of the Federal Register notice announcing the issuance of the Registration Standard (within 10 working days after the publication of the notice).
              (c) Index of the docket. The Agency will establish and keep current an index to the docket for each Registration Standard. The index will include, but is not limited to:
              (1) A list of each meeting between the Agency and any person or party outside of government, containing the date and subject of the meeting, the names of participants and the name of the person requesting the meeting.
              (2) A list of each document in the docket by title, source or recipient(s), and the date the document was received or provided by the Agency.
              (d) Availability of docket and indices. (1) The Agency will make available to the public for inspection and copying the docket and index for any Registration Standard.
              (2) The Agency will establish and maintain a mailing list of persons who have specifically requested that they receive indices for Registration Standard dockets. On a quarterly basis, EPA will distribute the indices of new materials placed in the public docket to these persons. Annually, EPA will require that persons on the list renew their requests for inclusion on the list.
              (3) The Agency will issue annually in the Federal Register (in conjunction with the annual schedule notice specified in § 155.25) a notice announcing the availability of docket indices.
              (4) Each Federal Register notice of availability of a Registration Standard will announce the availability of the docket index for that Standard.

              § 155.34
              Notice of availability.
              (a) The Agency will issue in the Federal Register a notice announcing the issuance and availability of Registration Standard which:
              (1) Concerns a previously unregistered active ingredient; or
              (2) Concerns a previously registered active ingredient, and the Registration Standard states that registrants will be required (under FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not limited to, chronic feeding, oncogenicity and reproduction) or teratology studies.
              (b) Interested persons may submit comments concerning any Registration Standard described by paragraph (a) of this section at any time.
              (c) The Agency will issue in the Federal Register a notice announcing the availability of, and providing opportunity for comment on, each proposed Registration Standard which concerns a previously registered active ingredient for which the Agency has determined that a substantially complete chronic health and teratology data base exists. Following the comment period and issuance of the Registration Standard, the Agency will issue in the Federal Register a notice of availability of the Registration Standard.

            Subpart C—Registration Review Procedures

              Source:
              71 FR 45732, Aug. 9, 2006, unless otherwise noted.

              § 155.40
              General.
              (a) Purpose. These regulations establish procedures for the registration review program required in FIFRA section 3(g). Registration review is the periodic review of a pesticide's registration to ensure that each pesticide registration continues to satisfy the FIFRA standard for registration. Under FIFRA section 3(g), each pesticide is required to be reviewed every 15 years.

              (1) Among other things, FIFRA requires that a pesticide generally will not cause unreasonable adverse effects on the environment. Registration review is intended to ensure that each pesticide's registration is based on current scientific and other knowledge regarding the pesticide, including its effects on human health and the environment.
              (2) If a product fails to satisfy the FIFRA standard for registration, the product's registration may be subject to cancellation or other remedies under FIFRA.
              (b) Applicability. This subpart applies to every pesticide product registered under FIFRA section 3 as well as all pesticide products registered under FIFRA section 24(c). It does not apply to products whose sale or distribution is authorized under FIFRA section 5 or section 18.
              (c) Limitations. (1) At any time, the Agency may undertake any other review of a pesticide under FIFRA, irrespective of the pesticide's past, ongoing, scheduled, or not yet scheduled registration review.
              (2) When the Agency determines that new data or information are necessary for a pesticide's registration review, it will require such data under FIFRA section 3(c)(2)(B).
              [71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75595, Dec. 12, 2008]

              § 155.42
              Registration review cases.
              (a) Establishing registration review cases. A registration review case will be composed of one or more active ingredients and all the products containing such ingredient(s). The Agency may group related active ingredients into a registration review case when the active ingredients are so closely related in chemical structure and toxicological profile as to allow common use of some or all required data for hazard assessment.
              (1) Existing pesticides. The Agency will assign each pesticide registered on or before the effective date of this regulation to a registration review case.
              (2) New pesticides. The Agency will assign each pesticide registered after the effective date of this regulation to an existing registration review case or to a new registration review case.
              (3) A pesticide product that contains multiple active ingredients will belong to the registration review cases for each of its active ingredients.
              (b) Modifying registration review cases. New data or information may suggest that a registration review case should be modified. The Agency may modify a registration review case in the following ways:
              (1) Add a new active ingredient to a registration review case. The Agency may determine that a new active ingredient is chemically and toxicologically similar to active ingredients in an existing registration review case and should be grouped with the ingredients in the existing registration review case.
              (2) Split a registration review case into two or more registration review cases. For example, new data or information may suggest that active ingredients in a registration review case are not as similar as previously believed and that they belong in two or more separate registration review cases.
              (3) Move an ingredient from one registration review case to another. For example, new data or information might suggest that an ingredient should not be grouped with the other ingredients in the registration review case and that it belongs in a different registration review case.
              (4) Merge two or more registration review cases into a single registration review case. For example, new data or information might suggest that the active ingredients in two or more registration review cases should be grouped together for registration review.
              (5) Delete an active ingredient from a registration review case. For example, the Agency will remove the ingredient from the case if the registrations of all products containing an active ingredient in a registration review case are canceled.
              (c) Closing a registration review case. The Agency will close a registration review case if all products in the case are canceled.
              (d) Establishing a baseline date for a registration review case. For the purpose of scheduling registration reviews, the Agency will establish a baseline date for each registration review case. In general, the baseline date will be the date of initial registration of the oldest pesticide product in the case or the date of reregistration, whichever is later. For the purpose of these procedures, the date of reregistration is the date on which the Reregistration Eligibility Decision or Interim Reregistration Decision was signed, whichever date the Agency determines to be more appropriate based on the comprehensiveness of the review.
              (1) The Agency generally will not change the baseline date for a registration review case when it modifies a case by adding or deleting ingredients or products.
              (2) When the Agency splits a registration review case into two or more cases, the new case(s) generally will have the baseline date of the original registration review case.
              (3) When the Agency merges two or more registration review cases into a single case, the Agency generally will use the earliest baseline date as the baseline date for the new case.
              (e) Announcing registration review cases and baseline dates. The Agency will maintain a list of registration review cases, including baseline dates, on its website.

              § 155.44
              Establish schedules for registration review.
              The Agency will develop schedules for registration review that are generally based on the baseline date of the registration review case or on the date of the latest registration review of the registration review case. The Agency may also take into account other factors, such as achieving process efficiencies by reviewing related cases together, when developing schedules for registration review. The Agency will maintain schedules for the current year and at least two subsequent years on its website.

              § 155.46
              Deciding that a registration review is complete and additional review is not needed.

              The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in § 155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the Federal Register announcing the availability of the proposed decision and provide a comment period of at least 60 calendar days. The Agency will publish a notice in the Federal Register announcing the availability of a final version of the decision, an explanation of any changes to the proposed decision and its response to any comments. The date of the final notice of availability would be used as the date of the latest registration review for the purpose of scheduling subsequent registration reviews.

              § 155.48
              Data Call-In.
              The Agency may issue a Data Call-In notice under FIFRA section 3(c)(2)(B) at any time if the Agency believes that the data are needed to conduct the registration review. The provisions in FIFRA section 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, compensation, and exemption of data required to conduct a registration review.

              § 155.50
              Initiate a pesticide's registration review.
              The Agency will initiate a pesticide's registration review by establishing a docket for each registration review case, except for cases covered under § 155.46, and opening it for public review.
              (a) Contents of the registration review case docket. The Agency will place in this docket information that will assist the public in understanding the types of information and issues that the Agency may consider in the course of the registration review. The Agency may include information from its files including, but not limited to, the following information:
              (1) An overview of registration review case status;

              (2) A list of current registrations and registrants, any Federal Register notices regarding pending registration actions, and current or pending tolerances;
              (3) Risk assessment documents;
              (4) Bibliographies concerning current registrations;
              (5) Summaries of incident data; and

              (6) Any other pertinent data or information.
              (b) Public review of the registration review case docket. The Agency will publish a notice in the Federal Register announcing the availability for public review of the information described in paragraph (a) of this section and establishing a comment period of at least 60 days. During this comment period, interested persons may identify any additional information they believe the Agency should consider in the course of the registration review.
              (c) Submission of data and other information during the comment period. The Agency may identify, either in the notice published under paragraph (b) of this section, or at any other time, data or information that it does not have but which may be useful, if available, for consideration in the registration review. Any person may submit data or information in response to such identification. In order to be considered during a pesticide's registration review, the submitted data or information must meet the requirements listed below.
              (1) In order to ensure that the Agency will consider data or information in the conduct of a registration review, interested persons must submit the data or information during the comment period established in the notice described in paragraph (b) of this section. The Agency may, at its discretion, consider data or information submitted at a later date.
              (2) The data or information must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
              (3) Submitters must clearly identify the source of any submitted data or information.
              (4) Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
              (d) For the purposes of this subpart, the provisions of subpart B do not apply.

              § 155.52
              Stakeholder engagement.
              In addition to the public participation opportunities described in § 155.50 and § 155.53(c), the Agency may meet with stakeholders regarding a forthcoming or ongoing registration review. For example, before conducting a pesticide's registration review, the Agency may consult with registrants or pesticide users regarding the use and usage of the pesticide. The Agency may consult with registrants, pesticide users, or other persons during a pesticide's registration review with regard to developing risk management options for a pesticide. The Agency may informally consult with officials of Federal, State or Tribal agencies regarding a forthcoming or ongoing registration review.
              (a) Minutes of meetings with persons outside of government. Subject to paragraph (c) of this section, if the Agency meets with one or more individuals that are not government employees to discuss matters relating to a registration review, the Agency will place in the docket a list of meeting attendees, minutes of the meeting, and any documents exchanged at the meeting, not later than the earlier of:
              (1) 45 days after the meeting; or
              (2) The date of issuance of the registration review decision.
              (b) Exchange of documents or other written material. In the course of a meeting with a person outside of government, the Agency or that person may provide the other with a copy of a document or other written material that has not yet been released to the public. The Agency will place a copy of any such document or other written material in the docket along with the minutes of the meeting where the materials were exchanged.
              (c) Confidential business information. The Agency will identify, but not include in the docket, any confidential business information whose disclosure is prohibited by FIFRA section 10.
              [71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75596, Dec. 12, 2008]

              § 155.53
              Conduct of a pesticide's registration review.
              The Agency will review data and information described in § 155.50(a), (b), and (c) or submitted in response to a Data Call-In notice that it believes should be considered in the pesticide's registration review.
              (a) Assess changes since a pesticide's last review. The Agency will assess any changes that may have occurred since the Agency's last registration decision in order to determine the significance of such changes and whether the pesticide still satisfies the FIFRA standard for registration. The Agency will consider whether to conduct a new risk assessment to take into account, among other things, any changes in statutes or regulations, policy, risk assessment procedures or methods, or data requirements. The Agency will consider whether any new data or information on the pesticide, including any data or information submitted under § 155.50 or in response to a Data Call-In notice, warrant conducting a new risk assessment or a new risk/benefit assessment. The Agency will also consider whether any new data or information regarding an individual pesticide product, including any data or information submitted under § 155.50 or in response to a Data Call-In notice, such as data or information about an inert ingredient in the pesticide product or other information or data relating to the composition, labeling or use of the pesticide product, warrant additional review of a pesticide product's registration.
              (b) Conduct new assessments as needed. (1) Active ingredient(s) in the registration review case. If the Agency finds that a new assessment of the pesticide is needed, it will determine whether it can base the new assessment on available data or information, including data or information submitted under § 155.50 or in response to a Data Call-In notice. If sufficient data or information are available, the Agency will conduct the new risk assessment or risk/benefit assessment. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B).
              (2) Individual product registrations. If the Agency finds that additional review of an individual product's registration is needed, it will review the pesticide product label, confidential statement of formula, product-specific data, or other pertinent data or information, as appropriate, to determine whether the registration of the individual product meets the FIFRA standard for registration. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B).
              (c) Public participation during a pesticide's registration review. The Agency will generally make available for public review and comment a draft risk assessment for a pesticide if a new risk assessment has been conducted. The Agency will publish a notice in the Federal Register announcing the availability of the draft risk assessment and provide a comment period of at least 30 calendar days. The Agency will publish a notice in the Federal Register announcing the availability of a revised risk assessment, an explanation of any changes to the proposed document, and its response to comments. If the revised risk assessment indicates risks of concern, the Agency may, in the notice announcing the availability of the revised risk assessment, provide a comment period of at least 30 calendar days for the public to submit suggestions for mitigating the risk identified in the revised risk assessment.
              (1) The Agency might not request comments on a draft risk assessment in cases where the Agency's initial screening of a pesticide indicates that it has low use/usage, affects few if any stakeholders or members of the public, poses low risk, and/or requires little or no risk mitigation. In such cases, the Agency will make a draft risk assessment available for public review and comment when it issues a proposed decision on the registration review case.
              (2) If the Agency finds that it is not necessary to conduct a new risk assessment, it will issue a proposed decision on the registration review case as described in § 155.58.

              § 155.56
              Interim registration review decision.
              The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. A FIFRA 3(c)(2)(B) notice requiring the needed data or information may precede, accompany, or follow issuance of the interim registration review decision. The Agency will follow procedures in § 155.58 when issuing an interim registration review decision.

              § 155.57
              Registration review decision.
              A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA.

              § 155.58
              Procedures for issuing a decision on a registration review case.
              (a) The Agency will publish a notice in the Federal Register announcing the availability of a proposed registration review decision or a proposed interim registration review decision. At that time, the Agency will place in the pesticide's registration review docket the Agency's proposed decision and the bases for the decision. There will be a comment period of at least 60 calendar days on the proposed decision.
              (b) In its proposed decision, the Agency will, among other things:
              (1) State its proposed findings with respect to the FIFRA standard for registration and describe the basis for such proposed findings.
              (2) Identify proposed risk mitigation measures or other remedies as needed and describe the basis for such proposed requirements.
              (3) State whether it believes that additional data are needed and, if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or final decision on the registration review case or a proposed or final interim decision on a registration review case.
              (4) Specify proposed labeling changes; and
              (5) Identify deadlines that it intends to set for completing any required actions.

              (c) After considering any comments on the proposed decision, the Agency will issue a registration review decision or interim registration review decision. This decision will include an explanation of any changes to the proposed decision and the Agency's response to significant comments. The Agency will publish a notice in the Federal Register announcing the availability of a registration review decision or interim registration review decision. The registration review case docket will remain open until all actions required in the final decision on the registration review case have been completed.
              (d) If the registrant fails to take the action required in a registration review decision or interim registration review decision, the Agency may take appropriate action under FIFRA.

          Pt. 156
          PART 156—LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES

              Subpart A—General Provisions
              Sec.
              156.3
              Definitions.
              156.10
              Labeling requirements.

              Subparts B-C [Reserved]

              Subpart D—Human Hazard and Precautionary Statements
              156.60
              General.
              156.62
              Toxicity Category.
              156.64
              Signal word.
              156.66
              Child hazard warning.
              156.68
              First aid statement.
              156.70
              Precautionary statements for human hazards.
              156.78
              Precautionary statements for physical or chemical hazards.

              Subpart E—Environmental Hazard and Precautionary Statements
              156.80
              General.
              156.85
              Non-target organisms.

              Subparts F-G [Reserved]

              Subpart H—Container Labeling
              156.140
              Identification of container types.
              156.144
              Residue removal instructions—general.
              156.146
              Residue removal instructions for nonrefillable containers—rigid containers with dilutable pesticides.
              156.156
              Residue removal instructions for refillable containers.
              156.159
              Compliance date.

              Subparts I-J [Reserved]

              Subpart K—Worker Protection Statements
              156.200
              Scope and applicability.
              156.203
              Definitions.
              156.204
              Modification and waiver of requirements.
              156.206
              General statements.
              156.208
              Restricted-entry statements.
              156.210
              Notification-to-workers statements.
              156.212
              Personal protective equipment statements.

            Authority:
            7 U.S.C. 136-136y.

            Subpart A—General Provisions

              § 156.3
              Definitions.
              Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this part, the following terms shall have the meanings set forth below.

                Dilutable means that the pesticide product's labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application or use.

                Transport vehicle means a cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode.
              [73 FR 64224, Oct. 29, 2008]

              § 156.10
              Labeling requirements.
              (a) General—(1) Contents of the label. Every pesticide product shall bear a label containing the information specified by the Act and the regulations in this part. The contents of a label must show clearly and prominently the following:
              (i) The name, brand, or trademark under which the product is sold as prescribed in paragraph (b) of this section;
              (ii) The name and address of the producer, registrant, or person for whom produced as prescribed in paragraph (c) of this section;
              (iii) The net contents as prescribed in paragraph (d) of this section;
              (iv) The product registration number as prescribed in paragraph (e) of this section;
              (v) The producing establishment number as prescribed in paragraph (f) of this section;
              (vi) An ingredient statement as prescribed in paragraph (g) of this section;
              (vii) Hazard and precautionary statements as prescribed in subpart D of this part for human and domestic animal hazards and subpart E of this part for environmental hazards.
              (viii) The directions for use as prescribed in paragraph (i) of this section; and
              (ix) The use classification(s) as prescribed in paragraph (j) of this section.
              (2) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information required on the labeling by the Act or the regulations in this part must be clearly legible to a person with normal vision, and must be placed with such conspicuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
              (ii) All required label text must:
              (A) Be set in 6-point or larger type;
              (B) Appear on a clear contrasting background; and
              (C) Not be obscured or crowded.
              (3) Language to be used. All required label or labeling text shall appear in the English language. However, the Agency may require or the applicant may propose additional text in other languages as is considered necessary to protect the public. When additional text in another language is necessary, all labeling requirements will be applied equally to both the English and other-language versions of the labeling.
              (4) Placement of Label—(i) General. The label shall appear on or be securely attached to the immediate container of the pesticide product. For purposes of this section, and the misbranding provisions of the Act, “securely attached” shall mean that a label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.
              (ii) Tank cars and other bulk containers—(A) Transportation. While a pesticide product is in transit, the appropriate provisions of 49 CFR parts 170-189, concerning the transportation of hazardous materials, and specifically those provisions concerning the labeling, marking and placarding of hazardous materials and the vehicles carrying them, define the basic Federal requirements. In addition, when any registered pesticide product is transported in a tank car, tank truck or other mobile or portable bulk container, a copy of the accepted label must be attached to the shipping papers, and left with the consignee at the time of delivery.
              (B) Storage. When pesticide products are stored in bulk containers, whether mobile or stationary, which remain in the custody of the user, a copy of the label of labeling, including all appropriate directions for use, shall be securely attached to the container in the immediate vicinity of the discharge control valve.
              (5) False or misleading statements. Pursuant to section 2(q)(1)(A) of the Act, a pesticide or a device declared subject to the Act pursuant to § 152.500, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims. Examples of statements or representations in the labeling which constitute misbranding include:
              (i) A false or misleading statement concerning the composition of the product;
              (ii) A false or misleading statement concerning the effectiveness of the product as a pesticide or device;
              (iii) A false or misleading statement about the value of the product for purposes other than as a pesticide or device;
              (iv) A false or misleading comparison with other pesticides or devices;
              (v) Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government;
              (vi) The name of a pesticide which contains two or more principal active ingredients if the name suggests one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling;
              (vii) A true statement used in such a way as to give a false or misleading impression to the purchaser;
              (viii) Label disclaimers which negate or detract from labeling statements required under the Act and these regulations;
              (ix) Claims as to the safety of the pesticide or its ingredients, including statements such as “safe,” “nonpoisonous,” “noninjurious,” “harmless” or “nontoxic to humans and pets” with or without such a qualifying phrase as “when used as directed”; and
              (x) Non-numerical and/or comparative statements on the safety of the product, including but not limited to:
              (A) “Contains all natural ingredients”;
              (B) “Among the least toxic chemicals known”
              (C) “Pollution approved”
              (6) Final printed labeling. (i) Except as provided in paragraph (a)(6)(ii) of this section, final printed labeling must be submitted and accepted prior to registration. However, final printed labeling need not be submitted until draft label texts have been provisionally accepted by the Agency.
              (ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk-screened directly onto glass or metal containers or large bag or drum labels. Such reproductions must be of microfilm reproduction quality.
              (b) Name, brand, or trademark. (1) The name, brand, or trademark under which the pesticide product is sold shall appear on the front panel of the label.
              (2) No name, brand, or trademark may appear on the label which:
              (i) Is false or misleading, or

              (ii) Has not been approved by the Administrator through registration or supplemental registration as an additional name pursuant to § 152.132.
              (c) Name and address of producer, registrant, or person for whom produced. An unqualified name and address given on the label shall be considered as the name and address of the producer. If the registrant's name appears on the label and the registrant is not the producer, or if the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as “Packed for * * *,” “Distributed by * * *,” or “Sold by * * *” to show that the name is not that of the producer.
              (d) Net weight or measure of contents. (1) The net weight or measure of content shall be exclusive of wrappers or other materials and shall be the average content unless explicitly stated as a minimum quantity.
              (2) If the pesticide is a liquid, the net content statement shall be in terms of liquid measure at 68 °F (20 °C) and shall be expressed in conventional American units of fluid ounces, pints, quarts, and gallons.
              (3) If the pesticide is solid or semisolid, viscous or pressurized, or is a mixture of liquid and solid, the net content statement shall be in terms of weight expressed as avoirdupois pounds and ounces.

              (4) In all cases, net content shall be stated in terms of the largest suitable units, i.e., “1 pound 10 ounces” rather than “26 ounces.”
              (5) In addition to the required units specified, net content may be expressed in metric units.
              (6) Variation above minimum content or around an average is permissible only to the extent that it represents deviation unavoidable in good manufacturing practice. Variation below a stated minimum is not permitted. In no case shall the average content of the packages in a shipment fall below the stated average content.
              (7) For a pesticide product packaged in a refillable container, an appropriately sized area on the label may be left blank to allow the net weight or measure of content to be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the pesticide. As required in paragraph (a)(1)(iii) of this section, the net contents must be shown clearly and prominently on the label.
              (e) Product registration number. The registration number assigned to the pesticide product at the time of registration shall appear on the label, preceded by the phrase “EPA Registration No.,” or the phrase “EPA Reg. No.” The registration number shall be set in type of a size and style similar to other print on that part of the label on which it appears and shall run parallel to it. The registration number and the required identifying phrase shall not appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency.
              (f) Producing establishment's registration number. The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container. It must appear on the wrapper or outside container of the package if the EPA establishment registration number on the immediate container cannot be clearly read through such wrapper or container. For a pesticide product packaged in a refillable container, an appropriately sized area on the label may be left blank after the phrase “EPA Est.” to allow the EPA establishment registration number to be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the pesticide.
              (g) Ingredient statement—(1) General. The label of each pesticide product must bear a statement which contains the name and percentage by weight of each active ingredient, the total percentage by weight of all inert ingredients; and if the pesticide contains arsenic in any form, a statement of the percentages of total and water-soluble arsenic calculated as elemental arsenic. The active ingredients must be designated by the term “active ingredients” and the inert ingredients by the term “inert ingredients,” or the singular forms of these terms when appropriate. Both terms shall be in the same type size, be aligned to the same margin and be equally prominent. The statement “Inert Ingredients, none” is not required for pesticides which contain 100 percent active ingredients. Unless the ingredient statement is a complete analysis of the pesticide, the term “analysis” shall not be used as a heading for the ingredient statement.
              (2) Position of ingredient statement. (i) The ingredient statement is normally required on the front panel of the label. If there is an outside container or wrapper through which the ingredient statement cannot be clearly read, the ingredient statement must also appear on such outside container or wrapper. If the size or form of the package makes it impracticable to place the ingredient statement on the front panel of the label, permission may be granted for the ingredient statement to appear elsewhere.
              (ii) The text of the ingredient statement must run parallel with other text on the panel on which it appears, and must be clearly distinguishable from and must not be placed in the body of other text.
              (3) Names to be used in ingredient statement. The name used for each ingredient shall be the accepted common name, if there is one, followed by the chemical name. The common name may be used alone only if it is well known. If no common name has been established, the chemical name alone shall be used. In no case will the use of a trademark or proprietary name be permitted unless such name has been accepted as a common name by the Administrator under the authority of section 25(c)(6).
              (4) Statements of percentages. The percentages of ingredients shall be stated in terms of weight-to-weight. The sum of percentages of the active and the inert ingredients shall be 100. Percentages shall not be expressed by a range of values such as “22-25%.” If the uses of the pesticide product are expressed as weight of active ingredient per unit area, a statement of the weight of active ingredient per unit volume of the pesticide formulation shall also appear in the ingredient statement.
              (5) Accuracy of stated percentages. The percentages given shall be as precise as possible reflecting good manufacturing practice. If there may be unavoidable variation between manufacturing batches, the value stated for each active ingredient shall be the lowest percentage which may be present.
              (6) Deterioration. Pesticides which change in chemical composition significantly must meet the following labeling requirements:
              (i) In cases where it is determined that a pesticide formulation changes chemical composition significantly, the product must bear the following statement in a prominent position on the label: “Not for sale or use after [date].”
              (ii) The product must meet all label claims up to the expiration time indicated on the label.
              (7) Inert ingredients. The Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment.
              (h) [Reserved]
              (i) Directions for Use—(1) General requirements—(i) Adequacy and clarity of directions. Directions for use must be stated in terms which can be easily read and understood by the average person likely to use or to supervise the use of the pesticide. When followed, directions must be adequate to protect the public from fraud and from personal injury and to prevent unreasonable adverse effects on the environment.
              (ii) Placement of directions for use. Directions may appear on any portion of the label provided that they are conspicuous enough to be easily read by the user of the pesticide product. Directions for use may appear on printed or graphic matter which accompanies the pesticide provided that:
              (A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag;
              (B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as “See directions in the enclosed circular:” and
              (C) The Administrator determines that it is not necessary for such directions to appear on the label.
              (iii) Exceptions to requirement for direction for use. (A) Detailed directions for use may be omitted from labeling of pesticides which are intended for use only by manufacturers of products other than pesticide products in their regular manufacturing processes, provided that:
              (1) The label clearly shows that the product is intended for use only in manufacturing processes and specifies the type(s) of products involved.
              (2) Adequate information such as technical data sheets or bulletins, is available to the trade specifying the type of product involved and its proper use in manufacturing processes;
              (3) The product will not come into the hands of the general public except after incorporation into finished products; and
              (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment.
              (B) Detailed directions for use may be omitted from the labeling of pesticide products for which sale is limited to physicians, veterinarians, or druggists, provided that:
              (1) The label clearly states that the product is for use only by physicians or veterinarians;
              (2) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment; and
              (3) The product is also a drug and regulated under the provisions of the Federal Food, Drug and Cosmetic Act.
              (C) Detailed directions for use may be omitted from the labeling of pesticide products which are intended for use only by formulators in preparing pesticides for sale to the public, provided that:
              (1) There is information readily available to the formulators on the composition, toxicity, methods of use, applicable restrictions or limitations, and effectiveness of the product for pesticide purposes;
              (2) The label clearly states that the product is intended for use only in manufacturing, formulating, mixing, or repacking for use as a pesticide and specifies the type(s) of pesticide products involved;
              (3) The product as finally manufactured, formulated, mixed, or repackaged is registered; and
              (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment.
              (2) Contents of Directions for Use. The directions for use shall include the following, under the headings “Directions for Use”:
              (i) The statement of use classification as prescribed in paragraph (j) of this section immediately under the heading “Directions for Use.”
              (ii) Immediately below the statement of use classification, the statement “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
              (iii) The site(s) of application, as for example the crops, animals, areas, or objects to be treated.
              (iv) The target pest(s) associated with each site.
              (v) The dosage rate associated with each site and pest.
              (vi) The method of application, including instructions for dilution, if required, and type(s) of application apparatus or equipment required.
              (vii) The frequency and timing of applications necessary to obtain effective results without causing unreasonable adverse effects on the environment.
              (viii) Worker protection statements meeting the requirements of subpart K of this part.
              (ix) Specific directions concerning the storage, residue removal and disposal of the pesticide and its container, in accordance with subpart H of this part. These instructions must be grouped and appear under the heading, “Storage and Disposal.” This heading must be set in type of the same minimum sizes as required for the child hazard warning. (See table in § 156.60(b))
              (x) Any limitations or restrictions on use required to prevent unreasonable adverse effects, such as:
              (A) Required intervals between application and harvest of food or feed crops.
              (B) Rotational crop restrictions.
              (C) Warnings as required against use on certain crops, animals, objects, or in or adjacent to certain areas.

              (D) For total release foggers as defined in § 156.78(d)(1), the following statements must be included in the “Directions for Use.”

                DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as closets, cabinets, or under counters or tables. Do not use in a room 5 ft. × 5 ft. or smaller; instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut off gas valves), other open flames, or running electrical appliances that cycle off and on (i.e., refrigerators, thermostats, etc.). Call your gas utility or management company if you need assistance with your pilot lights.”

              (E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not physically present at the site of application but nonetheless available to the person applying the pesticide, unless the Agency has determined that the pesticide may only be applied under the direct supervision of a certified applicator who is physically present.
              (F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment.
              (j) Statement of use classification. Any pesticide product for which some uses are classified for general use and others for restricted use shall be separately labeled according to the labeling standards set forth in this subsection, and shall be marketed as separate products with different registration numbers, one bearing directions only for general use(s) and the other bearing directions for restricted use(s) except that, if a product has both restricted use(s) and general use(s), both of these uses may appear on a product labeled for restricted use. Such products shall be subject to the provisions of paragraph (j)(2) of this section.
              (1) General Use Classification. Pesticide products bearing directions for use(s) classified general shall be labeled with the exact words “General Classification” immediately below the heading “Directions for Use.” And reference to the general classification that suggests or implies that the general utility of the pesticide extends beyond those purposes and uses contained in the Directions for Use will be considered a false or misleading statement under the statutory definitions of misbranding.
              (2) Restricted Use Classification. Pesticide products bearing direction for use(s) classified restricted shall bear statements of restricted use classification on the front panel as described below:
              (i) Front panel statement of restricted use classification. (A) At the top of the front panel of the label, set in type of the same minimum sizes as required for human hazard signal words (see table in paragraph (h)(1)(iv) of this section), and appearing with sufficient prominence relative to other text and graphic material on the front panel to make it unlikely to be overlooked under customary conditions of purchase and use, the statement “Restricted Use Pesticide” shall appear.
              (B) Directly below this statement on the front panel, a summary statement of the terms of restriction imposed as a precondition to registration shall appear. If use is restricted to certified applicators, the following statement is required: “For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification.” If, however, other regulatory restrictions are imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation.
              [40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR 36571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978. Redesignated and amended at 53 FR 15991, 15999, May 4, 1988; 57 FR 38146, Aug. 21, 1992; 60 FR 32096, June 19, 1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764, Dec. 14, 2001; 71 FR 47420, Aug. 16, 2006; 73 FR 75596, Dec. 12, 2008]

            Subparts B-C [Reserved]

            Subpart D—Human Hazard and Precautionary Statements

              Source:
              66 FR 64764, Dec. 14, 2001, unless otherwise noted.

              § 156.60
              General.

              Each product label is required to bear hazard and precautionary statements for humans and domestic animals (if applicable) as prescribed in this subpart. Hazard statements describe the type of hazard that may occur, while precautionary statements will either direct or inform the user of actions to take to avoid the hazard or mitigate its effects.
              (a) Location of statements—(1) Front panel statements. The signal word, child hazard warning, and, in certain cases, the first aid statement are required to appear on the front panel of the label, and also in any supplemental labeling intended to accompany the product in distribution or sale.
              (2) Statements elsewhere on label. Hazard and precautionary statements not required on the front panel may appear on other panels of the label, and may be required also in supplemental labeling. These include, but are not limited to, the human hazard and precautionary statements, domestic animal statements if applicable, a Note to Physician, and physical or chemical hazard statements.
              (b) Placement and prominence—(1) Front panel statements. All required front panel warning statements shall be grouped together on the label, and shall appear with sufficient prominence relative to other front panel text and graphic material to make them unlikely to be overlooked under customary conditions of purchase and use. The table below shows the minimum type size requirements for the front panel warning statements for various front panel sizes.

                Type Sizes for Front Panel Warning Statements

                  Size of Label Front Panel (Square Inches)
                  Point Size
                  Signal Word (All Capital Letters)
                  Child Hazard Warning

                  5 and under
                  6
                  6

                  Over 5 to 10
                  10
                  6

                  Over 10 to 15
                  12
                  8

                  Over 15 to 30
                  14
                  10

                  Over 30
                  18
                  12

              (2) Other required statements. All other hazard and precautionary statements must be at least 6 point type.

              § 156.62
              Toxicity Category.
              This section establishes four Toxicity Categories for acute hazards of pesticide products, Category I being the highest toxicity category. Most human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide product as sold or distributed. In addition, toxicity categories may be used for regulatory purposes other than labeling, such as classification for restricted use and requirements for child-resistant packaging. In certain cases, statements based upon the Toxicity Category of the product as diluted for use are also permitted. A Toxicity Category is assigned for each of five types of acute exposure, as specified in the table in this paragraph.

                Acute Toxicity Categories for Pesticide Products

                  Hazard Indicators
                  I
                  II
                  III
                  IV

                  Oral LD50

                  Up to and including 50 mg/kg
                  >50 thru 500 mg/kg
                  >500 thru 5,000 mg/kg
                  >5,000 mg/kg

                  Dermal LD50

                  Up to and including 200 mg/kg
                  >200 thru 2000 mg/kg
                  >2000 thru 20,000 mg/kg
                  >20,000 mg/kg

                  Inhalation LC50

                  Up to and including 0.2 mg/liter
                  >0.2 thru 2 mg/liter
                  >2 thru 20 mg/liter
                  >20 mg/liter

                  Eye irritation
                  Corrosive; corneal opacity not reversible within 7 days
                  Corneal opacity reversible within 7 days; irritation persisting for 7 days
                  No corneal opacity; irritation reversible within 7 days
                  No irritation

                  Skin irritation
                  Corrosive
                  Severe irritation at 72 hours
                  Moderate irritation at 72 hours
                  Mild or slight irritation at 72 hours

              § 156.64
              Signal word.
              (a) Requirement. Except as provided in paragraph (a)(4), each pesticide product must bear on the front panel a signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to which the product is assigned by any of the five routes of exposure in § 156.62. The signal word must also appear together with the heading for the human precautionary statement section of the labeling (see § 156.70).
              (1) Toxicity Category I. Any pesticide product meeting the criteria of Toxicity Category I for any route of exposure must bear on the front panel the signal word “DANGER.” In addition, if the product is assigned to Toxicity Category I on the basis of its oral, inhalation or dermal toxicity (as distinct from skin and eye irritation), the word “Poison” must appear in red on a background of distinctly contrasting color, and the skull and crossbones symbol must appear in immediate proximity to the word “Poison.”
              (2) Toxicity Category II. Any pesticide product meeting the criteria of Toxicity Category II as the highest category by any route of exposure must bear on the front panel the signal word “WARNING.”
              (3) Toxicity Category III. Any pesticide product meeting the criteria of Toxicity Category III as the highest category by any route of exposure must bear on the front panel the signal word “CAUTION.”
              (4) Toxicity Category IV. A pesticide product meeting the criteria of Toxicity Category IV by all routes of exposure is not required to bear a signal word. If a signal word is used, it must be “CAUTION.”
              (b) Use of signal words. In no case may a product:
              (1) Bear a signal word reflecting a higher Toxicity Category than indicated by the route of exposure of highest toxicity, unless the Agency determines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment;
              (2) Bear a signal word reflecting a lesser Toxicity Category associated with a diluted product. Although precautionary statements for use dilutions may be included on label, the signal word must reflect the toxicity of the product as distributed or sold; or
              (3) Bear different signal words on different parts of the label.

              § 156.66
              Child hazard warning.
              (a) Each pesticide product must bear on the front panel of the label the statement “Keep Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear on a separate line in close proximity to the signal word, if required. The statement is required on Toxicity Category IV products that do not otherwise require a signal word.
              (b) In its discretion, EPA may waive the requirement, or require or permit an alternative child hazard warning, if:
              (1) The applicant can demonstrate that the likelihood of exposure of children to the pesticide during distribution, marketing, storage or use is remote (for example, an industrial use product); or
              (2) The pesticide is approved for use on children (for example, an insect repellent).
              (c) EPA may approve an alternative child hazard warning that more appropriately reflects the nature of the pesticide product to which children may be exposed (for example, an impregnated pet collar). In this case, EPA may also approve placement on other than the front panel.

              § 156.68
              First aid statement.
              (a) Product as sold and distributed. Each product must bear a first aid statement if the product has systemic effects in Category I, II, or III, or skin or eye irritation effects in Category I or II.
              (b) Product as diluted for use. If the product labeling bears directions for dilution with water prior to use, the label may also include a statement describing how the first aid measures may be modified for the diluted product. Such a statement must reflect the Toxicity Category(ies) of the diluted product, based upon data for the route of exposure (or calculations if appropriate). If the labeling provides for a range of use dilutions, only that use dilution representing the highest concentration allowed by labeling may be used as the basis for a statement pertaining to the diluted product. The statement for a diluted product may not substitute for the statement for the concentrate, but augments the information provided for the concentrate.
              (c) Heading. The heading of the statement may be “First Aid” or “Statement of Practical Treatment.”

              (d) Location of first aid statement. The first aid statement must appear on the front panel of the label of all products assigned to Toxicity Category I by any route of exposure. Upon review, the Agency may permit reasonable variations in the placement of the first aid statement if a reference such as “See first aid statement on back panel” appears on the front panel. The first aid statement for products assigned to Toxicity Categories II or III may appear on any panel of the label.

              § 156.70
              Precautionary statements for human hazards.
              (a) Requirement. Human hazard and precautionary statements as required must appear together on the label or labeling under the general heading “Precautionary Statements” and under appropriate subheadings similar to “Humans and Domestic Animals,” “Environmental Hazards” (see subpart E of this part) and “Physical or Chemical Hazards.” The phrase “and Domestic Animals” may be omitted from the heading if domestic animals will not be exposed to the product.
              (b) Content of statements. When data or other information show that an acute hazard may exist to humans or domestic animals, the label must bear precautionary statements describing the particular hazard, the route(s) of exposure and the precautions to be taken to avoid accident, injury or toxic effect or to mitigate the effect. The precautionary paragraph must be immediately preceded by the appropriate signal word.
              (c) Typical precautionary statements. The table below presents typical hazard and precautionary statements. Specific statements pertaining to the hazards of the product and its uses must be approved by the Agency. With Agency approval, statements may be augmented to reflect the hazards and precautions associated with the product as diluted for use. Refer to § 156.68(b) for requirements for use dilution statements.

                Typical Human Hazard and Precautionary Statements

                  Toxicity Category
                  Systemic effects (oral, dermal, inhalation toxicity)
                  Irritation effects (skin and eye)
                  Sensitizer (There are no categories of sensitization.)

                  I
                  Fatal (poisonous) if swallowed [inhaled or absorbed through skin]. Do not breathe vapor [dust or spray mist]. Do not get in eyes, on skin, or on clothing. [Front panel first aid statement required.]
                  Corrosive, causes eye and skin damage [or skin irritation]. Do not get in eyes on skin, or on clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed. [Front panel first aid statement required.]
                  If product is a sensitizer: Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

                  II
                  May be fatal if swallowed, [inhaled or absorbed through the skin]. Do not breathe vapors [dust or spray mist]. Do not get in eyes, on skin, or on clothing. [Appropriate first aid statement required.]
                  Causes eye [and skin] irritation. Do not get in eyes, on skin, or on clothing. Harmful if swallowed. [Appropriate first aid statement required.]

                  III
                  Harmful if swallowed [inhaled or absorbed through the skin]. Avoid breathing vapors [dust or spray mist]. Avoid contact with skin [eyes or clothing]. [Appropriate first aid statement required.]
                  Avoid contact with skin, eyes or clothing.

                  IV
                  No precautionary statements required
                  No precautionary statements required.

              § 156.78
              Precautionary statements for physical or chemical hazards.
              (a) Requirement. Warning statements on the flammability or explosive characteristics of the pesticide product are required if a product meets the criteria in this section. Warning statements pertaining to other physical/chemical hazards (e.g., oxidizing potential, conductivity, chemical reactions leading to production of toxic substances) may be required on a case-by-case basis.
              (b) Pressurized products. The table below sets out the required flammability label statements for pressurized products.

                Flammability Statements for Pressurized Products

                  Flash point/flame extension of product
                  Required labeling statement

                  —Flash point at or below 20 °F

                    Extremely flammable. Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 130 °F may cause bursting.

                     OR

                  —Flashback at any valve opening

                  —Flash point >20 °F to 80 °F

                    Flammable. Contents under pressure. Keep away from heat, sparks and open flame. Do not puncture or incinerate container. Exposure to temperatures above 130 °F may cause bursting.

                     OR

                  —Flame extension more than 18 in. long at a distance of 6 in from the flame

                  All other pressurized products

                    Contents under pressure. Do not use or store near heat or open flame. Do not puncture or incinerate container. Exposure to temperatures above 130 °F may cause bursting.

              (c) Non-pressurized products. The table below sets out the required flammability label statements for non-pressurized products.

                Flammability Statements for Non-Pressurized Products

                  Flash point
                  Required labeling statement

                  At or below 20 °F

                    Extremely flammable. Keep away from fire, sparks and heated surfaces.

                  Greater than 20 °F to 80 °F

                    Flammable. Keep away from heat and open flame.

                  Greater than 80 °F to 150 °F

                    Combustible. Do not use or store near heat or open flame.

              (d) Total release fogger products. (1) A total release fogger is defined as a pesticide product in a pressurized container designed to automatically release the total contents in one operation, for the purpose of creating a permeating fog within a confined space to deliver the pesticide throughout the space.
              (2) If a pesticide product is a total release fogger containing a propellant with a flash point at or below 20 °F, then the following special instructions must be added to the “Physical and Chemical Hazards” warning statement, in addition to any flammability statement required by paragraph (b) of this section:
              This product contains a highly flammable ingredient. It may cause a fire or explosion if not used properly. Follow the Directions for Use on this label very carefully.
              (3) A graphic symbol depicting fire, such as illustrated in this paragraph, or an equivalent symbol, must be displayed along with the required language adjoining the “Physical and Chemical Hazards” warning statement. The graphic symbol must be no smaller than twice the size of the first character of the human hazard signal word.

                ER14DE01.011

              Highly Flammable Ingredient
              Ingrediente Altamente Inflamable

            Subpart E—Environmental Hazard and Precautionary Statements

              Source:
              66 FR 64767, Dec. 14, 2001, unless otherwise noted.

              § 156.80
              General.
              (a) Requirement. Each product is required to bear hazard and precautionary statements for environmental hazards, including hazards to non-target organisms, as prescribed in this subpart. Hazard statements describe the type of hazard that may be present, while precautionary statements direct or inform the user of actions to take to avoid the hazard or mitigate its effects.
              (b) Location of statements. Environmental hazard and precautionary statements may appear on any panel of the label and may be required also in supplemental labeling. The environmental hazard statements must appear together under the heading “Environmental Hazards.” Typically the statements are grouped as a sub-category within the “Precautionary Statements” section of the labeling.
              (c) Type size. All environmental hazard and precautionary statements must be at least 6 point type.

              § 156.85
              Non-target organisms.
              (a) Requirement. Where a hazard exists to non-target organisms, EPA may require precautionary statements of the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage.
              (b) Examples. The statements in this paragraph illustrate the types of hazard statements that EPA may require and the circumstances under which they are typically required. These statements are not comprehensive; other statements may be required if more appropriate to the formulation or use.

              (1) If a pesticide intended for outdoor use contains an active ingredient with a mammalian acute oral LD50 of 100 mg/kg or less, the statement, “This pesticide is toxic to wildlife” is required.

              (2) If a pesticide intended for outdoor use contains an active ingredient with a fish acute LC50 of 1 ppm or less, the statement, “This pesticide is toxic to fish” is required.

              (3) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD50 of 100 mg/kg or less, or a subacute dietary LC50 of 500 ppm or less, the statement, “This pesticide is toxic to wildlife” is required.
              (4) If either accident history or field studies demonstrate that the use of the pesticide may result in fatality to birds, fish or mammals, the statement, “This pesticide is extremely toxic to wildlife (fish)” is required.
              (5) If a product is intended for or involves foliar application to agricultural crops, forests or shade trees, or mosquito abatement treatments, and contains a pesticide toxic to pollinating insects, the label must bear appropriate label cautions.
              (6) If a product is intended for outdoor use other than aquatic applications, the label must bear the caution, “Keep out of lakes, ponds or streams. Do not contaminate water by cleaning of equipment or disposal of wastes.”

            Subparts F-G [Reserved]

            Subpart H—Container Labeling

              Source:
              71 FR 47420, Aug. 16, 2006, unless otherwise noted.

              § 156.140
              Identification of container types.
              For products other than plant-incorporated protectants, the following statements, as applicable, must be placed on the label or container. The information may be located on any part of the container except the closure. If the statements are placed on the container, they must be durably marked on the container. Durable marking includes, but is not limited to etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, or marking with durable ink.
              (a) Nonrefillable container. For nonrefillable containers, the statements in paragraphs (a)(1) through (a)(4) of this section are required except as provided in paragraphs (a)(5), (c), (d), and (e) of this section. If placed on the label, the statements in paragraphs (a)(1) through (a)(3) of this section must be under an appropriate heading under the heading “Storage and Disposal.” If any of the statements in paragraphs (a)(1) through (a)(3) of this section are placed on the container, an appropriate referral statement such as “See container for recycling [or other descriptive word] information.” must be placed on the label under the heading “Storage and Disposal.”
              (1) Statement identifying a nonrefillable container. The following phrase is required: “Nonrefillable container.”
              (2) Reuse statement. One of the following statements is required. Products with labels that allow household/residential use must use the statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All other products must use the statement in paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section.
              (i) “Do not reuse or refill this container.”
              (ii) “Do not reuse this container to hold materials other than pesticides or dilute pesticides (rinsate). After emptying and cleaning, it may be allowable to temporarily hold rinsate or other pesticide-related materials in the container. Contact your state regulatory agency to determine allowable practices in your state.”
              (iii) The following statement may be used if a product is “ready-to-use” and its directions for use allow a different product (that is a similar, but concentrated formulation) to be poured into the container and diluted by the end user: “Do not reuse or refill this container unless the directions for use allow a different (concentrated) product to be diluted in the container.”
              (3) Recycling or reconditioning statement. One of the following statements is required:
              (i) “Offer for recycling if available.”

              (ii) “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact [a pesticide container recycling organization] at [phone number] or [web site]. For example, this statement could be “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) or www.acrecycle.org.”
              (iii) A recycling statement approved by EPA and published in an EPA document, such as a Pesticide Registration Notice.
              (iv) An alternative recycling statement that has been reviewed and approved by EPA.
              (v) “Offer for reconditioning if appropriate.”
              (4) Batch code. A lot number, or other code used by the registrant or producer to identify the batch of the pesticide product which is distributed and sold is required.
              (5) Exemptions. Pesticide products in the following types of nonrefillable containers, and their packaging, are exempt from the requirements in paragraphs (a)(1) and (a)(2) of this section:
              (i) Aerosol cans.
              (ii) Devices as defined in § 152.500 of this chapter.
              (iii) One-time use caulking tubes and other one-time use squeezable tube containers for paste, gel, or other similar substances.
              (iv) Foil packets for water soluble packaging, repellent wipes, and other one-time use products.
              (v) One-time use portion control packets, such as polyethylene sleeve packages, or rodenticide placepacks.
              (vi) One-time use bait stations.
              (vii) One-time use cages for repellent or trapping strips.
              (viii) Pet collars or animal ear tags, such as cattle ear tags.
              (ix) One-time use semiochemical dispersion devices.
              (x) Any container that is destroyed by the use of the product contained.
              (xi) Any container that would be destroyed if reuse of the container were attempted.
              (b) Refillable container. For refillable containers, one of the following statements is required, except as provided in paragraphs (c), (d), and (e) of this section. If placed on the label, the statement must be under the heading “Storage and Disposal.” If the statement is placed on the container, an appropriate referral statement, such as “Refilling limitations are on the container.” must be placed under the heading “Storage and Disposal.”
              (1) “Refillable Container. Refill this container with pesticide only. Do not reuse this container for any other purpose.”

              (2) “Refillable Container. Refill this container with [common chemical name] only. Do not reuse this container for any other purpose.”
              (c) Modification. EPA may, on its own initiative or based on data or information submitted by any person, modify or waive the requirements of this section or permit or require alternative labeling statements.
              (d) Exemption for articles. Pesticidal articles that are not exempted from FIFRA regulation by § 152.25(a) of this chapter are exempt from the requirements of this section.
              (e) Exemption for transport vehicles. Transport vehicles are exempt from the requirements of this section.
              [71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

              § 156.144
              Residue removal instructions—general.
              (a) General. Except as provided by paragraphs (c) through (g) of this section, the label of each pesticide product must include the applicable instructions for removing pesticide residues from the container prior to container disposal that are specified in § 156.146 and § 156.156. The residue removal instructions are required for both nonrefillable and refillable containers.
              (b) Placement of residue removal statements. All residue removal instructions must be placed under the heading “Storage and Disposal.”
              (c) Exemption for residential/household use products. Residential/household use pesticide products are exempt from the residue removal instruction requirements in this section through § 156.156.
              (d) Modification. EPA may, on its own initiative or based on data submitted by any person, modify or waive the requirements of this section through § 156.156, or permit or require alternative labeling statements.
              (e) Exemption for gases. Pesticide products that are gaseous at atmospheric temperature and pressure are exempt from the residue removal instruction requirements in this section through § 156.156.
              (f) Exemption for articles. Pesticidal articles that are not exempted from FIFRA regulation by § 152.25(a) of this chapter are exempt from the residue removal instruction requirements in this section through § 156.156.
              (g) Exemption for transport vehicles. Transport vehicles are exempt from the requirements in this section through § 156.156.
              [71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

              § 156.146
              Residue removal instructions for nonrefillable containers—rigid containers with dilutable pesticides.
              The label of each dilutable (liquid or solid) pesticide product packaged in a rigid nonrefillable container must include the following residue removal instructions as appropriate.
              (a) Timing of the residue removal procedure. One of the following statements must immediately precede the instructions required in paragraph (b) of this section and must be consistent with the instructions in paragraphs (b) and (c) of this section:
              (1) “Clean container promptly after emptying.”
              (2) “Triple rinse or pressure rinse container (or equivalent) promptly after emptying.”
              (3) “Triple rinse container (or equivalent) promptly after emptying.”
              (b) Triple rinse instructions. The label of each dilutable pesticide product packaged in rigid nonrefillable containers must include one of the following sets of instructions.
              (1) For liquid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times.”
              (2) For solid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank. Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times.”

              (3) For containers that are too large to shake, use the following instructions: “Triple rinse as follows: Empty remaining contents into application equipment or a mix tank. Fill the container 1/4 full with water. Replace and tighten closures. Tip container on its side and roll it back and forth, ensuring at least one complete revolution, for 30 seconds. Stand the container on its end and tip it back and forth several times. Turn the container over onto its other end and tip it back and forth several times. Empty the rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Repeat this procedure two more times.”
              (c) Pressure rinse instructions. The label of each dilutable pesticide product packaged in rigid nonrefillable containers may include one of the following sets of instructions, and one of them must be used if the statement in paragraph (a)(2) of this section is used. If one of these statements is included on the label, it must immediately follow the triple rinse instructions specified in paragraph (b) of this section.
              (1) For liquid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank and continue to drain for 10 seconds after the flow begins to drip. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”
              (2) For solid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”
              (d) Non-water diluent. (1) A registrant who wishes to require users to clean a container with a diluent other than water (e.g., solvents) must submit to EPA a written request to modify the residue removal instructions of this section. The registrant may not distribute or sell the pesticide with the modified residue removal instructions until EPA approves the request in writing.
              (2) The registrant must indicate why a non-water diluent is necessary for efficient residue removal, and must propose residue removal instructions and disposal instructions that are appropriate for the characteristics and formulation of the pesticide product and non-water diluent. The proposed residue removal instructions must identify the diluent. If the Directions for Use permit the application of a mixture of the pesticide and the non-water diluent, the instructions may allow the rinsate to be added to the application equipment or mix tank. If the Directions for Use do not identify the non-water diluent as an allowable addition to the pesticide, the instructions must require collection and storage of the rinsate in a rinsate collection system.
              (3) EPA may approve the request if EPA finds that the proposed instructions are necessary and appropriate.

              § 156.156
              Residue removal instructions for refillable containers.
              The label of each pesticide product packaged in a refillable container must include the residue removal instructions in this section. Instructions must be given for all pesticide products that are distributed or sold in refillable containers, including those that do not require dilution prior to application.
              (a) Timing of the residue removal procedure. One of the following statements must immediately precede the instructions required in paragraph (b) of this section and must be consistent with the instructions in paragraph (b) of this section:
              (1) “Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”
              (2) “Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”
              (b) Residue removal instructions prior to container disposal. (1) Instructions for cleaning each refillable container prior to disposal are required. The residue removal instructions must be appropriate for the characteristics and formulation of the pesticide product and must be adequate to protect human health and the environment.
              (2) Subject to meeting the standard in paragraph (b)(1) of this section, the statement on residue removal instructions could include any one of the following:
              (i) The refilling residue removal procedure developed by the registrant for the pesticide product.
              (ii) Standard industry practices for cleaning refillable containers.
              (iii) For pesticides that require dilution prior to application, the following statement: “To clean the container before final disposal, empty the remaining contents from this container into application equipment or a mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this rinsing procedure two more times.”
              (iv) Any other statement the registrant considers appropriate.

              § 156.159
              Compliance date.
              Any pesticide product released for shipment by a registrant after August 16, 2011 must bear a label that complies with §§ 156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146 and 156.156.
              [75 FR 62326, Oct. 8, 2010]

            Subparts I-J [Reserved]

            Subpart K—Worker Protection Statements

              Source:
              57 FR 38146, Aug. 21, 1992, unless otherwise noted.

              § 156.200
              Scope and applicability.
              (a) Scope. (1) This subpart prescribes statements that must be placed on the pesticide label and in pesticide labeling. These statements incorporate by reference the Worker Protection Standard, part 170 of this chapter. The requirements addressed in these statements are designed to reduce the risk of illness or injury resulting from workers' and pesticide handlers' occupational exposures to pesticides used in the production of agricultural plants on agricultural establishments as defined in § 170.3 of this chapter. These statements refer to specific workplace practices designed to reduce or eliminate exposure and to respond to emergencies that may arise from the exposures that may occur.
              (2) This subpart prescribes interim requirements that must be placed on the pesticide label and in pesticide labeling. These interim requirements pertain to restricted-entry intervals, personal protective equipment, and notification. On a case-by-case basis, these interim requirements will be reviewed and may be revised during reregistration or other agency review processes.
              (b) Applicability. (1) The requirements of this subpart apply to each pesticide product that bears directions for use in the production of any agricultural plant on any agricultural establishment as defined in § 170.3 of this chapter, or whose labeling reasonably permits such use.
              (2) The requirements of this subpart do not apply to a product that bears directions solely for uses excepted by § 170.202(b) of this chapter.
              (c) Effective dates. No product to which this subpart applies shall be distributed or sold without amended labeling by any registrant after April 21, 1994, or by any person after October 23, 1995.
              [57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

              § 156.203
              Definitions.
              Terms in this subpart have the same meanings as they do in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, as used in this subpart, shall have the meanings stated below:

                Fumigant means any pesticide product that is a vapor or gas or forms a vapor or gas on application and whose method of pesticidal action is through the gaseous state.

                Restricted-entry interval or REI means the time after the end of a pesticide application during which entry to the treated area is restricted.
              [57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

              § 156.204
              Modification and waiver of requirements.
              (a) Modification on Special Review. If the Agency concludes in accordance with § 154.25(c) of this chapter that a pesticide should be placed in Special Review because the pesticide meets or exceeds the criteria for human health effects of § 154.7(a)(1)(2) or (6) of this chapter, the Agency may modify the personal protective equipment required for handlers or early-entry workers or both, the restricted-entry intervals, or the notification to workers requirements.
              (b) Other modifications. The Agency, pursuant to this subpart and authorities granted in FIFRA sections 3, 6, and 12, may, on its initiative or based on data submitted by any person, modify or waive the requirements of this subpart, or permit or require alternative labeling statements. Supporting data may be either data conducted according to Subdivisions U or K of the Pesticide Assessments guidelines or data from medical, epidemiological, or health effects studies. A registrant who wishes to modify any of the statements required in § 156.206, § 156.208, § 156.210, or § 156.212 must submit an application for amended registration unless specifically directed otherwise by the Agency.
              [57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]

              § 156.206
              General statements.
              (a) Application restrictions. Each product shall bear the statement: “Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application.” This statement shall be near the beginning of the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS.
              (b) 40 CFR part 170 reference statement. (1) Each product shall bear the reference statement: “Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170.” This statement shall be placed on the product label under the heading AGRICULTURAL USE REQUIREMENTS.
              (2) Each product shall bear the statement: “This standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statements on this label [in this labeling] about [use any of the following that are applicable] personal protective equipment, restricted-entry interval, and notification to workers.” These statements shall be placed immediately following the reference statement required by paragraph (b)(1) of this section, or they shall be placed in the supplemental product labeling under the heading AGRICULTURAL USE REQUIREMENTS.
              (3) If the statements in paragraph (b)(2) of this section are included in supplemental labeling rather than on the label of the pesticide container, the container label must contain this statement immediately following the statement required in paragraph (b)(1) of this section: “Refer to supplemental labeling entitled AGRICULTURAL USE REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for information about this standard.”
              (4) If the statements in paragraph (b)(2) of this section are included in supplemental labeling, they must be preceded immediately by the statement in paragraph (b)(1) of this section under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
              (c) Product-type identification. (1) If the product contains an organophosphate (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall be associated with the product name or product-type identification or shall be in the STATEMENT OF PRACTICAL TREATMENT or FIRST AID section of the label.
              (2) If the product is a fumigant, the label shall so state. The identification shall appear:
              (i) As part of the product name; or
              (ii) Close to the product name, as part of the product-type identification or as a separate phrase or sentence.
              (d) State restrictions. Each product shall bear the statement: “For any requirements specific to your State, consult the agency in your State responsible for pesticide regulation.” This statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
              (e) Spanish warning statements. If the product is classified as toxicity category I or toxicity category II according to the criteria in § 156.62, the signal word shall appear in Spanish in addition to English followed by the statement, “Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle. (If you do not understand the label, find some one to explain it to you in detail.)” The Spanish signal word “PELIGRO” shall be used for products in toxicity category I, and the Spanish signal word “AVISO” shall be used for products in toxicity category II. These statements shall appear on the label close to the English signal word.
              [57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

              § 156.208
              Restricted-entry statements.
              (a) Requirement. Each product with a restricted-entry interval shall bear the following statement: “Do not enter or allow worker entry into treated areas during the restricted-entry interval (REI).” This statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
              (b) Location of specific restricted-entry interval statements. (1) If a product has one specific restricted-entry interval applicable to all registered uses of the product on agricultural plants, the restricted-entry interval for the product shall appear as a continuation of the statement required in paragraph (a) of this section and shall appear as follows: “of X hours” or “of X days” or “until the acceptable exposure level of X ppm or mg/m3 is reached.”
              (2) If different restricted-entry intervals have been established for some crops or some uses of a product, the restricted-entry statement in paragraph (b)(1) of this section shall be associated on the labeling of the product with the directions for use for each crop each use to which it applies, immediately preceded or immediately followed by the words “Restricted-entry interval” (or the letters “REI”).
              (c) Restricted-entry interval based on toxicity of active ingredient—(1) Determination of toxicity category. A restricted-entry interval shall be established based on the acute toxicity of the active ingredients in the product. For the purpose of setting the restricted-entry interval, the toxicity category of each active ingredient in the product shall be determined by comparing the obtainable data on the acute dermal toxicity, eye irritation effects, and skin irritation effects of the ingredient to the criteria of § 156.62. The most toxic of the applicable toxicity categories that are obtainable for each active ingredient shall be used to determine the restricted-entry interval for that product. If no acute dermal toxicity data are obtainable, data on acute oral toxicity also shall be considered in this comparison. If no applicable acute toxicity data are obtainable on the active ingredient, the toxicity category corresponding to the signal word of any registered manufacturing-use product that is the source of the active ingredient in the end-use product shall be used. If no acute toxicity data are obtainable on the active ingredients and no toxicity category of a registered manufacturing-use product is obtainable, the toxicity category of the end-use product (corresponding to the signal word on its labeling) shall be used.
              (2) Restricted-entry interval for sole active ingredient products. (i) If the product contains only one active ingredient and it is in toxicity category I by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 48 hours. If, in addition, the active ingredient is an organophosphorus ester that inhibits cholinesterase and that may be applied outdoors in an area where the average annual rainfall for the application site is less than 25 inches per year, the following statement shall be added to the restricted-entry interval statement: “(72 hours in outdoor areas where average annual rainfall is less than 25 inches a year).”
              (ii) If the product contains only one active ingredient and it is in toxicity category II by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 24 hours.
              (iii) If the product contains only active ingredients that are in toxicity category III or IV by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 12 hours.
              (3) Restricted-entry interval for multiple active ingredient products. If the product contains more than one active ingredient, the restricted-entry interval (including any associated statement concerning use in arid areas under paragraph (c)(2)(i) of this section) shall be based on the active ingredient that requires the longest restricted-entry interval as determined by the criteria in this section.
              (d) Exception for fumigants. The criteria for determining restricted-entry intervals in paragraph (c) of this section shall not apply to any product that is a fumigant. For fumigants, any existing restricted-entry interval (hours, days, or acceptable exposure level) shall be retained. Entry restrictions for fumigants have been or shall be established on a case-by-case basis at the time of registration, reregistration, or other Agency review process.
              (e) Existing product-specific restricted-entry intervals. (1) A product-specific restricted-entry interval, based on data collected in accordance with § 158.1070 or § 161.390 of this chapter and Subdivision K of the Pesticide Assessment Guidelines, shall supersede any restricted-entry interval applicable to the product under paragraph (c) of this section.
              (2) Product-specific restricted-entry intervals established for pesticide products or pesticide uses that are not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
              (f) Existing interim restricted-entry intervals. (1) An interim restricted-entry interval established by the Agency before the effective date of this subpart will continue to apply unless a longer restricted-entry interval is required by paragraph (c) of this section.
              (2) Existing interim restricted-entry intervals established by the Agency for pesticide products or pesticide uses not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
              [57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 72 FR 61028, Oct. 26, 2007; 73 FR 75596, Dec. 12, 2008]

              § 156.210
              Notification-to-workers statements.
              (a) Requirement. Each product that meets the requirements of paragraph (b) of this section shall bear the posting and oral notification statements prescribed below. The statements shall be in the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS.
              (b) Notification to workers of pesticide application. (1) Each product that contains any active ingredient classified as toxicity category I for either acute dermal toxicity or skin irritation potential under the criteria in § 156.62 shall bear the statement: “Notify workers of the application by warning them orally and by posting warning signs at entrances to treated areas.” If no acute dermal toxicity data are obtainable, data on acute oral toxicity of the active ingredient shall be considered instead. If no data on acute dermal toxicity, skin irritation potential, or acute oral toxicity are obtainable on the active ingredient, the toxicity category corresponding to the signal word of any registered manufacturing-use product that is the source of the active ingredient in the end-use product shall be used. If none of the applicable acute toxicity data are obtainable on the active ingredient and no toxicity category of the registered manufacturing-use product is obtainable, the toxicity category of the end-use product corresponding to the product's signal word shall be used.

              (2) Each product that is a fumigant and is registered for use in a greenhouse (or whose labeling allows use in a greenhouse) shall bear the statement: “For greenhouse applications, notify workers of the application by warning them orally and by posting warning signs outside all entrances to the greenhouse.”
              [57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

              § 156.212
              Personal protective equipment statements.
              (a) Requirement. Each product shall bear the personal protective equipment statements prescribed in paragraphs (d) through (j) of this section.
              (b) Exceptions. (1) If personal protective equipment were required for a product before the effective date of this subpart, the existing requirements shall be retained on the labeling wherever they are more specific or more protective (as specified in EPA guidance materials) than the requirements in the table in paragraph (e) of this section.
              (2) Any existing labeling statement that prohibits the use of gloves or boots overrides the corresponding requirement in paragraph (e) of this section and must be retained on the labeling.
              (3) If the product labeling contains uses that are not covered by part 170 of this chapter, the registrant may adopt the personal protective equipment required in this section for those uses. However, if the personal protective equipment required in this section would not be sufficiently protective or would be onerously overprotective for uses not covered by part 170 of this chapter, the registrant must continue to apply the existing personal protective equipment requirements to those uses. The labeling must indicate which personal protective equipment requirements apply to uses covered by part 170 of this chapter and which personal protective equipment requirements apply to other uses.
              (c) Location of personal protective equipment statements—(1) Personal protective equipment statements for pesticide handlers. Personal protective equipment statements for pesticide handlers shall be in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) section of the labeling. The required statements may be combined to avoid redundancy as long as the requirements and conditions under which they apply are identified.
              (2) Personal protective equipment statements for early-entry workers. Personal protective equipment statements for early-entry workers shall be placed in the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately after the restricted-entry statement required in § 156.208(a).
              (d) Personal protective equipment statements for pesticide handlers. (1) The table in paragraph (e) of this section specifies minimum requirements for personal protective equipment (as defined in § 170.240 of this chapter) and work clothing for pesticide handlers. This personal protective equipment requirement applies to any product that presents a hazard through any route of exposure identified in the table (acute dermal toxicity, skin irritation potential, acute inhalation toxicity, and eye irritation potential).
              (2) The requirement for personal protective equipment is based on the acute toxicity category of the end-use product for each route of exposure as defined by § 156.62. If data to determine the acute dermal toxicity or the acute inhalation toxicity are not obtainable, the acute oral toxicity shall be used as a surrogate to determine the personal protective equipment requirements for that route of exposure. If data to determine the acute toxicity of the product by a specific route of exposure (including acute oral toxicity in lieu of acute dermal or acute inhalation toxicity) are not obtainable, the toxicity category corresponding to the signal word of the end-use product shall be used to determine personal protective equipment requirements for that route of exposure. If the signal word is “CAUTION,” toxicity category III will be used.

              (3) The minimum personal protective equipment and work clothing requirements specified in this section shall be included in a statement such as the following: “Applicators and other handlers must wear: (body protection statement); (glove statement, if applicable); (footwear statement, if applicable); (protective eyewear statement, if applicable); (respirator statement, if applicable).” The format of statements given in this paragraph is optional, but it is recommended for clarity.
              (e) Summary of personal protective equipment requirements. The following table 1 summarizes the personal protective equipment requirements by route of exposure and toxicity category:

                Table 1—Minimum Personal Protective Equipment (PPE) and Work Clothing for Handling Activities

                  Route of Exposure
                  Toxicity Category of End-Use Product
                  I
                  II
                  III
                  IV

                  Dermal Toxicity or Skin Irritation Potential 1

                  Coveralls worn over long-sleeved shirt and long pants
                  Coveralls worn over short-sleeved shirt and short pants
                  Long-sleeved shirt and long pants
                  Long-sleeved shirt and long pants

                  Socks
                  Socks
                  Socks
                  Socks

                  Chemical-resistant footwear
                  Chemical-resistant footwear
                  Shoes
                  Shoes

                  Chemical-resistant gloves 2

                  Chemical-resistant gloves 2

                  Chemical-resistant gloves 2

                  No minimum 4

                  Inhalation Toxicity
                  Respiratory protection device 3

                  Respiratory protection device 3

                  No minimum 4

                  No minimum 4

                  Eye Irritation Potential
                  Protective eyewear
                  Protective eyewear
                  No minimum 4

                  No minimum 4

                  1 If dermal toxicity and skin irritation potential are in different toxicity categories, protection shall be based on the more toxic (lower numbered) category.

                  2 For labeling language for chemical-resistant gloves, see paragraph (f) of this section.

                  3 For labeling language for respiratory protection device, see paragraphs (g) and (h) of this section.

                  4 Although no minimum PPE is required by this section for this toxicity category and route of exposure, the Agency may require PPE on a product-specific basis.

              (f) Chemical-resistant gloves labeling statements for pesticide handlers. If the table in paragraph (e) of this section indicates that chemical-resistant gloves are required, the glove statement shall be as specified in paragraph (f)(2), (3), (4), or (5) of this section.
              (1) Exception. The registrant shall specify a glove type other than that selected through the criteria in paragraphs (f)(2) through (5) of this section if information available to the registrant indicates that such a glove type is more appropriate or more protective than the glove type specified in this section. The statement must specify the particular types of chemical-resistant glove (such as nitrile, butyl, neoprene, and/or barrier-laminate).
              (2) Solid formulations. For products formulated and applied as solids or formulated as solids and diluted solely with water for application, the glove statement shall specify: “waterproof gloves.”
              (3) Aqueous-based formulations. For products formulated and applied as a water-based liquid or formulated as a water-based liquid and diluted solely with water for application, the glove statement may specify: “waterproof gloves” instead of the statement in paragraph (f)(4) of this section.
              (4) Other liquid formulations. For products formulated or diluted with liquids other than water, the glove statement shall specify: “chemical-resistant (such as nitrile or butyl) gloves.”
              (5) Gaseous formulations and applications. For products formulated or applied as gases, any existing glove statement established before the effective date of this subpart, including any glove prohibition statement, will continue to apply. If no glove statement or glove prohibition now exists, the glove statement shall specify “chemical-resistant (such as nitrile or butyl) gloves.”
              (g) Existing respirator requirement for pesticide handlers on product labeling—(1) General requirement. If a statement placed on a product's labeling before the effective date of this subpart indicates that respiratory protection is required, that requirement for protection shall be retained. The statement must specify, or be amended to specify, one of the following respirator types and the appropriate MSHA/NIOSH approval number prefix:
              (i) Dust/mist filtering respirator with MSHA/NIOSH/ approval number prefix TC-21C; or
              (ii) Respirator with an organic-vapor-removing cartridge and a prefilter approved for pesticides with MSHA/NIOSH approval number prefix TC-23C or with a canister approved for pesticides with MSHA/NIOSH approval number prefix TC-14G; or
              (iii) Supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C or self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval number TC-13F.
              (2) Respirator type already specified on labeling. If the existing respiratory protection requirement specifies a respirator type, it shall be retained. The respirator statement must be revised, if necessary, to conform to the wording in paragraph (g)(1) of this section.
              (3) Respirator type not already specified on labeling. If the existing respiratory protection requirement on product labeling does not specify a respirator type as listed in paragraph (g)(1) of this section, the specific respirator type shall be that required in the criteria in paragraphs (g)(3)(ii) through (vi) of this section.
              (i) Exception. The registrant shall specify a different type of respiratory protection device if information, such as vapor pressure value, is available to the registrant to indicate that the type of respiratory protection device selected through the criteria in paragraphs (g)(3)(ii) through (vi) of this section would not be adequately protective, or might increase risks to the user unnecessarily.
              (ii) Gases applied outdoors. For products that are formulated or applied as a gas (space and soil fumigants) and that may be used outdoors, the respiratory protection statement shall be: “For handling activities outdoors, use either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G).”
              (iii) Gases used in enclosed areas. For products that are formulated or applied as a gas (space and soil fumigants) and that may be used in greenhouses or other enclosed areas, the respiratory protection statement shall specify: “For handling activities in enclosed areas, use either a supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C, or a self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval number TC-13F.”
              (iv) Solids. For products that are formulated and applied as solids, the respiratory protection statement shall specify: “dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”
              (v) Liquids in toxicity category I. For products that are formulated or applied as liquids, and, as formulated, have an acute inhalation toxicity (or its surrogate as specified in paragraph (d)(2) of this section) in category I, the respiratory protection statement shall specify: “either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix 14G).”
              (vi) Liquids in toxicity category II. For products that are formulated or applied as liquids, and, as formulated, have an acute inhalation toxicity (or its surrogate as specified in paragraph (d)(2) of this section) in category II, the respiratory protection statement shall specify: “For handling activities during (select uses applicable to the product: airblast, mistblower, pressure greater than 40 p.s.i. with fine droplets, smoke, mist, fog, aerosol or direct overhead) exposures, wear either a respirator with an organic-vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix 14G). For all other exposures, wear a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”
              (h) New respirator requirement established for pesticide handlers in this part—(1) General requirement. If the table in paragraph (e) of this section indicates a respiratory protection device is required, and existing product labeling has no respiratory protection requirement, the registrant shall add a respiratory protection statement that specifies a: “dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).”
              (2) Exception. The registrant shall specify a different type of respiratory protection device if information, such as vapor pressure value, is available to the registrant to indicate that the type of respiratory protection device required in paragraph (h)(1) of this section would not be adequately protective or might increase risks to the user unnecessarily.
              (i) Additional personal protective equipment requirements for pesticide handlers. In addition to the minimum personal protective equipment and work clothing requirements given in the table in paragraph (e) of this section, the labeling statement for any product in toxicity category I or II on the basis of dermal toxicity or skin irritation potential (or their surrogate as specified in paragraph (d)(2) of this section), shall include the following personal protective equipment instructions, additions, or substitutions as applicable:
              (1) If the product is not ready-to-use and there is no existing requirement for a chemical-resistant suit, the following statement shall be included: “Mixers/Loaders: add a chemical-resistant apron.”
              (2) If the application of the product may result in overhead exposure to any handler (for example, applicator exposure during airblast spraying of orchards or flagger exposure during aerial application), the following statement shall be included: “Overhead Exposure: wear chemical-resistant headgear.”
              (3) If any type of equipment other than the product container may be used to mix, load, or apply the product, and there is no requirement for a chemical-resistant protective suit, the following statement shall be included: “For Cleaning Equipment: add a chemical-resistant apron.”
              (j) Personal protective equipment for early-entry workers. This paragraph specifies minimum requirements for personal protective equipment (as defined in § 170.240 of this chapter) and work clothing for early-entry workers.
              (1) For all pesticide products, add the statement: “For early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, wear: (list the body protection, glove, footwear, protective eyewear, and protective headgear, if applicable, statements specified for applicators and other handlers, but omit any respiratory protection statement).”
              (2) If the body protection statement in the personal protective equipment requirement for handlers specifies a long-sleeved shirt and long pants, “coveralls” must be specified in the statement of personal protective equipment for early-entry workers.
              (3) If there is no statement requiring gloves and no prohibition against gloves for applicators and other handlers under the heading HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a requirement for “waterproof gloves” in the statement of personal protective equipment for early-entry workers.
              [57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]

          Pt. 157
          PART 157—PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

              Subpart A [Reserved]

              Subpart B—Child-Resistant Packaging
              Sec.
              157.20
              General.
              157.21
              Definitions.
              157.22
              When required.
              157.24
              Exemptions.
              157.27
              Unit packaging.
              157.30
              Voluntary use of child-resistant packaging.
              157.32
              Standards.
              157.34
              Certification.
              157.36
              Recordkeeping.

            Authority:
            7 U.S.C. 136w.

            Source:
            51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, unless otherwise noted.

            Subpart A [Reserved]

            Subpart B—Child-Resistant Packaging

              § 157.20
              General.
              This subpart prescribes requirements for child-resistant packaging of pesticide products and devices. The requirements are established under the authority of FIFRA section 25(a)(1), which authorizes the Administrator to issue regulations to carry out the purposes of the Act, and FIFRA section 25(c)(3), which authorizes the Administrator to establish standards with respect to the package, container or wrapping in which a pesticide or device is enclosed in order to protect children and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated under the Act.

              § 157.21
              Definitions.
              Terms used in this subpart shall have the following meanings:

                Appropriate, when used with respect to child-resistant packaging, means that the packaging is chemically compatible with the pesticide contained therein.

                Child-resistant packaging means packaging that is designed and constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time, and that is not difficult for normal adults to use properly.

                Package or packaging means the immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.

                Practicable, when used with respect to child-resistant packaging, means that the packaging can be mass produced and can be used in assembly line production.

                Residential use means use of a pesticide or device:
              (1) Directly on humans or pets;
              (2) In, on, or around any structure, vehicle, article, surface or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles; or
              (3) In or around any preschool or day care facility.

                Technically feasible, when applied to child-resistant packaging, means that the technology exists to produce the child-resistant packaging for a particular pesticide.

                Unit packaging means a package that is labeled with directions to use the entire contents of the package in a single application.
              [51 FR 21286, June 11, 1986, as amended at 73 FR 75596, Dec. 12, 2008]

              § 157.22
              When required.
              Unless exempted under § 157.24, a pesticide product must be distributed and sold in child-resistant packaging complying with § 157.32 if it meets both of the following criteria:
              (a) Toxicity criterion. Based upon testing with an appropriate test species, the product meets any of the following toxicity criteria:
              (1) The pesticide has an acute oral LD50 of 1.5 g/kg or less;
              (2) The pesticide has an acute dermal LD50 of 2000 mg/kg or less;
              (3) The pesticide has an acute inhalation LC50 of 2 mg/liter or less;
              (4) The pesticide is corrosive to the eye (causes irreversible destruction of ocular tissue) or causes corneal involvement or irritation persisting for 21 days or more;
              (5) The pesticide is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe skin irritation (severe erythema or edema) at 72 hours; or
              (6) The pesticide or device has such characteristics that, based upon human toxicological data, use history, accident data or such other evidence as is available, the Agency determines there is serious hazard of accidental injury or illness which child-resistant packaging could reduce; and
              (b) Use criterion. The product's labeling either directly recommends residential use or reasonably can be interpreted to permit residential use.

              § 157.24
              Exemptions.
              (a) General exemptions. The Agency hereby exempts from the requirement for child-resistant packaging the following classes of products:
              (1) Products classified for restricted use. (i) A product restricted to use by or under the supervision of a certified applicator is not required to be distributed and sold in child-resistant packaging.
              (ii) Notwithstanding the exemption in paragraph (a)(1)(i) of this section, the Agency may require the use of child-resistant packaging for a product classified for restricted use by or under the direct supervision of a certified applicator if the Agency determines that the product poses a risk of serious accidental injury or illness which child-resistant packaging could reduce. If the Agency makes such a determination, it will notify the registrant in writing and provide a short statement of the basis of its determination. The registrant will then have 30 days to request a hearing on the Agency's determination. Thereafter the Agency will decide whether to require the product to be distributed only in child-resistant packaging and will notify the registrant of its decision.
              (2) Products packaged in large sizes. (i) Except as provided by paragraph (a)(2)(ii) of this section, a product is not required to be in child-resistant packaging if distributed and sold in the following sizes:
              (A) If the product is a solid product, regardless of pesticide type, a size of 50 pounds or greater;
              (B) If the product is a liquid product intended for use in swimming pools, a size greater than 7.5 gallons by volume;
              (C) If the product is a liquid product intended for any other pesticide use, a size of 5 gallons or greater by volume;
              (D) If the product is packaged as an aerosol (measured by weight), regardless of pesticide type, a weight of 2 pounds or greater.
              (ii) The Agency may require that a product packaged in a size exceeding that listed in paragraphs (a)(2)(i) (A) through (D) of this section be distributed and sold only in child-resistant packaging if the Agency determines that the product is, or is intended to be, distributed or sold to homeowners or other members of the general public. If the Agency makes such a determination, it will notify the registrant in writing and provide a short statement of the basis of its determination. The registrant will then have 30 days to request a hearing on the Agency's determination. Thereafter the Agency will decide whether to require the product to be distributed only in child-resistant packaging and will notify the registrant of its decision.
              (b) Exemptions requiring Agency approval. The Agency may, in accordance with paragraphs (b) (1) through (3) of this section, grant an exemption from the requirements of this subpart. An exemption may be withdrawn in accordance with paragraph (b)(4) of this section.
              (1) Requesting an exemption. A request for an exemption must be submitted to the Agency, and must be accompanied by two copies of the following information:
              (i) The name, address, and telephone number of the requester;
              (ii) The name and registration number (or file symbol) of the product(s) for which the exemption is requested;
              (iii) A description of the package and the size(s) for which the exemption is requested; and
              (iv) Documentation supporting the request for exemption, including the length of time for which the exemption is requested.
              (2) Exemption based upon lack of toxicity. The Agency may grant an exemption from the requirements of this subpart if the registrant or applicant demonstrates to the Agency's satisfaction that the hazards indicated by the toxicity criteria in § 157.22(a) are not indicative of the hazards to man. If granted, an exemption shall apply to other products of substantially similar composition. A notice will be issued in the Federal Register stating the nature of and reasons for the exemption.
              (3) Exemption based upon technical factors. The Agency may grant an exemption from the requirements of this subpart based upon technical considerations. If granted, the exemption will be for a specified length of time, and will apply to other products of substantially similar composition and intended uses. A notice of the granting of an exemption will be issued in the Federal Register. In considering whether to grant an exemption, the Agency will consider, among other things, the following:
              (i) Whether the toxicity of the product is such that it should not be allowed to be distributed or sold except in child-resistant packaging.
              (ii) Whether child-resistant packaging is technically feasible, practicable, or appropriate. An exemption may be granted if the Agency determines that any one of these criteria has not been met.
              (iii) Whether the composition or use pattern of the product necessitates a particular form of packaging for proper use.
              (iv) Whether child-resistant packaging that is technically feasible, practicable, and appropriate is available for the product or can reasonably be made available to the registrant in sufficient quantities to meet his packaging needs. This determination does not include a consideration of whether the packaging would be adaptable to a registrant's existing package type or packaging equipment.
              (v) Whether the registrant has made a timely and good faith effort to obtain child-resistant packaging for the product.
              (vi) If child-resistant packaging which is technically feasible, practicable, and appropriate is not yet available, when such packaging is likely to be available.
              (4) An exemption may be withdrawn by the Agency at any time if the lack of child-resistant packaging results in serious illnesses or injuries to children. If the Agency determines that an exemption should be withdrawn, it will notify the registrant, stating the basis for its determination. The registrant will then have 30 days to request a hearing on the Agency's determination. Thereafter the Agency will decide whether to withdraw the exemption, and will notify the registrant of its decision.

              § 157.27
              Unit packaging.
              Pesticide products distributed or sold as an aggregate of one or more unit packages and meeting the criteria of § 157.22 must be distributed or sold in child-resistant packaging either for each unit package or for the outer retail container which contains the unit packages. Child-resistant packaging is not required for both the outer package and the unit packages unless the Agency determines, on a case-by-case basis, that it is necessary for risk reduction.

              § 157.30
              Voluntary use of child-resistant packaging.
              A registrant whose product is not required to be in child-resistant packaging may distribute or sell his pesticide product in child-resistant packaging. If he does so, that packaging must meet the standards for child-resistant packaging stated in § 157.32. The registrant must certify to this effect in accordance with § 157.34, and must retain the records required by § 157.36.

              § 157.32
              Standards.
              (a) Effectiveness standard. The child-resistant packaging, when tested by the protocol specified in 16 CFR 1700.20, shall meet the effectiveness specifications in 16 CFR 1700.15(b).
              (b) Compatibility standard. The child-resistant packaging must continue to meet the effectiveness specifications of paragraph (a) of this section when in actual use as a pesticide container. This requirement may be satisfied by appropriate scientific evaluation of the compatibility of the substance with the child-resistant packaging to determine that the chemical and physical characteristics of the pesticide will not compromise or interfere with the proper functioning of the child-resistant packaging and that the packaging will not be detrimental to the integrity of the product during storage and use.
              (c) Durability standard. The child-resistant packaging must continue to meet the effectiveness and compatibility standards of paragraphs (a) and (b) of this section for the reasonably expected lifetime of the package, taking into account the number of times the package is customarily opened and closed. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress factors of packaging, the force required for activation, and other relevant factors.

              § 157.34
              Certification.
              (a) General. (1) The registrant of a pesticide product required to be in child-resistant packaging shall certify to the Agency that the package meets the standards of § 157.32.
              (2) Certification must be submitted with each application for new registration, if applicable. If the Agency determines, in accordance with § 157.24(a)(1)(ii), (2)(ii), or (b)(4), that a currently registered product is required to be packaged in child-resistant packaging, a certification must be submitted within 6 months after the Agency finally notifies the registrant of the requirement.
              (b) Contents of certification. The certification must contain the following information:
              (1) The name and EPA registration number of the product to which the certification applies, the registrant's name and address, the date, and the name, title and signature of the company official making the certification.
              (2) A statement that the packaging that is being used for the product will meet the standards of § 157.32. The statement, “I certify that the packaging that will be used for this product meets the standards of 40 CFR 157.32,” will suffice for this purpose.

              § 157.36
              Recordkeeping.
              For as long as the registration of a pesticide product required to be in child-resistant packaging is in effect, the registrant must retain the records listed in this section. The registrant must, upon request by the Agency, make them available to Agency representatives for inspection and copying, or must submit them to the Agency.
              (a) A description of the package, including a description of:
              (1) The container and its dimensions and composition.
              (2) The closure or child-resistant mechanism, including the name of its manufacturer and the manufacturer's designation for the closure or the physical working of the child-resistant packaging mechanism.
              (b) A copy of the certification statement required by § 157.34.
              (c) One of the following types of records verifying that each package for the product is child-resistant:
              (1) Test data on the package based on the Consumer Product Safety Commission protocol in 16 CFR 1700.20.
              (2) Test data, not conforming to the protocol in 16 CFR 1700.20, or a set of measurements on the package, together with an explanation as to why such data or measurements demonstrate that the package is child-resistant.
              (3) Test data, whether or not conforming to the protocol in 16 CFR 1700.20, on a different package, together with an explanation of why such data demonstrate that the package being used is child-resistant.
              (4) Written evidence that verifies that testing on the package has been conducted according to the protocol in 16 CFR 1700.20. Written evidence may be one of the following:
              (i) A letter or literature from the packaging supplier;
              (ii) A letter from the facility that conducted the testing; or
              (iii) A specification in the contract between the registrant or applicant and the packaging supplier;
              (5) When the container and closure are purchased separately by the registrant:
              (i) Information of the kinds described in paragraphs (c) (1) through (4) of this section showing that the closure is child-resistant; and
              (ii) A written explanation of why the container is child-resistant; and
              (iii) Information showing that the closure and container are compatible with each other, and a written explanation of why the resulting package is child-resistant.
              (6) A combination of the records listed in paragraphs (c) (1) through (5).
              (d) Records verifying that the package meets the compatibility and durability standards of § 157.32(b) and (c).
              [51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, as amended at 65 FR 39304, June 26, 2000]

          Pt. 158
          PART 158—DATA REQUIREMENTS FOR PESTICIDES

              Subpart A—General Provisions
              Sec.
              158.1
              Purpose and scope.
              158.3
              Definitions.
              158.5
              Applicability.
              158.30
              Flexibility.
              158.32
              Format of data submissions.
              158.33
              Confidential data.
              158.34
              Flagging of studies for potential adverse effects.
              158.45
              Waivers.
              158.60
              Minor use data policies.
              158.70
              Satisfying data requirements.
              158.75
              Requirements for additional data.
              158.80
              Use of other data.

              Subpart B—How To Use Data Tables
              158.100
              Pesticide use patterns.
              158.110
              Required and conditionally required data.
              158.120
              Determining data requirements.
              158.130
              Purposes of the registration data requirements.

              Subpart C—Experimental Use Permits
              158.200
              Experimental use permit data requirements tables.
              158.210
              Experimental use permit data requirements for product chemistry
              158.220
              Experimental use permit data requirements for product performance.
              158.230
              Experimental use permit data requirements for toxicology.
              158.240
              Experimental use permit data requirements for ecological effects.
              158.243
              Experimental use permit data requirements for terrestrial and aquatic nontarget organisms.
              158.250
              Experimental use permit data requirements for human exposure.
              158.260
              Experimental use permit data requirements for environmental fate.
              158.270
              Experimental use permit data requirements for residue chemistry.
              158.280-158.290
              [Reserved]

              Subpart D—Product Chemistry
              158.300
              Definitions.
              158.310
              Product chemistry data requirements table.
              158.320
              Product identity and composition.
              158.325
              Description of materials used to produce the product.
              158.330
              Description of production process.
              158.335
              Description of formulation process.
              158.340
              Discussion of formation of impurities.
              158.345
              Preliminary analysis.
              158.350
              Certified limits.
              158.355
              Enforcement analytical method.

              Subpart E—Product Performance
              158.400
              Product performance data requirements.

              Subpart F—Toxicology
              158.500
              Toxicology data requirements table.
              158.510
              Tiered testing options for nonfood pesticides.

              Subpart G—Ecological Effects
              158.630
              Terrestrial and aquatic nontarget organisms data requirements table.
              158.660
              Nontarget plant protection data requirements table.

              Subparts H-J [Reserved]
              158.700-158.900
              [Reserved]

              Subpart K—Human Exposure
              158.1000
              Applicator exposure—general requirements.
              158.1010
              Applicator exposure—criteria for testing.
              158.1020
              Applicator exposure data requirements table.
              158.1050
              Post-application exposure—general requirements.
              158.1060
              Post-application exposure—criteria for testing.
              158.1070
              Post-application exposure data requirements table.

              Subpart L—Spray Drift
              158.1100
              Spray drift data requirements table.

              Subpart M [Reserved]
              158.1200-158.1299
              [Reserved]

              Subpart N—Environmental Fate
              158.1300
              Environmental fate data requirements table.

              Subpart O—Residue Chemistry
              158.1400
              Definitions.
              158.1410
              Residue chemistry data requirements table.

              Subparts P-T [Reserved]
              158.1500-158.1900
              [Reserved]

              Subpart U—Biochemical Pesticides
              158.2000
              Biochemical pesticides definition and applicability.
              158.2010
              Biochemical pesticides data requirements.
              158.2030

              Biochemical pesticides product chemistry data requirements table.

              158.2040
              Biochemical pesticides residue data requirements table.
              158.2050
              Biochemical pesticides human health assessment data requirements table.
              158.2060
              Biochemical pesticides nontarget organisms and environmental fate data requirements table.
              158.2070
              Biochemical pesticides product performance data requirements.
              158.2080
              Experimental use permit data requirements—biochemical pesticides.
              158.2081
              Experimental use permit biochemical pesticides product chemistry data requirements table.
              158.2082
              Experimental use permit biochemical pesticides residue data requirements table.
              158.2083
              Experimental use permit biochemical pesticides human health assessment data requirements table.
              158.2084
              Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table.

              Subpart V— Microbial Pesticides
              158.2100
              Microbial pesticides definition and applicability.
              158.2110
              Microbial pesticides data requirements.
              158.2120
              Microbial pesticides product analysis data requirements table.
              158.2130
              Microbial pesticides residue data requirements table.
              158.2140
              Microbial pesticides toxicology data requirements table.
              158.2150
              Microbial pesticides nontarget organisms and environmental fate data requirements table.
              158.2160
              Microbial pesticides product performance data requirements.
              158.2170
              Experimental use permit data requirements—microbial pesticides.
              158.2171
              Experimental use permit microbial pesticides product analysis data requirements table.
              158.2172
              Experimental use permit microbial pesticides residue data requirements table.
              158.2173
              Experimental use permit microbial pesticides toxicology data requirements table.
              158.2174
              Experimental use permit microbial pesticides nontarget organisms and environmental fate data requirements table.

              Subpart W—Antimicrobial Pesticide Data Requirements
              158.2200
              Applicability.
              158.2201
              Antimicrobial use patterns.
              158.2203
              Definitions.
              158.2204
              Public health and nonpublic health claims.
              158.2210
              Product chemistry.
              158.2220
              Product performance.
              158.2230
              Toxicology.
              158.2240
              Nontarget organisms.
              158.2250
              Nontarget plant protection.
              158.2260
              Applicator exposure.
              158.2270
              Post-application exposure.
              158.2280
              Environmental fate.
              158.2290
              Residue chemistry.

              Subpart X-Z [Reserved]
              158.2300-158.2500
              [Reserved]

            Authority:
            7 U.S.C. 136-136y; 21 U.S.C. 346a.

            Source:
            72 FR 60957, Oct. 26, 2007, unless otherwise noted.

            Subpart A—General Provisions

              § 158.1
              Purpose and scope.
              (a) Purpose. The purpose of this part is to specify the kinds of data and information EPA requires in order to make regulatory judgments under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide products. Further, this part specifies the data and information needed to determine the safety of pesticide chemical residues under FFDCA sec. 408.
              (b) Scope. (1) This part describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process, e.g., as used in the registration review program; or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue.
              (2) This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action.
              (3) This part does not include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data.
              (c) Scope of individual subparts. (1) Conventional pesticides. Subparts A, B, C, D, F, G, K, L, N, and O apply to conventional pesticides.

              (2) Biochemical pesticides. Subparts A, B and U apply to biochemical pesticides.
              (3) Microbial pesticides. Subparts A, B and V apply to microbial pesticides.
              (4) Antimicrobial pesticides. Subparts A, B, C, D, and W of this part apply to antimicrobial pesticides.
              [72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]

              § 158.3
              Definitions.
              All terms defined in sec. 2 of the Federal Insecticide, Fungicide, and Rodenticide Act apply to this part and are used with the meaning given in the Act. Applicable terms from the Federal Food, Drug, and Cosmetic Act also apply to this part. Individual subparts may contain definitions that pertain solely to that subpart. The following additional terms apply to this part:

                Applicant means any person or entity, including for the purposes of this part a registrant, who submits, or is required to submit, to the Agency any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:
              (1) An application for registration or amended registration of a pesticide product under FIFRA sec. 3 or 24.
              (2) A submission of data required in conjunction with reregistration of a currently registered product under FIFRA sec. 4.
              (3) An application for an experimental use permit under FIFRA sec. 5.
              (4) A submission of data in response to a notice issued by EPA under FIFRA sec. 3(c)(2)(B).
              (5) A petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under FFDCA sec. 408.

                Registration includes a new registration, amended registration and reregistration, unless stated otherwise.

              § 158.5
              Applicability.
              (a) The requirements of this part apply to the following submissions:
              (1) An application for new or amended registration under FIFRA sec. 3 or 24.
              (2) An application for experimental use permit under FIFRA sec. 5.
              (3) A submission of data or information to support the continuation of a registration under FIFRA sec. 3, 4, or 24.
              (4) A petition to establish, modify or revoke a tolerance or exemption from a tolerance under FFDCA sec. 408.
              (b) The information specified in this part must be furnished with each submission described in paragraph (a) of this section if it has not been submitted previously, or if any previous submission is not accurate or complete.

              § 158.30
              Flexibility.
              (a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgments for pesticide products. EPA has the authority to establish or modify data needs for individual pesticide chemicals. The actual data required may be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. The Agency encourages each applicant to consult with EPA to discuss the data requirements particular to its product prior to and during the registration process.
              (b) The Agency cautions applicants that the data routinely required in this part may not be sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment. EPA may require the submission of additional data or information beyond that specified in this part if such data or information are needed to appropriately evaluate a pesticide product.
              (c) This part will be updated as needed to reflect evolving program needs and advances in science.

              § 158.32
              Format of data submissions.
              (a) General. (1) All data submitted under this part must be formatted in accordance with this section.

              (2) The requirements of this section do not apply to administrative materials accompanying a data submission, including forms, labeling, and correspondence.
              (b) Transmittal document. Each submission in support of a regulatory action must be accompanied by a transmittal document, which includes:
              (1) Identity of the submitter.
              (2) The transmittal date.
              (3) Identification of the regulatory action with which the submission is associated, e.g., the registration or petition number.
              (4) A list of the individual documents included in the submission.
              (c) Individual documents. Unless otherwise specified by the Agency, each submission must be in the form of individual documents or studies. Previously submitted documents should not be resubmitted unless specifically requested by the Agency, but should be cited with adequate information to identify the previously submitted document. Each study or document should include the following:
              (1) A title page including the following information:
              (i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.
              (ii) The author(s) of the study.
              (iii) The date the study was completed.
              (iv) If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes.
              (v) If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review.
              (vi) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication.
              (2) The appropriate statement(s) regarding any data confidentiality claims as described in § 158.33.
              (3) A statement of compliance or non-compliance with respect to Good Laboratory Practice Standards as required by 40 CFR 160.12, if applicable.
              (4) A complete and accurate English translation must be included for any information that is not in English.
              (5) A flagging statement as prescribed by § 158.34, if applicable.

              § 158.33
              Confidential data.
              (a) Definitions. For the purposes of this section:
              (1) Registered or previously registered pesticide means any pesticide containing an active ingredient contained in a product that is, or has ever been, an active ingredient in a product registered under sec. 3 of FIFRA. A registered pesticide that is the subject of an application for a new use falls within the category of “registered or previously registered pesticide.”
              (2) Safety and efficacy information means information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism.
              (b) Applicability. (1) This section applies to information submitted pursuant to this part. It supplements the general confidentiality procedures in 40 CFR part 2, subpart B, including FIFRA confidentiality procedures at 40 CFR 2.307. To the extent that provisions in this section conflict with those in 40 CFR part 2, subpart B, the provisions in this section take precedence. The provisions of 40 CFR 2.308 do not apply to information to which this section applies. In addition to complying with the requirements of this section, any confidentiality claims for information subject to 40 CFR part 174 (plant-incorporated protectants) must be substantiated at the time of submission as described in § 174.9 of this chapter.

              (2) FFDCA sec. 408(i) protects confidential information submitted in connection with an application for a tolerance or exemption to the same extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are deemed to apply equally to information submitted pursuant to FFDCA sec. 408, pursuant to the authority in sec. 408(i).
              (c) Method of asserting business confidentiality claims—(1) Claim required. Information to which this section applies (and which is submitted on or after the effective date of this regulation) will be deemed as not subject to a confidentiality claim unless a claim for that information is made in accordance with the procedures specified in this paragraph. Information not subject to a confidentiality claim may be made available to the public without further notice, subject to the requirements of FIFRA sec. 10(g).
              (2) Statement required. Upon submission to EPA, each document must be accompanied by a signed and dated document containing either the statements in paragraph (c)(2)(i) or (ii) of this section. No claims or markings on the document or any attachments, other than these statements and attachments submitted in accordance with paragraph (c)(3) of this section, will be recognized as asserting a claim of confidentiality. The format of data submissions is set forth in § 158.32.
              (i) No claim of confidentiality.

                No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA sec. 10(g).

              (ii) Claim of confidentiality.

                Information claimed as confidential has been removed to a confidential attachment.

              (3) Confidential attachment. (i) All information claimed as confidential must be submitted in a separate confidential attachment to the document and cross referenced to the specific location in the document from which it was removed. The confidential attachment must have its own title page and be paginated separately from the non-confidential document.
              (ii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) manufacturing or quality control processes must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(A).
              (iii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(B).
              (iv) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the identity or percentage quantity of any deliberately added inert ingredient of a pesticide must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(C).
              (v) Information in the confidential attachment that is designated in accordance with paragraphs (c)(3)(ii) - (iv) of this section must be on a separate page from information that is not so designated.
              (4) Voluntary release of information to States and foreign governments. (i) Submitters are encouraged to include with the statement required under paragraph (c)(2) of this section an additional statement to allow EPA to share information with State and foreign governments. EPA will not consider such a statement to be a waiver of confidentiality or proprietary claims for the information. The statement is as follows:

                I authorize the Environmental Protection Agency to release any information contained in this document to State or foreign governments, without relinquishing proprietary rights or any confidentiality claims asserted above.

              (ii) Information designated as releasable to state or foreign governments in accordance with this section may be released to such a government without further notice to the submitter. EPA will inform the State or foreign government of any of the confidentiality claims associated with the information.

              (d) Release of information. (1) Safety and efficacy information that was submitted to EPA on or after May 4, 1988 and that has not been designated by the submitter as FIFRA sec. 10(d)(1)(A), (B), or (C) information in accordance with the applicable requirements of this section is not entitled to confidential treatment and may be disclosed to the public without further notice to the submitter, in accordance with paragraph (d)(2) of this section. Safety and efficacy information which has been designated by the submitter as FIFRA sec. 10(d)(1) (A), (B), or (C) information is entitled to confidential treatment only to the extent provided by FIFRA sec. 10(b), this section, and 40 CFR 2.208.
              (2) Information that is not entitled to be protected as confidential in accordance with FIFRA sec. 10(b), this section and with EPA confidentiality regulations at 40 CFR part 2, subpart B, may be released to the public without the affirmation of non-multinational status provided under FIFRA sec. 10(g), provided that the information does not contain or consist of any complete unpublished report submitted to EPA, or excerpts or restatements of any such report which reveal the full methodology and complete results of the study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret the results.

              § 158.34
              Flagging of studies for potential adverse effects.
              (a) Any applicant who submits a study of a type listed in paragraph (b) of this section must submit with the study a statement in accordance with paragraph (c) of this section.
              (b) The following table indicates the study types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of study. Column 4 lists the reporting code to be included in the statement specified in paragraph (c) of this section when any criterion is met or exceeded.

                Table—Flagging Criteria

                  Study Type(s)
                  Guideline No.
                  Criteria: Treated animals show any of the following:
                  Criteria No.

                  Carcinogenicity or combined carcinogenicity/chronic feeding study
                  870.4200870.4300

                  An incidence of neoplasms in males or females which increases with dose (positive trend p≤0.05); or
                  1

                  A statistically significant (pairwise p≤0.05) increase of any type of neoplasm in any test group, males or females at any dose level, compared to concurrent control animals of the same sex; or
                  2

                  An increase in any type of uncommon or rare neoplasms in any test group, males or females animals at any dose level, compared to concurrent controls of the same sex; or
                  3

                  A decrease in the time to development of any type of neoplasms in any test group, males or females at any dose level, compared to concurrent controls of the same sex.
                  4

                  Prenatal developmental toxicityReproduction and fertility
                    Developmental neurotoxicity

                  870.3700870.3800
                    870.6300

                  When compared to concurrent controls, treated offspring show a dose-related increase in malformations, pre- or post-natal deaths, or persistent functional or behavioral changes on a litter basis in the absence of significant maternal toxicity at the same dose level.
                  5

                  Neurotoxicity
                  870.6100870.6200

                  When compared to concurrent controls, treated animals show a statistically or biologically significant increase in neuropathological lesions or persistent functional or behavioral changes.
                  6

                  Chronic feedingCarcinogenicity
                    Reproduction and fertility
                    Prenatal developmental toxicity
                    Developmental neurotoxicity
                    Acute or 90-day neurotoxicity

                  870.4100870.4200
                    870.3800
                    870.3700
                    870.6300
                    870.6200

                  The no observed adverse effect level (NOAEL) from one of these studies is less than the NOAEL currently used by the Agency as the basis for either the acute or chronic reference dose.
                  7

              (c) Identification of studies. For each study of a type identified in paragraph (b) of this section, the applicant shall include the appropriate one of the following two statements, together with the signature of the authorized representative of the company, and the date of signature:
              (1) Study does not meet or exceed criteria.

                I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria.

              (2) Study meets or exceeds criteria.

                I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes].

              § 158.45
              Waivers.
              (a) The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.
              (b)(1) Applicants are encouraged to discuss a data waiver request with the Agency before developing and submitting supporting data, information, or other materials.
              (2) All waiver requests must be submitted to the Agency in writing. The request must clearly identify the data requirement(s) for which a waiver is sought along with an explanation and supporting rationale why the applicant believes the data requirement should be waived. In addition, the applicant must describe any unsuccessful attempts to generate the required data, furnish any other information which the applicant(s) believe(s) would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement.

              (c) The Agency will review each waiver request and subsequently inform the applicant in writing of its decision. If the decision could apply to more than the requested product, the Agency, in its discretion, may choose to send a notice to all registrants or publish a notice in the Federal Register announcing the decision. An Agency decision denying a written request to waive a data requirement is a final Agency action.

              § 158.60
              Minor use data policies.
              FIFRA sec. 2(ll) defines the term “minor use”and FIFRA provides a number of statutory provisions concerning minor uses. In addition, EPA has established policies with respect to minor uses of pesticides, including, but not limited to, the following:
              (a) A new data requirement pertinent to both an unregistered minor use and a registered major use will not be applied to a minor use applicant until it is applied to the major use registration.
              (b) EPA will accept appropriate and adequate extrapolations and regional data to support establishment of individual minor use tolerances.

              § 158.70
              Satisfying data requirements.
              (a) General policy. The Agency will determine whether the data submitted or cited to fulfill the data requirements specified in this part are acceptable. This determination will be based on the design and conduct of the experiment from which the data were derived, and an evaluation of whether the data fulfill the purpose(s) of the data requirement. In evaluating experimental design, the Agency will consider whether generally accepted methods were used, sufficient numbers of measurements were made to achieve statistical reliability, and sufficient controls were built into all phases of the experiment. The Agency will evaluate the conduct of each experiment in terms of whether the study was conducted in conformance with the design, good laboratory practices were observed, and results were reproducible. The Agency will not reject data merely because they were derived from studies which, when initiated, were in accordance with an Agency-recommended protocol, even if the Agency subsequently recommends a different protocol, as long as the data fulfill the purposes of the requirements as described in this paragraph.
              (1) The provisions in this part 158 should be read in conjunction with the provisions in § 152.85 to claim eligibility for the formulators' exemption.
              (2) [Reserved]
              (b) Good laboratory practices. Applicants must adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 when conducting studies. Applicants must also adhere to GLP standards when conducting a study in support of a waiver request of any data requirement which is within the scope of the GLP requirements.
              (c) Agency guidelines. EPA has published Test Guidelines that contain standards for conducting acceptable tests, guidance on the evaluation and reporting of data, definition of terms, and suggested study protocols. Copies of the Test Guidelines may be obtained by visiting the agency's website at www.epa.gov/pesticides.

              (d) Study protocols—(1) General. Any appropriate protocol may be used to generate the data required by this part, provided that it meets the purpose of the test standards specified in the pesticide assessment guidelines, and provides data of suitable quality and completeness as typified by the protocols cited in the guidelines. Applicants should use the test procedure which is most suitable for evaluation of the particular ingredient, mixture, or product. Accordingly, failure to follow a suggested protocol will not invalidate a test if another appropriate methodology is used.
              (2) Organization for Economic Co-Operation and Development (OECD) protocols. Tests conducted in accordance with the requirements and recommendations of the applicable OECD protocols can be used to develop data necessary to meet the requirements specified in this part. Applicants should note, however, that certain of the OECD recommended test standards, such as test duration and selection of test species, are less restrictive than those recommended by EPA. Therefore, when using OECD protocols, care should be taken to observe the test standards in a manner such that the data generated by the study will satisfy the requirements of this part.
              (e) Combining studies. Certain toxicology studies may be combined to satisfy data requirements. For example, carcinogenicity studies in rats may be combined with the rat chronic toxicity study. Combining appropriate studies may be expected to reduce usage of test animals as well as reduce the cost of studies. EPA encourages this practice by including standards for acceptable combined tests in the Pesticide Assessment Guidelines. Registrants and applicants are encouraged to consider combining other tests when practical and likely to produce scientifically acceptable results. Registrants and applicants, however, must consult with the EPA before initiating combined studies.

              § 158.75
              Requirements for additional data.

              The data routinely required by this part may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties and effects of the pesticide.

              § 158.80
              Use of other data.
              (a) Data developed in foreign countries. With certain exceptions, laboratory and field study data developed outside the United States may be submitted in support of a pesticide registration. Data generated in a foreign country which the Agency will not consider include, but are not limited to, data from tests which involved field test sites or a test material, such as a native soil, plant, or animal, that is not characteristic of the United States. Applicants submitting foreign data must take steps to ensure that U.S. materials are used, or be prepared to supply data or information to demonstrate the lack of substantial or relevant differences between the selected material or test site and the U.S. material or test site. Once submitted, the Agency will determine whether or not the data meet the data requirements.
              (b) Data generated for other purposes. Data developed for purposes other than satisfaction of FIFRA data requirements, such as monitoring studies, may also satisfy data requirements in this part. Consultation with the Agency should be arranged if applicants are unsure about suitability of such data.

            Subpart B—How To Use Data Tables

              § 158.100
              Pesticide use patterns.
              (a) General use patterns for conventional, biochemical, and microbial pesticides. There are six broad use categories used in the data tables. The six broad categories include terrestrial outdoor uses, aquatic outdoor uses, greenhouse uses, forestry uses, residential outdoor uses, and indoor uses of all types. The 6 broad use categories are further subdivided into 12 general use patterns which are the bases for data requirements established by use pattern. Within the data tables, general use patterns have been combined into single columns when the data requirements are the same for the combined uses. If there are no data requirements for a specific use, the column for that use is not included in the table. The 12 general use pattern groups used in the data table in this part are:
              (1) Terrestrial food crop use.
              (2) Terrestrial feed crop use.
              (3) Terrestrial nonfood crop use.
              (4) Aquatic food crop use.
              (5) Aquatic nonfood use.
              (6) Greenhouse food crop use.
              (7) Greenhouse nonfood crop use.
              (8) Forestry use.
              (9) Residential outdoor use.
              (10) Residential indoor use.
              (11) Indoor food use.
              (12) Indoor nonfood use.
              (b) Pesticide use site index for conventional, biochemical, and microbial pesticides. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides is a comprehensive list of specific pesticide use sites. The index is alphabetized separately by site for all agricultural and all nonagricultural uses. The Pesticide Use Site Index associates each pesticide use site with one or more of the 12 general use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides will be updated periodically, and is available from the Agency or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides.

              (c) Antimicrobial pesticide use patterns. The general use patterns for antimicrobial pesticides are described in § 158.2201.
              (d) Pesticide use site index for antimicrobial pesticides. The Pesticide Use Site Index for Antimicrobial Pesticides is a comprehensive list of specific antimicrobial use sites. The index is alphabetized by antimicrobial use sites, and associates each antimicrobial use site with one or more of the antimicrobial use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide Use Site Index for Antimicrobial Pesticides will be updated periodically, and is available from the Agency or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides.

              (e) Determination of use pattern. Applicants unsure of the correct use pattern for their particular product should consult the Agency.
              [72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]

              § 158.110
              Required and conditionally required data.
              The tables in this part use the descriptors R (required), CR (conditionally required), and NR (not required) as a general indication of the applicability of a data requirement. In all cases, the test notes referred to in the table must be consulted to determine the actual applicability of the data requirement.
              (a) EPA requires data designated as “required”(R) for products with a given use pattern in order to evaluate the risks or benefits of a product having that use pattern under any conditions established by the test notes.
              (b) Data designated as “conditionally required” (CR) for products with a given use pattern are required by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the notes accompanying the requirement. The determination of whether the data must be submitted is based on the product's use pattern, physical or chemical properties, expected exposure of nontarget organisms, and/or results of previous testing (for example, tier testing). Applicants must evaluate each applicable test note for the conditions and criteria to be considered in determining whether conditionally required data must be submitted.
              (c) Data not required for the Agency's assessment of the risks and benefits of a particular use pattern are designated “not required” (NR) in data tables.

              § 158.120
              Determining data requirements.
              As with current practice, the actual data and studies required may be modified on an individual basis to fully characterize the use and properties of specific pesticide products under review. While EPA is attempting to assist the applicant in this subpart, it is important to emphasize that it is the applicant's obligation under FIFRA to demonstrate that an individual product meets the standard under FIFRA and/or FFDCA. Accordingly, applicants are encouraged to consult with the Agency on the appropriate data requirements as set forth here as they relate to their specific product prior to and during the registration process.
              (a) Finding the appropriate data table. (1) Pesticide data requirements for conventional chemical active ingredients and related substances are presented in subparts D, E, F, G, K, L, N, and O of this part in the form of a series of data tables, each addressing a particular scientific discipline or data topic. Data requirements for biochemical and microbial pest control agents are contained and are described separately within subparts U and V of this part, respectively.
              (2) Key to table notations. R = required data; CR = conditionally required data; NR = Not required; MP = manufacturing-use product; EP = end-use product; TEP = typical end-use product; TGAI = technical grade of the active ingredient; PAI = pure active ingredient; PAIRA = pure active ingredient, radiolabeled; Choice = choice of several test substances depending on studies required.
              (b) Identifying required studies. To determine the specific kinds of data needed to support the registration use of each pesticide product, the applicant may:
              (1) Refer to the applicable subpart(s) of this part. These subparts describe the data requirements including data tables for each subject area.
              (2) Select the general use pattern(s) that best cover the use pattern(s) specified on the pesticide product label as explained in § 158.100. All applicable use patterns must be included.
              (3) Proceed down the appropriate general use pattern column in the table and note which tests are required (R), conditionally required (CR), or not required (NR). Required and conditionally required studies are described in § 158.110.

              (4) Review the notes for each requirement to determine its applicability to the specific product proposed for registration.

              (5)(i) Proceed down the Test substance columns and determine the appropriate test substance needed for that study. If the data are intended to support a manufacturing-use product, use the MP column. If the data are intended to support an end-use product, use the EP column.
              (ii) The test substances columns specify which substance is to be used for testing. Applicants should note that the substance that must be used when performing the study may or may not be the product itself. For example, the data from a certain study may be required to support the registration of an end-use product, but the test substance column may state that the particular test shall be performed using the technical grade of the active ingredient(s) in the end-use product.
              (iii) Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no intentionally added inert ingredients are considered identical in composition to each other, and to the technical grade of the active ingredient (TGAI) from which they were derived. Therefore, the data from a test conducted using any one of these as the test substance is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances.
              (6) Refer to the Pesticide Assessment Guideline reference number for each study located in the first column. See § 158.70(c) for information pertaining to the guidelines and how to obtain copies.

              § 158.130
              Purposes of the registration data requirements.
              (a) General. The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide.
              (b) Product chemistry—(1) Product composition. Data on product composition are needed:
              (i) To support the conclusions expressed in the statement of formula;
              (ii) To compare to the composition of materials used in required testing under this part; and
              (iii) To determine whether a product is “identical or substantially similar”to another product, a determination that involves the comparison of product composition.
              (2) Nominal concentration and certified limits. The nominal concentration of a product, defined as that concentration that is expected to be present in a product as a result of the production or formulation process, is used to gauge the acceptability of the certified limits, which define the outer limits of the range of the product's ingredients. The certified limits are used to enforce the composition of the product and to ensure the accuracy of hazard assessments.
              (3) Physical and chemical characteristics. The physical and chemical characteristics of an active ingredient or product are used:
              (i) To confirm or provide supportive information on the identity and composition of the product;
              (ii) To assess the hazards of the ingredient or product; and
              (iii) To trigger or evaluate certain other studies required by this part.
              (c) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to man in any area of the inanimate environment and those pesticides used to control vertebrates (such as rodents, birds, bats and skunks) that may directly or indirectly transmit diseases to humans.
              (d) Toxicology-humans and domestic animals. Data required to assess hazards to humans and domestic animals are derived from a variety of acute, subchronic and chronic toxicity tests, and tests to assess mutagenicity and pesticide metabolism.
              (1) Acute studies. Determination of acute oral, dermal and inhalation toxicity is usually the initial step in the assessment and evaluation of the toxic characteristics of a pesticide. These data provide information on health hazards likely to arise soon after, and as a result of, short-term exposure. Data from acute studies serve as a basis for classification and precautionary labeling. For example, acute toxicity data are used to calculate farmworker reentry intervals and to develop precautionary label statements pertaining to protective clothing requirements for applicators. They also provide information used in establishing the appropriate dose levels in subchronic and other studies; provide initial information on the mode of toxic action(s) of a substance; and determine the need for child resistant packaging. Information derived from primary eye and primary dermal irritation studies serves to identify possible hazards from exposure of the eyes, associated mucous membranes and skin.
              (2) Subchronic studies. Subchronic tests provide information on health hazards that may arise from repeated exposures over a limited period of time. They provide information on target organs and accumulation potential. The resulting data are also useful in selecting dose levels for chronic studies and for establishing safety criteria for human exposure. These tests are not capable of detecting those effects that have a long latency period for expression (e.g., carcinogenicity).
              (3) Chronic studies. Chronic toxicity studies (usually conducted by feeding the test substance to the test species) are intended to determine the effects of a substance in a mammalian species following prolonged and repeated exposure. Under the conditions of this test, effects which have a long latency period or are cumulative should be detected. The purpose of long-term carcinogenicity studies is to observe test animals over most of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.
              (4) Developmental toxicity and reproduction studies. The developmental toxicity study is designed to determine the potential of the test substance to induce structural and/or other abnormalities to the fetus as the result of exposure of the mother during pregnancy. Two-generation reproduction testing is designed to provide information concerning the general effects of a test substance on gonadal function, estrus cycles, mating behavior, conception, parturition, lactation, weaning, and the growth and development of the offspring. The study may also provide information about the effects of the test substance on neonatal morbidity, mortality, and preliminary data on prenatal developmental toxicity and serve as a guide for subsequent tests.
              (5) Mutagenicity studies. For each test substance a battery of tests is required to assess the potential to affect the mammalian cell's genetic components. The objectives underlying the selection of a battery of tests for mutagenicity assessment are:
              (i) To detect, with sensitive assay methods, the capacity of a chemical to alter genetic material in cells.
              (ii) To determine the relevance of these mutagenic changes to mammals.
              (iii) When mutagenic potential is demonstrated, to incorporate these findings in the assessment of heritable effects, carcinogenicity, and, possibly, other health effects.
              (6) Metabolism studies. Data from studies on the absorption, distribution, metabolism, and excretion of a pesticide aid in the valuation of test results from other toxicity studies and in the extrapolation of data from animals to man. The main purpose of metabolism studies is to produce data which increases the Agency's understanding of the behavior of the chemical when considering the human exposure anticipated from intended uses of the pesticide.
              (e) Hazards to nontarget organisms—(1) General. The information required to assess hazards to nontarget organisms is derived from tests to determine pesticidal effects on birds, mammals, fish, terrestrial and aquatic invertebrates and plants. These tests include short-term acute, subacute, reproduction, simulated field, and full field studies arranged in a hierarchical or tier system which progresses from the basic laboratory tests to the applied field tests. The results of each tier of testing must be evaluated to determine the potential of the pesticide to cause adverse effects, and to determine whether further testing is required. A purpose common to all data requirements is to provide data which determine the need for (and appropriate wording for) precautionary label statements to minimize the potential adverse effects to nontarget organisms.
              (2) Short-term studies. The short-term acute and subchronic laboratory studies provide basic toxicity information which serves as a starting point for the hazard assessment. These data are used: To establish acute toxicity levels of the active ingredient to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on fish, wildlife and other nontarget organisms; and to indicate whether further laboratory and/or field studies are needed.
              (3) Long-term and field studies. Additional studies (i.e., avian, fish, and invertebrate reproduction, life cycle studies and plant field studies) may be required when basic data and environmental conditions suggest possible problems. Data from these studies are used to: Estimate the potential for chronic effects, taking into account the measured or estimated residues in the environment; and to determine if additional field or laboratory data are necessary to further evaluate hazards. Simulated field and/or field data are used to examine acute and chronic adverse effects on captive or monitored fish and wildlife populations under natural or near-natural environments. Such studies are required only when predictions as to possible adverse effects in less extensive studies cannot be made, or when the potential for adverse effects is high.
              (f) Applicator and post-application exposure. Data are used to evaluate exposures to persons in occupational and non-occupational settings, including agricultural, residential, commercial, institutional and recreational sites. Data include oral, dermal and inhalation exposure data, post-application residue data, post-application monitoring data, use information, and human activity information. These data, together with toxicology data, are used to determine whether application or post-application risks are of concern, and, where appropriate, to develop post-application restrictions such as reentry restrictions.
              (g) Pesticide spray drift evaluation. Data required to evaluate pesticide spray drift are derived from studies of droplet size spectrum and spray drift field evaluations. These data contribute to the development of the overall exposure estimate and, along with data on toxicity for humans, fish and wildlife, or plants, are used to assess the potential hazard of pesticides to these organisms. A purpose common to all these tests is to provide data which will be used to determine the need for (and appropriate wording for) precautionary labeling to minimize the potential adverse effect to nontarget organisms.
              (h) Environmental fate—(1) General. The data generated by environmental fate studies are used to: Assess the toxicity to man through exposure of humans to pesticide residues remaining after application, either upon reentering treated areas or from consuming inadvertantly-contaminated food; assess the presence of widely distributed and persistent pesticides in the environment which may result in loss of usable land, surface water, ground water, and wildlife resources; and, assess the potential environmental exposure of other nontarget organisms, such as fish and wildlife, to pesticides. Another specific purpose of the environmental fate data requirements is to help applicants and the Agency estimate expected environmental concentrations of pesticides in specific habitats where threatened or endangered species or other wildlife populations at risk are found.
              (2) Degradation studies. The data from hydrolysis and photolysis studies are used to determine the rate of pesticide degradation and to identify pesticides that may adversely affect nontarget organisms.
              (3) Metabolism studies. Data generated from aerobic and anaerobic metabolism studies are used to determine the nature and availability of pesticides to rotational crops and to aid in the evaluation of the persistence of a pesticide.
              (4) Mobility studies. These data requirements pertain to leaching, adsorption/desorption, and volatility of pesticides. They provide information on the mode of transport and eventual destination of the pesticide in the environment. This information is used to assess potential environmental hazards related to: Contamination of human and animal food; loss of usable land and water resources to man through contamination of water (including ground water); and habitat loss of wildlife resulting from pesticide residue movement or transport in the environment.
              (5) Dissipation studies. The data generated from dissipation studies are used to assess potential environmental hazards (under actual field use conditions) related to: Reentry into treated areas; hazards from residues in rotational crops and other food sources; and the loss of land as well as surface and ground water resources.
              (i) Residue chemistry. (1) Residue chemistry data are used by the Agency to estimate the exposure of the general population to pesticide residues in food and for setting and enforcing tolerances for pesticide residues in food or feed.
              (2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of the pesticide application, and results of tests on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage.
              (3) Residue chemistry data are also needed to support the adequacy of one or more methods for the enforcement of the tolerance, and to support practicable methods for removing residues that exceed any proposed tolerance.
              (4) Accumulation studies. Accumulation studies indicate pesticide residue levels in food supplies that originate from wild sources or from rotational crops. Rotational crop studies are necessary to establish realistic crop rotation restrictions and to determine if tolerances may be needed for residues on rotational crops. Data from irrigated crop studies are used to determine the amount of pesticide residues that could be taken up by representative crops irrigated with water containing pesticide residues. These studies allow the Agency to establish label restrictions regarding application of pesticides on sites where the residues can be taken up by irrigated crops. These data also provide information that aids the Agency in establishing any corresponding tolerances that would be needed for residues on such crops. Data from pesticide accumulation studies in fish are used to establish label restrictions to prevent applications in certain sites so that there will be minimal residues entering edible fish or shellfish. These residue data are also used to determine if a tolerance or action level is needed for residues in aquatic animals eaten by humans.

            Subpart C—Experimental Use Permits

              § 158.200
              Experimental use permit data requirements tables.
              Sections 158.200 through 158.270 describe how to use these tables to determine the experimental use permit data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed at the end of each table. Refer to 40 CFR part 172 for further information on experimental use permits.

              § 158.210
              Experimental use permit data requirements for product chemistry.
              All product chemistry data, as described in § 158.310, must be submitted to support a request for an experimental use permit.

              § 158.220
              Experimental use permit data requirements for product performance.
              All product performance data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
              (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.
              (2) Data are also required for forestry and residential outdoor uses.
              (b) Key. CR = Conditionally required; NR = Not required; R = Required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product.
              (c) Table. The following table shows the experimental use data requirements for product performance. The test notes are shown in paragraph (d) of this section.

                Table—Experimental Use Permit Data Requirements for Product Performance

                  Guideline No.
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Food Crop
                  Nonfood Crop
                  Aquatic
                  Food Crop
                  Nonfood Crop
                  Greenhouse
                  Food Crop
                  Nonfood Crop
                  Forestry
                  Residential Outdoors
                  Indoor
                  Test substance to support
                  MP
                  EP
                  Test Note No.

                  Efficacy of antimicrobial agents

                  91-8
                  Products for treating water systems
                  NR
                  NR
                  CR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  EP
                  1

                  Efficacy of fungicides and nematicides

                  93-16
                  Products for control of organisms producing mycotoxins
                  CR
                  NR
                  CR
                  NR
                  CR
                  NR
                  NR
                  NR
                  NR
                  NR
                  EP
                  1

                  Efficacy of vertebrate control agents

                  96-5
                  Avian toxicants
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  96-6
                  Avian repellents
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  96-7
                  Avian frightening agents
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  96-9
                  Bat toxicants and repellents
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  EP
                  1

                  96-10
                  Commensal rodenticides
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  TEP
                  EP
                  1

                  96-12
                  Rodenticides on farm and rangelands
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  95-13
                  Rodent fumigants
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  95-16
                  Rodent reproductive inhibitors
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  95-17
                  Mammalian predacides
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

              (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

                1. The Agency has waived the requirement to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.
                2. [Reserved]

              [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

              § 158.230
              Experimental use permit data requirements for toxicology.
              All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
              (a) Use patterns. (1) Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use.
              (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, forestry use, residential outdoor use, indoor nonfood use, and indoor residential use.
              (b) Key. CR = Conditionally required; NR = Not required; R = Required; EP = End-use product; MP = Manufacturing-use product; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient.
              (c) Table. The following table shows the experimental use data requirements for toxicology. The test notes are shown in paragraph (d) of this section.

                Table—Experimental Use Permit Toxicity Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Food
                  Nonfood
                  Test substance to support
                  MP
                  EP
                  Test Note No.

                  Acute Testing

                  870.1100
                  Acute oral toxicity - rat
                  R
                  R
                  MP and TGAI
                  TGAI, EP
                  1

                  870.1200
                  Acute dermal toxicity
                  R
                  R
                  MP and TGAI
                  TGAI, EP
                  1, 2

                  870.1300
                  Acute inhalation toxicity - rat
                  R
                  R
                  MP and TGAI
                  TGAI and EP
                  3

                  870.2400
                  Primary eye irritation - rabbit
                  R
                  R
                  MP
                  TGAI and EP
                  2

                  870.2500
                  Primary dermal irritation
                  R
                  R
                  MP
                  TGAI and EP
                  1, 2

                  870.2600
                  Dermal sensitization
                  R
                  R
                  MP
                  TGAI and EP
                  2, 4

                  870.6100
                  Delayed neurotoxicity (acute) - hen
                  CR
                  CR
                  TGAI
                  TGAI
                  5

                  Subchronic Testing

                  870.3100
                  90-day Oral - rodent
                  R
                  NR
                  TGAI
                  TGAI
                  —

                  870.3150
                  90-day Oral - non-rodent
                  R
                  NR
                  TGAI
                  TGAI
                  —

                  Chronic Testing

                  870.4100
                  Chronic oral - rodent
                  R
                  NR
                  TGAI
                  TGAI
                  6

                  Developmental Toxicity and Reproduction

                  870.3700
                  Prenatal Developmental toxicity - rat and rabbit, preferred
                  R
                  NR
                  TGAI
                  TGAI
                  7, 8

                  870.3800
                  Reproduction
                  R
                  NR
                  TGAI
                  TGAI
                  6

                  Mutagenicity Testing

                  870.5100
                  Bacterial reverse mutation assay
                  R
                  NR
                  TGAI
                  TGAI
                  9

                  870.5300870.5375

                    In vitro mammalian cell assay
                  R
                  NR
                  TGAI
                  TGAI
                  9, 10

                  870.5385870.5395

                    In vivo cytogenetics
                  R
                  NR
                  TGAI
                  TGAI
                  9, 11

              (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

                1. Not required if test material is a gas or a highly volatile liquid.
                2. Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
                3. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
                4. Required if repeated dermal exposure is likely to occur under conditions of use.
                5. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters, thioesters, or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids, or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids, or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.
                6. These studies are seldom required to support EUPs. They may be required if the dietary exposure for these EUPs occupies a large part, e.g., greater than 50%, of the reference dose.
                7. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.
                8. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
                9. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
                10. Choice of assay using either:
                i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

                ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or
                iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
                11. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.

              [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

              § 158.240
              Experimental use permit data requirements for ecological effects.
              All data for terrestrial nontarget organisms and aquatic nontarget organisms as described in § 158.243 must be submitted to support a request for an experimental use permit. No data for nontarget plant protection must be submitted to support a request for an experimental use permit.

              § 158.243
              Experimental use permit data requirements for terrestrial and aquatic nontarget organisms.
              All terrestrial and aquatic nontarget organism data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
              (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.
              (2) Data are also required for the general use patterns of forestry and residential outdoor use.
              (b) Key. CR = Conditionally required; NR = Not required; R = Required; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; commas between the test substances (e.g. TGAI, TEP) indicate that data may be required on the TGAI or TEP depending on the conditions set forth in the test note.
              (c) Table. The following table shows the experimental use data requirements for terrestrial and aquatic nontarget organisms. The test notes are shown in paragraph (d) of this section.

                Table—Experimental Use Permit Terrestrial and Aquatic Nontarget Organism Data Requirements

                  Guideline No.
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Aquatic
                  Forestry
                  Residential Outdoor
                  Greenhouse
                  Indoor
                  Test substance
                  Test Note No.

                  Avian and Mammalian Testing

                  850.2100
                  Avian oral toxicity
                  R
                  R
                  R
                  R
                  CR
                  CR
                  TGAI
                  1, 2, 3

                  850.2200
                  Avian dietary toxicity
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI
                  1, 4

                  Aquatic Organisms Testing

                  850.1075
                  Freshwater fish toxicity
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI, TEP
                  1, 2, 5, 6, 11

                  850.1010
                  Acute toxicity freshwater invertebrates
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI, TEP
                  1, 2, 6, 7, 11

                  850.1300
                  Aquatic invertebrate life cycle (freshwater)
                  NR
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI
                  1, 7, 8

                  850.1400
                  Fish early-life stage (freshwater)
                  NR
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI
                  1, 8, 9

                  Accumulation Study

                  850.1730
                  Fish
                  CR
                  CR
                  CR
                  NR
                  NR
                  NR
                  TGAI or PAIRA
                  10

                  Insect Pollinator Testing

                  850.3020
                  Honeybee acute contact toxicity
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI
                  1

              (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

                1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to, turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
                2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.
                3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
                4. Data are required on waterfowl and upland game bird species.
                5. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
                6. EP or TEP testing is required for any product which meets any of the following conditions:
                i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.

                ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50 of the TGAI when the EP is used as directed.
                iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
                7. Data are required on one freshwater aquatic invertebrate species.
                8. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

                9. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96 hour LC50 on that species must also be provided.
                10. Not required when:
                i. The octanol/water partition coefficients of the pesticide and its major degradates are <1,000; or
                ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
                iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
                11. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. A freshwater invertebrate must also be tested with the EP or TEP using the same species tested with the TGAI.

              [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

              § 158.250
              Experimental use permit data requirements for human exposure.
              No data for applicator exposure and post-application exposure must be submitted to support a request for an experimental use permit.

              § 158.260
              Experimental use permit data requirements for environmental fate.
              All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
              (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, aquatic nonfood residential, and aquatic nonfood outdoors. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.
              (2) Data are also required for the general use patterns of forestry use and residential outdoor use.
              (b) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient.
              (c) Table. The following table shows the experimental use data requirements for environmental fate. The test notes are shown in paragraph (d) of this section.

                Table—Experimental Use Permit Environmental Fate Data Requirements

                  Guideline No.
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Aquatic
                  Greenhouse
                  Indoors
                  Forestry
                  Residential Outdoors
                  Test substance
                  Test Note No.

                  Degradation Study - Laboratory

                  835.2120
                  Hydrolysis
                  R
                  R
                  R
                  NR
                  R
                  R
                  TGAI or PAIRA
                  1

                  Metabolism Studies - Laboratory

                  835.4100
                  Aerobic soil
                  R
                  CR
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  2

                  835.4300
                  Aerobic aquatic
                  NR
                  R
                  NR
                  NR
                  NR
                  NR
                  TGAI or PAIRA
                  —

                  Mobility Study

                  835.1230835.1240

                  Leaching and adsorption/desorption
                  R
                  NR
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  3

              (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

                1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.
                2. Required for aquatic uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.
                3. Adsorption and desorption using a batch equilibrium method is preferred. However, in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.

              [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

              § 158.270
              Experimental use permit data requirements for residue chemistry.
              All residue chemistry data, as described in § 158.1410, are required for an experimental use permit for which a temporary tolerance under FFDCA section 408(r) is sought. Residue chemistry data are not required for an experimental use permit issued on a crop-destruct basis.

              §§ 158.280-158.290
              [Reserved]

            Subpart D—Product Chemistry

              § 158.300
              Definitions.
              The following terms are defined for the purposes of this subpart:

                Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, defoliant, or nitrogen stabilizer, within the meaning of FIFRA sec. 2(b).

                End-use product means a pesticide product whose labeling:
              (1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, or as a nitrogen stabilizer, and
              (2) does not state that the product may be used to manufacture or formulate other pesticide products.

                Formulation means:

              (1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing-use product or an end-use product, or
              (2) The repackaging of any registered product.

                Impurity means any substance (or group of structurally similar substances if specified by the Agency), in a pesticide product other than an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products, contaminants, and degradation products.

                Impurity associated with an active ingredient means:
              (1) Any impurity present in the technical grade of active ingredient; and
              (2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product.

                Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than the active ingredient, which is intentionally included in a pesticide product.

                Integrated system means a process for producing a pesticide product that:
              (1) Contains any active ingredient derived from a source that is not an EPA-registered product; or
              (2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.

                Manufacturing-use product means any pesticide product other than an end-use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients, such as stabilizers or solvents.

                Nominal concentration means the amount of an ingredient which is expected to be present in a typical sample of a pesticide product at the time the product is produced, expressed as a percentage by weight.

                Starting material means a substance used to synthesize or purify a technical grade of active ingredient (or the practical equivalent of the technical grade ingredient if the technical grade cannot be isolated) by chemical reaction.

                Technical grade of active ingredient means a material containing an active ingredient:
              (1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and
              (2) Which is produced on a commercial or pilot plant production scale (whether or not it is ever held for sale).

              § 158.310
              Product chemistry data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (f) of the section.
              (b) Use patterns. Product chemistry data are required for all pesticide products and are not use-specific.
              (c) Test substance. Data requirements that list only the manufacturing-use product as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added.
              (d) Key. R = Required; CR = Conditionally required; MP = Manufacturing-use product; NR = Not required; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient.
              (e) Table. The following table shows the data requirements for product chemistry. The table notes are shown in paragraph (f) of this section.

                Product Chemistry Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  All
                  Test substance to support
                  MP
                  EP
                  Test Note No.

                  Product Identity and Composition

                  830.1550
                  Product identity and composition
                  R
                  MP
                  EP
                  1

                  830.1600
                  Description of materials used to produce the product
                  R
                  MP
                  EP
                  2

                  830.1620
                  Description of production process
                  R
                  MP
                  EP
                  3

                  830.1650
                  Description of formulation process
                  R
                  MP
                  EP
                  4

                  830.1670
                  Discussion of formulation of impurities
                  R
                  MP, and possibly TGAI
                  EP, and possibly TGAI
                  5

                  830.1700
                  Preliminary analysis
                  CR
                  MP, and possibly TGAI
                  EP, and possibly TGAI
                  6, 9, 10

                  830.1750
                  Certified limits
                  R
                  MP
                  EP
                  7

                  830.1800
                  Enforcement analytical method
                  R
                  MP
                  EP
                  8

                  830.1900
                  Submittal of samples
                  CR
                  MP, PAI and TGAI
                  EP, PAI, TGAI
                  9, 11

                  Physical and Chemical Properties

                  830.6302
                  Color
                  R
                  MP and TGAI
                  EP
                  9

                  830.6303
                  Physical state
                  R
                  MP and TGAI
                  EP and TGAI
                  9

                  830.6304
                  Odor
                  R
                  MP and TGAI
                  EP
                  9

                  830.6313
                  Stability to normal and elevated temperatures, metals, and metal ions
                  R
                  MP and TGAI
                  EP
                  9, 12, 26

                  830.6314
                  Oxidation/reduction: chemical incompatibility
                  CR
                  MP
                  EP
                  13

                  830.6315
                  Flammability
                  CR
                  MP
                  EP
                  14

                  830.6316
                  Explodability
                  CR
                  MP
                  EP
                  15

                  830.6317
                  Storage stability
                  R
                  MP
                  EP

                  830.6319
                  Miscibility
                  CR
                  MP
                  EP
                  16

                  830.6320
                  Corrosion characteristics
                  R
                  MP
                  EP

                  830.6321
                  Dielectric breakdown voltage
                  CR
                  NR
                  EP
                  17

                  830.7000
                  pH
                  CR
                  MP and TGAI
                  EP and TGAI
                  9, 18

                  830.7050
                  UV/visible light absorption
                  R
                  TGAI or PAI
                  NR
                  —

                  830.7100
                  Viscosity
                  CR
                  MP
                  EP
                  19

                  830.7200
                  Melting point/melting range
                  R
                  TGAI or PAI
                  TGAI or PAI
                  9, 20

                  830.7220
                  Boiling point/boiling range
                  R
                  TGAI or PAI
                  TGAI or PA
                  9, 21

                  830.7300
                  Density/relative density/bulk density
                  R
                  MP and TGAI
                  EP and TGAI
                  9

                  830.7370
                  Dissociation constants in water
                  R
                  TGAI or PAI
                  TGAI or PAI
                  9, 22

                  830.7520
                  Particle size, fiber length, and diameter distribution
                  CR
                  TGAI or PAI
                  EP
                  23

                  830.7550830.7560
                    830.7570

                  Partition coefficient (n-octanol/water)
                  R
                  TGAI or PAI
                  TGAI or PAI
                  24

                  830.7840830.7860

                  Water solubility
                  R
                  TGAI or PAI
                  TGAI or PAI
                  9

                  830.7950
                  Vapor pressure
                  R
                  TGAI or PAI
                  TGAI or PAI
                  9, 25

              (f) Test notes. The following test notes are applicable to the product chemistry data requirements in the table to paragraph (e) of this section:

                1. Data must be provided in accordance with § 158.320.
                2. Data must be provided in accordance with § 158.325.
                3. Data must be provided in accordance with § 158.330.
                4. Data must be provided in accordance with § 158.335.
                5. Data must be provided in accordance with § 158.340.
                6. Data must be provided in accordance with § 158.345.
                7. Data must be provided in accordance with § 158.350.
                8. Data must be provided in accordance with § 158.355.
                9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI.
                10. Data are required if the product is produced by an integrated system.
                11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.
                12. Data on the stability to metals and metal ions are required only if the TGAI is expected to come into contact with either material.
                13. Required when the product contains an oxidizing or reducing agent.
                14. Required when the product contains combustible liquids.
                15. Required when the product is potentially explosive.
                16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.
                17. Required when the EP is a liquid and is to be used around electrical equipment.
                18. Required when the test substance is soluble or dispersible in water.
                19. Required when the product is a liquid.
                20. Required when the TGAI is solid at room temperature.
                21. Required when the TGAI is liquid at room temperature.
                22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).

                23. Required for water insoluble test substances (>10−6 g/l) and fibrous test substances with diameter of ≥0.1 µm.
                24. Required if technical chemical is organic and non-polar.
                25. Not required for salts.
                26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures >50 °C (122 °F) during production or storage.

              § 158.320
              Product identity and composition.
              Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b), and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must be provided.
              (a) Active ingredient. The following information is required for each active ingredient in the product:
              (1) If the source of any active ingredient in the product is an EPA-registered product:
              (i) The chemical and common name (if any) of the active ingredient, as listed on the source product.
              (ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.
              (iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 158.350.

              (2) If the source of any active ingredient in the product is not an EPA-registered product:

              (i) The chemical name according to Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, and any common names.
              (ii) The molecular, structural, and empirical formulae and the molecular weight or weight range.
              (iii) The nominal concentration.
              (iv) Upper and lower certified limits of the active ingredient in accordance with § 158.350.
              (v) The purpose of the ingredient in the formulation.
              (b) Inert ingredients. The following information is required for each inert ingredient (if any) in the product:
              (1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.
              (2) The nominal concentration.
              (3) Upper and lower certified limits in accordance with § 158.350.
              (4) The purpose of the ingredient in the formulation.
              (c) Impurities of toxicological significance associated with the active ingredient. For each impurity associated with the active ingredient that is determined by EPA to be toxicologically significant, the following information is required:
              (1) Identification of the ingredient as an impurity.
              (2) The chemical name of the impurity.
              (3) The nominal concentration of the impurity in the product.
              (4) A certified upper limit, in accordance with § 158.350.
              (d) Other impurities associated with the active ingredient. For each other impurity associated with an active ingredient that was found to be present in any sample at a level ≥0.1 percent by weight of the technical grade active ingredient the following information is required:
              (1) Identification of the ingredient as an impurity.
              (2) The chemical name of the impurity.
              (3) The nominal concentration of the impurity in the final product.
              (e) Impurities associated with an inert ingredient. [Reserved]
              (f) Ingredients that cannot be characterized. If the identity of any ingredient or impurity cannot be specified as a discrete chemical substance (such as mixtures that cannot be characterized or isomer mixtures), the applicant must provide sufficient information to enable EPA to identify its source and qualitative composition.

              § 158.325
              Description of materials used to produce the product.
              The following information must be submitted on the materials used to produce the product:
              (a) Products not produced by an integrated system. (1) For each active ingredient that is derived from an EPA-registered product:
              (i) The name of the EPA-registered product.
              (ii) The EPA registration number of that product.
              (2) For each inert ingredient:
              (i) Each brand name, trade name, common name, or other commercial designation of the ingredient.
              (ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.

              (iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.
              (b) Products produced by an integrated system. (1) The information required by paragraph (a)(1) of this section concerning each active ingredient that is derived from an EPA-registered product (if any).
              (2) The following information concerning each active ingredient that is not derived from an EPA-registered product:
              (i) The name and address of the producer of the ingredient (if different from the applicant).
              (ii) Information about each starting material used to produce the active ingredient, as follows:
              (A) Each brand name, trade name, or other commercial designation of the starting material.
              (B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.
              (C) All information that the applicant knows (or that is reasonably available to him), concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.
              (3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.
              (c) Additional information. On a case-by-case basis, the Agency may require additional information on substances used in the production of the product.

              § 158.330
              Description of production process.
              If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information about the formulation process, in accordance with § 158.335.
              (a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.
              (b) The following information must be provided for each process resulting in a separately isolated substance:
              (1) The name and address of the producer who uses the process, if not the same as the applicant.
              (2) A general characterization of the process (e.g., whether it is a batch or continuous process).
              (3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of the duration of each step and of the entire process.
              (4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.
              (5) A description of the equipment used that may influence the composition of the substance produced.
              (6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.
              (7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
              (8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.

              § 158.335
              Description of formulation process.
              The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient) as required by the following sections:
              (a) Section 158.330(b)(2), pertaining to characterization of the process.
              (b) Section 158.330(b)(4), pertaining to ingredients used in the process.

              (c) Section 158.330(b)(5), pertaining to process equipment.

              (d) Section 158.330(b)(6), pertaining to the conditions of the process.
              (e) Section 158.330(b)(8), pertaining to quality control measures.

              § 158.340
              Discussion of formation of impurities.
              The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the impurity and the amounts at which it might be present. The impurities which must also be discussed are the following, as applicable:
              (a) Technical grade active ingredients and products produced by an integrated system. (1) Each impurity associated with the active ingredient which was found to be present in any analysis of the product conducted by or for the applicant.
              (2) Each other impurity which the registrant or applicant has reason to believe may be present in his product at any time before use at a level ≥0.1 percent (1,000 ppm) by weight of the technical grade of the active ingredient, based on what he knows about the following:
              (i) The composition (or composition range) of each starting material used to produce his product.
              (ii) The impurities which the applicant knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of these impurities.
              (iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.
              (iv) The possible degradation of the ingredients in the product after its production but prior to its use.
              (v) Post-production reactions between the ingredients in the product.
              (vi) The possible migration of components of packaging materials into the pesticide.
              (vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.
              (viii) The process control, purification and quality control measures used to produce the product.
              (b) Products not produced by an integrated system. Each impurity associated with the active ingredient which the applicant has reason to believe may be present in the product at any time before use at a level ≥0.1 percent (1,000 ppm) by weight of the product based on what he knows about the following:
              (1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.
              (2) The possible carryover of impurities present in the inert ingredients in the product.
              (3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredient and the production equipment.
              (4) Post-production reactions between any of the product's active ingredients and any other component of the product or its packaging.
              (5) Possible migration of packaging materials into the product.
              (6) Possible contaminants resulting from earlier use of equipment to produce other products.
              (c) Expanded discussion. On a case-by-case basis, the Agency may require an expanded discussion of information on impurities:
              (1) From other possible chemical reactions.
              (2) Involving other ingredients.
              (3) At additional points in the production or formulation process.

              § 158.345
              Preliminary analysis.
              (a) If the product is produced by an integrated system, the applicant must provide a preliminary analysis of each technical grade of active ingredient contained in the product to identify all impurities present at 0. 1 percent or greater of the technical grade of the active ingredient. The preliminary analysis should be conducted at the point in the production process after which no further chemical reactions designed to produce or purify the substances are intended.
              (b) Based on the preliminary analysis, a statement of the composition of the technical grade of the active ingredient must be provided. If the technical grade of the active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of the active ingredient must be submitted.

              § 158.350
              Certified limits.
              The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use. If the product label bears a statement prohibiting use after a certain date, the certified limits will apply only until that date.
              (a) Ingredients for which certified limits are required. Certified limits are required on the following ingredients of a pesticide product:
              (1) An upper and lower limit for each active ingredient.
              (2) An upper and lower limit for each inert ingredient.
              (3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.
              (4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.
              (b) EPA determination of standard certified limits for active and inert ingredients. (1) Unless the applicant proposes different limits as provided in paragraph (c) of this section, the upper and lower certified limits for active and inert ingredients will be determined by EPA. EPA will calculate the certified limits on the basis of the nominal concentration of the ingredient in the product, according to the table in paragraph (b)(2) of this section.
              (2) Table of standard certified limits.

                Standard Certified Limits

                  If the nominal concentration (N) for the ingredient and percentage by weight for the ingredient is:
                  The certified limits for that ingredient will be as follows:
                  Upper Limit
                  Lower Limit

                  N ≤1.0%
                  N + 10%N
                  N - 10%N

                  1.0% ≤N ≤20.0%
                  N + 5%N
                  N - 5%N

                  20.0% ≤N ≤100.0%
                  N + 3%N
                  N - 3%N

              (c) Applicant proposed limits. (1) The applicant may propose a certified limit for an active or inert ingredient that differs from the standard certified limit calculated according to paragraph (b)(2) of this section.
              (2) If certified limits are required for impurities, the applicants must propose a certified limit. The standard certified limits may not be used for such substances.
              (3) Certified limits should:
              (i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.
              (ii) Allow for all sources of variability likely to be encountered in the production process.
              (iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale or distribution.

              (4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (e.g., sample analysis, quantitative estimate based on production process), and its accuracy and precision. This will be particularly useful if the range of the certified limit for an active or inert ingredient is greater than the standard certified limits.
              (d) Special cases. If the Agency finds unacceptable any certified limit (either standard, or applicant proposed), the Agency will inform the registrant or applicant of its determination and will provide supporting reasons. The Agency may also recommend alternative limits to the applicant. The Agency may require, on a case-by-case basis, any or all of the following:
              (1) More precise limits.
              (2) More thorough explanation of how the certified limits were determined.
              (3) A narrower range between the upper and lower certified limits than that proposed.
              (e) Certification statement. The applicant must certify the accuracy of the information presented, and that the certified limits of the ingredients will be maintained. The following statement, signed by the authorized representative of the company, is acceptable:

                I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [insert product name], EPA Reg. No. [insert registration number], refers to the composition set forth on the Statement of Formula and supporting materials. This description includes the representations that: (1) no ingredient will be present in the product in an amount greater than the upper certified limit or in an amount less than the lower certified limit (if required) specified for that ingredient in a currently approved Statement of Formula (or as calculated by the Agency); and (2) if the Agency requires that the source of supply of an ingredient be specified, that all quantities of such ingredient will be obtained from the source specified in the Statement of Formula.

              § 158.355
              Enforcement analytical method.
              An analytical method suitable for enforcement purposes must be provided for each active ingredient in the product and for each other ingredient or impurity that the Agency determines to be toxicologically significant.

            Subpart E—Product Performance

              § 158.400
              Product performance data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product performance data requirements for a particular pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. Data are also required for the general use patterns of forestry use, residential outdoor use, and indoor use, which includes both food and nonfood uses.
              (c) Key. CR = Conditionally required; NR = Not required; R = Required; EP = End-use product; MP = Manufacturing-use product; TEP = Typical end-use product.
              (d) Table. The following table lists the data requirements that pertain to product performance. The table notes are shown in paragraph (e) of this section.

                Table—Product Performance Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Food Crop
                  Nonfood Crop
                  Aquatic
                  Food
                  Nonfood
                  Greenhouse
                  Food Crop
                  Nonfood Crop
                  Forestry
                  Residential Outdoor
                  Indoor
                  Test substance to support
                  MP
                  EP
                  Test Note No.

                  810.2700
                  Products with prion-related claims
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  EP
                  1

                  Efficacy of fungicides and nematicides

                  93-16
                  Products for control of organisms producing mycotoxins
                  CR
                  NR
                  CR
                  NR
                  CR
                  NR
                  NR
                  NR
                  NR
                  NR
                  EP
                  1

                  Efficacy of vertebrate control agents

                  96-5
                  Avian toxicants
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  96-6
                  Avian repellents
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  96-7
                  Avian frightening agents
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  96-9
                  Bat toxicants and repellents
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  EP
                  1

                  96-10
                  Commensal rodenticides
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  TEP
                  EP
                  1

                  96-12
                  Rodenticides on farm and rangelands
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

                  95-13
                  Rodent fumigants
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  95-16
                  Rodent reproductive inhibitors
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  R
                  NR
                  EP
                  1

                  95-17
                  Mammalian predacides
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  EP
                  1

              (e) Test notes. The following notes appy to the data requirements table in paragraph (d) of this section.

                1. The Agency has waived the requirement to submit product performance data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration.
                2. [Reserved]

              [72 FR 60957, Oct. 26, 2007, as amended at 78 FR 13507, Feb. 28, 2013; 78 FR 26978, May 8, 2013]

            Subpart F—Toxicology

              § 158.500
              Toxicology data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use the data table in paragraph (d) of this section to determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test in the table are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use.
              (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood use, greenhouse nonfood crop use, forestry use, residential outdoor use, and indoor nonfood use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient radio-labeled; Choice = Choice of several test substances depending on study required.
              (d) Table. The following table lists the toxicology data requirements. The table notes are shown in paragraph (e) of this section.

                Table—Toxicology Data Requirements

                  Guideline Number
                  Data Requirements
                  Use Pattern
                  Food
                  Nonfood
                  Test substance to support
                  MP
                  EP
                  Test Note No.

                  Acute Testing

                  870.1100
                  Acute oral toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI, EP, and possibly diluted EP
                  1, 2

                  870.1200
                  Acute dermal toxicity
                  R
                  R
                  TGAI and MP
                  TGAI, EP
                  1, 2, 3

                  870.1300
                  Acute inhalation toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  4

                  870.2400
                  Primary eye irritation - rabbit
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  3

                  870.2500
                  Primary dermal irritation
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 3

                  870.2600
                  Dermal sensitization
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  3, 5

                  870.6100
                  Delayed neurotoxicity (acute) - hen
                  CR
                  CR
                  TGAI
                  TGAI
                  6

                  870.6200
                  Acute neurotoxicity - rat
                  R
                  R
                  TGAI
                  TGAI
                  7

                  Subchronic Testing

                  870.3100
                  90-day Oral - rodent
                  R
                  CR
                  TGAI
                  TGAI
                  8, 9

                  870.3150
                  90-day Oral - non-rodent
                  R
                  CR
                  TGAI
                  TGAI
                  36

                  870.3200
                  21/28-day Dermal
                  R
                  NR
                  TGAI
                  TGAI and EP
                  10, 11

                  870.3250
                  90-day Dermal
                  CR
                  R
                  TGAI
                  TGAI and EP
                  11, 12

                  870.3465
                  90-day Inhalation - rat
                  CR
                  CR
                  TGAI
                  TGAI
                  13, 14

                  870.6100
                  28-day Delayed neurotoxicity-hen
                  CR
                  CR
                  TGAI
                  TGAI
                  6, 15

                  870.6200
                  90-day Neurotoxicity - rat
                  R
                  R
                  TGAI
                  TGAI
                  7, 16

                  Chronic Testing

                  870.4100
                  Chronic oral - rodent
                  R
                  CR
                  TGAI
                  TGAI
                  17, 18, 19

                  870.4200
                  Carcinogenicity - two rodent species - rat and mouse preferred
                  R
                  CR
                  TGAI
                  TGAI
                  9, 17, 18, 19, 20, 21

                  Developmental Toxicity and Reproduction

                  870.3700
                  Prenatal Developmental toxicity - rat and rabbit, preferred
                  R
                  R
                  TGAI
                  TGAI
                  22, 23, 24, 25, 26

                  870.3800
                  Reproduction and fertility effects
                  R
                  R
                  TGAI
                  TGAI
                  26, 27, 29

                  870.6300
                  Developmental neurotoxicity
                  CR
                  CR
                  TGAI
                  TGAI
                  27, 28, 29

                  Mutagenicity Testing

                  870.5100
                  Bacterial reverse mutation assay
                  R
                  R
                  TGAI
                  TGAI
                  30

                  870.5300870.5375

                    In vitro mammalian cell assay
                  R
                  R
                  TGAI
                  TGAI
                  30, 31

                  870.5385870.5395

                    In vivo cytogenetics
                  R
                  R
                  TGAI
                  TGAI
                  30, 32

                  Special Testing

                  870.7485
                  Metabolism and pharmacokinetics
                  R
                  CR
                  PAI or PAIRA
                  PAI or PAIRA
                  33

                  870.7200
                  Companion animal safety
                  CR
                  CR
                  NR
                  TGAI or EP
                  34

                  870.7600
                  Dermal penetration
                  CR
                  CR
                  Choice
                  Choice
                  35

                  870.7800
                  Immunotoxicity
                  R
                  R
                  TGAI
                  TGAI

              (e) Test notes. The following test notes apply to the requirements in the table to paragraph (d) of this section:

                1. Not required if test material is a gas or a highly volatile liquid.
                2. Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under § 152.170(b) or special review consideration under § 154.7(a)(1).

                3. Not required if the test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.

                4. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
                5. Required if repeated dermal exposure is likely to occur under conditions of use.
                6. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters; thioesters or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids; or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids; or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.
                7. As determined by the Agency, additional measurements may also be required, such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates. The route of exposure must correspond with the primary route of exposure.
                8. Required for nonfood use pesticides if oral exposure could occur.
                9. The 90-day study is required in the rat for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would strongly encourage the registrant to conduct a 90-day range finding for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study. The registrant is also encouraged to consult with the Agency on the results of the 90-day mouse study prior to conducting the carcinogenicity study.
                10. Required for agricultural uses or if repeated human dermal exposure may occur. Not required if an acceptable 90-day dermal toxicity study is performed and submitted.
                11. EP testing is required if the product, or any component of it, may increase dermal absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic effects.
                12. Required for food uses if either of the following criteria is met:
                (i) The use pattern is such that the dermal route would be the primary route of exposure; or
                (ii) The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite is the toxic moiety.
                13. Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
                14. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21- or 28-days, may be sufficient to satisfy this requirement. Registrants should consult with the Agency to determine whether studies of shorter duration would meet this requirement.
                15. Required if results of acute neurotoxicity study indicate significant statistical or biological effects, or if other available data indicate the potential for this type of delayed neurotoxicity, as determined by the Agency.
                16. All 90-day subchronic studies in rats can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity study using separate groups of animals for testing. Although the subchronic guidelines include the measurement of neurological endpoints, they do not meet the requirement of the 90-day neurotoxicity study.
                17. Required if either of the following are met:
                (i) The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as determined by the Agency;
                (ii) The use requires a tolerance or an exemption from the requirement of a tolerance.
                18. Based on the results of the acute and subchronic neurotoxicity studies, or other available data, a combined chronic toxicity and neurotoxicity study may be required.

                19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (i.e., a combined study) may be conducted. Minimum acceptable study durations are:
                (i) Chronic rodent feeding study (food use) - 24 months.
                (ii) Chronic rodent feeding study (nonfood use) - 12 months.
                (iii) Mouse carcinogenicity study - 18 months.
                (iv) Rat carcinogenicity study - 24 months.
                20. Required if any of the following, as determined by the Agency, are met:
                (i) The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of either frequency, duration, or magnitude of exposure;
                (ii) The use requires a tolerance or an exemption from the requirement of a tolerance; or

                (iii) The active ingredient, metabolite, degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes mutagenic effects as demonstrated by in vitro or in vivo testing, or (c) produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change.
                21. If this study is modified or waived, a subchronic 90-day oral study conducted in the same species may be required.
                22. Testing in two species is required for all uses.

                23. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.

                24. Additional testing by other routes may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.
                25. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
                26. Required to support products intended for food uses and to support products intended for nonfood uses if use of the product is likely to result in significant human exposure over a portion of the human life span in terms of frequency, magnitude or duration of exposure.
                27. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.
                28. Study required using a weight-of-evidence approach considering:

                (i) The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of neurotoxicity, neuropathology, functional or behavioral effects).

                (ii) The pesticide causes treatment-related neurological effects in developing animals, following pre- and postnatal exposure (i.e., nervous system malformations or neuropathy, brain weight changes in offspring, functional or behavioral changes in the offspring).
                (iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.
                (iv) The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (e.g., SAR relationship to known neurotoxicants, altered neuroreceptor or neurotransmitter responses).
                29. The use of a combined study that utilizes the 2-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
                30. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
                31. Choice of assay using either:
                (i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

                (ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or
                (iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
                32. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
                33. Required when chronic or carcinogenicity studies are required. May be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism studies.
                34. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application.
                35. A risk assessment assuming that dermal absorption is equal to oral absorption must be performed to determine if the study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.
                36. A 1-year non-rodent study (i.e., 1-year dog study) would be required if the Agency finds that a pesticide chemical is highly bioaccumulating and is eliminated so slowly that it does not achieve steady state or sufficient tissue concentrations to elicit an effect during a 90-day study. EPA would require the appropriate tier II metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half-life, and steady state to determine if a longer duration dog toxicity study is needed.

              § 158.510
              Tiered testing options for nonfood pesticides.
              For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.1020, § 158.1070, and § 158.1410) studies. Applicants are to select one of the following:

              (a) Acute, subchronic, chronic, and other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set of toxicology study requirements is based on the anticipated exposure to the pesticide as determined by the Agency. If hazards are identified based upon review of these studies, specific exposure data will be required to evaluate risk.

              (b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data submitted in a tiered system. Exposure data must be submitted along with first tier toxicology data. The requirement for additional second and third level toxicology testing will be determined by the Agency based on the results of the first tiered studies.
              (1) The required first-tier toxicology studies consist of:
              (i) Battery of acute studies.
              (ii) A subchronic 90-day dermal study or a subchronic 90-day inhalation study.
              (iii) An acute and subchronic neurotoxicity screening battery in the rat.
              (iv) Prenatal developmental toxicity studies in both the rat and rabbit.
              (v) Reproduction and fertility studies in rats.
              (vi) Battery of mutagenicity studies.
              (vii) Immunotoxicity study.
              (2) The conditionally required second-tier studies include:
              (i) Subchronic 90-day feeding studies in both the rodent and nonrodent.
              (ii) Dermal penetration study.
              (3) The conditionally required third-tier studies include:
              (i) Chronic feeding studies in the rodent.
              (ii) Carcinogenicity.
              (iii) Metabolism study.
              (iv) Additional mutagenicity testing.

            Subpart G— Ecological Effects

              § 158.630
              Terrestrial and aquatic nontarget organisms data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget data requirements for a particular pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood use patterns. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use.
              (2) Data are also required for the general use patterns of forestry and residential outdoor use.

              (3) In general, for all outdoor end-uses, including turf, the following studies are required: Two avian oral LD50, two avian dietary LC50, two avian reproduction studies, two freshwater fish LC50, one freshwater invertebrate EC50, one honeybee acute contact LD50, one freshwater fish early-life stage, one freshwater invertebrate life cycle, and three estuarine acute LC50/EC50 studies — fish, mollusk and invertebrate. All other outdoor residential uses, i.e., gardens and ornamental will not usually require the freshwater fish early-life stage, the freshwater invertebrate life-cycle, and the acute estuarine tests.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAI = Pure active ingredient; EP = end-use product. Commas between the test substances (i.e., TGAI, TEP) indicate that data may be required on the TGAI or the TEP depending on the conditions set forth in the test note.
              (d) Table. The following table shows the data requirements for nontarget terrestrial and aquatic organism. The table notes are shown in paragraph (e) of this section.

                Terrestrial and Aquatic Nontarget Organism Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Aquatic
                  Forestry
                  Residential Outdoor
                  Greenhouse
                  Indoor
                  Test substance
                  Test Note No.

                  Avian and Mammalian Testing

                  850.2100
                  Avian oral toxicity
                  R
                  R
                  R
                  R
                  CR
                  CR
                  TGAI
                  1, 2, 3

                  850.2200
                  Avian dietary toxicity
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI
                  1, 4

                  850.2400
                  Wild mammal toxicity
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  5

                  850.2300
                  Avian reproduction
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI
                  1, 4

                  850.2500
                  Simulated or actual field testing
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TEP
                  6, 7

                  Aquatic Organisms Testing

                  850.1075
                  Freshwater fish toxicity
                  R
                  R
                  R
                  R
                  CR
                  CR
                  TGAI, TEP
                  1, 2, 8, 9, 26

                  850.1010
                  Acute toxicity freshwater invertebrates
                  R
                  R
                  R
                  R
                  CR
                  CR
                  TGAI, TEP
                  1, 2, 9, 10, 26

                  850.1025850.1035
                    850.1045
                    850.1055
                    850.1075

                  Acute toxicity estuarine and marine organisms
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI, TEP
                  1, 9, 11, 12, 26

                  850.1300
                  Aquatic invertebrate life cycle (freshwater)
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI
                  1, 10, 12

                  850.1350
                  Aquatic invertebrate life cycle (saltwater)
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  12, 14, 15

                  850.1400
                  Fish early-life stage (freshwater)
                  R
                  R
                  R
                  R
                  NR
                  NR
                  TGAI
                  1, 12, 13

                  850.1400
                  Fish early-life stage (saltwater)
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  12, 15, 16

                  850.1500
                  Fish life cycle
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  17, 18

                  850.1710850.1730
                    850.1850

                  Aquatic organisms bioavailability, biomagnification, toxicity
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI, PAI, degradate
                  19

                  850.1950
                  Simulated or actual field testing for aquatic organisms
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TEP
                  7, 20

                  Sediment Testing

                  850.1735
                  Whole sediment: acute freshwater invertebrates
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  21

                  850.1740
                  Whole sediment: acute marine invertebrates
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  21, 23

                  Whole sediment: chronic invertebrates freshwater and marine
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TGAI
                  22, 23

                  Insect Pollinator Testing

                  850.3020
                  Honeybee acute contact toxicity
                  R
                  CR
                  R
                  R
                  NR
                  NR
                  TGAI
                  1

                  850.3030
                  Honey bee toxicity of residues on foliage
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TEP
                  24

                  850.3040
                  Field testing for pollinators
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  TEP
                  25

              (e) Test notes. The following test notes apply to terrestrial and aquatic nontarget organisms data requirements in the table to paragraph (d) of this section:

                1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
                2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.
                3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
                4. Data are required on waterfowl and upland game bird species.
                5. Tests are required based on the results of lower tier toxicology studies, such as the acute and subacute testing, intended use pattern, and environmental fate characteristics that indicate potential exposure.
                6. Higher tier testing may be required for a specific use pattern when a refined risk assessment indicates a concern based on laboratory toxicity endpoints and refined exposure assessments.
                7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
                8. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
                9. EP or TEP testing is required for any product which meets any of the following conditions:
                i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.

                ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50 of the TGAI when the EP is used as directed.
                iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
                10. Data are required on one freshwater aquatic invertebrate species.

                11. Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species.

                12. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

                13. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96-hour LC50 on that species must also be provided.
                14. Data are required on one estuarine/marine invertebrate species.
                15. Data are required on estuarine/marine species if the product meets any of the following conditions:
                i. Intended for direct application to the estuarine or marine environment.
                ii. Expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
                iii. If the acute LC50 or EC50 <1 milligram/liter (mg/l).

                iv. If the estimated environmental concentration (EEC) in water is ≥0.01 of the acute EC50 or LC50 or if any of the following conditions exist:
                A. Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
                B. Physicochemical properties indicate bioaccumulation of the pesticide.
                C. The pesticide is persistent in water (e.g., half-life in water >4 days).
                16. Data are required on one estuarine/marine fish species.
                17. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
                18. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when any of the following conditions apply:
                i. If the estimated environmental concentration (EEC) is ≥0.1 of the no-observed-effect level in the fish early-life stage or invertebrate life cycle test;
                ii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
                19. Not required when:
                i. The octanol/water partition coefficients of the pesticide and its major degradates are <1,000; or
                ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
                iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
                20. Data are required based on the results of lower tier studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that indicate significant potential exposure.
                21. Data are required if:
                i. The half-life of the pesticide in the sediment is ≤10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:
                A. The soil partition coefficient (Kd) is ≥50.
                B. The log Kow is ≥3.
                C. The Koc ≥1,000.
                ii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
                22. Data are required if:

                i. The estimated environmental concentration (EEC) in sediment is >0.1 of the acute LC50/EC50 values and
                ii. The half-life of the pesticide in the sediment is >10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:
                A. The soil partition coefficient (Kd) is ≥50.
                B. The log Kow is ≥3.
                C. The Koc ≥1,000.
                iii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
                23. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in concentrations which the Agency believes to be significant, either by runoff or erosion, because of its expected use or mobility pattern.

                24. Data are required only when the formulation contains one or more active ingredients having an acute LD50 of <11 micrograms per bee as determined in the honey bee acute contact study and the use pattern(s) indicate(s) that honey bees may be exposed to the pesticide.
                25. Required if any of the following conditions are met:
                i. Data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.);
                ii. Data from residual toxicity studies indicate extended residual toxicity.
                iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.
                26. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be tested with the EP or TEP using the same species tested with the TGAI.

              § 158.660
              Nontarget plant protection data requirements table.
              (a) General. Sections 158.100 through158.130 describe how to use this table to determine the nontarget plant data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes only the general use patterns of aquatic food crops and aquatic nonfood.
              (2) Data are also required for the general use patterns of forestry use and residential outdoor use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
              (d) Table. The following table shows the nontarget plant protection data requirements. The table notes are shown in paragraph (e) of this section.

                Table—Nontarget Plant Protection Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Aquatic
                  Forestry and Residential Outdoor
                  Test substance
                  Test Note No.

                  Nontarget Area Phytotoxicity - Tier I

                  850.4100
                  Seedling emergence
                  R
                  R
                  R
                  TEP
                  1, 2, 7

                  850.4150
                  Vegetative vigor
                  R
                  R
                  R
                  TEP
                  1, 2, 3, 7

                  850.4400850.5400

                  Aquatic plant growth (algal and aquatic vascular plant toxicity)
                  R
                  R
                  R
                  TEP or TGAI
                  1, 2, 7

                  Nontarget Area Phytotoxicity - Tier II

                  850.4100
                  Seedling emergence
                  CR
                  CR
                  CR
                  TEP
                  1, 4, 5, 7

                  850.4150
                  Vegetative vigor
                  CR
                  CR
                  CR
                  TEP
                  1, 3, 4, 5, 7

                  850.4400850.5400

                  Aquatic plant growth (algal and aquatic vascular plant toxicity)
                  CR
                  CR
                  CR
                  TEP or TGAI
                  1, 4, 6, 7

                  Nontarget Area Phytotoxicity - Tier III

                  850.4300
                  Terrestrial field
                  CR
                  CR
                  CR
                  TEP
                  1, 7, 8, 10

                  850.4450
                  Aquatic field
                  CR
                  CR
                  CR
                  TEP
                  1, 7, 8, 10

                  Target Area Phytotoxicity

                  850.4025
                  Target area phytotoxicity
                  CR
                  CR
                  CR
                  TEP
                  1, 7, 9, 10

              (e) Test notes. The following test notes apply to the table in paragraph (d) of this section.

                1. Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
                2. Not required for known phytotoxicants.
                3. Generally not required for granular formulations. May be requested on a case-by-case basis.
                4. Required for known phytotoxicants such as herbicides, desiccants and defoliants.
                5. Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the Tier I testing.

                6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the tier I testing.
                7. Not required for aquatic residential uses.
                8. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
                9. Tests are required on a case-by-case basis based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
                10. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.

            Subparts H-J [Reserved]

              §§ 158.700-158.900
              [Reserved]

            Subpart K—Human Exposure

              § 158.1000
              Applicator exposure—general requirements.
              (a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA), provide adequate protection from risk under FIFRA for a particular pesticide use pattern, exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing prior to the initiation of studies.
              (b) The Agency may accept surrogate exposure data estimations from other sources to satisfy applicator exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. In order to be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address applicator exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the applicator activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.

              § 158.1010
              Applicator exposure—criteria for testing.
              Applicator exposure data described in paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, at least one of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
              (a) Toxicity criteria. (1) Evidence of potentially significant adverse effects have been observed in any applicable toxicity study.
              (2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide.
              (b) Exposure criteria. (1) Dermal exposure may occur during the prescribed use.
              (2) Respiratory exposure may occur during the prescribed use.

              § 158.1020
              Applicator exposure data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the applicator exposure data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood crop, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food use, and indoor nonfood use. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.

              (2) Residential use patterns include residential outdoor use and residential indoor use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.
              (c) Key. R = Required; CR = Conditionally required; TEP = Typical end-use product.
              (d) Table. The data requirements listed pertain to pesticide products that meet the testing criteria outlined in § 158.1010. The table notes are shown in paragraph (e) of this section.

                Table—Applicator Exposure Data Requirements

                  Guideline Number
                  Data requirement
                  Use pattern
                  Occupational
                  Residential
                  Test substance
                  Test Note No.

                  875.1100
                  Dermal outdoor exposure
                  R
                  R
                  TEP
                  1, 2, 3

                  875.1200
                  Dermal indoor exposure
                  R
                  R
                  TEP
                  1, 2, 4

                  875.1300
                  Inhalation outdoor exposure
                  R
                  R
                  TEP
                  1, 2, 3

                  875.1400
                  Inhalation indoor exposure
                  R
                  R
                  TEP
                  1, 2, 4

                  875.1500
                  Biological monitoring
                  CR
                  CR
                  TEP
                  1, 2

                  875.1600
                  Data reporting and calculations
                  R
                  R
                  TEP
                  5

                  875.1700
                  Product use information
                  R
                  R
                  TEP
                  —

              (e) Test notes. The following notes apply to the data requirements in the table to paragraph (d) of this section:

                1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.

                2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmacokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.
                3. Data are required if the product is applied outdoors.
                4. Data are required if the product is applied indoors.
                5. Data reporting and calculations are required when handler exposure data are submitted.

              § 158.1050
              Post-application exposure—general requirements.
              (a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing before the initiation of studies.
              (b) The Agency may accept surrogate exposure data from other sources to satisfy post-application exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific needs of EPA. In order to be acceptable, among other things, the Agency must find that the surrogate exposure data have adequate information to address post-application exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the post-application activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.

              § 158.1060
              Post-application exposure—criteria for testing.
              Exposure data described in § 158.1070(d) are required based upon toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, either or both of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
              (a) Toxicity criteria. (1) Evidence of potentially significant adverse health effects have been observed in any applicable toxicity study.
              (2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.
              (b) Exposure criteria. The need for data from potential exposure resulting from situations not covered by this paragraph should be discussed with the Agency.
              (1) For outdoor uses. (i) Occupational human post-application exposure to pesticide residues on plants or in soil could occur as the result of cultivation, pruning, harvesting, mowing or other work-related activity. Such uses include agricultural food, feed, and fiber commodities, forest trees, ornamental plants, and turf grass.
              (ii) Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such uses may include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.
              (2) For indoor uses. (i) Occupational human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at agricultural or commercial sites, such as, but not limited to, agricultural animal facilities and industrial or manufacturing facilities.
              (ii) Residential human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.

              § 158.1070
              Post-application exposure data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the post-application data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood use, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food, and indoor nonfood. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.

              (2) Residential use patterns include residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; TEP = Typical end-use product.
              (d) Table. The data requirements listed in the following table pertain to pesticide products that meet the testing criteria outlined in § 158.1060. The table notes are shown in paragraph (e) of this section.

                Table—Post-Application Exposure Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Occupational
                  Residential
                  Test Substance
                  Test Note No.

                  875.2100
                  Dislodgeable foliar residue and turf transferable residues
                  R
                  R
                  TEP
                  1, 2, 3, 4, 5

                  875.2200
                  Soil residue dissipation
                  R
                  CR
                  TEP
                  1, 2, 6, 7

                  875.2300
                  Indoor surface residue dissipation
                  R
                  R
                  TEP
                  1, 2, 8, 9

                  875.2400
                  Dermal exposure
                  R
                  R
                  TEP
                  1, 2, 10, 11, 12

                  875.2500
                  Inhalation exposure
                  R
                  R
                  TEP
                  1, 10, 11, 12

                  875.2600
                  Biological monitoring
                  CR
                  CR
                  TEP
                  1, 12, 13

                  875.2700
                  Product use information
                  R
                  R
                  TEP
                  —

                  875.2800
                  Description of human activity
                  R
                  R
                  TEP
                  —

                  875.2900
                  Data reporting and calculations
                  R
                  R
                  TEP
                  14

                  875.3000
                  Nondietary ingestion exposure
                  NR
                  R
                  TEP
                  1, 11, 15

              (e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section:

                1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
                2. Bridging applicable residue dissipation data to dermal exposure data is required.
                3. Turf grass transferable residue dissipation data are required when pesticides are applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants other than turf grass.
                4. Data are required for occupational sites if (i) there are uses on turf grass or other plant foliage, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated foliage while participating in typical activities.
                5. Data are required for residential sites if there are uses on turf grass or other plant foliage.
                6. Data are required for occupational sites, if (i) there are outdoor or greenhouse uses to or around soil or other planting media, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated soil or planting media while participating in typical activities.
                7. Data are required for residential sites if the pesticide is applied to or around soil or other planting media both outdoors and indoors, e.g., residential greenhouse or houseplant uses.
                8. Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces, e.g., flooring or countertops, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated indoor surfaces while participating in typical activities.
                9. Data are required for residential sites if the pesticide is applied to or around non-plant surfaces, e.g., flooring and countertops.
                10. Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.
                11. Data are required for residential sites if post-application exposures are likely.

                12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for a back-calculation to the total internal dose.
                13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer exposure to pesticides.
                14. Data reporting and calculations are required when any post-application exposure monitoring data are submitted.
                15. The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are applicable (e.g., soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues).

            Subpart L—Spray Drift

              § 158.1100
              Spray drift data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the spray drift data requirements for a particular pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. Data are also required for the general use patterns of forestry use, residential outdoor use, and indoor use.
              (c) Key. CR = Conditionally required; NR = Not required; TEP = Typical end-use product; MP = Manufacturing use product; EP = End-use product.
              (d) Table. The following table lists the data requirements that pertain to spray drift. The table notes are shown in paragraph (e) of this section.

                Table—Spray Drift Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Food Crop
                  Nonfood Crop
                  Aquatic
                  Food
                  Nonfood
                  Greenhouse
                  Food Crop
                  Nonfood Crop
                  Forestry
                  Residential Outdoor
                  Indoor
                  Test substance
                  MP
                  EP
                  Test Note No.

                  201-1
                  Droplet size spectrum
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  NR
                  NR
                  TEP
                  TEP
                  1

                  202-1
                  Droplet size spectrum
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  NR
                  NR
                  TEP
                  TEP
                  1

              (e) Test notes. The following notes apply to the requirements in the table to paragraph (d) of this section:

                1. This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants.
                2. [Reserved]

            Subpart M [Reserved]

              §§ 158.1200-158.1299
              [Reserved]

            Subpart N—Environmental Fate

              § 158.1300
              Environmental fate data requirements table.
              (a) General. All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for registration.
              (b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, and aquatic nonfood. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.
              (2) Data are also required for the general use patterns of forestry use and residential outdoor use.
              (c) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
              (d) Table. The following table shows the data requirements for environmental fate. The test notes are shown in paragraph (e) of this section.

                Table—Environmental Fate Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial
                  Aquatic
                  Greenhouse
                  Indoor
                  Forestry
                  Residential Outdoor
                  Test substance
                  Test Note No.

                  Degradation Studies - Laboratory

                  835.2120
                  Hydrolysis
                  R
                  R
                  R
                  CR
                  R
                  R
                  TGAI or PAIRA
                  1

                  835.2240
                  Photodegradation in water
                  R
                  R
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  2

                  835.2410
                  Photodegradation on soil
                  R
                  NR
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  3

                  835.2370
                  Photodegradation in air
                  CR
                  NR
                  CR
                  NR
                  CR
                  CR
                  TGAI or PAIRA
                  4

                  Metabolism Studies - Laboratory

                  835.4100
                  Aerobic soil
                  R
                  CR
                  R
                  NR
                  R
                  R
                  TGAI or PAIRA
                  5

                  835.4200
                  Anaerobic soil
                  R
                  NR
                  NR
                  NR
                  NR
                  NR
                  TGAI or PAIRA
                  —

                  835.4300
                  Aerobic aquatic
                  R
                  R
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  —

                  835.4400
                  Anaerobic aquatic
                  R
                  R
                  NR
                  NR
                  R
                  NR
                  TGAI or PAIRA
                  —

                  Mobility Studies

                  835.1230835.1240

                  Leaching and adsorption/desorption
                  R
                  R
                  R
                  NR
                  R
                  R
                  TGAI or PAIRA
                  6

                  835.1410
                  Volatility - laboratory
                  CR
                  NR
                  CR
                  NR
                  NR
                  NR
                  TEP
                  4

                  835.8100
                  Volatility - field
                  CR
                  NR
                  CR
                  NR
                  NR
                  NR
                  TEP
                  —

                  Dissipation Studies - Field

                  835.6100
                  Terrestrial
                  R
                  CR
                  NR
                  NR
                  CR
                  R
                  TEP
                  5, 7, 12

                  835.6200
                  Aquatic (sediment)
                  CR
                  R
                  NR
                  NR
                  NR
                  NR
                  TEP
                  7, 8

                  835.6300
                  Forestry
                  NR
                  NR
                  NR
                  NR
                  CR
                  NR
                  TEP
                  7, 9, 12

                  835.6400
                  Combination and tank mixes
                  CR
                  CR
                  NR
                  NR
                  NR
                  NR
                  TEP
                  10

                  Ground Water Monitoring

                  835.7100
                  Ground water monitoring
                  CR
                  NR
                  NR
                  NR
                  CR
                  CR
                  TEP
                  7, 9, 11

              (e) Test notes. The following test notes apply to the requirements in the table to paragraph (d) of this section:

                1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.
                2. Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm.
                3. Not required when the chemical is to be applied only by soil injection or is incorporated in the soil.
                4. Requirement based on use patterns and other pertinent factors including, but not limited to, the Henry's Law Constant of the chemical. In view of methodological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
                5. Required for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to, cranberry bogs and rice paddies.
                6. Adsorption and desorption using a batch equilibrium method is preferred. However in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.
                7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
                8. Requirement for terrestrial uses is based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, nontarget aquatic toxicity or bioaccumulation. Not required for aquatic residential uses. Field testing under the terrestrial field dissipation requirement may be more appropriate for some aquatic food crops, such as rice and cranberry uses, that are managed to have a dry-land period for production. The registrant is encouraged to consult with the Agency on protocols.
                9. Agency approval of a protocol is necessary prior to initiation of the study.
                10. This study may be triggered if there is specific evidence that the presence of one pesticide can affect the dissipation characteristics of another pesticide when applied simultaneously or serially.
                11. Required if the weight-of-evidence indicates that the pesticide and/or its degradates is likely to leach to ground water, taking into account other factors such as the toxicity of the chemicals(s), available monitoring data, and the vulnerability of ground water resources in the pesticide use area.
                12. If the terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required.

            Subpart O—Residue Chemistry

              § 158.1400
              Definitions.
              The following terms are defined for the purposes of this subpart:

                Livestock, for the purposes of this section, includes all domestic animals that are bred for human consumption, including, but not limited to, cattle, swine, sheep, and poultry.

                Plant or animal metabolite means a pesticide chemical residue that is the result of biological breakdown of the parent pesticide within the plant or animal.

                Residue of concern means the parent pesticidal compound and its metabolites, degradates, and impurities of toxicological concern.

                Tolerance, for the purposes of this section, includes the establishment of a new tolerance or tolerance exemption, or amended tolerance or tolerance exemption.

              § 158.1410
              Residue chemistry data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use.
              (2) Data may be required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses will be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient radio-labeled; Residue of concern= the active ingredient and its metabolites, degradates, and impurities of toxicological concern; TEP = Typical end-use product.
              (d) Table. The following table list the data requirements for residue chemistry related to food uses. The table notes are shown in paragraph (e) of this section.

                Table—Residue Chemistry Data Requirements for Food Uses

                  Guideline Number
                  Data Requirement
                  Use Pattern
                  Terrestrial Food or Feed
                  Aquatic Food
                  Greenhouse Food
                  Indoor Food
                  Residential Outdoor
                  Test substance
                  Test Note No.

                  Supporting Information

                  860.1100
                  Chemical identity
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  —

                  860.1200
                  Directions for use
                  R
                  R
                  R
                  R
                  R
                  —
                  —

                  860.1550
                  Proposed tolerance
                  R
                  R
                  R
                  CR
                  NR
                  —
                  1

                  860.1560
                  Reasonable grounds in support of petition
                  R
                  R
                  R
                  CR
                  NR
                  —
                  1

                  860.1650
                  Submittal of analytical reference standards
                  R
                  R
                  R
                  CR
                  NR
                  PAI and residue of concern
                  1, 2, 25

                  Nature of the residue

                  860.1300
                  Nature of the residue in plants
                  R
                  R
                  R
                  CR
                  CR
                  PAIRA
                  3, 4, 25

                  860.1300
                  Nature of the residue in livestock
                  CR
                  CR
                  CR
                  CR
                  NR
                  PAIRA or radiolabeled plant metabolite
                  1, 6, 25

                  860.1850
                  Confined rotational crops
                  CR
                  CR
                  NR
                  NR
                  NR
                  PAIRA
                  7

                  Analytical methods

                  860.1340
                  Residue analytical methods
                  R
                  R
                  R
                  CR
                  CR
                  Residue of concern
                  1, 3, 8, 9, 10, 25

                  860.1360
                  Multiresidue method
                  R
                  R
                  R
                  CR
                  NR
                  Residue of concern
                  1, 11, 25

                  Magnitude of the residue

                  860.1380
                  Storage stability
                  R
                  R
                  R
                  CR
                  CR
                  TEP or residue of concern
                  1, 3, 10, 12, 25

                  860.1500
                  Crop field trials
                  R
                  R
                  R
                  CR
                  CR
                  TEP
                  3, 10, 14, 24, 25

                  860.1520
                  Processed food or feed
                  CR
                  CR
                  CR
                  CR
                  NR
                  TEP
                  1, 15, 25

                  860.1480
                  Meat/milk/poultry/eggs
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI or plant metabolite
                  1, 16, 17, 18, 25

                  860.1400
                  Potable water
                  NR
                  R
                  NR
                  NR
                  NR
                  TEP
                  19, 25

                  860.1400
                  Fish
                  NR
                  R
                  NR
                  NR
                  NR
                  TEP
                  5, 25

                  860.1400
                  Irrigated crops
                  NR
                  CR
                  NR
                  NR
                  NR
                  TEP
                  20, 25

                  860.1460
                  Food handling
                  NR
                  NR
                  NR
                  CR
                  NR
                  TEP
                  1, 21, 25

                  860.1540
                  Anticipated residues
                  CR
                  CR
                  CR
                  CR
                  NR
                  Residue of concern
                  1, 13, 22, 26

                  860.1900
                  Field rotational crops
                  CR
                  CR
                  NR
                  NR
                  NR
                  TEP
                  23, 25

              (e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section.

                1. Required if indoor use could result in pesticide residues in or on food or feed.
                2. Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
                3. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
                4. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).

                5. Data for fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.

                6. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
                7. Required when the Agency determines that it is reasonably foreseeable that a food or feed crop could be subsequently planted on the site of pesticide application after harvest or failure of the treated crop. Typically not required for pesticide uses in permanent food crops (e.g., various tree crops, vines) or semi-permanent crops (e.g., asparagus, pineapples).
                8. A residue analytical method suitable for enforcement purposes is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
                9. New analytical methods to be used for enforcement purposes must include results from an independent laboratory validation.
                10. A residue method, storage stability data, and crop field trials are required for the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues found on the green tobacco, additional data may be required on cured/dried tobacco and pyrolysis products.
                11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
                12. Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
                13. Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a statistical design accepted by the Agency.
                14. Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).
                15. Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
                16. Required when the pesticide use is a direct application to livestock.
                17. Data are required if pesticide residues are present in or on livestock feed items or intentionally added to drinking water. These studies, however, may not be required in cases where the livestock metabolism studies indicate negligible transfer of the pesticide's residues of concern to tissues, milk, and eggs at the maximum expected exposure level for the animals.
                18. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock feeding study involving dosing with the plant metabolite(s) may also be required.
                19. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
                20. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
                21. Data are required whenever a pesticide may be used in a food handling or feed handling establishment.
                22. Required when residues at the tolerance level may result in a risk of concern. These data may include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
                23. Typically required if pesticide residues of concern greater than 0.01 ppm are found in crops at the appropriate plant back intervals (taking into account plant back restrictions on product labels) in the confined rotational crop study. If residues of concern in the confined study are greater than 0.01 ppm but less than the limit of quantitation of the analytical method to be used on field trial samples, the Agency will consider not requiring, on a case-by-case basis, the limited field trials. If there are particular toxicological concerns with the parent pesticide or any metabolites, limited field studies may be needed if such residues are identified at levels below 0.01 ppm in the confined study.
                24. Crop field trials are required to establish tolerances on rotational crops when quantifiable residues of concern are observed in the field rotational crops study.
                25. Not required for an exemption from a tolerance provided that dietary exposure estimates are not needed due to low toxicity or that theoretical estimates of exposure are adequate to assess dietary risk.
                26. Not required for an exemption from a tolerance.

            Subparts P-T [Reserved]

              §§ 158.1500-158.1900
              [Reserved]

            Subpart U—Biochemical Pesticides

              Source:
              72 FR 61002, Oct. 26, 2007, unless otherwise noted.

              § 158.2000
              Biochemical pesticides definition and applicability.
              This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section.
              (a) Definitions. The following terms are defined for the purposes of subpart U of this part.
              (1) A biochemical pesticide is a pesticide that:
              (i) Is a naturally-occurring substance or structurally-similar and functionally identical to a naturally-occurring substance;
              (ii) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically-derived biochemical pesticides, is equivalent to a naturally-occurring substance that has such a history; and
              (iii) Has a non-toxic mode of action to the target pest(s).
              (2) A Pheromone is a compound produced by a living organism or is a synthetically derived substance that is structurally similar and functionally identical to a naturally-occurring pheromone, which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.
              (i) An Arthropod Pheromone is a pheromone produced by a member of the taxonomic phylum Arthropoda.
              (ii) A Lepidopteran Pheromone is an arthropod pheromone produced by a member of the insect order Lepidoptera.
              (iii) A Straight Chain Lepidopteran Pheromone is a lepidopteran pheromone consisting of an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone.
              (b) Examples. Biochemical pesticides include, but are not limited to:
              (1) Semiochemicals (insect pheromones and kairomones),
              (2) Natural plant and insect regulators,
              (3) Naturally-occurring repellents and attractants, and
              (4) Enzymes.
              (c) Applicability. The Agency may review, on a case-by-case basis, naturally-occurring pesticides that do not clearly meet the definition of a biochemical pesticide in an effort to ensure, to the greatest extent possible, that only the minimum testing sufficient to make scientifically sound regulatory decisions would be conducted. The Agency will review applications for registration of naturally-occurring pesticides to determine whether to review the pesticide under this subpart U.

              § 158.2010
              Biochemical pesticides data requirements.
              (a) Sections 158.2030 through 158.2070 identify the data requirements that are required to support registration of biochemical pesticides. Sections 158.2080 through 158.2084 identify the data requirements that are required to support Experimental Use Permits (EUPs). Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000.
              (b) Each data table includes “use patterns” under which the individual data are required, with variations including food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances.
              (c) The categories for each data requirement are “R”, which stands for required, and “CR” which stands for conditionally required. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied.

              (d) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances (i.e., TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note.
              (e) The data requirements are organized into a tier-testing system with specified additional studies at higher tiers being required if warranted by adverse effects observed in lower tier studies. The lower tier studies are a subset of those required for conventional pesticides, and the studies overall are generally selected from those required for conventional pesticides.
              (f) Two sets of guideline numbers are provided for some of the environmental fate data requirements. For ease of understanding, the current guidelines will be used as an interim measure until the new guidelines (in parentheses) are finalized.

              § 158.2030
              Biochemical pesticides product chemistry data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section.
              (2) Definitions in § 158.300 apply to data requirements in this section.
              (b) Use patterns. Product chemistry data are required for all pesticide products and are not use specific.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above.
              (d) Table. The following table shows the data requirements for biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section.

                Table—Biochemical Pesticides Product Chemistry Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance
                  MP
                  EP
                  Test Notes

                  Product Identity and Composition

                  880.1100
                  Product identity and composition
                  R
                  TGAI, MP
                  TGAI, EP
                  1, 2

                  880.1200
                  Description of starting materials, production and formulation process
                  R
                  TGAI, MP
                  TGAI, EP
                  2, 3

                  880.1400
                  Discussion of formation of impurities
                  R
                  TGAI and MP
                  TGAI and EP
                  4

                  Analysis and Certified Limits

                  830.1700
                  Preliminary analysis
                  CR
                  TGAI and MP
                  TGAI and EP
                  5, 8

                  830.1750
                  Certified limits
                  R
                  MP
                  EP
                  6

                  830.1800
                  Enforcement analytical method
                  R
                  MP
                  EP
                  7

                  Physical and Chemical Characteristics

                  830.6302
                  Color
                  R
                  TGAI
                  TGAI
                  8

                  830.6303
                  Physical state
                  R
                  TGAI and MP
                  TGAI and EP
                  8

                  830.6304
                  Odor
                  R
                  TGAI
                  TGAI
                  8

                  830.6313
                  Stability to normal and elevated temperatures, metals and metal ions
                  R
                  TGAI
                  TGAI
                  8, 17

                  830.6315
                  Flammability
                  CR
                  MP
                  EP
                  9

                  830.6317
                  Storage stability
                  R
                  MP
                  EP
                  —

                  830.6319
                  Miscibility
                  CR
                  MP
                  EP
                  10

                  830.6320
                  Corrosion characteristics
                  R
                  MP
                  EP
                  —

                  830.7000
                  pH
                  CR
                  TGAI and MP
                  TGAI and EP
                  8, 11

                  830.7050
                  UV/Visible light absorption
                  R
                  TGAI
                  TGAI
                  —

                  830.7100
                  Viscosity
                  CR
                  MP
                  EP
                  12

                  830.7200
                  Melting point/melting range
                  CR
                  TGAI
                  TGAI
                  8, 13

                  830.7220
                  Boiling point/boiling range
                  CR
                  TGAI
                  TGAI
                  8, 14

                  830.7300
                  Density/relative density/bulk density
                  R
                  TGAI and MP
                  TGAI and EP
                  8, 18

                  830.7520
                  Particle size, fiber length, and diameter distribution
                  CR
                  TGAI
                  TGAI
                  8, 15

                  830.7550830.7560
                    830.7570

                  Partition coefficient (n-Octanol /Water)
                  CR
                  TGAI
                  TGAI
                  16

                  830.7840
                  Water solubility
                  R
                  TGAI
                  TGAI
                  8

                  830.7950
                  Vapor pressure
                  R
                  TGAI
                  TGAI
                  8, 19

              (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section.

                1. Data must be provided in accordance with § 158.320.
                2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI.
                3. Data must be provided in accordance with §§ 158.325, 158.330, and § 158.335.
                4. Data must be provided in accordance with § 158.340.
                5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis.
                6. Data must be provided in accordance with § 158.350.
                7. Data must be provided in accordance with § 158.355.
                8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
                9. Required if the product contains combustible liquids.
                10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
                11. Required if the test substance is soluble or dispersible in water.
                12. Required if the product is a liquid.
                13. Required when the technical chemical is a solid at room temperature.
                14. Required when the technical chemical is a liquid at room temperature.

                15. Required for water insoluble test substances (>10−6g/l) and fibrous test substances with diameter ≥0.1 µm.
                16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
                17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
                18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
                19. Not required for salts.

              § 158.2040
              Biochemical pesticides residue data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food.
              (2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing end-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Data requirements table. The following table shows the data requirements for biochemical pesticides residue. The test notes are shown in paragraph (e) of this section.

                Table—Biochemical Residue Data Requirements for Specific Uses

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Terrestrial
                  Food/Feed
                  Aquatic
                  Food
                  Greenhouse Food
                  Indoor Food
                  Test Substance
                  Test Notes

                  Supporting Information

                  860.1100
                  Chemical identity
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  1, 2, 4

                  860.1200
                  Directions for use
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 3, 4

                  Nature of the Residue

                  860.1300
                  Nature of the residue in plants
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  1, 4, 5, 6

                  860.1300
                  Nature of the residue in livestock
                  CR
                  CR
                  CR
                  CR
                  TGAI or plant metabolite
                  1, 7, 8, 10, 13

                  860.1340
                  Residue analytical method
                  CR
                  CR
                  R
                  CR
                  Residue of concern
                  4, 9, 10

                  860.1360
                  Multiresidue method
                  CR
                  CR
                  R
                  CR
                  Residue of concern
                  10, 11

                  Magnitude of the Residue

                  860.1400
                  Potable water
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 12

                  860.1400
                  Fish
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 13

                  860.1400
                  Irrigated crops
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 14

                  860.1460
                  Food handling
                  NR
                  NR
                  NR
                  CR
                  TGAI
                  1, 15

                  860.1480
                  Meat/milk/poultry/eggs
                  CR
                  CR
                  CR
                  CR
                  TGAI or plant metabolites
                  1, 7, 8, 10

                  860.1500
                  Crop field trials
                  CR
                  CR
                  CR
                  CR
                  TEP
                  1, 3, 4

                  860.1520
                  Processed food/feed
                  CR
                  CR
                  CR
                  CR
                  TEP
                  1, 16

                  860.1540
                  Anticipated residues
                  CR
                  CR
                  CR
                  CR
                  Residue of concern
                  1, 10, 17

                  860.1550
                  Proposed tolerances
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 18

                  860.1560
                  Reasonable grounds in support of the petition
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 10

                  860.1650
                  Submittal of analytical reference standards
                  CR
                  CR
                  CR
                  CR
                  TGAI and residue of concern
                  10, 19

              (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are in the last column of the table contained in paragraph (d) of this section.

                1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, § 158.2050.
                2. The same chemical identity data are required for biochemical product chemistry data requirements, § 158.2030, with an emphasis on impurities.
                3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
                4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
                5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
                6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
                7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed.
                8. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
                9. A residue analytical method suitable for enforcement of tolerances is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
                10. Required if indoor use could result in pesticide residues in or on food or feed.
                11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
                12. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
                13. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited by fish that may be caught or harvested for human consumption.
                14. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
                15. Data are required whenever a pesticide may be used in food/feed handling establishments.

                16. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
                17. Required when residues at the tolerance level may result in risk of concern. These data may include washing, cooking, processing, or degradation studies as well as market basket surveys for a more precise residue determination.
                18. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
                19. Required when a residue analytical method is required.

              § 158.2050
              Biochemical pesticides human health assessment data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the biochemical human health assessment data requirements for a particular biochemical pesticide product.
              (2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
              (b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use.
              (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section.

                Table—Biochemical Pesticides Human Health Assessment Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Food
                  Nonfood
                  Test Substance
                  MP
                  EP
                  Test Notes

                  Tier I

                  Acute Testing

                  870.1100
                  Acute oral toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1

                  870.1200
                  Acute dermal toxicity
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 2

                  870.1300
                  Acute inhalation toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  3

                  870.2400
                  Primary eye irritation - rabbit
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  2

                  870.2500
                  Primary dermal irritation
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 2

                  870.2600
                  Dermal sensitization
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  2, 4

                  none
                  Hypersensitivity incidents
                  R
                  R
                  All
                  All
                  5

                  Subchronic Testing

                  870.3100
                  90-day oral (one species)
                  R
                  CR
                  TGAI
                  TGAI
                  6

                  870.3250
                  90-day dermal - rat
                  CR
                  CR
                  TGAI
                  TGAI
                  7

                  870.3465
                  90-day inhalation - rat
                  CR
                  CR
                  TGAI
                  TGAI
                  8

                  Developmental Toxicity

                  870.3700
                  Prenatal developmental - rat preferably
                  R
                  CR
                  TGAI
                  TGAI
                  9

                  Mutagenicity Testing

                  870.5100
                  Bacterial reverse mutation test
                  R
                  CR
                  TGAI
                  TGAI
                  10

                  870.5300870.5375

                    In vitro mammalian cell assay
                  R
                  CR
                  TGAI
                  TGAI
                  10, 11

                  Tier II

                  Mutagenicity Testing (In vivo cytogenetics)

                  870.5385870.5895

                    In vivo Mammalian Cytogenetics
                  CR
                  CR
                  TGAI
                  TGAI
                  13

                  Developmental Toxicity

                  870.3700
                  Prenatal developmental
                  CR
                  CR
                  TGAI
                  TGAI
                  9

                  Special Tests

                  880.3550
                  Immunotoxicity
                  CR
                  CR
                  TGAI
                  TGAI
                  12, 13

                  Applicator/User Exposure

                  875.1100
                  Dermal outdoor exposure
                  CR
                  CR
                  TGAI
                  TGAI
                  15

                  875.1200
                  Dermal indoor exposure
                  CR
                  CR
                  TGAI
                  TGAI
                  15

                  875.1300
                  Inhalation outdoor exposure
                  CR
                  CR
                  TGAI
                  TGAI
                  15

                  875.1400
                  Inhalation indoor exposure
                  CR
                  CR
                  TGAI
                  TGAI
                  15

                  875.1500
                  Biological monitoring
                  CR
                  CR
                  TGAI
                  TGAI
                  15

                  Tier III

                  Chronic Testing/Special Testing

                  880.3800
                  Immune response
                  CR
                  CR
                  TGAI
                  TGAI
                  14

                  870.3800
                  Reproduction and fertility effects
                  CR
                  CR
                  TGAI
                  TGAI
                  16

                  870.4100
                  Chronic oral - rodent and nonrodent
                  CR
                  CR
                  TGAI
                  TGAI
                  17

                  870.4200
                  Carcinogenicity - two species - rat and mouse preferred
                  CR
                  CR
                  TGAI
                  TGAI
                  18

                  870.5380
                  Mammalian spermatogonial chromosome aberration test
                  CR
                  CR
                  TGAI
                  TGAI
                  19

                  Special Testing

                  870.7200
                  Companion animal safety
                  CR
                  CR
                  NR
                  TGAI or EP
                  20

              (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section.

                1. Required unless the test material is a gas or highly volatile (vapor pressure >10−4torr (mm/Hg)).

                2. Required unless the test material is corrosive to skin or has pH <2 or >11.5.

                3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
                4. Required if repeated contact with human skin is likely to occur under conditions of use.
                5. Hypersensitivity incidents must be reported as adverse effects data.
                6. Required for non-food uses that are likely to result in repeated oral exposure to humans.
                7. Required to support uses involving purposeful application to the human skin or which would result in comparable prolonged human exposure to the product (e.g., insect repellents) and if any of the following criteria are met:
                i. Data from a 90-day oral study are not required.
                ii. The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern.
                iii. The use pattern is such that the dermal route would be the primary route of exposure.
                8. Required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
                9. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.
                10. Required to support nonfood uses if either:
                i. The use is likely to result in significant human exposure; or
                ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen. Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
                11. Choice of assay using either:
                i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

                ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or
                iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
                12. Required if there are effects on hematology, clinical chemistry, lymphoid organ weights, and histopathology are observed in the 90-day studies.
                13. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
                14. Required if adverse effects are observed in the Tier II immunotoxicity study. The protocol for evaluating adverse effects to the immune response should be developed after evaluating the effects noted in the immunotoxicity study.
                15. These data are required when the data used for the human health assessment indicates that the biochemical may pose a potential hazard to the applicator/user.
                16. Required if there is evidence of:
                i. Endocrinological effects from the subchronic toxicity studies.
                ii. Developmental effects in the prenatal developmental toxicity study(s), or
                iii. Genotoxicity to mammals based on results from the mutagenicity tests.
                The use of a combined study that utilizes the two-generation reproduction study in rodents (guideline 870.3800) as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
                17. Required if the potential for adverse chronic effects is indicated based on any of the following:
                i. The subchronic effect level established in the following Tier I studies: 90-day oral toxicity study, 90-day dermal toxicity study, or 90-day inhalation toxicity study.
                ii. The pesticide use pattern (e.g., rate, frequency, and site of application).
                iii. The frequency and level of repeated human exposure that is expected.
                18. Required if the product meets either of the following criteria:
                i. The active ingredient (or any of its metabolites, degradation products, or impurities) produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia or metaplasia) in any organ that potentially could lead to neoplastic change.
                ii. Adverse cellular effects suggesting carcinogenic potential are observed in Tier II immunotoxicity and Tier III immune response study or in Tier II mammalian mutagenicity assays.
                In addition, a 90-day range finding study in both rats and mice is required to determine the dose levels if carcinogenicity studies are required. If the mouse carcinogenicity study is not required, the 90-day mouse subchronic study is likewise not required.

                19. Required if results from lower tiered mutation or reproductive studies indicate there is potential for chromosomal aberration to occur.
                20. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application or consumption of treated feed.

              § 158.2060
              Biochemical pesticides nontarget organisms and environmental fate data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, one acute freshwater invertebrate study, plant toxicity testing, and a honeybee acute contact study.

              (2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
              (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include: forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for biochemical pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

                Table—Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Terrestrial
                  Food/Feed/Nonfood
                  Aquatic
                  Food/Nonfood
                  Greenhouse
                  Food/Nonfood
                  Forestry, Residential Outdoor
                  Indoor
                  Food/Nonfood
                  Test Substance
                  Test Notes

                  Tier I

                  Avian Testing

                  850.2100
                  Avian acute oral toxicity
                  R
                  R
                  CR
                  R
                  CR
                  TGAI, EP
                  1, 2, 3, 4

                  850.2200
                  Avian dietary toxicity
                  R
                  R
                  CR
                  R
                  CR
                  TGAI, EP
                  1, 2, 3, 4

                  Aquatic Organism Testing

                  850.1075
                  Fish acute toxicity, freshwater
                  R
                  R
                  CR
                  R
                  CR
                  TGAI, EP
                  2, 3, 4, 5

                  850.1010
                  Aquatic invertebrate acute toxicity, freshwater
                  R
                  R
                  CR
                  R
                  CR
                  TGAI, EP
                  2, 3, 5

                  Nontarget Plant Testing

                  850.4100
                  Terrestrial Plant Toxicity, Seedling emergence
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  5

                  850.4150
                  Terrestrial Plant Toxicity, Vegetative vigor
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  5

                  Insect Testing

                  880.4350
                  Nontarget Insect Testing
                  R
                  R
                  R
                  R
                  NR
                  TGAI
                  14

                  Tier II

                  Environmental Fate Testing

                  163-1 (835.1230)
                  Sediment and soil adsorption/desorption for parent and degradates
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  163-1 (835.1240)
                  Soil column leaching
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  163-2 (835.1410)
                  Laboratory volatilization from soil
                  CR
                  NR
                  CR
                  CR
                  NR
                  TEP
                  7

                  161-1 (835.2120)
                  Hydrolysis
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  161-1 (835.4100)
                  Aerobic soil metabolism
                  CR
                  NR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  161-2 (835.2240)
                  Photodegradation in water
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  161-3 (835.2410)
                  Photodegradation on soil
                  CR
                  NR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  162-2 (835.4200)
                  Anaerobic soil metabolism
                  CR
                  NR
                  NR
                  NR
                  NR
                  TGAI
                  6

                  162-4 (835.4300)
                  Aerobic aquatic metabolism
                  CR
                  CR
                  CR
                  CR
                  NR
                  TGAI
                  6

                  162-3 (835.4400)
                  Anaerobic aquatic metabolism
                  CR
                  CR
                  NR
                  NR
                  NR
                  TGAI
                  6

                  880.4425
                  Dispenser - water leaching
                  CR
                  NR
                  CR
                  CR
                  NR
                  EP
                  8

                  Nontarget Plant

                  850.4225
                  Seedling emergence
                  R
                  R
                  NR
                  R
                  NR
                  TGAI
                  9

                  850.4250
                  Vegetative vigor
                  R
                  R
                  NR
                  R
                  NR
                  TGAI
                  9

                  Tier III

                  Aquatic Fauna Chronic, Life Cycle, and Field Studies

                  850.1300850.1400
                    850.1500

                  Freshwater fish/invertebrate testing
                  CR
                  CR
                  NR
                  CR
                  NR
                  TGAI
                  10

                  850.1025850.1035
                    850.1045
                    850.1055
                    850.1350
                    850.1400
                    850.1500

                  Marine/Estuarine fish/invertebrate animal testing
                  CR
                  CR
                  NR
                  CR
                  NR
                  TGAI
                  10

                  850.1950
                  Aquatic field fish/invertebrate testing
                  CR
                  CR
                  NR
                  CR
                  NR
                  EP
                  10

                  Terrestrial Wildlife

                  850.2300
                  Avian Reproduction
                  CR
                  CR
                  NR
                  CR
                  NR
                  TGAI
                  11

                  850.2400
                  Wild mammal acute toxicity
                  CR
                  CR
                  NR
                  CR
                  NR
                  TGAI
                  11

                  850.2500
                  Terrestrial field testing
                  CR
                  CR
                  NR
                  CR
                  NR
                  EP
                  11

                  Beneficial Insects

                  850.3040
                  Field testing for Pollinators
                  CR
                  CR
                  NR
                  CR
                  NR
                  TEP
                  12

                  Nontarget Plants

                  850.4225850.4250
                    850.4300
                    850.4450

                  Nontarget plant
                  CR
                  CR
                  NR
                  CR
                  NR
                  TGAI
                  13

              (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides nontarget organisms and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

                1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
                2. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, physical/chemical properties, production volume, and other pertinent factors.

                3. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 × 10−5atm m3/mol).
                4. Preferred test species are Upland game, waterfowl, or passerine for avian acute oral toxicity studies; Upland game and waterfowl for avian dietary studies; and coldwater fish species for acute freshwater fish studies.
                5. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
                6. Required on a case-by-case basis when results from Tier I studies indicate adverse effects.
                7. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied on land. In view of methdological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
                8. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied in a passive dispenser.

                9. Required to support registration of known phytotoxicants, i.e., herbicides, desiccants, defoliants, and plant growth regulators.

                10. Required if environmental fate characteristics indicate that the estimated environmental concentration of the pesticide in the aquatic environment is >0.01 of any EC50
                  or LC50 determined in the aquatic nontarget organism testing.
                11. Required if either of the following criteria are met:

                i. Environmental fate characteristics indicate that the estimated concentration of the pesticide in the terrestrial environment is >0.20 the avian dietary LC50 or equal to >0.20 the avian oral single dose LD50 (converted to ppm).
                ii. The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian or mammalian feed.
                12. Required when results of Tier I nontarget organism studies indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects. Additional insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., threatened or endangered species).
                13. Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement would be determined by the results of the Tier II environmental fate studies.
                14. Required depending on pesticide mode of action, method and timing of application, and results of any available efficacy data. Typically the honeybee acute toxicity guideline (guideline 850.3020) satisfies this requirement, however, additional nontarget insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., endangered species.)

              § 158.2070
              Biochemical pesticides product performance data requirements.
              Product performance data must be developed for all biochemical pesticides. However, the Agency typically does not require applicants to submit such efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.

              § 158.2080
              Experimental use permit data requirements—biochemical pesticides.
              (a) Sections 158.2081 through 158.2084 describe the experimental use permit (EUP) data requirements for biochemical pesticides. Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000.
              (b) For general information on the data requirement tables, see § 158.2010(b)-(f).

              § 158.2081
              Experimental use permit biochemical pesticides product chemistry data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular biochemical pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section.
              (2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
              (b) Use patterns. Product chemistry data are required for all pesticide products and are not use specific.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for experimental use permit biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section.

                Table—EUP Biochemical Pesticides Product Chemistry Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance
                  MP
                  EP
                  Test Notes

                  Product Identity and Composition

                  880.1100
                  Product identity and composition
                  R
                  TGAI, MP
                  TGAI, EP
                  1, 2

                  880.1200
                  Description of starting materials, production and formulation process
                  R
                  TGAI, MP
                  TGAI, EP
                  2, 3

                  880.1400
                  Discussion of formation of impurities
                  R
                  TGAI and MP
                  TGAI and EP
                  4

                  Analysis and Certified Limits

                  830.1700
                  Preliminary analysis
                  CR
                  TGAI and MP
                  TGAI and EP
                  5, 8

                  830.1750
                  Certified limits
                  R
                  MP
                  EP
                  6

                  830.1800
                  Enforcement analytical method
                  R
                  MP
                  EP
                  7

                  Physical and Chemical Characteristics

                  830.6302
                  Color
                  R
                  TGAI
                  TGAI
                  8

                  830.6303
                  Physical state
                  R
                  TGAI and MP
                  TGAI and EP
                  8

                  830.6304
                  Odor
                  R
                  TGAI
                  TGAI
                  8

                  830.6313
                  Stability to normal and elevated temperatures, metals and metal ions
                  R
                  TGAI
                  TGAI
                  8, 17

                  830.6315
                  Flammability
                  CR
                  MP
                  EP
                  9

                  830.6317
                  Storage stability
                  R
                  MP
                  EP
                  —

                  830.6319
                  Miscibility
                  CR
                  MP
                  EP
                  10

                  830.6320
                  Corrosion characteristics
                  R
                  MP
                  EP
                  —

                  830.7000
                  pH
                  CR
                  TGAI and MP
                  TGAI and EP
                  8, 11

                  830.7050
                  UV/Visible light absorption
                  R
                  TGAI
                  TGAI
                  —

                  830.7100
                  Viscosity
                  CR
                  MP
                  EP
                  12

                  830.7200
                  Melting point/melting range
                  CR
                  TGAI
                  TGAI
                  8, 13

                  830.7220
                  Boiling point/boiling range
                  CR
                  TGAI
                  TGAI
                  8, 14

                  830.7300
                  Density/relative density/bulk density
                  R
                  TGAI and MP
                  TGAI and EP
                  8, 18

                  830.7520
                  Particle size, fiber length, and diameter distribution
                  CR
                  TGAI
                  TGAI
                  8, 15

                  830.7550830.7560
                    830.7570

                  Partition coefficient (n-Octanol /Water)
                  CR
                  TGAI
                  TGAI
                  16

                  830.7840
                  Water solubility
                  R
                  TGAI
                  TGAI
                  8

                  830.7950
                  Vapor pressure
                  R
                  TGAI
                  TGAI
                  8, 19

              (e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section.

                1. Data must be provided in accordance with § 158.320.
                2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI.

                3. Data must be provided in accordance with § 158.325, § 158.330, and § 158.335.

                4. Data must be provided in accordance with § 158.340.
                5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit.
                6. Data must be provided in accordance with § 158.350.
                7. Data must be provided in accordance with § 158.355.
                8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
                9. Required if the product contains combustible liquids.
                10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
                11. Required if the test substance is soluble or dispersible in water.
                12. Required if the product is a liquid.
                13. Required when the technical chemical is a solid at room temperature.
                14. Required when the technical chemical is a liquid at room temperature.

                15. Required for water insoluble test substances (>10−6g/l) and fibrous test substances with diameter ≥0.1 µm.
                16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
                17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
                18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
                19. Not required for salts.

              § 158.2082
              Experimental use permit biochemical pesticides residue data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food.
              (2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing end-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates,and impurities of toxicological concern. All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Data table. The following table shows the data requirements for biochemical pesticides residue. The test notes are shown in paragraph (e) of this section.

                Table—EUP Biochemical Pesticides Residue Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Terrestrial
                  Food/Feed
                  Aquatic
                  Food
                  Greenhouse Food
                  Indoor Food
                  Test Substance
                  Test Notes

                  Supporting Information

                  860.1100
                  Chemical identity
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  1, 2, 4

                  860.1200
                  Directions for use
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 3, 4

                  Nature of Residue

                  860.1300
                  Nature of the residue in plants
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  1, 4, 5, 6

                  860.1300
                  Nature of the residue in livestock
                  CR
                  CR
                  CR
                  CR
                  TGAI or plant metabolite
                  1, 7, 8, 9, 13

                  Magnitude of the Residue

                  860.1400
                  Potable water
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 11

                  860.1400
                  Fish
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 12

                  860.1400
                  Irrigated crops
                  NR
                  CR
                  NR
                  NR
                  TGAI
                  1, 13

                  860.1460
                  Food handling
                  NR
                  NR
                  NR
                  CR
                  TGAI
                  1, 14

                  860.1480
                  Meat/milk/poultry/eggs
                  CR
                  CR
                  CR
                  CR
                  TGAI or plant metabolites
                  1, 7, 8, 9

                  860.1500
                  Crop field trials
                  CR
                  CR
                  CR
                  CR
                  TEP
                  1, 3, 4

                  860.1520
                  Processed food/feed
                  CR
                  CR
                  CR
                  CR
                  TEP
                  1, 15

                  860.1540
                  Anticipated residues
                  CR
                  CR
                  CR
                  CR
                  Residue of concern
                  1, 9, 16

                  860.1550
                  Proposed tolerances
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 17

                  860.1560
                  Reasonable grounds in support of the petition
                  CR
                  CR
                  CR
                  CR
                  —
                  1, 9

                  860.1650
                  Submittal of analytical reference standards
                  CR
                  CR
                  CR
                  CR
                  TGAI and residue of concern
                  9, 18

              (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are referenced referenced in the last column of the table contained in paragraph (d) of this section.

                1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, § 158.2050.
                2. The same chemical identity data are required for biochemical product chemistry data requirements,§ 158.2030 with an emphasis on impurities.
                3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
                4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
                5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
                6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).

                7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants form those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
                8. Livestock feeding studies are required whenever a pesticide residue is present in livestock feed or when direct application to livestock uses occurs.
                9. Required if indoor use could result in pesticide residues in or on food or feed.
                10. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
                11. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
                12. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
                13. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
                14. Data are required whenever a pesticide may be used in food/feed handling establishments.
                15. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
                16 Anticipated residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level of exposure. Data, using single serving samples of a raw agricultural commodity, on the level or residue in food as consumed would be used to obtain a more precise estimate of potential dietary exposure. These data may also include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
                17. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
                18. Required when a residue analytical method is required.

              § 158.2083
              Experimental use permit biochemical pesticides human health assessment data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the human health assessment data requirements for a particular biochemical pesticide product.
              (2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
              (b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use.
              (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for experimental use permit biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section.

                Table—EUP Biochemical Pesticides Human Health Assessment Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Food
                  Nonfood
                  Test Substance
                  MP
                  EP
                  Test Notes

                  Tier I

                  Acute Testing

                  870.1100
                  Acute oral toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1

                  870.1200
                  Acute dermal toxicity
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 2

                  870.1300
                  Acute inhalation toxicity - rat
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  3

                  870.2400
                  Primary eye irritation - rabbit
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  2

                  870.2500
                  Primary dermal irritation
                  R
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 2

                  none
                  Hypersensitivity incidents
                  R
                  R
                  All
                  All
                  4

                  Subchronic Testing

                  870.3100
                  90-day oral (one species)
                  R
                  NR
                  TGAI
                  TGAI
                  —

                  Developmental Toxicity

                  870.3700
                  Prenatal developmental - rat preferably
                  R
                  CR
                  TGAI
                  TGAI
                  5

                  Mutagenicity Testing

                  870.5100
                  Bacterial reverse mutation test
                  R
                  CR
                  TGAI
                  TGAI
                  6

                  870.5300

                    In vivo mammalian cell assay
                  R
                  CR
                  TGAI
                  TGAI
                  6, 7

                  Tier II

                  Developmental Toxicity

                  870.3700
                  Prenatal developmental
                  CR
                  CR
                  TGAI
                  TGAI
                  5

              (e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section.

                1. Required unless the test material is a gas or highly volatile (vapor pressure >10−4torr (mm/Hg)).
                2. Required unless the test material is corrosive to skin or has pH <2 or >11.5.
                3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
                4. Hypersensitivity incidents must be reported as adverse effects data.
                5. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.
                6. Required to support nonfood uses if either:
                i. The use is likely to result in significant human exposure; or

                ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen.

                Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
                7. Choice of assay using either:

                i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

                ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vivo test for clastogenicity; or
                iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.

              § 158.2084
              Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table.
              (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, and one acute freshwater invertebrate study.

              (2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
              (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for experimental use permit biochemical pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

                Table—EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Terrestrial
                  Food/Feed/Nonfood
                  Aquatic
                  Food/Nonfood
                  Greenhouse
                  Food/Nonfood
                  Forestry, Residential Outdoor
                  Indoor
                  Food/Nonfood
                  Test Substance
                  Test Notes

                  Tier I

                  Avian Testing

                  850.2100
                  Avian acute oral toxicity
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  1, 2, 3

                  850.2200
                  Avian dietary toxicity
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  1, 2, 3

                  Aquatic Organism Testing

                  850.1075
                  Fish acute toxicity, freshwater
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  2, 3, 4

                  850.1010
                  Aquatic invertebrate acute toxicity, freshwater
                  R
                  R
                  NR
                  R
                  NR
                  TGAI, EP
                  2, 4

              (e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides nontarget organisms and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

                1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).

                2. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 × 10−5atm m3/mol).
                3. Preferred test species are: upland game, waterfowl, or passerine for avian acute oral toxicity studies; upland game or waterfowl for avian dietary studies; and coldwater fish for acute freshwater fish studies.
                4. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.

            Subpart V—Microbial Pesticides

              Source:
              72 FR 61002, Oct. 26, 2007, unless otherwise noted.

              § 158.2100
              Microbial pesticides definition and applicability.
              (a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section.
              (b) Definition.
                Microbial pesticide is a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:
              (1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi;
              (2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
              (3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.
              (c) Applicability. (1) This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (c)(3), and (c)(4) of this section.
              (2) Each new isolate of a microbial pesticide is a new active ingredient and must be registered independently of any similarly designated and already registered microbial pesticide active ingredient. Each new isolate for which registration is sought must have a unique identifier following the taxonomic name of the microorganism, and the registration application must be supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is established, to support registration.
              (3) Genetically modified microbial pesticides may be subject to additional data or information requirements on a case-by-case basis depending on the particular microbial agent and/or its parental strains, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified.
              (4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA as authorized by section 25(b) of FIFRA and specified in § 152.20 (a) of this chapter.
              [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]

              § 158.2110
              Microbial pesticides data requirements.
              (a) For all microbial pesticides. (1) The following § 158.2120 through § 158.2150 identify the data requirements that are required to support registration of microbial pesticides. The variations in the test conditions are identified within the test notes.
              (2) Each data table includes “use patterns” under which the individual data are required, with variations including all use patterns, food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances.
              (3) The categories for each data requirement are “R,” which stands for required, and “CR” which stands for conditionally required. If a bracket appears around the “R” or “CR,” the data are required for both the registration and experimental use permit requests. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied.

              (4) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances (i.e., TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note. Data requirements which list two test substances (i.e., TGAI and EP) indicate that both are required to be tested. Data requirements that list only MP as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added. Data requirements listing the EP as the test substance apply to any EP with an ingredient in the end-use formulation other than the active ingredient that is expected to enhance the toxicity of the product.
              (b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.

              § 158.2120
              Microbial pesticides product analysis data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section.
              (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above.
              (c) Table. The table in this paragraph shows the data requirements for microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.

                Table—Microbial Pesticides Product Analysis Data Requirements

                  Test guideline No.
                  Data requirement
                  All usepatterns

                  Test substance
                  MP
                  EP
                  Test notes

                    Product Chemistry and Composition

                  885.1100
                  Product identity
                  R
                  MP
                  EP

                  885.1200
                  Manufacturing process
                  R
                  TGAI and MP
                  TGAI and EP

                  885.1250
                  Deposition of a sample in a nationally recognized culture collection
                  R
                  TGAI
                  TGAI
                  1

                  885.1300
                  Discussion of formation of unintentional ingredients
                  R
                  TGAI and MP
                  TGAI and EP

                    Analysis and Certified Limits

                  885.1400
                  Analysis of samples
                  R
                  TGAI and MP
                  TGAI and EP
                  2

                  885.1500
                  Certification of limits
                  R
                  MP
                  EP

                    Physical and Chemical Characteristics

                  830.6302
                  Color
                  R
                  TGAI
                  TGAI

                  830.6303
                  Physical state
                  R
                  TGAI
                  TGAI

                  830.6304
                  Odor
                  R
                  TGAI
                  TGAI

                  830.6313
                  Stability to normal and elevated temperatures, metals, and metal ions
                  R
                  TGAI
                  TGAI

                  830.6317
                  Storage stability
                  R
                  TGAI and MP
                  TGAI and EP

                  830.6319
                  Miscibility
                  R
                  MP
                  EP
                  3

                  830.6320
                  Corrosion characteristics
                  R
                  MP
                  EP
                  4

                  830.7000
                  pH
                  R
                  TGAI
                  TGAI

                  830.7100
                  Viscosity
                  R
                  MP
                  EP
                  5

                  830.7300
                  Density/relative density/bulk density (specific gravity)
                  R
                  TGAI
                  TGAI

              (d) Test notes. The following test notes are applicable to the data requirements for microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section.

                1. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s).
                2. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
                3. Only required for emulsifiable liquid forms of microbial pesticides.
                4. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
                5. Only required for liquid forms of microbial pesticides.

              [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]

              § 158.2130
              Microbial pesticides residue data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in paragraph (d) of this section, and the procedures appear in paragraph (e) of this section.
              (b) Key. R = required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:
              (c) Table. The following table shows the data requirements for microbial pesticides residue. The test notes are shown in paragraph (d) of this section.

                Table—Microbial Pesticides Residue Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance Data to Support MP or EP
                  Test Notes

                  885.2100
                  Chemical Identity
                  CR
                  EP
                  1

                  885.2200
                  Nature of the Residue in plants
                  CR
                  EP
                  1

                  885.2250
                  Nature of the Residue in animals
                  CR
                  EP
                  1

                  885.2300
                  Analytical methods - plants
                  CR
                  TGAI
                  1

                  885.2350
                  Analytical methods - animals
                  CR
                  TGAI
                  1

                  885.2400
                  Storage Stability
                  CR
                  EP
                  1

                  885.2500
                  Magnitude of residue in plants
                  CR
                  EP
                  1

                  885.2550
                  Magnitude of residues in meat, milk, poultry, eggs
                  CR
                  EP
                  1

                  885.2600
                  Magnitude of residues in potable water, fish, and irrigated crops
                  CR
                  EP
                  1

              (d) Test notes. The following test note is applicable to the data requirements for microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section.

                1. Required when the results of testing:
                i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and
                ii. The use pattern is such that residues may be present in or on food or feed crops.

              § 158.2140
              Microbial pesticides toxicology data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section.
              (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:
              (c) Table. The following table shows the data requirements for microbial pesticides toxicology. The test notes are shown in paragraph (d) of this section.

                Table—Microbial Pesticides Toxicology Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance
                  Test Notes

                  Tier I

                  885.3050
                  Acute oral toxicity/pathogenicity
                  R
                  TGAI
                  1

                  885.3150
                  Acute pulmonary toxicity/pathogenicity
                  R
                  TGAI
                  —

                  885.3200
                  Acute injection toxicity/pathogenicity/(intravenous)Acute injection toxicity/pathogenicity/(intraperitoneal)

                  R
                  TGAI
                  2

                  885.3400
                  Hypersensitivity incidents
                  R
                  All
                  3

                  885.3500
                  Cell culture
                  R
                  TGAI
                  4

                  870.1100
                  Acute oral toxicity
                  R
                  MP , EP
                  1, 5

                  870.1200
                  Acute dermal toxicity
                  R
                  MP , EP
                  5

                  870.1300
                  Acute inhalation toxicity
                  R
                  MP , EP
                  5, 6

                  870.2400
                  Acute eye irritation
                  R
                  MP , EP
                  5

                  870.2500
                  Primary dermal irritation
                  R
                  MP , EP
                  5

                  Tier II

                  885.3550
                  Acute toxicology
                  CR
                  TGAI
                  7

                  885.3600
                  Subchronic toxicity/pathogenicity
                  CR
                  TGAI
                  8

                  Tier III

                  885.3650
                  Reproductive fertility effects
                  CR
                  TGAI
                  9, 13

                  870.4200
                  Carcinogenicity
                  CR
                  TGAI
                  10, 13

                  870.7800
                  Immunotoxicity
                  CR
                  TGAI
                  11, 13

                  885.3000
                  Infectivity/pathogenicity analysis
                  CR
                  TGAI
                  12, 13

              (d) Test notes. The following test notes are applicable to the data requirements for microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section:

                1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.
                2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.
                3. Hypersensitivity incidents, including immediate type and delayed-type reactions of humans or domestic animals, occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.
                4. Data must be submitted only for products whose active ingredient is a virus.
                5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
                6. Required when the product consists of, or under conditions of use would result in, an inhalable material (e.g., gas, volatile substances, or aerosol particulate).
                7. Data required when significant toxicity, in the absence of pathogenicity and significant infectivity, is observed in acute oral, injection, or pulmonary studies (Tier I). Route(s) of exposure correspond to route(s) where toxicity was observed in Tier I studies. The toxic component of the TGAI is to be tested.
                8. Data required when significant infectivity and/or unusual persistence is observed in the absence of pathogenicity or toxicity in Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to routes in Tier I studies where adverse effects were noted. Data may also be required to evaluate adverse effects due to microbial contaminants or to toxic byproducts.
                9. Data are required when one or more of the following criteria are met:
                i. Significant infectivity of the microbial pest control agent (MPCA) was observed in test animals in the Tier II subchronic study and in which no significant signs of toxicity or pathogenicity were observed.
                ii. The microbial pesticide is a virus which can persist or replicate in mammalian cell culture lines.
                iii. The microbial pesticide is not amenable to thorough taxonomic classification, and is related to organisms known to be parasitic for mammalian cells.
                iv. The microbial pesticide preparation is not well purified, and may contain contaminants which are parasitic for mammals.
                10. Data may be required for products known to contain or suspected to contain carcinogenic viruses or for microbial components that are identified as having significant toxicity in Tier II testing.
                11. Data may be required for products known to contain or suspected to contain viruses that can interact in an adverse manner with components of the mammalian immune system.
                12. An analysis of human infectivity/pathogenicity potential using scientific literature, genomic analysis, and/or actual specific cell culture/animal data may be required for products known to contain or suspected of containing intracellular parasites of mammalian cells for products that exhibit pathogenic characteristics in Tier I and/or Tier II, for products which are closely related to known human pathogens based on the product analysis data, or for known human pathogens that have been “disarmed” or rendered non-pathogenic for humans.
                13. Test standards may have to be modified depending on the characteristics of the microorganism. Requirements may vary for these studies depending on the active ingredient being tested. Consultation with the Agency is advised before performing these Tier III studies.

              § 158.2150
              Microbial pesticides nontarget organisms and environmental fate data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

                Table—Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Aquatic
                  Food/Feed
                  Nonfood
                  Terrestrial
                  Food/Feed/Nonfood
                  Forestry
                  Residential
                  Outdoor
                  Greenhouse
                  Food/Nonfood
                  Indoor
                  Food/Nonfood
                  Industrial
                  Test Substance
                  Test Notes

                  Tier I

                  885.4050
                  Avian oral toxicity
                  R
                  R
                  R
                  R
                  R
                  CR
                  CR
                  CR
                  TGAI
                  1, 2

                  885.4100
                  Avian inhalation toxicity/pathogenicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  1, 2, 3

                  885.4150
                  Wild mammal toxicity/pathogenicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  1, 4

                  885.4200
                  Freshwater fish toxicity/ pathogenicity
                  R
                  R
                  R
                  R
                  CR
                  CR
                  CR
                  CR
                  TGAI or TEP
                  1, 2, 5

                  885.4240
                  Freshwater invertebrate toxicity/pathogenicity
                  R
                  R
                  R
                  R
                  CR
                  CR
                  CR
                  CR
                  TGAI or TEP
                  1, 2, 5

                  885.4280
                  Estuarine/Marine fish testingEstuarine and marine invertebrate testing

                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  1, 6

                  885.4300
                  Nontarget planttesting

                  CR
                  CR
                  CR
                  R
                  CR
                  NR
                  CR
                  CR
                  TEP
                  1, 7

                  885.4340
                  Nontarget insect testing
                  R
                  R
                  R
                  R
                  R
                  CR
                  NR
                  CR
                  TGAI
                  1, 8

                  885.4380
                  Honey bee testing
                  R
                  R
                  R
                  R
                  R
                  CR
                  NR
                  CR
                  TGAI
                  1

                  Tier II

                  885.5200
                  Terrestrial environmental expression tests
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI or TEP
                  9

                  885.5300
                  Freshwater environmental expression tests
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI or TEP
                  10

                  885.5400
                  Marine or estuarine environmental expression tests
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI or TEP
                  11, 12

                  Tier III

                  885.4600
                  Avian chronic pathogenicity and reproduction test
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  12, 13

                  885.4650
                  Aquatic invertebrate range testing
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  12, 14

                  885.4700
                  Fish life cycle studies
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  12, 14

                  885.4750
                  Aquatic ecosystem test
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI
                  15

                  Tier IV

                  850.2500850.1950

                  Field testing for terrestrial wildlife and Field testing for aquatic organisms
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TGAI or TEP
                  11, 16

                  850.2500
                  Simulated or actual field tests (birds, mammals)
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TEP
                  16, 17, 20

                  850.1950
                  Simulated or actual field test (aquatic organisms)
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TEP
                  16, 18, 19, 20

                  850.2500
                  Simulated or actual field tests (insect predators, parasites)
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TEP
                  16, 18, 19, 20

                  850.3040
                  Simulated or actual field tests (insect pollinators)
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TEP
                  16, 18, 19, 20

                  850.4300
                  Simulated or actual field tests (plants)
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  NR
                  CR
                  TEP
                  16, 18, 19, 20

              (e) Test notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

                1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
                2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test the passerine if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish species are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrate testing is also required.
                3. Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds.
                4. Required on a case-by-case basis if results of tests required by § 158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals.
                5. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
                6. Required if the product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of expected use or mobility pattern.
                7. Required if the microbial pesticide is taxonomically related to a known plant pathogen.

                8. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., may create an epizootic condition in nontarget insects.
                9. Required if toxic or pathogenic effects are observed in one or more of the following tests for microbial pesticides:
                i. Avian acute oral or avian inhalation studies.
                ii. Wild mammal studies.
                iii. Nontarget plant studies (terrestrial).
                iv. Honey bee studies.
                v. Nontarget insect studies.
                10. Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
                i. Freshwater fish studies.
                ii. Freshwater invertebrate studies.
                iii. Nontarget plant studies (aquatic).
                11. Required if product is applied on land or in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pesticides:
                i. Estuarine and marine animal toxicity and pathogenicity.
                ii. Plant studies - estuarine or marine species.
                12. An appropriate dose-response toxicity test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms (including plants) are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the microbial agent to the affected nontarget terrestrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget organism and environmental expression studies.
                13. Required when one or more of the following are present:
                i. Pathogenic effects are observed in Tier I avian studies.
                ii. Tier II environmental expression testing indicate that long-term exposure of terrestrial animals is likely.
                14. Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I aquatic studies.
                15. Required if, after an analysis of the microbial pesticide's ability to survive and multiply in the environment and what ecological habitat it would occupy, the intended use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments. Testing is to determine if applications of the microbial pest control would be expected to disrupt the balance of populations in the target ecosystem.
                16. Tier IV studies may be conducted as a condition of registration as post-registration monitoring if the potential for unreasonable adverse effects appears to be minimal during that period of use due to implementation of mitigation measures.
                17. Required when both of the following conditions occur:
                i. Pathogenic effects observed at actual or expected field residue exposure levels are reported in Tier III; and
                ii. The Agency determines that quarantine methods would not prevent the microbial pesticide from contaminating areas adjacent to the test area.
                18. Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates.
                19. Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or life-cycle effects may result from intended use.
                20. Since test standards would be developed on a case-by-case basis, consultation with the Agency and development of a protocol is advised before performing these Tier IV studies.

              § 158.2160
              Microbial pesticides product performance data requirements.
              Product performance data must be developed for all microbial pesticides. However, the Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.

              § 158.2170
              Experimental use permit data requirements—microbial pesticides.
              (a) For all microbial pesticides. (1) The following § 158.2171 through § 158.2174 identify the data requirements that are required to support experimental use permits for microbial pesticides. The variations in the test conditions are identified within the test notes.
              (2) For general information on the data requirement tables, see § 158.2110(a)(2)-(4).
              (b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.

              § 158.2171
              Experimental use permit microbial pesticides product analysis data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section.
              (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above.
              (c) Table. The table in this paragraph shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.

                Table—EUP Microbial Pesticides Product Analysis Data Requirements

                  Test guideline No.
                  Data requirement
                  All use patterns
                  Test substance
                  MP
                  EP
                  Test notes

                    Product Chemistry and Composition

                  885.1100
                  Product identity
                  R
                  MP
                  EP

                  885.1200
                  Manufacturing process
                  R
                  TGAI and MP
                  TGAI and EP
                  1, 2

                  885.1250
                  Deposition of a sample in a nationally recognized culture collection
                  R
                  TGAI
                  TGAI
                  3

                  885.1300
                  Discussion of formation of unintentional ingredients
                  R
                  TGAI and MP
                  TGAI and EP
                  2

                    Analysis and Certified Limits

                  885.1400
                  Analysis of samples
                  R
                  TGAI and MP
                  TGAI and EP
                  2, 4

                  885.1500
                  Certification of limits
                  R
                  MP
                  EP

                    Physical and Chemical Characteristics

                  830.6302
                  Color
                  R
                  TGAI
                  TGAI

                  830.6303
                  Physical state
                  R
                  TGAI
                  TGAI

                  830.6304
                  Odor
                  R
                  TGAI
                  TGAI

                  830.6313
                  Stability to normal and elevated temperatures, metals, and metal ions
                  R
                  TGAI
                  TGAI

                  830.6317
                  Storage stability
                  R
                  TGAI and MP
                  TGAI and EP

                  830.6319
                  Miscibility
                  R
                  MP
                  EP
                  5

                  830.6320
                  Corrosion characteristics
                  R
                  MP
                  EP
                  6

                  830.7000
                  pH
                  R
                  TGAI
                  TGAI

                  830.7100
                  Viscosity
                  R
                  MP
                  EP
                  7

                  830.7300
                  Density/relative density/bulk density (specific gravity)
                  R
                  TGAI
                  TGAI

              (d) Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section.

                1. If an experimental use permit is being sought, and if the pesticide is not already under full-scale production, a schematic diagram and/or description of the manufacturing process suffices.
                2. If an experimental use permit is being sought, and if the product is not already under full-scale production, a discussion of unintentional ingredients is required to be submitted to the extent this information is available.
                3. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated experimental use permit(s).
                4. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
                5. Only required for emulsifiable liquid forms of microbial pesticides.
                6. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
                7. Only required for liquid forms of microbial pesticides.

              [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52613, Aug. 30, 2012]

              § 158.2172
              Experimental use permit microbial pesticides residue data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in (d) of this section, and the procedures appear in paragraph (e) of this section.
              (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:
              (c) Table. The following table shows the data requirements for experimental use permit microbial pesticides residue. The test notes are shown in paragraph (d) of this section.

                Table—EUP Microbial Pesticides Residue Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance Data to Support MP or EP
                  Test Notes

                  885.2100
                  Chemical Identity
                  CR
                  EP
                  1

                  885.2200
                  Nature of the Residue in plants
                  CR
                  EP
                  1

                  885.2250
                  Nature of the Residue in animals
                  CR
                  EP
                  1

                  885.2300
                  Analytical methods - plants
                  CR
                  TGAI
                  1

                  885.2350
                  Analytical methods-animals
                  CR
                  TGAI
                  1

                  885.2400
                  Storage Stability
                  CR
                  EP
                  1

                  885.2500
                  Magnitude of residue in plants
                  CR
                  EP
                  1

                  885.2550
                  Magnitude of residues in meat, milk, poultry, eggs
                  CR
                  EP
                  1

                  885.2600
                  Magnitude of residues in potable water, fish, and irrigated crops
                  CR
                  EP
                  1

              (d) Test notes. The following test note is applicable to the data requirements for experimental use permit microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section.

                1. Required when the results of testing:
                i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and
                ii. The use pattern is such that residues may be present in or on food or feed crops.

              § 158.2173
              Experimental use permit microbial pesticides toxicology data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular microbial pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section.
              (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:
              (c) Table. The following table shows the data requirements for microbial pesticide toxicology. The test notes are shown in paragraph (d) of this section.

                Table—EUP Microbial Pesticides Toxicology Data Requirements

                  Guideline Number
                  Data Requirement
                  All Use Patterns
                  Test Substance
                  Test Notes

                  885.3050
                  Acute oral toxicity/pathogenicity
                  R
                  TGAI
                  1

                  885.3150
                  Acute pulmonary toxicity/pathogenicity
                  R
                  TGAI
                  —

                  885.3200
                  Acute injection toxicity/pathogenicity/(intravenous)Acute injection toxicity/pathogenicity/(intraperitoneal)

                  R
                  TGAI
                  2

                  885.3400
                  Hypersensitivity incidents
                  R
                  All
                  3

                  885.3500
                  Cell culture
                  R
                  TGAI
                  4

                  870.1100
                  Acute oral toxicity
                  R
                  MP, EP
                  1, 5

                  870.1200
                  Acute dermal toxicity
                  R
                  MP, EP
                  5

                  870.1300
                  Acute inhalation toxicity
                  R
                  MP, EP
                  5, 6

                  870.2400
                  Acute eye irritation
                  R
                  MP, EP
                  5

                  870.2500
                  Primary dermal irritation
                  CR
                  MP, EP
                  5

              (d) Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section:

                1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.

                2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.
                3. Hypersensitivity incidents, including immediate type and delayed type reactions of humans or domestic animals occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.
                4. Data must be submitted only for products whose active ingredient is a virus.
                5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
                6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).

              § 158.2174
              Experimental use permit microbial pesticides nontarget organisms and environmental fate data requirements table.
              (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
              (b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
              (d) Table. The following table shows the data requirements for experimental use permit microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

                Table—EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements

                  Guideline Number
                  Data Requirement
                  Use Patterns
                  Aquatic
                  Food/Feed
                  Nonfood
                  Terrestrial
                  Food/Feed/Nonfood
                  Forestry
                  Residential
                  Outdoor
                  Greenhouse
                  Food/Nonfood
                  Indoor
                  Food/Nonfood
                  Industrial
                  Test Substance
                  Test Notes

                  885.4050
                  Avian oraltoxicity

                  NR
                  R
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  TGAI
                  1, 2

                  885.4200
                  Freshwater fish toxicity/pathogenicity
                  NR
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  TGAI
                  1, 2, 3

                  885.4240
                  Freshwater invertebrate toxicity/pathogenicity
                  NR
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  TGAI
                  1, 2, 3

                  885.4300
                  Nontarget planttesting

                  NR
                  NR
                  NR
                  R
                  NR
                  NR
                  NR
                  NR
                  TEP
                  1, 4

                  885.4340
                  Nontarget insect testing
                  R
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  TGAI
                  1, 5

                  885.4380
                  Honey bee testing
                  R
                  R
                  R
                  R
                  NR
                  NR
                  NR
                  NR
                  TGAI
                  1

              (e) Test notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

                1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors. Tests to support EUP's are based on the application timing and acreage.
                2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test a passerine species if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrates are preferred for invertebrate testing.
                3. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
                4. Required if the microbial pesticide is taxonomically related to a known plant pathogen.

                5. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., may create an epizootic condition in nontarget insects.

            Subpart W—Antimicrobial Pesticide Data Requirements

              Source:
              78 FR 26978, May 8, 2013, unless otherwise noted.

              § 158.2200
              Applicability.
              Part 158, subpart W establishes data requirements for any pesticide product that is:
              (a) A pesticide that is intended for use as an “antimicrobial pesticide” within the meaning of FIFRA sec. 2(mm)(1)(A), regardless of whether it also meets the criterion of FIFRA sec. 2(mm)(1)(B). That criterion excludes from the definition any antimicrobial product that is intended for a food-use requiring a tolerance or exemption under FFDCA sec. 408 or a food additive regulation or clearance under FFDCA sec. 409. EPA will apply this subpart to all products intended for an antimicrobial use, purpose or function; the exclusion in FIFRA sec. 2(mm)(1)(B) does not exclude products from the data requirements of this subpart.
              (b) A product that bears both antimicrobial and non-antimicrobial uses or claims. Such a product is subject to the data requirements for pesticides in subparts C through O, and U or V of this part with respect to its non-antimicrobial uses and claims, and to the requirements of this subpart with respect to its antimicrobial uses and claims.
              (c) A wood preservative, including a product that is intended to prevent wood degradation problems due to fungal rot or decay, sapstain, or molds.
              (d) An antifoulant, including a product that is intended to kill or repel organisms that can attach to underwater surfaces, such as boat bottoms.

              § 158.2201
              Antimicrobial use patterns.
              (a) Antimicrobial use patterns. The 12 general use patterns used in the data tables in this subpart are:
              (1) Agricultural premises and equipment.
              (2) Food-handling/storage establishments, premises and equipment.
              (3) Commercial, institutional and industrial premises and equipment.
              (4) Residential and public access premises.
              (5) Medical premises and equipment.
              (6) Human drinking water systems.
              (7) Materials preservatives.
              (8) Industrial processes and water systems.
              (9) Antifoulant paints and coatings.
              (10) Wood preservatives.
              (11) Swimming pools.
              (12) Aquatic areas.
              (b) Use site index. The Pesticide Use Site Index for Antimicrobial Pesticides is a comprehensive list of specific antimicrobial use sites. The Index associates antimicrobial use sites with one or more of the 12 antimicrobial use patterns. It is to be used in conjunction with the data tables in this subpart to determine the applicability of data requirements to specific uses. The Antimicrobial Pesticide Use Site Index, which will be updated periodically, is available from the Agency or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides.

              § 158.2203
              Definitions.
              The following terms are defined for the purposes of this subpart:

                Disinfectant means a substance, or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi and viruses, but not necessarily bacterial spores, in the inanimate environment.

                Fungicide means a substance, or mixture of substances, that destroys fungi (including yeasts) and fungal spores pathogenic to man or other animals in the inanimate environment.

                Microbiological water purifier means any unit, water treatment product or system that removes, kills or inactivates all types of disease-causing microorganisms from the water, including bacteria, viruses and protozoan cysts, so as to render the treated water safe for drinking.

                Sanitizer means a substance, or mixture of substances, that reduces the bacteria population in the inanimate environment by significant numbers, but does not destroy or eliminate all bacteria. Sanitizers meeting Public Health Ordinances are generally used on food contact surfaces and are termed sanitizing rinses.

                Sterilant means a substance, or mixture of substances, that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses.

                Tuberculocide means a substance, or mixture of substances, that destroys or irreversibly inactivates tubercle bacilli in the inanimate environment.

                Virucide means a substance, or mixture of substances, that destroys or irreversibly inactivates viruses in the inanimate environment.

              § 158.2204
              Public health and nonpublic health claims.
              (a) Public health claim. An antimicrobial pesticide is considered to make a public health claim if the pesticide product bears a claim to control pest microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including but not limited to, microorganisms infectious to man in any area of the inanimate environment. A product makes a public health claim if one or more of the following apply:

              (1) A claim is made for control of specific microorganisms that are directly or indirectly infectious or pathogenic to man (or both man and animals). Examples of specific microorganisms include, but are not limited to: Mycobacterium tuberculosis, Pseudomonas aeruginosa,
                Escherichia coli (E. coli), human immunodeficiency virus (HIV), Streptococcus, and Staphylococcus aureus. Claims for control of microorganisms infectious or pathogenic only to animals (such as canine distemper virus or hog cholera virus) are not considered public health claims.
              (2) A claim is made for the pesticide product as a sterilant, disinfectant, virucide, sanitizer, or tuberculocide against microorganisms that are infectious or pathogenic to man.
              (3) A claim is made for the pesticide product as a fungicide against fungi infectious or pathogenic to man, or the product does not clearly state that it is intended for use only against nonpublic health fungi.
              (4) A claim is made for the pesticide product as a microbiological water purifier or microbial purification system.
              (5) A non-specific claim is made that the pesticide product will beneficially impact or affect public health at the site of use or in the environment in which it is applied, and:
              (i) The pesticide product contains one or more ingredients that, under the criteria in 40 CFR 153.125(a), is an active ingredient with respect to a public health microorganism and there is no other functional purpose for the ingredient in the product; or
              (ii) The pesticide product is similar in composition to a registered pesticide product that makes antimicrobial public health claims.
              (b) Nonpublic health claim. An antimicrobial pesticide is considered to make a nonpublic health claim if the pesticide product bears a claim to control microorganisms of economic or aesthetic significance, where the presence of the microorganism would not normally lead to infection or disease in humans. Examples of nonpublic health claims include, but are not limited to: Algaecides, slimicides, preservatives and products for which a pesticidal claim with respect to odor sources is made.

              § 158.2210
              Product chemistry.
              The product chemistry data requirements of subpart D of this part apply to antimicrobial products covered by this subpart.

              § 158.2220
              Product performance.
              (a) General—(1) Product performance requirement for all antimicrobial pesticides. Each applicant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment.
              (2) Product performance data for each product that bears a public health claim. Each product that bears a public health claim, as described in § 158.2204(a), must be supported by product performance data, as listed in the table in paragraph (c) of this section. Product performance data must be submitted with any application for registration or amended registration.
              (3) Product performance data for each product that bears a nonpublic health claim. Each product that bears a nonpublic health claim, as described in § 158.2204(b), must be supported by product performance data. Each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment.
              (4) Determination of data requirements. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the product performance data requirements for antimicrobial pesticide products.
              (b) Key. R = Required; EP = End-use product.
              (c) Antimicrobial product performance data requirements table. The following table shows the data requirements for antimicrobial product performance.

                Table—Antimicrobial Product Performance Data Requirements

                  Guideline No.
                  Data requirement
                  All use patterns
                  Test substance

                  810.2100
                  Sterilants—Efficacy Data Recommendations
                  R
                  EP

                  810.2200
                  Disinfectants for Use on Hard Surfaces—Efficacy Data Recommendations
                  R
                  EP

                  810.2300
                  Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations
                  R
                  EP

                  810.2400
                  Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations
                  R
                  EP

                  810.2500
                  Air Sanitizers—Efficacy Data Recommendations
                  R
                  EP

                  810.2600
                  Disinfectants for Use in Water—Efficacy Data Recommendations
                  R
                  EP

              § 158.2230
              Toxicology.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (g) of this section to determine the toxicology data requirements for an antimicrobial pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are listed in paragraph (h) of this section.
              (b) Uses. The applicant for registration must first determine whether the use is likely to result in pesticide residues in food or water and therefore consult the “Food Use” columns of the table in paragraph (g) of this section. Generally, if the residues of the antimicrobial result from an application to a surface or if incorporated into a material that may come into contact with food or feed, and residues may be expected to transfer to such food or feed, then the “Indirect Food Uses” columns is to be consulted.
              (c) Tiering of data requirements. Applicants for registration of antimicrobials may perform tests in a tiered fashion. After the initially required tests are conducted, additional testing may be required if results of the initial tests trigger the need for additional data. Conditions that trigger the need for additional data are given in the test notes in paragraph (h) of this section.
              (d) 200 parts per billion (ppb). The 200 ppb level was originally used by the Food and Drug Administration with respect to the concentration of residues in or on food for tiering of data requirements for indirect food use biocides. The Agency has also adopted this same residue level for determining toxicology data requirements for indirect food uses of antimicrobial pesticides. The 200 ppb level is the concentration of antimicrobial residues in the total estimated daily dietary intake.
              (e) Use of OSHA standards. If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA standards), provide adequate protection for a particular pesticide or a particular use pattern, additional toxicity data may not be required for that pesticide or the use pattern.
              (f) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabeled; Choice = choice of several test substances depending on studies required.
              (g) Antimicrobial toxicology data requirements table. The following table shows the data requirements for toxicology. The test notes applicable to the data requirements in this table appear in paragraph (h) of this section.

                Table—Antimicrobial Toxicology Data Requirements

                  GuidelineNo.

                  Datarequirement

                  Food uses
                  Direct food uses
                  Indirect food uses (>200 ppb)
                  Indirect food uses (≤200 ppb)
                  Nonfood uses
                  Swimming pools,aquatic areas,
                    wood preservatives, metal working fluids

                  All other nonfood uses
                  Test substance
                  MP
                  EP
                  Test note No.

                    Acute Testing

                  870.1100
                  Acute oral toxicity—rat
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  1, 2

                  870.1200
                  Acute dermal toxicity
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  1, 2, 3

                  870.1300
                  Acute inhalation toxicity—rat
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  2, 4

                  870.2400
                  Primary eye irritation—rabbit
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  1, 2, 3

                  870.2500
                  Primary dermal irritation
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  1, 2, 3

                  870.2600
                  Dermal sensitization
                  R
                  R
                  R
                  R
                  R
                  MP and TGAI
                  EP and TGAI
                  1, 2, 3, 5

                  870.2600
                  Acute neurotoxicity—rat
                  R
                  R
                  CR
                  R
                  CR
                  TGAI
                  TGAI
                  6, 11

                    Subchronic Testing

                  870.3100
                  90-Day oral toxicity—rodent
                  R
                  R
                  R
                  R
                  CR
                  TGAI
                  TGAI
                  8, 9, 15, 38

                  870.3150
                  90-Day oral toxicity—nonrodent
                  R
                  R
                  CR
                  R
                  CR
                  TGAI
                  TGAI
                  10, 15

                  870.3200
                  21/28-Day dermal toxicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  EP and TGAI
                  12, 13

                  870.3250
                  90-Day dermal toxicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  EP and TGAI
                  7, 13, 14, 15

                  870.3465
                  90-Day inhalation toxicity—rat
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  7, 15, 16, 17

                  870.6200
                  90-Day neurotoxicity—rat
                  R
                  R
                  CR
                  R
                  CR
                  TGAI
                  TGAI
                  6, 8

                    Chronic Testing

                  870.4100
                  Chronic oral toxicity—rodent
                  R
                  R
                  CR
                  R
                  CR
                  TGAI
                  TGAI
                  18, 19, 20

                  870.4200
                  Carcinogenicity—two rodent species—rat and mouse preferred
                  R
                  R
                  CR
                  R
                  CR
                  TGAI
                  TGAI
                  19, 21, 22

                    Developmental Toxicity and Reproduction

                  870.3700
                  Prenatal developmental toxicity—rat and rabbit preferred
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  23, 24, 25, 26

                  870.3800
                  Reproduction and fertility effects
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  26, 27, 28, 29

                  870.6300
                  Developmental neurotoxicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  28, 29, 30

                    Mutagenicity

                  870.5100
                  Reverse mutation assay
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  31, 32

                  870.5300870.5375

                    In vitro mammalian gene mutation
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  31, 33

                  870.5385870.5395

                    In vivo cytogenetics
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  31, 34

                    Special Testing

                  870.7485
                  Metabolism and pharmacokinetics
                  R
                  R
                  CR
                  R
                  CR
                  PAI or PAIRA
                  PAI or PAIRA
                  35, 39

                  870.7200
                  Companion animal safety
                  CR
                  CR
                  CR
                  CR
                  CR
                  NR
                  Choice
                  36

                  870.7600
                  Dermal penetration
                  CR
                  CR
                  CR
                  CR
                  CR
                  Choice
                  Choice
                  3, 37

                  870.7800
                  Immunotoxicity
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  8

              (h) Test notes. The following test notes apply to the data requirements in the table to paragraph (g) of this section:
              1. Not required if test material is a gas or highly volatile liquid.

              2. The six end-use product (EP) acute toxicity studies are required using the product as formulated for sale and distribution. In addition, if the EP label has directions for diluting the product, then, the applicant may also need to conduct certain of the acute toxicity studies using the highest concentration labeled for dilution (i.e., the least diluted product). The end-use dilution testing is in addition to the testing conducted on the EP.
              3. Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5.
              4. Data are required when the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol or particulates).
              5. Data are required if repeated dermal exposure is likely to occur under conditions of use.
              6. For indirect food uses ≤200 ppb, and all other nonfood uses, data are required if the neurotoxicity screen in the 90-day oral rodent study or other data indicate neurotoxicity.
              7. The 90-day dermal toxicity study and/or 90-day inhalation toxicity study are required if the Agency determines that dermal and/or inhalation exposure is the primary route of exposure.
              8. All 90-day subchronic studies in the rodent can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity and/or immunotoxicity studies by adding separate groups of animals for testing of neurotoxicity and/or immunotoxicity parameters.
              9. The 90-day study is required in the rodent for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would encourage the applicant to conduct a 90-day range finding study for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study.
              10. A 1-year non-rodent study (i.e., 1-year dog study) may be required if the Agency finds that a pesticide chemical is highly bioaccumulative and slowly eliminated. EPA may also require the appropriate metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half life, and steady state to determine if a longer duration dog toxicity study is needed.
              11. Although the subchronic toxicity testing guidelines include measurement of neurological endpoints, such screens do not meet the requirement of the 90-day neurotoxicity study. For nonfood uses, if the 90-day study does not include a neurotoxicity screen, then the acute neurotoxicity study will be required.
              12. Data are required if all of the following criteria are met:
              i. The intended use of the antimicrobial pesticide product is expected to result in repeated dermal human exposure to the product.
              ii. Data from a 90-day dermal toxicity study are not available.
              iii. The 90-day dermal toxicity study has not been triggered.
              13. EP testing is required if the product or any component of the product may increase dermal absorption of the active ingredient(s) or increases its toxic or pharmacologic effects, as determined by testing using the TGAI or based on available information about the toxic effects of the product or its components.
              14. Data are required if the active ingredient in the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is the toxic moiety.
              15. A 90-day oral toxicity test is not required for heating, ventilation, air conditioning, and refrigeration systems (collectively referred to as HVAC&R). Instead, two 90-day toxicity tests, one by the dermal route and one by the inhalation route are required.
              16. Data are required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.

              17. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21- or 28-days, may be sufficient to satisfy this requirement. The prime consideration in determining the appropriateness of a shorter duration study is the likely period of time for which humans will be exposed.

              18. Based on the positive results of the acute or 90-day neurotoxicity studies, or on other data indicating neurotoxicity, a chronic neurotoxicity study (i.e., a chronic study with additional neurotoxicity evaluations) may be required to provide information about potential neurotoxic effects from long-term exposures.

              19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (i.e., a combined study) may be conducted.
              20. For indirect food uses ≤200 ppb, and all other nonfood uses, data are required if either of the following criteria are met:
              i. The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan; or
              ii. The use requires that a tolerance, tolerance exemption, or food additive regulation or clearance be established.
              21. For indirect food uses ≤200 ppb, and all other nonfood uses, data are required if any of the following criteria, are met:
              i. The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of frequency, time, duration, and/or magnitude of exposure.
              ii. The use requires that a tolerance, tolerance exemption, or food additive regulation or clearance be established.
              iii. The active ingredient, metabolite, degradate, or impurity:
              A. Is structurally related to a recognized carcinogen;
              B. Causes mutagenic effects as demonstrated by in vitro or in vivo testing; or
              C. Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change.
              22. If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same species may be required.
              23. Testing in two species is required for all uses.
              24. The oral route, by oral intubation, is preferred, unless the chemical or physical properties of the test substance, or the pattern of human exposure, suggest a more appropriate route of exposure.
              25. Additional testing by other routes of exposure may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.
              26. The developmental toxicity study in rodents may be combined with the two-generation reproduction study in rodents by using a second mating of the parental animals in either generation. Protocols must be approved by the Agency prior to the initiation of the study.
              27. A two-generation reproduction study is required.
              28. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal. Applicants must submit any alternative proposed testing protocols and supporting scientific rationale to the Agency. Protocols must be approved by the Agency prior to the initiation of the study.
              29. The use of a combined two-generation reproduction/developmental neurotoxicity study that utilizes the two-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
              30. A DNT study is required using a weight-of-evidence approach when:

              i. The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of neurotoxicity, neuropathology, functional or behavioral effects).

              ii. The pesticide causes treatment-related neurological effects in developing animals, following pre- or post-natal exposure (i.e., nervous system malformations or neuropathy, brain weight changes in offspring, functional or behavioral changes in the offspring).
              iii. The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.

              iv. The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (i.e., structure-activity-relationship (SAR) to known neurotoxicants, altered neuroreceptor or neurotransmitter responses).
              31. To facilitate the weight-of-evidence determination for the pesticide's mutagenicity, in addition to those specifically listed in this table, the Agency requires submission of other mutagenicity test results that may have been performed. A reference list of all studies and papers known to the applicant concerning the mutagenicity of the test chemical must be submitted with the required studies.
              32. Due to the nature of antimicrobials, if testing with bacterial strains has not been conducted, then testing using a mammalian cell assay such as the mouse lymphoma TK ±assay is preferred. If reverse mutation assay testing with bacterial strains has already been conducted, and the testing was conducted at levels that did not cause toxicity to the bacterial strains tested, then the applicant may submit the study to fulfill this data requirement.
              33. For the in vitro mammalian gene mutation study, there is a choice of assays using either mouse lymphoma L5178Y cell thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression and detection; Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (v79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vitro test for clastogenicity; or CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
              34. There is a choice of assays, but the micronucleus rodent bone marrow assay is preferred; the rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
              35. Data are required when chronic toxicity or carcinogenicity studies are also required.
              36. Data is required if the product label directs that it be applied to domestic animals, such as cats, dogs, cattle, pigs, and horses.
              37. In the absence of dermal absorption data or a repeated dose dermal toxicity study, the assumption of 100 percent dermal absorption would be used in a risk assessment to determine if a dermal penetration study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.
              38. Required for nonfood uses, if oral exposure could occur.
              39. Data may be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism and pharmacokinetics studies.
              [78 FR 26978, May 8, 2013, as amended at 84 FR 18996, May 3, 2019]

              § 158.2240
              Nontarget organisms.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the terrestrial and aquatic nontarget organisms data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section.
              (1) Terrestrial and aquatic nontarget organism data are required to support the registration of most end-use and manufacturing-use antimicrobial products.
              (2) Data are generally not required to support end-use products of a gas, highly volatile liquid, highly reactive solid, or a highly corrosive material.
              (3) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation/degradation products or leachate residues meet one of the following criteria:

              (i) More toxic, persistent, or bioaccumulative than the parent;

              (ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or
              (iii) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.
              (4) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.630 apply.
              (5) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:
              (i) Agricultural premises and equipment.
              (ii) Food-handling/storage establishments, premises, and equipment.
              (iii) Commercial, institutional and industrial premises and equipment.
              (iv) Residential and public access premises.
              (v) Medical premises and equipment.
              (vi) Human drinking water systems.
              (vii) Materials preservatives.
              (viii) Swimming pools.
              (b) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAIRA = Pure active ingredient radiolabeled; a.i. = active ingredient.
              (c) Antimicrobial nontarget organism data requirements table. The following table shows the data requirements for nontarget organisms. The test notes appear in paragraph (d) of this section.

                Table—Antimicrobial Nontarget Organism Data Requirements

                  Guideline No.
                  Datarequirement

                  Use pattern
                  Industrialprocesses and water systems

                  Antifoulant coatings and paints
                  Woodpreservatives

                  Aquatic areas
                  All other use patternscategory

                  Test substance
                  MP
                  EP
                  Test note No.

                    Tier One Testing

                  850.2100
                  Acute avian oral toxicity
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  1

                  850.1010
                  Acute freshwater invertebrates toxicity
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  2

                  850.1075
                  Acute freshwater fish toxicity
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  3

                    Higher Tier Testing

                  Avian Testing

                  850.2200
                  Avian dietary toxicity
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  4

                  850.2300
                  Avian reproduction
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  1, 6

                    Aquatic Organisms Testing

                  850.1010
                  Acute freshwater invertebrates toxicity
                  CR
                  CR
                  CR
                  CR
                  CR

                  TEP
                  2, 5, 7

                  850.1075
                  Acute freshwater fish toxicity
                  CR
                  CR
                  CR
                  CR
                  CR

                  TEP
                  3, 5, 7

                  850.1025
                  Acute estuarine and marine organisms toxicity
                  CR
                  R
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  8, 9

                  850.1035

                  850.1045

                  850.1055
                  Acute estuarine and marine organisms toxicity
                  CR
                  CR
                  CR
                  CR
                  CR

                  TEP
                  5, 7, 8

                  850.1075

                  850.1400
                  Fish early-life stage
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  10

                  850.1300
                  Aquatic invertebrate life-cycle
                  R
                  R
                  R
                  R
                  R
                  TGAI
                  TGAI
                  10

                  850.1350

                  850.1500
                  Fish life-cycle
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  11, 12

                  850.1710
                  Aquatic organisms, bioavailability, biomagnification, toxicity tests
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI, PAI, degradate
                  TGAI, PAI, degradate
                  13

                  850.1730

                  850.1850

                  850.1950
                  Simulated or actual field testing for aquatic organisms
                  CR
                  CR
                  CR
                  CR
                  CR
                  TEP
                  TEP
                  14, 15, 16

                    Sediment Testing

                  850.1735
                  Whole sediment; acute freshwater invertebrates
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  15, 17

                  850.1740
                  Whole sediment; acute marine invertebrates
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  15, 17, 19

                  None
                  Whole sediment; chronic invertebrates fresh-water and marine
                  CR
                  CR
                  CR
                  CR
                  CR
                  TGAI
                  TGAI
                  15, 18, 19

                    Insect Pollinator Testing

                  850.3020
                  Honeybee acute contact
                  NR
                  NR
                  R
                  NR
                  CR
                  TGAI
                  TGAI
                  20

                  850.3030
                  Toxicity of residues to honeybees
                  NR
                  NR
                  R
                  NR
                  CR
                  TGAI
                  TEP or treated wood
                  20, 21

              (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section:
              1. For industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic areas, data are required for two avian species: one waterfowl species and one upland game bird species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required for one avian species.
              2. Data are required on one freshwater aquatic invertebrate species.

              3. For the industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic use pattern areas, data are required on two species of fish, one cold water species and one warm water species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required on one species of fish, either one cold water species or one warm water species. Testing on a second species is required if the active ingredient or principal transformation products are stable in the environment and the LC50 in the first species is less than or equal to 1 ppm or 1 mg/L.

              4. Data are required on one avian species, either one waterfowl species or one upland game bird species, if the avian acute oral LD50 (TGAI testing) is less than or equal to 100 mg/a.i./kg and a.i. residues or its principal transformation products are likely to occur in avian feed items. Data on the second species are required if the avian dietary LC50 in the first species tested is less than or equal to 500 ppm a.i. in the diet.
              5. If TEP testing cannot be conducted due to the physical characteristics of the test substance (for example, a paint), then the applicant should request a waiver.
              6. Data are required if one or more of the following criteria are met:
              i. Birds may be subjected to repeated or continued exposure to the pesticide or any of its transformation products, especially preceding or during the breeding season.
              ii. The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that a potentially toxic amount may persist in avian feed.

              iii. The pesticide or any of its major metabolites or degradation products are stored or accumulated in plant or animal tissues, as indicated by the octanol/water partition coefficient (Kow is greater than or equal to 1,000), accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
              iv. Any other information, such as that derived from mammalian reproduction studies, indicates that reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the pesticide product.
              7. TEP testing is required for any product which meets one or more of the following conditions:

              i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in the aquatic environment is equal to or greater than one-half the LC50/EC50 of the TGAI.

              ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration exceeds the acute concentration of concern (i.e., one-half the LC50/EC50).
              iii. If an ingredient in the end-use product other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
              iv. The end-use antimicrobial product will be applied directly into an aquatic environment.
              8. Data are required on one estuarine/marine mollusk, one other estuarine/marine invertebrate, and one estuarine/marine fish species.
              9. For the all other use patterns category (as specified in § 158.2240(a)(5)), industrial processes and water systems, wood preservatives, and aquatic areas, data are required if the pesticide residues from the parent compound and/or transformation products are likely to enter the estuarine/marine environment.

              10. Testing must be conducted with the most sensitive organism (either freshwater or estuarine/marine vertebrates, or freshwater or estuarine/marine invertebrates), as determined from the results of the acute toxicity tests (acute EC50 freshwater invertebrates; acute LC50/EC50 estuarine and marine organisms; acute freshwater fish LC50).
              11. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
              12. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when one or more of the following conditions apply:
              i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in water is equal to or greater than 0.1 of the no-observed-adverse-effect concentration or no-observed-adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or invertebrate life cycle tests.

              ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration based on probabilistic modeling exceeds for 20 days or more the chronic concentration of concern (i.e., one-tenth the NOAEC or NOAEL) determined in the fish early-life stage or invertebrate life cycle tests.
              iii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
              13. Not required when:
              i. The octanol/water partition coefficients of the pesticide and its major degradates are less than 1,000;
              ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
              iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
              14. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
              15. Protocols must be approved by the Agency prior to the initiation of the study.
              16. Data are required if the intended use pattern, and the physical/chemical properties and environmental fate characteristics of the antimicrobial indicate significant potential exposure, and, based on the results of the acute and chronic aquatic organism testing, significant impairment of nontarget aquatic organisms could result.
              17. Data are required if the half-life of the pesticide in the sediment is equal to or less than 10 days in either the aerobic soil or aquatic metabolism studies, and if one or more of the following conditions are met:
              i. The soil partition coefficient (Kd) is equal to or greater than 50 L/kg.
              ii. The log Kow is equal to or greater than 3.
              iii. The Koc is equal to or greater than 1,000.

              18. Data are required if the EEC in sediment is greater than 0.1 of the acute LC50/EC50 values and if one or more of the following conditions are met:
              i. The soil partition coefficient (Kd) is equal to or greater than 50 L/kg.
              ii. The log Kow is equal to or greater than 3.
              iii. The Koc is equal to or greater than 1,000.
              19. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in significant concentrations either by runoff or erosion, because of its expected use or mobility pattern.
              20. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required only for beehive applications when the beehive (empty or occupied) may be treated.
              21. A study similar to “Honey Bee Toxicity of Residues on Foliage” is required using treated wood instead of the foliage. Protocols must be approved by the Agency prior to the initiation of the study.

              § 158.2250
              Nontarget plant protection.

              (a) Subpart B of this part and § 158.2201 describe how to use the table in paragraph (f) of this section to determine the nontarget plant protection data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (g) of this section.
              (b) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation products or leachate residues meet one of the following criteria:
              (1) More toxic, persistent, or bioaccumulative than the parent;
              (2) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or
              (3) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.
              (c) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:
              (1) Agricultural premises and equipment.
              (2) Food-handling/storage establishments, premises, and equipment.
              (3) Commercial, institutional and industrial premises and equipment.
              (4) Residential and public access premises.
              (5) Medical premises and equipment.
              (6) Human drinking water systems.
              (7) Materials preservatives.
              (8) Swimming pools.
              (d) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.660 apply.
              (e) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
              (f) Nontarget plant protection data requirements table. The following table shows the data requirements for nontarget plant protection. The test notes appear in paragraph (g) of this section.

                Table—Nontarget Plant Protection Data Requirements

                  Guideline No.
                  Datarequirement

                  Use pattern
                  Industrial processes and water systems
                  Antifoulant coatings and paints
                  Wood preservatives
                  Aquatic areas
                  All other use patternscategory

                  Test substance
                  MP
                  EP
                  Test note No.

                  850.4225
                  Seedling emergence, Tier II—dose response
                  CR
                  CR
                  CR
                  CR
                  CR
                  TEP
                  TEP
                  1, 2

                  850.4250
                  Vegetative vigor, Tier II—dose response
                  CR
                  NR
                  CR
                  CR
                  CR
                  TEP
                  TEP
                  1, 3

                  850.4400
                  Aquatic plant growth (aquatic vascular plant) Tier II—dose response
                  R
                  R
                  R
                  R
                  CR
                  TGAI, TEP
                  TGAI, TEP
                  4, 10

                  850.5400
                  Aquatic plant growth (algal) Tier II (dose response)
                  R
                  R
                  R
                  R
                  R
                  TGAI, TEP
                  TGAI, TEP
                  4, 5, 6

                  850.4300
                  Terrestrial field
                  CR
                  CR
                  CR
                  CR
                  CR
                  TEP
                  TEP
                  7, 8, 9

                  850.4450
                  Aquatic field
                  CR
                  CR
                  CR
                  CR
                  CR
                  TEP
                  TEP
                  7, 8, 9

              (g) Test notes. The following test notes apply to the data requirements in the table to paragraph (f) of this section:
              1. Data on only one plant species (rice, Oryza sativa) are required.
              2. Data are required if the risk quotient from any aquatic plant growth Tier II study exceeds a level of concern for aquatic plants.
              3. Not required when:
              i. There are no potential exposures to plants;
              ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9; or

              iii. The results of a biodegradation study indicate that the active ingredient or principal degradation products are not biodegradable in 28 days, i.e., the biodegradation curve has not reached a plateau for at least three determinations within the 28 days.
              4. For TEP testing, data are required for the applicant's end-use product if an ingredient in the end-use product, other than the active ingredient, is expected to enhance the toxicity of the active ingredient.
              5. One Tier II (dose response) study, conducted with Selenastrum capricornutum, is required for the all other use patterns category (as specified in § 158.2250(c)). If the results of this study exhibit detrimental effects (EC50 less than 1.0 ppm or mg/L), then additional Tier II (dose response) studies are required on three species (Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema costatum).

              6. For industrial processes and water systems, antifoulant coatings and paints, wood preservatives, and aquatic areas, Tier II (dose response) studies are required on four species (Anabaena flos-aquae, Navicula pelliculosa, Skeletonema costatum, and Selenastrum capricornutum).
              7. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
              8. Tests are required on a case-by-case basis based on the results of lower tier plant protection studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
              9. Protocols must be approved by the Agency prior to the initiation of the study.
              10. For the all other use patterns category (as specified in § 158.2250(c)), data are required if the aquatic (algal) plant growth Tier II study demonstrates detrimental effects at less than 1.0 ppm or mg/L.

              § 158.2260
              Applicator exposure.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (d) of this section to determine the applicator exposure data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (e) of this section.
              (1) The Agency may accept surrogate exposure data estimations and/or modeling estimations from other sources to satisfy exposure data requirements. The surrogate data must meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. To be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address the applicable exposure data requirements and contain adequate monitoring events of acceptable quality. The data must reflect the specific use prescribed on the label and the activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information.

              (2) Occupational uses include not only handlers, mixers, loaders, and applicators, but also commercial applications to residential sites. Residential uses are limited to non-occupational, i.e., non-professional, antimicrobial applications. Both occupational and residential applicator data may be required for the same product.
              (b) Criteria for testing. Applicator exposure data described in the table to paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if at least one of the toxicity criteria in paragraph (b)(1) of this section, and at least one of the exposure criteria in paragraph (b)(2) of this section are met.

              (1) Toxicity criteria. (i) Evidence of potentially significant adverse effects have been observed in any applicable toxicity studies.
              (ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have resulted from exposure to the pesticide.
              (2) Exposure criteria. (i) Dermal exposure may occur during product use.
              (ii) Respiratory exposure may occur during product use.
              (c) Key. R = Required; CR = Conditionally required; TEP = Typical end-use product.
              (d) Antimicrobial applicator exposure data requirements table. The following table shows the data requirements for applicator exposure. The test notes appear in paragraph (e) of this section.

                Table—Antimicrobial Applicator Exposure Data Requirements

                  Guideline No.
                  Data requirements
                  Use sites
                  Occupational
                  Residential
                  Testsubstance

                  Test note No.

                  875.1100
                  Dermal exposure
                  R
                  R
                  TEP
                  1, 2, 3, 4

                  875.1200

                  875.1300
                  Inhalation exposure
                  R
                  R
                  TEP
                  1, 2, 3, 4

                  875.1400

                  875.1500
                  Biological monitoring
                  CR
                  CR
                  TEP
                  1, 2, 3

                  875.1600
                  Data reporting and calculations
                  R
                  R
                  TEP
                  5

                  875.1700
                  Product use information
                  R
                  R
                  TEP

              (e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section:

              1. Prior to initiation of the study, protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the Human Studies Review Board (http://www.epa.gov/osa/hsrb/index.htm).

              2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation passive dosimetry exposure data, provided the human pharmacokinetics of the pesticide or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to the total internal dose.
              3. For products with both indoor and outdoor uses, and similar conditions of use, data are generally required for the indoor applications only. However, data for outdoor uses are required if the Agency expects outdoor uses to result in greater exposure than indoor uses (e.g., higher use rates and application frequency, or longer exposure duration, or application methods/equipment create potential for increased dermal or inhalation exposure in outdoor versus indoor use sites). In certain cases, when a pesticide may be used both indoors and outdoors under dissimilar conditions of use, the Agency may require submission of applicator exposure data for both use patterns.
              4. EPA will consider waiving this data requirement for antimicrobials applied via closed loading systems if the antimicrobial has a low vapor pressure.
              5. Data reporting and calculations are required only if handler exposure data are required.

              § 158.2270
              Post-application exposure.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (d) of this section to determine the post-application exposure data requirements for antimicrobial pesticide products. The data generated during these studies are used to determine the quantity of pesticide to which people may be exposed after application. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test, are listed in paragraph (e) of this section.

              (1) Post-application exposure data are required when certain toxicity criteria are met and the human activities associated with the pesticide's use pattern can lead to potential adverse exposures.
              (2) The Agency may accept surrogate exposure data estimations and/or modeling estimations from other sources to satisfy exposure data requirements. The surrogate data must meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. To be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address the applicable exposure data requirements and contain adequate monitoring events of acceptable quality. The data must reflect the specific use prescribed on the label and the activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information.
              (b) Criteria for testing. Post-application exposure data described in the table to paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if at least one of the toxicity criteria in paragraph (b)(1) of this section, and at least one of the exposure criteria in paragraph (b)(2) of this section are met.
              (1) Toxicity criteria. (i) Evidence of potentially significant adverse effects have been observed in any applicable toxicity studies.
              (ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have resulted from exposure to the pesticide.
              (2) Exposure criteria—(i) Outdoor uses. (A) Occupational human post-application or bystander exposure to residues of antimicrobial pesticides could occur as the result of, but is not limited to, worker reentry into treatment sites, clean-up and equipment maintenance tasks, handling wood preservative-treated wood, or other work-related activity.
              (B) Residential human post-application or bystander exposure to residues of antimicrobial pesticides could occur following the application of antimicrobial pesticides to outdoor areas and spaces at residential sites, such as, but not limited to homes, daycare centers, and other public buildings.
              (ii) Indoor uses. (A) Occupational human post-application or bystander exposure to pesticide residues could occur following the application of the antimicrobial pesticide to indoor spaces or surfaces.
              (B) Residential human post-application or bystander exposure to pesticide residues could occur following the application of the antimicrobial pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.
              (c) Key. R = Required; CR = Conditionally required; NR = Not required; TEP = Typical end-use product.
              (d) Antimicrobial post-application exposure data requirements table. The following table shows the data requirements for post-application exposure. The test notes appear in paragraph (e) of this section.

                Table—Antimicrobial Post-Application Exposure Data Requirements

                  Guideline No.
                  Data requirement
                  Use sites
                  Occupational
                  Residential
                  Testsubstance

                  Test note No.

                  875.2200
                  Soil residue dissipation
                  CR
                  CR
                  TEP
                  2, 3

                  875.2300
                  Indoor surface residue dissipation
                  CR
                  R
                  TEP
                  3, 4, 5, 6

                  875.2400
                  Dermal exposure
                  CR
                  CR
                  TEP
                  1, 7, 8

                  875.2500
                  Inhalation exposure
                  CR
                  CR
                  TEP
                  1,7, 8, 9

                  875.2600
                  Biological monitoring
                  CR
                  CR
                  TEP
                  1, 8

                  875.2700
                  Product use information
                  R
                  R
                  TEP

                  875.2800
                  Description of human activity
                  R
                  R
                  TEP

                  875.2900
                  Data reporting and calculations
                  R
                  R
                  TEP
                  10

              (e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section:

              1. Prior to initiation of the study, protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the Human Studies Review Board (HSRB) (http://www.epa.gov/osa/hsrb/index.htm).

              2. For residential wood preservative uses, data may be required if soil has the potential to be an important exposure pathway, and soil is in contact with or adjacent to treated wood, including but not limited to decks, play sets, and gazebos,
              3. Protocols must be approved by the Agency prior to the initiation of the study.
              4. For wood preservatives, data are required for treated wood surfaces where post-application contact with treated wood is anticipated.
              5. For occupational uses, data are required if the pesticide may be applied to or around surfaces, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated surfaces while participating in typical activities.
              6. Data are required for residential use sites, schools, and daycare institutions. This includes but is not limited to the following: Residential and public access premises; material preservatives (including those used in residential products, including but not limited to clothing and plastic toys) and wood preservatives (when contact with treated wood is likely to occur).
              7. Data are required for occupational and residential uses if the human activity data indicate the potential for post-application dermal and/or inhalation exposures while participating in typical activities and no acceptable modeling options are available.

              8. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation passive dosimetry exposure data provided the human pharmacokinetics of the pesticide or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for a back-calculation to the total internal dose.
              9. Data are required for occupational and residential uses if there is the potential for bystander exposure and the pesticide use could result in respirable and/or inhalable material (e.g., gas, vapor, aerosol, or particulates).
              10. Data reporting and calculations are required only if post-application exposure data are required.

              § 158.2280
              Environmental fate.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the environmental fate data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section.
              (1) Environmental fate data are required to support the registrations of all end-use and manufacturing-use antimicrobial products.
              (2) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation products or leachate residues meet one of the following criteria:
              (i) More toxic, persistent, or bioaccumulative than the parent;
              (ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or
              (iii) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.
              (3) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:
              (i) Agricultural premises and equipment.
              (ii) Food-handling/storage establishments, premises, and equipment.
              (iii) Commercial, institutional and industrial premises and equipment.
              (iv) Residential and public access premises.
              (v) Medical premises and equipment.
              (vi) Human drinking water systems.
              (vii) Materials preservatives.
              (viii) Swimming pools.
              (b) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAIRA = Pure active ingredient radiolabeled; ROC = residue of concern.
              (c) Antimicrobial environmental fate data requirements table. The following table shows the data requirements for environmental fate. The test notes appear in paragraph (d) of this section.

                Table—Antimicrobial Environmental Fate Data Requirements

                  Guideline No.
                  Datarequirement

                  Use pattern
                  Industrialprocesses and
                    water systems

                  Antifoulant coatings and paints
                  Woodpreservatives

                  Aquatic areas
                  All other use patternscategory

                  Test substance
                  MP
                  EP
                  Test note No.

                    Degradation Studies—Laboratory

                  835.2120
                  Hydrolysis
                  R
                  R
                  R
                  R
                  R
                  TGAI or PAIRA
                  TGAI or PAIRA
                  1

                  835.2240
                  Photodegradation in water
                  R
                  R
                  R
                  R
                  R
                  TGAI or PAIRA
                  TGAI or PAIRA
                  2

                  835.2410
                  Photodegradation in soil
                  NR
                  NR
                  R
                  NR
                  NR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  10

                    Toxicity and Fate in Wastewater Systems

                  850.6800
                  Activated Sludge, Respiration Inhibition Test
                  R
                  R
                  R
                  NR
                  R
                  TGAI
                  TGAI
                  21

                  OECD 209

                  835.1110
                  Activated Sludge Sorption Isotherm
                  CR
                  CR
                  CR
                  NR
                  CR
                  TGAI
                  TGAI
                  19, 20

                  835.3110
                  Ready Biodegradability
                  CR
                  CR
                  CR
                  NR
                  CR
                  TGAI
                  TGAI
                  3, 4, 18

                  835.3220
                  Porous Pot Study
                  CR
                  CR
                  CR
                  NR
                  CR
                  TGAI
                  TGAI
                  3, 18

                  835.3280
                  Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater
                  CR
                  CR
                  CR
                  NR
                  CR
                  TGAI
                  TGAI
                  3, 18

                  835.3240
                  Simulation Test—Aerobic Sewage Treatment: A. Activated Sludge Units
                  CR
                  CR
                  CR
                  NR
                  CR
                  TGAI
                  TGAI
                  3, 18

                    Mobility Studies

                  835.1230
                  Leaching and adsorption/de-sorption
                  R
                  R
                  R
                  R
                  CR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  5, 6

                  835.1240

                    Metabolism Studies—Laboratory

                  835.4100
                  Aerobic soil metabolism
                  CR
                  NR
                  R
                  CR
                  CR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  7, 8, 9

                  835.4200
                  Anaerobic soil metabolism
                  NR
                  NR
                  R
                  NR
                  CR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  5, 8

                  835.4300
                  Aerobic aquatic metabolism
                  R
                  R
                  R
                  R
                  CR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  5, 8

                  835.4400
                  Anaerobic aquatic metabolism
                  R
                  R
                  R
                  R
                  CR
                  TGAI or PAIRA
                  TGAI or PAIRA
                  5, 8

                    Dissipation Studies—Field

                  835.6200
                  Aquatic (sediment)
                  CR
                  R
                  CR
                  R
                  CR
                  TEP
                  TEP
                  11, 12, 13

                    Ground and Surface Water Monitoring

                  None
                  Monitoring of representative U.S. waters
                  CR
                  CR
                  CR
                  CR
                  CR
                  ROC
                  ROC
                  11, 14, 17

                    Special Studies

                  None
                  Special leaching
                  NR
                  R
                  R
                  NR
                  NR
                  TGAI
                  TEP
                  15, 16

              (d) Test notes. The following test notes apply to the data requirements in the table in paragraph (c) of this section:
              1. For testing antifoulant paints and coatings, testing is to be performed separately with both sterile buffered distilled water and sterile synthetic seawater at pHs 5, 7, and 9.
              2. Not required if:
              i. The electronic absorption spectra, measured at pHs 5, 7 and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm, inclusive; or
              ii. The results of the hydrolysis study at all three pHs (5, 7, and 9) demonstrates a half-life of less than 30 days.
              3. The results of the activated sludge, respiration inhibition (ASRI) test determine which of the following tests are required: Ready biodegradability, porous pot, the biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater,” or simulation test—aerobic sewage treatment: A. activated sludge units.
              i. If the ASRI test EC50 is equal to or less than 20 mg/L, then the applicant must choose either to:
              A. Conduct the biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater”;
              B. Conduct the porous pot test; or
              C. Conduct the simulation test—aerobic sewage treatment: A. activated sludge units.
              ii. If the ASRI test EC50 is greater than 20 mg/L, then the applicant must choose either to:
              A. Conduct a ready biodegradability study; or
              B. Conduct one of the following studies: The biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater,” the porous pot test, or the simulation test—aerobic sewage treatment: A. activated sludge units.

              4. Pass criteria for the ready biodegradability study are: 70 percent removal of dissolved organic carbon (DOC) and 60 percent removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO2) production for respirometric methods. These pass levels must be reached in a 10-day window within the 28-day period of the test. If the antimicrobial passes the ready biodegradability study, then no further testing is required. If the antimicrobial fails the ready biodegradability study, then the applicant must conduct one of the following studies: The biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater,” the porous pot test, or the simulation test—aerobic sewage treatment: A. activated sludge units.
              5. For the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on a weight-of-evidence evaluation of the results of the hydrolysis, photodegradation in water, activated sludge sorption isotherm, biodegradability, and activated sludge, respiration inhibition tests.
              6. Adsorption and desorption using a batch equilibrium method is preferred. In some cases, as when the antimicrobial pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.
              7. For industrial processes and water systems, aquatic areas, and the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on a weight-of-evidence evaluation of the results of the hydrolysis, photodegradation in water, activated sludge sorption isotherm, biodegradability, and activated sludge, respiration inhibition tests.
              8. The environmental media (soil, water, hydrosoil, and biota) to be utilized in these studies must be collected from areas representative of potential use sites.
              9. For industrial processes and water systems, and aquatic areas, data are required for use sites that are intermittently dry.

              10. Data are not required if the antimicrobial is an inorganic substance or a metal salt; or if the standardized soil profiles demonstrate that the antimicrobial is likely to readily degrade either microbially or via redox reactions (chemically) and no transformation/degradate/leachate products of concern (as described under § 158.2280(a)(2)) are produced.
              11. Analytical methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory.
              12. Protocols must be approved by the Agency prior to the initiation of the study.
              13. For industrial processes and water systems, wood preservatives, and the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on the potential for aquatic exposure and if the weight-of-evidence indicates that the active ingredient or principal transformation products are likely to have the potential for persistence, mobility, nontarget aquatic toxicity, or bioaccumulation.
              14. Data are required if the weight-of-evidence indicates that the active ingredient or principal transformation products are likely to occur in nontarget freshwater, estuarine, or marine waters such that human or environmental exposures are likely to occur. In making that determination, the Agency takes into account other factors such as the toxicity of the chemical(s), available monitoring data and the vulnerability of the freshwater, estuarine, or marine water resources in the antimicrobial use area.
              15. For wood preservatives, an aquatic leaching study is required. A soil leaching study is required if human or environmental exposures are likely to occur from leachates that contain the active ingredient or principal transformation products from wood treated with a preservative product. Protocols must be approved by the Agency prior to the initiation of the study.
              16. For antifoulant paints and coatings, a leaching study is required. Protocols must be approved by the Agency prior to the initiation of the study.
              17. Protocols, which include the residues of concern (such as parent, degradate/transformation product, and/or leachate residues) that would be monitored, must be approved by the Agency prior to the initiation of the study.
              18. A biodegradation study is not required if the antimicrobial meets one or more of the following criteria:
              i. Classified as a metal,
              ii. Relatively volatile, but not hydrophobic,
              iii. Highly reactive,
              iv. Both the parent and all transformation/degradate products (as described under § 158.2280(a)(2)) have half-lives of less than 3 hours,
              v. None of the registered or proposed product uses would result in transport of the parent and its transformation/degradate products (as described under § 158.2280(a)(2)) to a wastewater treatment plant.
              19. The activated sludge sorption isotherm test is not required if the antimicrobial is:
              i. Relatively volatile, but not hydrophobic;
              ii. Highly reactive; or
              iii. The log Kow is less than 3.0.
              20. If the criteria of test note 19 of this paragraph are not met, then the activated sludge sorption isotherm test is required if one or more of the following criteria are also met:
              i. The antimicrobial is a metal,
              ii. The log Kow is greater than or equal to 3.0,
              iii. The antimicrobial is positively charged or polycationic,
              iv. The EC50 in the activated sludge, respiration inhibition test is less than or equal to 20 mg/L,
              v. The EC50 in the activated sludge, respiration inhibition test is greater than 20 mg/L, and the antimicrobial fails the ready biodegradability study.
              21. The activated sludge respiration inhibition study is not required if none of the registered or proposed product uses would result in transport of the parent and its transformation/degradate products (as described under § 158.2280(a)(2)) to a wastewater treatment plant.

              § 158.2290
              Residue chemistry.
              (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (h) of this section to determine the residue chemistry data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (i) of this section.
              (b) Residue chemistry data are required for:
              (1) Antimicrobial end-use products with uses that may result in residues in or on food, including but not limited to:
              (i) Products that require a tolerance, tolerance exemption, or food additive regulation or clearance.
              (ii) Products that may be used to treat livestock or poultry drinking water, for food egg washing, or for fruit and vegetable rinses.
              (iii) Products that may be applied to a surface or incorporated into a material that may contact food or feed. Data are required regardless of whether the antimicrobial is applied or impregnated for the purpose of imparting antimicrobial protection to external surfaces of the substance or article, or for the purpose of protecting the substance or article itself.
              (iv) Products that may be applied to water that have the potential to result in residues in potable water, or in water used for livestock and poultry drinking water, irrigation of crops, or water containing fish that may be used for human food.
              (v) Wood preservative or antifoulant products intended for treating submerged materials that may result in food contact (e.g., lobster pots, fish cages on fish farms).
              (2) Each manufacturing-use product bearing directions for formulation into an end-use product bearing uses described in paragraph (b)(1) of this section.
              (c) Residue chemistry data are not required under paragraph (b) of this section if no adverse effects (no toxicity endpoints) are associated with dietary exposure to the active ingredient or if theoretical (high-end) dietary exposure estimates combined with the applicable toxicity endpoint result in acute and chronic dietary risks that are below the Agency levels of concern.
              (d) For purposes of this section, Magnitude of the Residue Studies include the following: Food-handling, migration studies, potable water, fish, irrigated crops, meat/milk/poultry/eggs, crop field trails, processed food or feed, and anticipated residues.
              (e) If the antimicrobial chemical may be applied to a field crop, then the residue chemistry data requirements of § 158.1410 apply.

              (f) The following term is defined for the purposes of this section: Residue of concern means the parent pesticidal compound and its metabolites, degradates, and impurities of toxicological concern.
              (g) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAI = Pure active ingredient; PAIRA = Pure active ingredient radiolabeled; ROC = Residue of concern.
              (h) Antimicrobial residue chemistry data requirements table. The following table shows the data requirements for residue chemistry. The test notes appear in paragraph (i) of this section.

                Table—Antimicrobial Residue Chemistry Data Requirements

                  Guideline No.
                  Data requirement
                  Uses
                  Agriculturalpremise

                  Indirect food
                  Direct food
                  Aquatic
                  Testsubstance

                  Test note No.

                    Supporting Information

                  860.1100
                  Chemical identity
                  R
                  R
                  R
                  R
                  TGAI

                  860.1200
                  Directions for use
                  R
                  R
                  R
                  R

                  860.1550
                  Proposed tolerance/tolerance exemption
                  R
                  R
                  R
                  R

                  1

                  860.1560
                  Reasonable grounds in support of petition
                  R
                  R
                  R
                  R

                  1

                  860.1650
                  Submittal of analytical reference standards
                  R
                  R
                  R
                  R
                  PAI/ROC
                  2

                    Food-Contact Surfaces or Impregnated Materials

                  860.1460
                  Food-handling
                  CR
                  CR
                  CR
                  CR
                  TEP
                  3

                  None
                  Nature of residue on surfaces
                  CR
                  CR
                  CR
                  CR
                  PAIRA or TGAI
                  4

                  None
                  Migration studies
                  CR
                  CR
                  CR
                  CR
                  TEP
                  5

                  860.1340
                  Residue analytical method for data collection
                  CR
                  CR
                  CR
                  CR
                  ROC
                  6

                  860.1380
                  Storage stability
                  R
                  R
                  R
                  R
                  TEP or ROC
                  7

                    Higher tiered

                  860.1300
                  Nature of the residue in plants
                  CR
                  CR
                  CR
                  CR
                  PAIRA
                  8

                  860.1300
                  Nature of the residue in livestock
                  CR
                  CR
                  CR
                  CR
                  PAIRA
                  9

                  860.1340
                  Residue analytical methods for tolerance/tolerance exemption enforcement
                  CR
                  CR
                  CR
                  CR
                  ROC
                  10

                  860.1360
                  Multiresidue method testing
                  CR
                  CR
                  CR
                  CR
                  ROC
                  11

                  860.1400
                  Potable water
                  CR
                  CR
                  CR
                  CR
                  TEP
                  12

                  860.1400
                  Fish
                  CR
                  CR
                  CR
                  CR
                  TEP
                  13

                  860.1400
                  Irrigated crops
                  CR
                  CR
                  CR
                  CR
                  TEP
                  14

                  860.1480
                  Meat/milk/poultry/eggs
                  CR
                  CR
                  CR
                  CR
                  TGAI or ROC
                  15

                  860.1500
                  Crop field trials
                  CR
                  CR
                  CR
                  CR
                  TEP
                  16

                  860.1520
                  Processed food or feed
                  CR
                  CR
                  CR
                  CR
                  TEP
                  17

                  None
                  Anticipated residues
                  CR
                  CR
                  CR
                  CR
                  ROC
                  18

              (i) Test notes. The following test notes apply to the data requirements in the table to paragraph (h) of this section:
              1. A petition proposing a numerical tolerance or a tolerance exemption is required for any food or feed use subject to section 408 of FFDCA if the use is not covered by an existing tolerance or tolerance exemption. If the use is subject to FFDCA section 409, the applicant must identify to EPA an applicable section 409 food additive regulation or clearance, or submit a copy of a petition to FDA requesting a section 409 food additive regulation or clearance for the food or feed use.
              2. An analytical reference standard is required for any food or feed use requiring a numeric tolerance or exemption. Material safety data sheets as specified by the Occupational Safety and Health Administration in 29 CFR 1910.1200 must accompany analytical standards.
              3. Data are required if a pesticide may be used in a food-handling establishment unless data including, but not limited to, theoretical (high-end) estimates, radiolabeled laboratory data, or the nature of the residue on surfaces study show that residues will not occur in food or feed.
              4. If an antimicrobial pesticide may be applied to a food-contact surface or impregnated into a food-contact material and if theoretical (high-end) estimates of exposure exceed EPA's risk level of concern, then the nature of the residue on surfaces study is required. Protocols must be approved by the Agency prior to the initiation of the study.
              5. Based on the results of the nature of the residue on surfaces study, if residues of concern are identified, then the migration study will be required. Protocols must be approved by the Agency prior to the initiation of the study.
              6. If a magnitude of the residue study, as specified in § 158.2290(d), is required, then a residue analytical method suitable for collecting data is also required. The method must be capable of determining all residues of concern, to permit calculation of dietary risk or to establish a tolerance or tolerance exemption.
              7. If a magnitude of the residue study, as specified in § 158.2290(d), is required, then storage stability data are also required, unless analytical samples are stored for 30 days or less. If, during hazard characterization, a residue has been identified as “of concern” and is known to be volatile or labile, then storage stability data are required regardless of sample storage time.
              8. If crop plants or metabolically active raw agricultural commodities of food crops may be directly or indirectly exposed to an antimicrobial, plant metabolism studies are required to determine the transformation products that may enter the human diet. Such exposure could include, but is not limited to:
              i. Treatment of storage or shipping containers,
              ii. Postharvest fruit and vegetable treatment prior to shipping or storage,
              iii. Use of antimicrobial-treated water for irrigation, and
              iv. Any direct food contact use.
              9. If livestock may be exposed to an antimicrobial, then hen and ruminant metabolism studies are required to determine the identities of residues of concern that may enter the human diet from consumption of livestock commodities. Livestock may be exposed via the oral, dermal, or inhalation route following treatment or contamination of sites including, but not limited to, livestock premises, feed, and drinking water. Shell eggs and other metabolically active livestock products may also be treated. If livestock may be exposed to one or more residues of concern differing from those found in animals, then one or more additional livestock metabolism studies involving dosing with these residues may be required.
              10. If there is a numerical tolerance or tolerance exemption level to enforce, then a residue analytical method suitable for enforcement purposes is required. The method must be supported by an independent laboratory validation.

              11. If there is a numerical tolerance or tolerance exemption level to enforce, then testing is required to determine whether the Food and Drug Administration/United States Department of Agriculture multiresidue methodology would detect and identify the antimicrobial and its residues of concern, as part of programs to monitor pesticides in the U.S. food supply.
              12. Data are required if an antimicrobial may be applied directly to water or if there is the potential that the antimicrobial-treated water could be used directly for drinking water purposes by humans or animals or that contaminated water could run-off, leach, or be discharged from treated sites or materials and make its way into potable water.
              13. Data are required if an antimicrobial may be applied directly to water inhabited by fish or that will be inhabited by fish or if contaminated water could run-off, leach, or be discharged from treated sites or materials and make its way into bodies of water containing fish that may be used for human consumption.
              14. Data are required if an antimicrobial may be applied directly to water used for irrigation of food crops or such that contaminated water could run-off, leach, or be discharged from treated sites or materials to make its way into water used for irrigation of food crops.
              15. If the antimicrobial may be applied directly to livestock, metabolically-active livestock commodities (e.g., eggs), livestock feed or drinking water, or livestock premises, or a livestock metabolism study indicates that residues of the antimicrobial may result in livestock commodities, studies are required to determine the magnitude of the residues of concern in fat, meat, meat by-products, milk, poultry, and eggs that may be consumed by humans. These studies, however, may not be required in cases where the livestock metabolism studies indicate that transfer of pesticide residues of concern to tissues, milk, and eggs is not expected to occur at the maximum expected exposure level for the animals.
              16. If food crops or raw agricultural commodities of food crops may be exposed to an antimicrobial, then residue studies are required to determine the magnitude of the residues of concern that may enter the human diet. Such exposures include, but are not limited to, postharvest fruit and vegetable treatments and application of antimicrobial chemicals to field crops, mushroom houses, empty or occupied beehives, or wood used to construct beehives.
              17. Data on the nature and magnitude of residues in processed food or feed are required if antimicrobial residues could potentially concentrate on processing. If so, the establishment of a separate tolerance higher than that in the raw agricultural commodity may be required.
              18. Data are required when dietary exposure values at the tolerance level or screening-level (high-end) result in estimates of dietary or aggregate risk that meet or exceed the Agency's level of concern. These data may include, but are not limited to, washing, cooking, processing, or degradation studies as well as market basket surveys for a more realistic residue determination. Protocols must be approved by the Agency prior to the initiation of the study.

            Subparts X-Z [Reserved]

              §§ 158.2300-158.2500
              [Reserved]

          Pt. 159
          PART 159—STATEMENTS OF POLICIES AND INTERPRETATIONS

              Subparts A-C [Reserved]

              Subpart D—Reporting Requirements for Risk/Benefit Information
              Sec.
              159.152
              What the law requires of registrants.
              159.153
              Definitions.
              159.155
              When information must be submitted.
              159.156
              How information must be submitted.
              159.158
              What information must be submitted.
              159.159
              Information obtained before promulgation of the rule.
              159.160
              Obligations of former registrants.
              159.165
              Toxicological and ecological studies.
              159.167
              Discontinued studies.
              159.170
              Human epidemiological and exposure studies.
              159.178
              Information on pesticides in or on food, feed, or water.
              159.179
              Metabolites, degradates, contaminants, and impurities.
              159.184
              Toxic or adverse effect incident reports.
              159.188
              Failure of performance information.
              159.195
              Reporting of other information.

            Authority:
            7 U.S.C. 136-136y.

            Source:
            63 FR 49388, Sept. 19, 1997, unless otherwise noted.

            Subparts A-C [Reserved]

            Subpart D—Reporting Requirements for Risk/Benefit Information

              § 159.152
              What the law requires of registrants.
              (a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) states: “If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator.”
              (b) Section 152.50(f)(3) of this chapter requires applicants to submit, as part of an application for registration, any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on humans or the environment, which would be required to be reported under section 6(a)(2) if the product were registered.
              (c) Compliance with this part will satisfy a registrant's obligations to submit additional information pursuant to section 6(a)(2) and will satisfy an applicant's obligation to submit additional information pursuant to § 152.50(f)(3) of this chapter.

              § 159.153
              Definitions.
              (a) For the purposes of reporting information pursuant to FIFRA section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 CFR part 152 apply to this part unless superseded by a definition in paragraph (b) of this section.
              (b) For purposes of reporting information pursuant to FIFRA section 6(a)(2), the following definitions apply only to this subpart:

                Established level means a tolerance, temporary tolerance, food additive regulation, action level, or other limitation on pesticide residues imposed by law, regulation, or other authority.

                Formal Review means Special Review, Rebuttable Presumption Against Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA section 6(b) cancellation proceeding, whether completed or not.

                Hospitalization means admission for treatment to a hospital, clinic or other health care facility. Treatment as an out-patient is not considered to be hospitalization.

                Maximum contaminant level (MCL) means the maximum permissible level, established by EPA, for a contaminant in water which is delivered to any user of a public water system.

                Non-target organism means any organism for which pesticidal control was either not intended or not legally permitted by application of a pesticide.

                Pesticide means a pesticide product which is or was registered by EPA, and each active ingredient, inert ingredient, impurity, metabolite, contaminant or degradate contained in, or derived from, such pesticide product.

                Qualified expert means one who, by virtue of his or her knowledge, skill, experience, training, or education, could be qualified by a court as an expert to testify on issues related to the subject matter on which he or she renders a conclusion or opinion. Under Rule 702 of the Federal Rules of Evidence, a person may be qualified as an expert on a particular matter by virtue of “knowledge, skill, experience, training, or education.” In general, EPA wants registrants to report information when a person has relevant expert credentials, e.g., a medical doctor giving a medical opinion, a plant pathologist giving an opinion on plant pathology, etc.

                Registrant includes any person who holds, or ever held, a registration for a pesticide product issued under FIFRA section 3 or 24(c).

                Similar species means two or more species belonging to the same general taxonomic groups: The general taxonomic groups for purposes of this requirement are: mammals, birds, reptiles, amphibians, fish, aquatic invertebrates, insects, arachnids, aquatic plants (including macrophyte, floating, and submerged plants), and terrestrial (all non-aquatic) plants.

                Water reference level means the level specified in paragraph (1) or (2) of this definition, whichever is lower.

              (1) Ten percent of the maximum contaminant level (MCL) established by EPA, or if no MCL has been established by EPA, 10 percent of the most recent draft or final long-term health advisory level (HAL) established by EPA, or if EPA has not published or proposed an MCL or HAL, the lowest detectable amount of the pesticide.
              (2) The ambient water quality criteria for the protection of aquatic life, established by EPA pursuant to section 304(a) of the Clean Water Act.
              [62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998; 73 FR 75596, Dec. 12, 2008]

              § 159.155
              When information must be submitted.
              (a) The following reportable information must be received by EPA not later than the 30th calendar day after the registrant first possesses or knows of the information:
              (1) Scientific studies described in § 159.165.
              (2) Information about discontinued studies described in § 159.167.
              (3) Human epidemiological and exposure studies described in § 159.170.
              (4) Detection of a pesticide in or on food or feed described in § 159.178(a).
              (5) Detection of metabolites, degradates, contaminates, impurities described in § 159.179.
              (6) Failure of performance studies described in § 159.188(a)(2), (b)(2), and (c).
              (7) Other information described in § 159.195.
              (b) Reportable information concerning detections of pesticides in water described in § 159.178(b), adverse effects incidents described in § 159.184(a), and efficacy failure incidents described in § 159.188(a)(1) and (b)(1) must be reported according to the time frames set forth in § 159.184(d).
              (c) EPA may, in its discretion, notify a registrant in writing of a different reporting period that will apply to specific types of reportable information or eliminate reporting requirements entirely. Such notification supersedes otherwise applicable reporting requirements set forth in this part.
              (d) For purposes of this part, a registrant possesses or knows of information at the time any officer, employee, agent, or other person acting for the registrant first comes into possession of, or knows of, such information; provided that, such person performs any activities for the registrant related to the development, testing, sale or registration of a pesticide or the person could be reasonably expected to come into possession of information otherwise reportable under this part. In the case of information known to or possessed by an agent or other person acting for the registrant, a registrant is responsible for such information only if the agent or other person acquired such information while acting for the registrant.
              [63 FR 33582, June 19, 1998]

              § 159.156
              How information must be submitted.
              A submission under FIFRA section 6(a)(2) must be delivered to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              (a) Include a cover letter which contains the information requested in paragraphs (d) and (e) of this section, and a prominent statement that the information is being submitted in accordance with FIFRA section 6(a)(2).
              (b) Contain the name of the submitter, registrant name and registration number, date of transmittal to EPA, the type of study or incident being reported under §§ 159.165 through 159.195, and a statement of why the information is considered reportable under this part.
              (c) Identify the substance tested or otherwise covered by the information (including, if known, the EPA registration number(s) to which the information pertains, and if known, the CAS Registry Number).
              (d) In reporting incidents, provide the data listed in § 159.184, to the extent such information is available.
              (e) In submitting scientific studies, follow the procedures set forth in § 158.32 or § 161.32 of this chapter, as applicable.

              (f) If the information is part of a larger package being submitted in order to comply with another provision of FIFRA (e.g., sections 3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual studies being submitted under this part.

              (g) If a claim of confidentiality is made under FIFRA section 10 for information relating to any part of a study or incident report contained in the submission, follow the procedures set forth in § 158.33 or § 161.33 of this chapter, as applicable regarding the identification and segregation of information claimed to be confidential.
              (h) If a submission includes a study subject to the flagging requirements of § 158.34 or § 161.34 of this chapter, as applicable, comply with the requirements of that section, and, if the flagging statement is positive, identify it as 6(a)(2) information in the transmittal.
              (i) If a submission is a follow-up to an earlier study or incident report submitted to EPA, the transmittal must state that fact, and must cite the earlier submission, as follows:
              (1) If the earlier submission was a study to which EPA assigned a Master Record Identifier number (MRID), cite the MRID.
              (2) If the previous submission was an incident report to which no MRID number was assigned, cite the date of the initial submission of the incident information or report.
              [63 FR 49388, Sept. 19, 1997, as amended at 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006; 72 FR 61028, Oct. 26, 2007]

              § 159.158
              What information must be submitted.
              (a) General. Information which is reportable under this part must be submitted if the registrant possesses or receives the information, and the information is relevant to the assessment of the risks or benefits of one or more specific pesticide registrations currently or formerly held by the registrant. Information relevant to the assessment of the risks or benefits also includes conclusion(s) or opinion(s) rendered by a person who meets any of the following:
              (1) Who was employed or retained (directly or indirectly) by the registrant, and was likely to receive such information.
              (2) From whom the registrant requested the opinion(s) or conclusion(s) in question.
              (3) Who is a qualified expert as described in § 159.153(b).
              (b) Exceptions—(1) Clearly erroneous information. Information need not be submitted if before that date on which the registrant must submit such information if all of the following conditions are met:
              (i) The registrant discovers that any analysis, conclusion, or opinion was predicated on data that were erroneously generated, recorded, or transmitted, or on computational errors.
              (ii) Every author of each such analysis, conclusion, or opinion, or as many authors as can be contacted through the use of reasonable diligence, has acknowledged in writing that the analysis, conclusion, or opinion was improper and has either corrected the original analysis, conclusion, or opinion accordingly, or provided an explanation as to why it cannot be corrected.
              (iii) As a result of the correction, the information is no longer required to be reported under FIFRA section 6(a)(2), or if no correction was possible, the authors agree that the original analysis, conclusion or opinion has no scientific validity.
              (2) Previously submitted information. Information regarding an incident, study, or other occurrence need not be submitted if before the date on which the registrant must submit such information, the registrant is aware that the reportable information concerning that incident, study, or other occurrence is contained completely in one of the following:
              (i) Documents officially logged in by the EPA Office of Pesticide Programs.

              (ii) EPA publications, EPA hearing records, or publications cited in EPA Federal Register notices.
              (iii) Any other documents which are contained in the official files and records of the EPA Office of Pesticide Programs.

              (iv) Any documents officially logged in by the EPA Office of Pollution Prevention and Toxics under the provisions of section 8(e) of the Toxic Substances Control Act, provided that if the information pertains to a chemical compound which, subsequent to the submission of data under section 8(e), becomes the subject of an application for registration as a pesticide active ingredient, information is submitted to the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
              (3) Publications. A published article or report containing information otherwise reportable under this part need not be submitted if it fits into either of the following categories:
              (i) Any scientific article or publication which has been abstracted in a recognized database of scientific and medical literature, such as Medline, ENBASE, Toxline or Index Medicus, if the abstract in question clearly identified the active ingredient or the registered pesticide(s) to which the information pertains. Otherwise reportable information received by or known to the registrant prior to publication of an abstract concerning the information must be reported and may not be withheld pending such publication.
              (ii) Reports or publications which have been made available to the public by any of the following Federal agencies: Centers for Disease Control and Prevention, Consumer Products Safety Commission, Department of Agriculture, Department of the Interior, Food and Drug Administration or any other agency or institute affiliated with the Department of Health and Human Services. Otherwise reportable information concerning research which was performed, sponsored, or funded by the registrant which may also appear in forthcoming Government reports or publications must be reported and may not be withheld pending publication.
              (4) Information concerning former inerts, contaminants or impurities. Notwithstanding any other provisions of this part, a registrant need not report information concerning a chemical compound that was at one time an inert ingredient or a contaminant or impurity of a pesticide product, and would otherwise be reportable under this part, if both of the following conditions are met:
              (i) The compound has been eliminated from its registered product due to changes in manufacturing processes, product formulation or by other means.
              (ii) The registrant has informed the appropriate product manager in the Office of Pesticide Programs in writing of the presence previously of the inert, contaminant or impurity in the product and its subsequent elimination from the product.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]

              § 159.159
              Information obtained before promulgation of the rule.
              (a) Notwithstanding any other provision of this part, information held by registrants on August 17, 1998 which has not been previously submitted to the Agency, but which is reportable under the terms of this part, must be submitted to the Agency if it meets any of the following criteria:
              (1) Information is otherwise reportable under § 159.184, and pertains to an incident that is alleged to have occurred on or after January 1, 1994, and to have involved any of the following:
              (i) A fatality or hospitalization of a human being.
              (ii) A fatality of a domestic animal.
              (iii) A fatality or fatalities to fish or wildlife, if the incident meets the criteria for the exposure type and severity category designation “W-A” set forth in § 159.184(c)(5)(iii).
              (2) Submission of the information is requested by the Agency pursuant to § 159.195(c).
              (b) If a registrant possesses information required to be submitted by paragraph (a)(1) of this section, the registrant must submit on or before June 16, 1999 in accordance with § 159.156(c), (d), and (e) an inventory of the incidents that meet the requirements of paragraphs (a)(1) of this section. Such an inventory must include the separate number of incidents that meet the requirements of paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this section, and for each type of incident, the total numbers of fatalities or hospitalizations involved.
              (c) If a registrant possesses information required to be submitted by paragraph (a)(2) of this section, the information must be submitted in accordance with any schedule contained in the Agency's request for the information.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at 63 FR 41193, Aug. 3, 1998]

              § 159.160
              Obligations of former registrants.
              (a) General. A former registrant is obliged to continue to submit information concerning the registration of a pesticide product previously held by the registrant and otherwise reportable under the provisions of this part for a period of 5 years after the registration of the pesticide product has been canceled or transferred to another registrant, with the exceptions provided by paragraph (b) of this section.
              (b) Exceptions. Notwithstanding the provisions of paragraph (a) of this section, a former registrant is not obligated to report information pursuant to this part if any of the following conditions are applicable:
              (1) The information is first obtained by the person more than 1 year after the date on which the person ceased to hold the registration of the product to which the information pertains, and the person holds no active pesticide registrations, or for some other reason cannot reasonably be expected to receive information concerning the formerly registered product.
              (2) The information is associated solely with an inert ingredient, contaminant, impurity, metabolite, or degradate contained in a product, and the information is first obtained by the person more than 1 year after the date upon which the person ceased to hold the registration of the product.
              (3) The information is associated with an active ingredient or a formerly registered product, and the active ingredient or every active ingredient contained in the formerly registered product has not been contained in any pesticide product registered in the United States for any part of the 3-year period preceding the date on which the person first obtained the information.
              (4) The information pertains solely to a formerly registered product that no longer meets the definition of “pesticide” in section 2(u) of FIFRA.
              (c) Information arising from litigation. Notwithstanding any other provisions of this section, a former registrant is obliged to submit information otherwise reportable under this part concerning formerly-registered pesticide products which arises in the course of litigation concerning the effects of such products, regardless of when the information is first acquired, provided that neither of the provisions of paragraphs (b)(3) or (b)(4) of this section are met. Such information shall be submitted in the same manner and according to the same schedules as it would have to be submitted by a current registrant of a pesticide product to which the information pertained.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at 73 FR 75596, Dec. 12, 2008]

              § 159.165
              Toxicological and ecological studies.
              Adverse effects information must be submitted as follows:
              (a) Toxicological studies. (1) The results of a study of the toxicity of a pesticide to humans or other non-target domestic organisms if, relative to all previously submitted studies, they show an adverse effect under any of the following conditions:
              (i) That is in a different organ or tissue of the test organism.
              (ii) At a lower dosage, or after a shorter exposure period, or after a shorter latency period.
              (iii) At a higher incidence or frequency.
              (iv) In a different species, strain, sex, or generation of test organism.
              (v) By a different route of exposure.

              (2) Acute oral, acute dermal, acute inhalation or skin and eye irritation studies in which the only change in toxicity is a numerical decrease in the median lethal dose (LD50), median lethal concentration (LC50) or irritation indices, are not reportable under this part unless the results indicate a more restrictive toxicity category for labeling under the criteria of 40 CFR 156.62.
              (b) Ecological studies. The results of a study of the toxicity of a pesticide to terrestrial or aquatic wildlife or plants if, relative to all previously submitted studies, they show an adverse effect under any of the following conditions:

              (1) At levels 50 percent or more lower than previous acute toxicity studies with similar species, including determinations of the median lethal dose (LD50), median lethal concentration (LC50), or median effective concentration (EC50).

              (2) At lower levels in a chronic study than previous studies with similar species.

              (3) In a study with a previously untested species the results indicate the chronic no observed effect level (NOEL) is 10 percent or less of the lowest LC50 or LD50 for a similar species.
              (4) For plants when tested at the maximum label application rate or less, if either of the following conditions is met:
              (i) More than 25 percent of terrestrial plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigor, reproduction and yields.
              (ii) More than 50 percent of aquatic plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigor, reproduction and yields.

              (c) Results from a study that demonstrates any toxic effect (even if corroborative of information already known to the Agency), must be submitted if the pesticide is or has been the subject of a Formal Review based on that effect within 5 years of the time the results are received. Within 30 calendar days of the publication of a Notice of Commencement of a Formal Review in the Federal Register, all information which has become reportable due to the commencement of the Formal Review must be submitted.
              (d) Incomplete studies. Information from an incomplete study of the toxicity to any organism of a registered pesticide product or any of its ingredients, impurities, metabolites, or degradation products which would otherwise be reportable under paragraphs (a), (b) or (c) of this section must be submitted if the information meets any one of the folowing three sets of criteria:
              (1) Short-term studies. A study using a test regimen lasting 90 calendar days or less, and all of the following conditions are met:
              (i) All testing has been completed.
              (ii) A preliminary data analysis or gross pathological analysis has been conducted.
              (iii) Final analysis has not been completed.
              (iv) A reasonable period for completion of the final analysis not longer than 90 calendar days following completion of testing has elapsed.
              (v) Comparable information concerning the results of a completed study would be reportable.
              (2) Long-term studies. A study using a test regimen lasting more than 90 calendar days, and all of the following conditions are met:
              (i) All testing has been completed.
              (ii) A preliminary data analysis or gross pathological analysis has been conducted.
              (iii) Final analysis has not been completed.
              (iv) A reasonable period of completion of final analysis (not longer that 1 year following completion of testing) has elapsed.
              (v) Comparable information concerning the results of a completed study would be reportable.
              (3) Serious adverse effects. Any study in which testing or analysis of results is not yet complete but in which serious adverse effects have already been observed which may reasonably be attributed to exposure to the substances tested, because the effects observed in exposed organisms differ from effects observed in control organisms, are atypical in view of historical experience with the organism tested, or otherwise support a reasonable inference of causation, and 30 days have passed from the date the registrant first has the information.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998; 73 FR 75597, Dec. 12, 2008]

              § 159.167
              Discontinued studies.
              The fact that a study has been discontinued before the planned termination must be reported to EPA, with the reason for termination, if submission of information concerning the study is, or would have been, required under this part.

              § 159.170
              Human epidemiological and exposure studies.

              Information must be submitted which concerns any study that a person described in § 159.158(a) has concluded, or might reasonably conclude, shows that a correlation may exist between exposure to a pesticide and observed adverse effects in humans. Information must also be submitted which concerns exposure monitoring studies that indicate higher levels of risk or exposure than would be expected based on previously available reports, data, or exposure estimates. Such information must be submitted regardless of whether the registrant considers any observed correlation or association to be significant.

              § 159.178
              Information on pesticides in or on food, feed or water.
              (a) Food and feed. Information must be submitted if it shows that the pesticide is present in or on food or feed at a level in excess of established levels, except that information on excess residues resulting solely from studies conducted under authority of FIFRA section 5 or under other controlled research studies conducted to test a pesticide product need not be submitted, provided that the treated crop is not marketed as a food or feed commodity. The information to be submitted is the same as that required in § 159.184(c)(1), (2), (3), and (4)(iv)(E), (F), (G), and (H).
              (b) Water. (1) Information must be submitted if it shows that a pesticide is present above the water reference level in any of the following instances:
              (i) Waters of the United States, as defined in § 122.2 of this chapter, except paragraph (d) of § 122.2.
              (ii) Ground water.
              (iii) Finished drinking water.
              (2) If the lowest detectable amount of the pesticide is reported, the detection limit must also be reported.
              (3) Information need not be submitted regarding the detection of a pesticide in waters of the United States or finished drinking water if the pesticide is registered for use in finished drinking water or surface water and the amount detected does not exceed the amounts reported by a registrant in its application for registration, as resulting in those waters from legal applications of the pesticide.
              (4) Information need not be submitted concerning detections of pesticides in waters of the United States, ground water or finished drinking water if the substance detected is an inert ingredient, or a metabolite, degradate, contaminant or impurity of a pesticide product, unless EPA has established or proposed a maximum contaminant level (MCL) or health advisory level (HAL) for that substance, or has estimated a health advisory level based on an established reference dose (RfD) for that substance, and notified registrants of that level.
              (5) Information to be submitted is the same as that required in § 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]

              § 159.179
              Metabolites, degradates, contaminants, and impurities.
              (a) Metabolites and degradates. Information which shows the existence of any metabolite or degradate of a pesticide product must be submitted if either of the following conditions is met:
              (1) The metabolite or degradate may occur or be present under conditions of use of the pesticide product, and the existence of the metabolite or degradate or the association of the metabolite or degradate with the pesticide product has not been previously reported to EPA.
              (2) The metabolite or degradate has been previously reported, but it is detected at levels higher than any previously reported; and either of the following conditions is met:
              (i) Any person described in § 159.158(a) has concluded that the metabolite or degradate may pose a toxicological or ecological risk based on any one or more of the following:
              (A) The physical or chemical properties of the metabolite or degradate.
              (B) Data regarding structurally analogous chemicals.
              (C) Data regarding chemical reactivity of the metabolite or degradate and structurally analogous substances.
              (D) Data on the metabolite or degradate.

              (ii) The registrant has concluded, or has been advised by any person described in § 159.158(a) that the metabolite or degradate, or analogous chemicals, may have any experimentally determined half-life greater than 3 weeks as shown from laboratory aerobic soil metabolism studies or field dissipation studies, or may have any experimentally determined resistance to hydrolytic degradation, or photolytic degradation on soil or in water, under any conditions, resulting in degradation of less than 10 percent in a 30-day period.
              (b) Contaminants and impurities. The presence in any pesticide product of a contaminant or impurity not previously identified by the registrant as part of the pesticide product's approved composition must be reported pursuant to this part if the contaminant or impurity is present in the product in any of the following quantities:
              (1) Quantities greater than 0.1 percent by weight (1,000 parts per million).
              (2) Quantities that EPA considers, and so informs registrants, to be of toxicological significance.
              (3) Quantities that the registrant considers to be of toxicological significance.
              (4) Quantities above a level for which the registrant has information indicating that the presence of the contaminant or impurity may pose a risk to health or the environment.
              (5) Quantities that a person described in § 159.158(a) has informed the registrant is likely to be of toxicological significance.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]

              § 159.184
              Toxic or adverse effect incident reports.
              (a) General. Information about incidents affecting humans or other non-target organisms must be submitted if the following three conditions are met:
              (1) The registrant is aware, or has been informed that a person or non-target organism may have been exposed to a pesticide.
              (2) The registrant is aware, or has been informed that the person or non-target organism suffered a toxic or adverse effect, or may suffer a delayed or chronic adverse effect in the future.
              (3) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
              (b) Exceptions. Information regarding an incident need not be submitted if any of the following conditions are met:
              (1) The registrant is aware of facts which clearly establish that the reported toxic effect, or reported exposure, did not or will not occur.
              (2) The registrant has been notified in writing by the Agency that the reporting requirement has been waived for this incident or category of incidents, and the registrant has not been notified in writing by the Agency that the waiver is rescinded.
              (3) It concerns a toxic effect to non-target plants, which were at the use site at the time the pesticide was applied, if the label provides adequate notice of such a risk.
              (4) It concerns non-lethal phytotoxicity to the treated crop if the label provides an adequate notice of such a risk.
              (5) It concerns a toxic effect to pests not specified on the label, provided that such pests are similar to pests specified on the label.
              (6) It concerns minor skin or eye irritation effects warned of on the label of a product which is registered for use in residential use sites, and the effects occurred as a result of use in a residential site.
              (c) Required information on individual incidents. To the extent that the registrant has any of the information listed in paragraphs (c)(1) through (c)(4) of this section, the registrant must supply the information on each pesticide incident that meets the requirements outlined in paragraph (a) of this section. If the registrant acquires additional information concerning an incident previously reported to the Agency under this part, such information shall be reported if it meets the criteria set forth in paragraph (f) of this section. In the future, the Agency may by notice specify a format for such submissions. The Administrative, Pesticide, Circumstance and Exposure Type(s) of information must be reported for individual incidents, except where the provisions of paragraph (e) of this section allow for aggregated summary forms of reporting, or if EPA in the future grants permission in writing for alternative reporting formats. The registrant must also provide one or more Exposure Type and Severity categories and their designations for each incident as set forth in paragraph (c)(5) of this section, depending on the applicability of the criteria listed below. The criteria listed should be used in assigning a category. For example, an incident which allegedly caused serious but non-fatal effects to human beings and domestic animals might be designated “H-B: D-B.” When a single incident involves multiple pesticides, the registrant need only report on their specific product. However, if a single incident involves more than one type of non-target organism—for example, both humans and domestic animals are involved—all appropriate available information dealing with each of the victims must also be reported. The informational items below are grouped by sections for ease in reporting pesticide incidents.
              (1) Administrative. Pesticide incident reports must be submitted if the registrant possesses or receives any of the following information, and the incident meets the minimum requirements set forth in paragraph (a) of this section:
              (i) Name of reporter, address, and telephone number.
              (ii) Name, address, and telephone number of contact person (if different than reporter).
              (iii) Incident report status (e.g., new or update); if update, include the date of original submission.
              (iv) Date registrant became aware of the incident.
              (v) Date of incident (if appropriate, list start and end dates).
              (vi) Location of incident (city, county and state).
              (vii) Is incident part of a larger study.
              (viii) Source if different from reporting registrant.
              (2) Pesticide. Pesticide incident reports must be submitted for each pesticide that may have contributed to the incident, if the registrant possesses or receives any of the following information, and the incident meets the minimum requirements set forth in paragraph (a) of this section:
              (i) Product name.
              (ii) Active ingredient(s).
              (iii) EPA Registration Number.
              (iv) Diluted for use, or concentrate.
              (v) Formulation, if known.
              (3) Circumstance. Pesticide incident reports must be submitted if the registrant possesses or receives any of the following information, and the incident meets the minimum requirements set forth in paragraph (a) of this section:
              (i) Evidence the label directions were not followed (e.g., yes, no, unknown).
              (ii) How exposed (e.g., spill, drift, equipment failure, container failure, mislabeling, runoff, etc.).
              (iii) Situation (e.g., household use, mixing/loading, application, reentry, disposal, transportation, other (describe)).
              (iv) Use site (e.g., home, yard, commercial turf, agricultural (specify crop), industrial, building/office, school, nursery, greenhouse, pond/lake/stream, well, forest/woods, other.
              (v) Applicator certified (yes, no, unknown).
              (vi) A brief description of the circumstances of the incident.
              (4) Other incident specific information. Pesticide incident reports must be submitted if the registrant possesses or receives any of the following information, and the incident meets the minimum requirements set forth in paragraph (a) of this section:
              (i) If the incident involves humans:
              (A) Route of exposure (skin, eye, respiratory, oral).
              (B) List signs/symptoms/adverse effects.
              (C) If laboratory tests were performed, list name of test(s) and results.
              (D) If available, submit laboratory report(s).
              (E) Time between exposure and onset of symptoms.
              (F) Was adverse effect the result of suicide/homicide or attempted suicide/homicide.
              (G) Type of medical care sought, (e.g., none, Poison Control Center, hospital emergency department, hospital inpatient, private physician, clinic, other).
              (H) Demographics (sex, age, occupation).
              (I) If female, pregnant?
              (J) Exposure data: amount of pesticide; duration of exposure; weight of victim.
              (K) Was exposure occupational; days lost due to illness.
              (L) Was protective clothing worn (specify).
              (ii) If domestic animal:

              (A) Type of animal (e.g., livestock, poultry, bird, fish, household pet e.g., dog/cat etc.).
              (B) List signs/symptoms/adverse effects.
              (C) Breed/species (name and number affected, per adverse effect).
              (D) Route of exposure (e.g., skin, eye, respiratory, oral).
              (E) Time between exposure and onset of symptoms.
              (F) If laboratory test(s) performed, list name of tests and results.
              (G) If available, submit laboratory report(s).
              (iii) If fish, wildlife, plants or other non-target organisms:
              (A) List species affected, and number of individuals per species.
              (B) List symptoms or adverse effects.
              (C) Magnitude of the effect (e.g., miles of streams, square area of terrestrial habitat).
              (D) Pesticide application rate, intended use site (e.g., corn, turf), and method of application.
              (E) Description of the habitat and the circumstances under which the incident occurred.
              (F) If plant, type of plant life (i.e., crop, forest, orchard, home garden, ornamental, forage).
              (G) Formulation of pesticide if not indicated by brand name (granular, flowable).
              (H) Distance from treatment site.
              (I) If laboratory test(s) performed, list name of test(s) and results.
              (J) If available, submit laboratory report(s).
              (iv) If surface water:
              (A) If raw water samples, water bodies sampled and approximate locations in each water body.
              (B) If raw water samples, proximity of sampling locations to drinking water supply intakes and identities of systems supplied.
              (C) If finished water samples, water supply systems sampled.
              (D) If finished water samples, percent surface water source by specific surface water sources to water supply system(s).
              (E) Sample type (grab, composite).
              (F) Sampling times/frequency.
              (G) Pesticides and degredates analyzed for, the detection limits, and the amount detected.
              (H) Method of analysis.
              (v) If ground water:
              (A) Pesticides and degredates analyzed for, the analytical method used, the detection limits, and the amount detected.
              (B) Sample date.
              (C) Amount pesticide applied (lbs-ai/acre).
              (D) Date of last application.
              (E) Depth to water.
              (F) Latitude/longitude.
              (G) Soil series and texture (sand/silt/clay).
              (H) Frequency of applications per year.
              (I) Aquifer description (confined/unconfined).
              (J) Method of application.
              (K) Years pesticide used.
              (L) Well use and well identifier.
              (M) Screened interval.
              (N) Annual cumulative rainfall (inches).
              (O) Maximum rainfall and date.
              (P) Cumulative irrigation (inches).
              (Q) Hydrologic group.
              (R) Hydraulic conductivity.
              (S) pH.
              (T) Organic matter or organic carbon (percent).
              (vi) If property damage.
              (A) Provide description.
              (B) [Reserved]
              (5) Exposure types and severity category designations—(i) Humans. If an effect involves a human, provide the appropriate 2-letter exposure types and severity categories and their designations, based upon the following categories:
              (A) H-A: If the person died.
              (B) H-B: If the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse reproductive effects or in residual disability.
              (C) H-C: If the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms. Usually some form of treatment of the person would have been Indicated. Symptoms were not life threatening and the person has returned to his/her pre-exposure state of health with no additional residual disability.

              (D) H-D: If the person alleged or exhibited some symptoms, but they were minimally traumatic. The symptoms resolved rapidly and usually involve skin, eye or respiratory irritation.
              (E) H-E: If symptoms are unknown, unspecified or are alleged to be of a delayed or chronic nature that may appear in the future.
              (ii) Domestic animals. If an effect involves a domestic animal, provide the appropriate 2-letter notation based upon the following categories:
              (A) D-A: If the domestic animal died or was euthanized.
              (B) D-B: If the domestic animal exhibited or was alleged to have exhibited symptoms which may have been life-threatening or resulted in residual disability.
              (C) D-C: If the domestic animal exhibited or was alleged to have exhibited symptoms which are more pronounced, more prolonged or of a more systemic nature than minor symptoms. Usually some form of treatment would have been indicated to treat the animal. Symptoms were not life threatening and the animal has returned to its pre-exposure state of health with no additional residual disability.
              (D) D-D: If the domestic animal was alleged to have exhibited symptoms, but they were minimally bothersome. The symptoms resolved rapidly and usually involve skin, eye or respirator irritation.
              (E) D-E: If symptoms are unknown or not specified.
              (iii) Fish or wildlife. If an alleged effect involves fish or wildlife, label the incident W-A if any of the following criteria are met, or W-B if none of the criteria are met:
              (A) Involves any incident caused by a pesticide currently in Formal Review forecological concerns.
              (B) Fish: Affected 1,000 or more individuals of a schooling species or 50 or more individuals of a non-schooling species.
              (C) Birds: Affected 200 or more individuals of a flocking species, or 50 or moreindividuals of a songbird species, or 5 or more individuals of a predatory species.
              (D) Mammals, reptiles, amphibians: Affected 50 or more individuals of a relatively common or herding species or 5 or more individuals of a rare or solitary species.
              (E) Involves effects to, or illegal pesticide treatment (misuse) of a substantial tract of habitat (greater than or equal to 10 acres, terrestrial or aquatic).
              (F) Involves a major spill or discharge (greater than or equal to 5,000 gallons) of a pesticide.
              (G) Involves adverse effects caused by a pesticide, to federally listed endangered or threatened species.
              (iv) Plants. If an alleged effect involves damage to plants, label the incident P-A if the following criterion is met, or P-B if the criterion is not met:
              (A) The effect is alleged to have occurred on more than 45 percent of the acreage exposed to the pesticide.
              (B) [Reserved]
              (v) Other non-target organisms. If an alleged effect involves damage to non-target organisms other than fish, wildlife or plants (for example, beneficial insects), label the incident ONT.
              (vi) Water contamination. If a pesticide is alleged to have been detected in groundwater, surface water or finished drinking water, label the incident in accordance with the following criteria:
              (A) G-A: If the pesticide was detected at levels greater than the maximum contaminant level (MCL) or health advisory level (HAL) or an applicable criterion for ambient water quality.
              (B) G-B: If the pesticide was detected at levels greater than 10 percent of the MCL, HAL or a criterion for ambient water quality but does not exceed the MCL or other applicable level.
              (C) G-C: If the pesticide was detected at levels less than 10 percent of the MCL, HAL, or other applicable level, or there is no established level of concern.
              (vii) Property damage. If an incident involves alleged property damage the applicable term(s) shall be included along with any other applicable effect category label; for example, “H-B: property damage.” Label the incident in accordance with the following criteria:
              (A) PD-A: The product is alleged to have caused damage in a manner that could have caused direct human injury, such as fire or explosion.

              (B) PD-B: The product is alleged to have caused damage in excess of $5,000.

              (C) PD-C: Any allegation of property damage that does not meet the criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including cases in which the level of damages is not specified.
              (d) Time requirements for submitting incident information. Information concerning incidents reportable under this section must be submitted within the time frames listed for different exposure and severity categories, as follows:
              (1) For allegations involving human fatality (H-A), registrants must submit the required information, to the extent it is available, no later than 15 days after learning of an allegation.
              (2) Information concerning incidents which meet the criteria for the following exposure and severity category labels described in paragraph (c)(5) of this section, reports of detections of pesticides in water, and efficacy failure incidents may be described in § 159.188(a)(1) and (b)(1), may be accumulated for a 30-day period, and submitted to the Agency within 30 days after the end of each 30-day accumulation period for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; Property Damage, PD-A.
              (3) Incidents or reports of detections of pesticides in water meeting all other exposure and severity label categories, information may be accumulated by registrants for 90 days and submitted within 60 days after the end of each 90-day accumulation period.
              (e) Aggregated reports. For incidents that are reportable under the schedule requirements of paragraph (d)(3) of this section, in lieu of individual reports containing the information listed in paragraphs (c)(1) through (c)(4) of this section, registrants must provide an aggregated report listing:
              (1) The time period covered by the report.
              (2) For each exposure and severity label category, a count of the number of incidents, listed by product registration number (if known) or active ingredient.
              (3) A count of domestic animal incidents in categories, other than D-A or D-B, which can be added together and reported as a single number.
              (f) Reporting additional information. If, after the submission of an incident report to the Agency, a registrant acquires additional information concerning that incident, the information should be submitted within the same time frame as applied to the original incident report, if any of the following conditions apply:
              (1) The information concerns an alleged human fatality (H-A), and the information consists of any of the elements listed in paragraphs (c)(1) through (c)(4) of this section.
              (2) The information concerns an incident originally reported as alleging a major human illness or injury (H-B), or fatality to a domestic animal (D-A), or wildlife (W-A), and the additional information consists of pesticide or circumstance information listed in paragraphs (c)(2) or (c)(3) of this section, or is a laboratory report concerning persons or animals involved in the incident.
              (3) The information concerns any incident not originally reported with one of the exposure and severity labels H-A, or H-B for human incidents, or at the “A” level of severity for any other exposure or incident type, and the new information would result in labeling the incident H-A or H-B for a human incident, or at the “A” level of severity for any other exposure or incident type listed in paragraph (c)(5) of this section.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]

              § 159.188
              Failure of performance information.
              (a) Microorganisms that pose a risk to human health. Information must be submitted which concerns either incidents described in paragraph (a)(1) of this section or a study described in paragraph (a)(2) of this section:
              (1) Information which concerns an incident which meets all of the following conditions:
              (i) The registrant has been informed that a pesticide product may not have performed as claimed against target microorganisms.
              (ii) The possible failures of the pesticide to perform as claimed involved the use against microorganisms which may pose a risk to human health.

              (iii) The pesticide product's use site is other than residential.

              (iv) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
              (2) A study which indicates that the pesticide may not perform in accordance with one or more claims made by the registrant regarding uses intended for control of microorganisms tha may pose a risk to human health, including any of the public health antimicrobials identified in part 161 of this chapter.
              (b) Animals that pose a risk to human health. For the purposes of this section, any animal (including insects) poses a risk to human health if it may cause disease in humans, either directly or as a disease vector; produce toxins that are harmful to humans; or cause direct physical harm to humans. Information must be submitted which concerns either incidents described in paragraph (b)(1) of this section or a study described in paragraph (b)(2) of this section.
              (1) Information which concerns an incident which meets all of the following conditions:
              (i) The registrant has been informed by municipal, State, or Federal public health officials that a pesticide product may not have performed as claimed against target animals.
              (ii) The possible failures of the pesticide to perform as claimed involved the use against animals that pose a risk to human health.
              (iii) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
              (2) A study which indicates that the pesticide may not perform in accordance with one or more claims by the registrant regarding uses intended for control of animals that pose a risk to human health, including any of the public health pesticides identified in part 158 of this chapter.
              (c) Development of pesticide resistance. Information must be submitted concerning substantiation of any incident of a pest having developed resistance to any pesticide (both public health and non-public health) that occurred under conditions of use, application rates and methods specified on the label if either of the following conditions is met:
              (1) The survival of the suspected pesticide-resistant pest was significantly higher than that of a known susceptible pest when both the suspected resistant and susceptible pests were treated with the pesticide under controlled conditions.
              (2) Biochemical tests or DNA sequencing indicate that the pest is resistant to the pesticide.
              [63 FR 49388, Sept. 19, 1997, as amended at 72 FR 61029, Oct. 26, 2007]

              § 159.195
              Reporting of other information.
              (a) The registrant shall submit to the Administrator information other than that described in §§ 159.165 through 159.188 if the registrant knows, or reasonably should know, that if the information should prove to be correct, EPA might regard the information alone or in conjunction with other information about the pesticide as raising concerns about the continued registration of a product or about the appropriate terms and conditions of registration of a product. Examples of the types of information which must be provided if not already reportable under some other provision of this part include but are not limited to information showing:
              (1) Previously unknown or unexpected bioaccumulation of a pesticide by various life forms.
              (2) Greater than anticipated drift of pesticides to non-target areas.
              (3) Use of a pesticide may pose any greater risk than previously believed or reported to the Agency.
              (4) Use of a pesticide promotes or creates secondary pest infestations.
              (5) Any information which might tend to invalidate a study submitted to the Agency to support a pesticide registration.
              (b) A registrant is not obligated under paragraph (a) of this section to provide information to the Administrator if the registrant is aware of facts which establish that otherwise reportable information is not correct.

              (c) The registrant shall submit to the Administrator information other than that described in §§ 159.165 through 159.188 if the registrant has been informed by EPA that such additional information has the potential to raise questions about the continued registration of a product or about the appropriate terms and conditions of registration of a product.
              [62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]

          Pt. 160
          PART 160—GOOD LABORATORY PRACTICE STANDARDS

              Subpart A—General Provisions
              Sec.
              160.1
              Scope and applicability.
              160.3
              Definitions.
              160.10
              Applicability to studies performed under grants and contracts.
              160.12
              Statement of compliance or non-compliance.
              160.15
              Inspection of a testing facility.
              160.17
              Effects of non-compliance.

              Subpart B—Organization and Personnel
              160.29
              Personnel.
              160.31
              Testing facility management.
              160.33
              Study director.
              160.35
              Quality assurance unit.

              Subpart C—Facilities
              160.41
              General.
              160.43
              Test system care facilities.
              160.45
              Test system supply facilities.
              160.47
              Facilities for handling test, control, and reference substances.
              160.49
              Laboratory operation areas.
              160.51
              Specimen and data storage facilities.

              Subpart D—Equipment
              160.61
              Equipment design.
              160.63
              Maintenance and calibration of equipment.

              Subpart E—Testing Facilities Operation
              160.81
              Standard operating procedures.
              160.83
              Reagents and solutions.
              160.90
              Animal and other test system care.

              Subpart F—Test, Control, and Reference Substances
              160.105
              Test, control, and reference substance characterization.
              160.107
              Test, control, and reference substance handling.
              160.113
              Mixtures of substances with carriers.

              Subpart G—Protocol for and Conduct of a Study
              160.120
              Protocol.
              160.130
              Conduct of a study.
              160.135
              Physical and chemical characterization studies.

              Subparts H-I [Reserved]

              Subpart J—Records and Reports
              160.185
              Reporting of study results.
              160.190
              Storage and retrieval of records and data.
              160.195
              Retention of records.

            Authority:
            7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.

            Source:
            54 FR 34067, Aug. 17, 1989, unless otherwise noted.

            Subpart A—General Provisions

              § 160.1
              Scope and applicability.
              (a) This part prescribes good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. This part is intended to assure the quality and integrity of data submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and section 408 or 409 of the Federal Food, Drug and Cosmetic Act.
              (b) This part applies to any study described by paragraph (a) of this section which any person conducts, initiates, or supports on or after October 16, 1989.
              [73 FR 75597, Dec. 12, 2008]

              § 160.3
              Definitions.
              As used in this part the following terms shall have the meanings specified:

                Application for research or marketing permit means any of the following:
              (1) An application for registration, amended registration, or reregistration of a pesticide product under FIFRA sections 3, 4 or 24(c).
              (2) An application for an experimental use permit under FIFRA section 5.

              (3) An application for an exemption under FIFRA section 18.

              (4) A petition or other request for establishment or modification of a tolerance, for an exemption for the need for a tolerance, or for other clearance under FFDCA section 408.
              (5) A petition or other request for establishment or modification of a food additive regulation or other clearance by EPA under FFDCA section 409 that was submitted prior to August 3, 1996.
              (6) A submission of data in response to a notice issued by EPA under FIFRA section 3(c)(2)(B).
              (7) Any other application, petition, or submission sent to EPA intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide.

                Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to § 160.105(a).

                Carrier means any material, including but not limited to feed, water, soil, nutrient media, with which the test substance is combined for administration to a test system.

                Control substance means any chemical substance or mixture, or any other material other than a test substance, feed, or water, that is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test substance for known chemical or biological measurements.

                EPA means the U.S. Environmental Protection Agency.

                Experimental start date means the first date the test substance is applied to the test system.

                Experimental termination date means the last date on which data are collected directly from the study.

                FDA means the U.S. Food and Drug Administration.

                FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 321 et seq).

                FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act as amended (7 U.S.C. 136 et seq).

                Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit thereof, or any other legal entity.

                Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies.

                Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. “Raw data” may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

                Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurements.

                Specimen means any material derived from a test system for examination or analysis.

                Sponsor means:
              (1) A person who initiates and supports, by provision of financial or other resources, a study;
              (2) A person who submits a study to the EPA in support of an application for a research or marketing permit; or
              (3) A testing facility, if it both initiates and actually conducts the study.

                Study means any experiment at one of more test sites, in which a test substance is studied in a test system under laboratory conditions or in the environment to determine or help predict its effects, metabolism, product performance (efficacy studies only as required by 40 CFR 158.400 or 161.640, as applicable), environmental and chemical fate, persistence and residue, or other characteristics in humans, other living organisms, or media. The term “study”does not include basic exploratory studies carried out to determine whether a test substance or a test method has any potential utility.

                Study completion date means the date the final report is signed by the study director.

                Study director means the individual responsible for the overall conduct of a study.

                Study initiation date means the date the protocol is signed by the study director.

                Test substance means a substance or mixture administered or added to a test system in a study, which substance or mixture:
              (1) Is the subject of an application for a research or marketing permit supported by the study, or is the contemplated subject of such an application; or
              (2) Is an ingredient, impurity, degradation product, metabolite, or radioactive isotope of a substance described by paragraph (1) of this definition, or some other substance related to a substance described by that paragraph, which is used in the study to assist in characterizing the toxicity, metabolism, or other characteristics of a substance described by that paragraph.

                Test system means any animal, plant, microorganism, chemical or physical matrix, including but not limited to soil or water, or subparts thereof, to which the test, control, or reference substance is administered or added for study. “Test system” also includes appropriate groups or components of the system not treated with the test, control, or reference substance.

                Testing facility means a person who actually conducts a study, i.e., actually uses the test substance in a test system. “Testing facility” encompasses only those operational units that are being or have been used to conduct studies.

                Vehicle means any agent which facilitates the mixture, dispersion, or solubilization of a test substance with a carrier.
              [54 FR 34067, Aug. 17, 1989, as amended at 72 FR 61029, Oct. 26, 2007; 73 FR 75597, Dec. 12, 2008]

              § 160.10
              Applicability to studies performed under grants and contracts.
              When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study that must be conducted in compliance with the provisions of this part.

              § 160.12
              Statement of compliance or non-compliance.
              Any person who submits to EPA an application for a research or marketing permit and who, in connection with the application, submits data from a study to which this part applies shall include in the application a true and correct statement, signed by the applicant, the sponsor, and the study director, of one of the following types:
              (a) A statement that the study was conducted in accordance with this part; or
              (b) A statement describing in detail all differences between the practices used in the study and those required by this part; or
              (c) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part.

              § 160.15
              Inspection of a testing facility.
              (a) A testing facility shall permit an authorized employee or duly designated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this part applies. The records inspection and copying requirements should not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except that EPA may seek production of these records in litigation or formal adjudicatory hearings.

              (b) EPA will not consider reliable for purposes of supporting an application for a research or marketing permit any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to EPA.

              § 160.17
              Effects of non-compliance.
              (a) EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with this part.
              (b) Submission of a statement required by § 160.12 which is false may form the basis for cancellation, suspension, or modification of the research or marketing permit, or denial or disapproval of an application for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or FFDCA section 406 or 409, or for criminal prosecution under 18 U.S.C. 2 or 1001 or FIFRA section 14, or for imposition of civil penalties under FIFRA section 14.

            Subpart B—Organization and Personnel

              § 160.29
              Personnel.
              (a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
              (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study.
              (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
              (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems.
              (e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.
              (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, and test, control, and reference substances, and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study.

              § 160.31
              Testing facility management.
              For each study, testing facility management shall:
              (a) Designate a study director as described in § 160.33 before the study is initiated.
              (b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
              (c) Assure that there is a quality assurance unit as described in § 160.35.
              (d) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
              (e) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.
              (f) Assure that personnel clearly understand the functions they are to perform.
              (g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.

              § 160.33
              Study director.

              For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. The study director shall assure that:
              (a) The protocol, including any change, is approved as provided by § 160.120 and is followed.
              (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
              (c) Unforseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
              (d) Test systems are as specified in the protocol.
              (e) All applicable good laboratory practice regulations are followed.
              (f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

              § 160.35
              Quality assurance unit.
              (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. The quality assurance unit shall conduct inspections and maintain records appropriate to the study.
              (b) The quality assurance unit shall:
              (1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance, and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
              (2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
              (3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately.
              (4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
              (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
              (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
              (7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
              (c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.
              (d) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.

            Subpart C—Facilities

              § 160.41
              General.
              Each testing facility shall be of suitable size and construction to facilitate the proper conduct of studies. Testing facilities which are not located within an indoor controlled environment shall be of suitable location to facilitate the proper conduct of studies. Testing facilities shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.

              § 160.43
              Test system care facilities.
              (a) A testing facility shall have a sufficient number of animal rooms or other test system areas, as needed, to ensure: proper separation of species or test systems, isolation of individual projects, quarantine or isolation of animals or other test systems, and routine or specialized housing of animals or other test systems.
              (1) In tests with plants or aquatic animals, proper separation of species can be accomplished within a room or area by housing them separately in different chambers or aquaria. Separation of species is unnecessary where the protocol specifies the simultaneous exposure of two or more species in the same chamber, aquarium, or housing unit.
              (2) Aquatic toxicity tests for individual projects shall be isolated to the extent necessary to prevent cross-contamination of different chemicals used in different tests.
              (b) A testing facility shall have a number of animal rooms or other test system areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, and reference substances known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
              (c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory test system diseases. These areas shall provide effective isolation for the housing of test systems either known or suspected of being diseased, or of being carriers of disease, from other test systems.
              (d) Facilities shall have proper provisions for collection and disposal of contaminated water, soil, or other spent materials. When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
              (e) Facilities shall have provisions to regulate environmental conditions (e.g., temperature, humidity, photoperiod) as specified in the protocol.
              (f) For marine test organisms, an adequate supply of clean sea water or artificial sea water (prepared from deionized or distilled water and sea salt mixture) shall be available. The ranges of composition shall be as specified in the protocol.
              (g) For freshwater organisms, an adequate supply of clean water of the appropriate hardness, pH, and temperature, and which is free of contaminants capable of interfering with the study, shall be available as specified in the protocol.
              (h) For plants, an adequate supply of soil of the appropriate composition, as specified in the protocol, shall be available as needed.

              § 160.45
              Test system supply facilities.
              (a) There shall be storage areas, as needed, for feed, nutrients, soils, bedding, supplies, and equipment. Storage areas for feed nutrients, soils, and bedding shall be separated from areas where the test systems are located and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
              (b) When appropriate, plant supply facilities shall be provided. As specified in the protocol, these include:
              (1) Facilities for holding, culturing, and maintaining algae and aquatic plants.

              (2) Facilities for plant growth, including, but not limited to greenhouses, growth chambers, light banks, and fields.

              (c) When appropriate, facilities for aquatic animal tests shall be provided. These include, but are not limited to, aquaria, holding tanks, ponds, and ancillary equipment, as specified in the protocol.

              § 160.47
              Facilities for handling test, control, and reference substances.
              (a) As necessary to prevent contamination or mixups, there shall be separate areas for:
              (1) Receipt and storage of the test, control, and reference substances.
              (2) Mixing of the test, control, and reference substances with a carrier, e.g., feed.
              (3) Storage of the test, control, and reference substance mixtures.
              (b) Storage areas for test, control, and/or reference substance and for test, control, and/or reference mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the substances and mixtures.

              § 160.49
              Laboratory operation areas.
              Separate laboratory space and other space shall be provided, as needed, for the performance of the routine and specialized procedures required by studies.

              § 160.51
              Specimen and data storage facilities.
              Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.

            Subpart D—Equipment

              § 160.61
              Equipment design.
              Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance.

              § 160.63
              Maintenance and calibration of equipment.
              (a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated, and/or standardized.
              (b) The written standard operating procedures required under § 160.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/ or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.
              (c) Written records shall be maintained of all inspection, maintenance, testing, calibrating, and/or standardizing operations. These records, containing the dates of the operations, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect.

            Subpart E—Testing Facilities Operation

              § 160.81
              Standard operating procedures.
              (a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
              (b) Standard operating procedures shall be established for, but not limited to, the following:
              (1) Test system area preparation.
              (2) Test system care.

              (3) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances.
              (4) Test system observations.
              (5) Laboratory or other tests.
              (6) Handling of test systems found moribund or dead during study.
              (7) Necropsy of test systems or postmortem examination of test systems.
              (8) Collection and identification of specimens.
              (9) Histopathology.
              (10) Data handling, storage and retrieval.
              (11) Maintenance and calibration of equipment.
              (12) Transfer, proper placement, and identification of test systems.
              (c) Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures.
              (d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.

              § 160.83
              Reagents and solutions.
              All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used.

              § 160.90
              Animal and other test system care.
              (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals and other test systems.
              (b) All newly received test systems from outside sources shall be isolated and their health status or appropriateness for the study shall be evaluated. This evaluation shall be in accordance with acceptable veterinary medical practice or scientific methods.
              (c) At the initiation of a study, test systems shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If during the course of the study, the test systems contract such a disease or condition, the diseased test systems should be isolated, if necessary. These test systems may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorization of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.
              (d) Warm-blooded animals, adult reptiles, and adult terrestrial amphibians used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require these test systems to be removed from and returned to their test system-housing units for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification (e.g., tattoo, color code, ear tag, ear punch, etc.). All information needed to specifically identify each test system within the test system-housing unit shall appear on the outside of that unit. Suckling mammals and juvenile birds are excluded from the requirement of individual identification unless otherwise specified in the protocol.
              (e) Except as specified in paragraph (e)(1) of this section, test systems of different species shall be housed in separate rooms when necessary. Test systems of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to test, control, or reference substances or test system mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.
              (1) Plants, invertebrate animals, aquatic vertebrate animals, and organisms that may be used in multispecies tests need not be housed in separate rooms, provided that they are adequately segregated to avoid mixup and cross contamination.
              (2) [Reserved]
              (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, growth chambers, and other holding, rearing and breeding areas, and accessory equipment, shall be cleaned and sanitized at appropriate intervals.

              (g) Feed, soil, and water used for the test systems shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed, soil, or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.
              (h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.
              (i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.
              (j) All plant and animal test systems shall be acclimatized to the environmental conditions of the test, prior to their use in a study.

            Subpart F—Test, Control, and Reference Substances

              § 160.105
              Test, control, and reference substance characterization.
              (a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test, control, or reference substance shal1 be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control, or reference substance shall be documented by the sponsor or the testing facility, and the location of such documentation shall be specified.
              (b) When relevant to the conduct of the study the solubility of each test, control, or reference substance shall be determined by the testing facility or the sponsor before the experimental start date. The stability of the test, control, or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
              (c) Each storage container for a test, control, or reference substance shall be labeled by name, chemical abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular test substance for the duration of the study.
              (d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of test, control, and reference substances shall be retained for the period of time provided by § 160.195.
              (e) The stability of test, control, and reference substances under storage conditions at the test site shall be known for all studies.

              § 160.107
              Test, control, and reference substance handling.
              Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that:
              (a) There is proper storage.
              (b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
              (c) Proper identification is maintained throughout the distribution process.
              (d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.

              § 160.113
              Mixtures of substances with carriers.
              (a) For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
              (1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture.
              (2) When relevant to the conduct of the study, to determine the solubility of each test, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date.

              (3) To determine the stability of the test, control, or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.

              (b) Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.
              (c) If a vehicle is used to facilitate the mixing of a test substance with a carrier, assurance shall be provided that the vehicle does not interfere with the integrity of the test.

            Subpart G—Protocol for and Conduct of a Study

              § 160.120
              Protocol.
              (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information:
              (1) A descriptive title and statement of the purpose of the study.
              (2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.
              (3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.
              (4) The proposed experimental start and termination dates.
              (5) Justification for selection of the test system.
              (6) Where applicable, the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
              (7) The procedure for identification of the test system.
              (8) A description of the experimental design, including methods for the control of bias.
              (9) Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
              (10) The route of administration and the reason for its choice.
              (11) Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration.
              (12) The type and frequency of tests, analyses, and measurements to be made.
              (13) The records to be maintained.
              (14) The date of approval of the protocol by the sponsor and the dated signature of the study director.
              (15) A statement of the proposed statistical method to be used.
              (b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol.

              § 160.130
              Conduct of a study.
              (a) The study shall be conducted in accordance with the protocol.
              (b) The test systems shall be monitored in conformity with the protocol.
              (c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
              (d) In animal studies where histopathology is required, records of gross findings for a specimen from postmortem observations shall be available to a pathologist when examining that specimen histopathologically.

              (e) All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the day of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.

              § 160.135
              Physical and chemical characterization studies.
              (a) All provisions of the GLP standards shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies) of test, control, or reference substances.

              (b) The following GLP standards shall not apply to studies, other than those designated in paragraph (a) of this section, designed to determine physical and chemical characteristics of a test, control, or reference substance:

                § 160.31 (c), (d), and (g)
                § 160.35 (b) and (c)
                § 160.43
                § 160.45
                § 160.47
                § 160.49
                § 160.81(b) (1), (2), (6) through (9), and (12)
                § 160.90
                § 160.105 (a) through (d)
                § 160.113
                § 160.120(a) (5) through (12), and (15)
                § 160.185(a) (5) through (8), (10), (12), and (14)
                § 160.195 (c) and (d)

            Subparts H-I [Reserved]

            Subpart J—Records and Reports

              § 160.185
              Reporting of study results.
              (a) A final report shall be prepared for each study and shall include, but not necessarily be limited to, the following:
              (1) Name and address of the facility performing the study and the dates on which the study was initiated and was completed, terminated, or discontinued.
              (2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
              (3) Statistical methods employed for analyzing the data.
              (4) The test, control, and reference substances identified by name, chemical abstracts service (CAS) number or code number, strength, purity, and composition, or other appropriate characteristics.
              (5) Stability and, when relevant to the conduct of the study the solubility of the test, control, and reference substances under the conditions of administration.
              (6) A description of the methods used.
              (7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
              (8) A description of the dosage, dosage regimen, route of administration, and duration.
              (9) A description of all circumstances that may have affected the quality or integrity of the data.
              (10) The name of the study director, the names of other scientists or professionals and the names of all supervisory personnel, involved in the study.
              (11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
              (12) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed.
              (13) The locations where all specimens, raw data, and the final report are to be stored.
              (14) The statement prepared and signed by the quality assurance unit as described in § 160.35(b)(7).
              (b) The final report shall be signed and dated by the study director.

              (c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. Modification of a final report to comply with the submission requirements of EPA does not constitute a correction, addition, or amendment to a final report.
              (d) A copy of the final report and of any amendment to it shall be maintained by the sponsor and the test facility.

              § 160.190
              Storage and retrieval of records and data.
              (a) All raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final report, also shall be retained.
              (b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents of specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
              (c) An individual shall be identified as responsible for the archives.
              (d) Only authorized personnel shall enter the archives.
              (e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.

              § 160.195
              Retention of records.
              (a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this subchapter.
              (b) Except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for whichever of the following periods is longest:
              (1) In the case of any study used to support an application for a research or marketing permit approved by EPA, the period during which the sponsor holds any research or marketing permit to which the study is pertinent.
              (2) A period of at least 5 years following the date on which the results of the study are submitted to the EPA in support of an application for a research or marketing permit.
              (3) In other situations (e.g., where the study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.
              (c) Wet specimens, samples of test, control, or reference substances, and specially prepared material which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. In no case shall retention be required for longer periods than those set forth in paragraph (b) of this section.
              (d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 160.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b) of this section.

              (e) Summaries of training and experience and job descriptions required to be maintained by § 160.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraph (b) of this section.
              (f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 160.63 (b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
              (g) If a facility conducting testing or an archive contracting facility goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The EPA shall be notified in writing of such a transfer.
              (h) Specimens, samples, or other non-documentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no longer required by EPA. Such notification normally will be furnished upon request after EPA or FDA has completed an audit of the particular study to which the materials relate and EPA has concluded that the study was conducted in accordance with this part.
              (i) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

          Pt. 162
          PART 162—STATE REGISTRATION OF PESTICIDE PRODUCTS

              Subparts A-C [Reserved]

              Subpart D—Regulations Pertaining to State Registration of Pesticides To Meet Special Local Needs
              Sec.
              162.150
              General.
              162.151
              Definitions.
              162.152
              State registration authority.
              162.153
              State registration procedures.
              162.154
              Disapproval of State registrations.
              162.155
              Suspension of State registration authority.
              162.156
              General requirements.

              Subpart E [Reserved]

            Subparts A-C [Reserved]

            Subpart D—Regulations Pertaining to State Registration of Pesticides To Meet Special Local Needs

              Authority:
              7 U.S.C. 136v, 136w.

              Source:
              46 FR 2014, Jan. 7, 1981, unless otherwise noted.

              § 162.150
              General.
              (a) Scope. This subpart sets forth regulations governing the registration by any State of pesticide products, or uses thereof, formulated for distribution and use within the State to meet special local needs under sec. 24(c) of the Act. It also sets forth regulations governing the exercise by the Administrator of the power to disapprove specific State registrations and to suspend a State's registration authority under sec. 24(c). Unless otherwise indicated, any reference herein to registrations issued by a State includes amendments of registrations issued by States.
              (b) Applicability. This subpart applies only to State registration authority granted by sec. 24(c) of FIFRA. It does not apply to any authority granted, or procedures established, by State law with respect to registration, licensing, or approval required for use within the State of federally registered pesticide products.
              [46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 32097, June 19, 1995]

              § 162.151
              Definitions.
              Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this subpart, the following terms shall apply:

                Federally registered means currently registered under section 3 of the Act, after having been initially registered under the Federal Insecticide, Fungicide, and Rodenticide Act of 1947 by the Secretary of Agriculture or under FIFRA by the Administrator.

                Manufacturing-use product means any pesticide product other than a product to be labeled with directions for end use. This term includes any product intended for use as a pesticide after reformulation or repackaging.

                New product means a pesticide product which is not a federally registered product.

                Pest problem means:
              (1) A pest infestation and its consequences, or
              (2) Any condition for which the use of plant regulators, defoliants, or desiccants would be appropriate.

                Product or pesticide product means a pesticide offered for distribution and use, and includes any labeled container and any supplemental labeling.

                Similar composition means a pesticide product which contains only the same active ingredient(s), or combinations of active ingredients, and which is in the same toxicity category, as defined in § 156.62 of this chapter, as a federally registered pesticide product.

                Similar product means a pesticide product which, when compared to a federally registered product, has a similar composition and a similar use pattern.

                Similar use pattern means a use of a pesticide product which, when compared to a federally registered use of a product with a similar composition, does not require a change in precautionary labeling under part 156 of this chapter, and which is substantially the same as the federally registered use. Registrations involving changed use patterns are not included in this term.

                Special local need means an existing or imminent pest problem within a State for which the State lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available.

                State or State lead agency means the State agency designated by the State to be responsible for registering pesticides to meet special local needs under section 24(c) of the Act.
              [73 FR 75597, Dec. 12, 2008]

              § 162.152
              State registration authority.
              (a) Statutory limitations. In accordance with sec. 24(c) of the Act, each State is authorized to register a new end use product for any use, or an additional use of a federally registered pesticide product, if the following conditions exist:
              (1) There is a special local need for the use within the State;

              (2) The use is covered by necessary tolerances, exemptions or other clearances under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346 et seq.), if the use is a food or feed use;
              (3) Registration for the same use has not previously been denied, disapproved, suspended or cancelled by the Administrator, or voluntarily cancelled by the registrant subsequent to issuance by the Administrator of a notice of intent to cancel that registration, because of health or environmental concerns about an ingredient contained in the pesticide product, unless such denial, disapproval, suspension or cancellation has been superseded by subsequent action of the Administrator; and
              (4) The registration is in accord with the purposes of FIFRA.
              (b) Types of registrations—(1) Amendments to federal registrations. (i) Subject to the provisions of paragraphs (a) and (b)(1)(ii) through (iv) of this section, States may register any new use of a federally registered pesticide product.
              (ii) A State may register any use of a federally registered product for which registration of other uses of the product was denied, disapproved, suspended, or cancelled by the Administrator, provided that the State may register a use not considered by the Administrator in reaching such a determination only after the State consults with appropriate EPA personnel.
              (iii) Except as provided in paragraph (a)(3) of this section, a State may register any use of a federally registered product for which registration of some or all uses has been voluntarily cancelled by the registrant, provided that a State may register such a use only after the State has consulted with appropriate EPA personnel.
              (iv) A State may not register an amendment to a federally registered manufacturing-use product.
              (2) New products. (i) Subject to the provisions of paragraph (a) and subparagraphs (b)(2) (ii) and (iii) of this section, a State may issue registrations to meet special local needs for the following types of new end-use products:

              (A) A product which is identical in composition to a federally registered product, but which has differences in packaging, or in the identity of the formulator.
              (B) A product which contains the same active and inert ingredients as a federally registered product, but in different percentages.
              (C) Subject to the requirements of paragraph (b)(2)(ii) of this section, a product containing a new combination of active, or active and inert, ingredients.
              (ii) A State may register a new product only if each of the active ingredients in the new product is present because of the use of one or more federally registered products and if each of the inert ingredients in the new product is contained in a federally registered product.
              (iii) A State may not register a new manufacturing-use product.
              (iv) A State may register any use of a new product containing an ingredient described in paragraph (a)(3) of this section, if the new product registration is for a formulation or a use not included in the denial, disapproval, suspension, or cancellation, or if the federally registered use was voluntarily cancelled without a prior notice of intent to cancel by the Administrator. However, a formulation or use of such a new product which was not considered by the Administrator during such proceedings, or which was not the subject of a notice of intent to cancel, may be registered by a State only after the State consults with appropriate EPA personnel regarding the registration application.
              (c) Effect of State registration. (1) A State registration issued under FIFRA sec. 24(c) which meets the conditions described in paragraphs (a) and (b) of this section, and which is not disapproved by the Administrator under § 162.154, shall be considered a federal registration, but shall authorize distribution and use only within that State. Accordingly, such registrations are subject to all provisions of FIFRA which apply to currently registered products, including provisions for cancellation and suspension of registrations, and reregistration of products.
              (2) A State may require, as a condition of distribution or use of a pesticide product within the State, that the pesticide product be registered under State law as well as under FIFRA. Neither FIFRA sec. 24(c) nor §§ 162.150-162.156 affects a State's right under its own law to revoke, suspend, cancel, or otherwise affect such a registration issued under State law. However, the federal registration, whether issued under FIFRA sec. 3 or 24(c), is not affected by such a State action.
              [46 FR 2014, Jan. 7, 1981, as amended at 73 FR 75597, Dec. 12, 2008]

              § 162.153
              State registration procedures.
              (a) Application for registration. States shall require all applicants for registration to submit the following information:
              (1) Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use.
              (2) The name of the pesticide product, and, if the application is for an amendment to a federally registered product, the EPA registration number of that product.
              (3) A copy of proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of:
              (i) For a new product, a copy of the complete proposed labeling; or,
              (ii) For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy of the labeling for the federally registered product.
              (4) The complete formula of the product, if the application is for a new product registration.
              (5) Any other information which is required to be reviewed prior to registration under this section.
              (b) Special local need determination. In reviewing any application for registration, the State shall determine whether there is a special local need for the registration. Situations which a State may consider as not involving a special local need may include, but are not limited to, applications for registrations to control a pest problem present on a nationwide basis, or for use of a pesticide product registered by other States on an interregional or nationwide basis.
              (c) Unreasonable adverse effects determination. (1) Prior to issuing a registration in the following cases, the State shall determine that use of the product for which registration is sought will not cause unreasonable adverse effects on man or the environment, when used in accordance with labeling directions or widespread and commonly recognized practices:
              (i) For use of a product which has a composition not similar to any federally registered product.
              (ii) For use of a project involving a use pattern not similar to any federally registered use of the same product or of a product with a similar composition.
              (iii) For use of a product for which other uses of the same product, or of a product with a similar composition, have had registration denied, disapproved, suspended, or cancelled by the Administrator.
              (2) Determinations required by paragraph (c)(1) of this section shall be based on data and criteria consistent with those sections of part 152 of this chapter, applicable to the type of product or use under consideration. Such determinations may also involve consideration of the effect of the anticipated classification of the product or use under paragraph (g) of this section.
              (d) Efficacy determination. Prior to registration of any use of a product for public health purposes—that is, a use which could result in substantial harm to the public health if the product does not perform its intended function, the State shall determine that the product warrants the claims made for it in the registration application. Such determinations shall be based on criteria specified in applicable sections of part 152 of this chapter and on any additional criteria established by the State.
              (e) Labeling requirements. (1) Prior to issuing any registration, the State shall review the proposed labeling submitted with the application to determine compliance with this paragraph. In addition, the State shall review a copy of the final printed labeling as soon as practical after a registration is issued in order to verify compliance with this paragraph.
              (2) For a new product, the State must, as a condition of the registration, require that the product be accompanied from the time it enters the stream of commerce by labeling meeting all applicable criteria of § 156.10 of this chapter. New product labeling must all contain:
              (i) A statement identifying the State where registration is to be valid.
              (ii) The special local need registration number assigned by the State.
              (3) Except as provided in paragraph (e)(4) of this section, as a condition for a registration of an additional use of a federally registered product, the State must require that at the time of sale to users, labeling from the federally registered product be accompanied by supplemental labeling which contains:
              (i) A statement identifying the State where registration is valid.
              (ii) Directions for use to meet the special local need which satisfy the criteria of § 156.10(i) of this chapter.
              (iii) The trade name of the product.
              (iv) The name and address of the section 24(c) registrant.
              (v) The EPA registration number of the federally registered product.
              (vi) The special local need registration number assigned by the State.
              (vii) A statement prohibiting use of the product in a manner inconsistent with all applicable directions, restrictions, and precautions found in the labeling of the federally registered product and accompanying supplemental labeling.
              (4) When a federally registered product is already in the stream of commerce at the time the State issues a registration for an additional use of that product, the State must ensure that supplemental labeling for the additional use, meeting the criteria of paragraph (e)(3) of this section, is made available to purchasers and users of the product within 45 days of the date on which the State approves the final printed supplemental labeling.

              (5) If a State classifies for restricted use a product or use registered by the State, which is not required to be so classified by paragraph (g) of this section, then the State may require supplemental labeling for the product or use containing additional appropriate precautions, and a statement that the product or use is for restricted use within that State.
              (f) Packaging and coloration standards. All products registered by a State must meet all appropriate packaging standards prescribed by the Administrator under sec. 25(c)(3) of FIFRA. State registered products must also meet all appropriate standards for coloration, or discoloration, established by regulation under sec. 25(c) of FIFRA, including the standards contained in subpart H of part 153 of this chapter. Prior to issuing any registration, the State shall determine that the product will conform to these requirements.
              (g) Classification. (1) As part of the registration of any product or use, a State shall classify the product or use as a restricted use pesticide if:
              (i) The product is identical or similar in composition to a federally registered product:
              (A) For which all federally registered uses have been classified as restricted by the Administrator; or
              (B) For which a use similar to the State registered use has been classified as restricted by the Administrator; or
              (ii) The State registered product or use meets the criteria for classification as a restricted use pesticide under the applicable provisions of § 152.170 of this chapter.
              (2) [Reserved]
              (h) Notification and submission of data. (1) Within ten working days from the date a State issues, amends, or revokes a registration, the State shall notify EPA, in writing, of the action. Notification of State registrations, or amendments thereto, shall include the effective date of the registration or amendment, a confidential statement of the formula of any new product, and a copy of the draft labeling reviewed and approved by the State, provided that labeling previously approved by the Administrator as part of a federal registration need not be submitted.
              (2) Notification of State registrations or amendments shall be supplemented by the State sending to EPA a copy of the final printed labeling approved by the State within 60 days after the effective date of the registration or amendment.
              (3) Notification of revocation of a registration by a State shall indicate the effective date of revocation, and shall state the reasons for revocation.
              (4) The Administrator or his designee may request, when appropriate, that a State submit to EPA any data used by the State to determine that unreasonable adverse effects will not be caused when the State registers any use described in paragraph (c)(1) of this section. Within 15 working days of receipt of such a request from EPA, the State shall submit two copies of the requested data.
              (i) Federal Register publication. The Administrator shall publish in the Federal Register, on a regular basis, a summary of all State registrations made under sec. 24(c) during a previous reporting period established by the Administrator. For each product or use registered, the notice shall indicate:
              (1) The name of the product.
              (2) The name of the registrant.
              (3) The registered use(s) of the product.
              (4) The effective date of the State registration.
              (5) If the registration is for an additional use of a federally registered product, whether the State registration involves a changed use pattern.
              (j) Electronic reporting under State registration of pesticide products for special local needs. States that choose to receive electronic documents under the regulations pertaining to state registration of pesticides to meet special local needs, must ensure that the requirements of 40 CFR Part 3—(Electronic reporting) are satisfied by their state procedures for such registrations.
              [46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 32097, June 19, 1995; 70 FR 59888, Oct. 13, 2005; 73 FR 75597, Dec. 12, 2008]

              § 162.154
              Disapproval of State registrations.
              (a) General disapprovals. (1) Except as provided in paragraph (b) of this section, the Administrator may disapprove, on any reasonable grounds, any state registration which, when compared to a federally registered product, does not have both a similar composition and a similar use pattern; provided that the Administrator may not disapprove such a registration solely because of a lack of essentiality. Grounds for disapproval of State registrations not involving similar products may include, but are not limited to:
              (i) Probable creation of unreasonable adverse effects on man or the environment by the registered use.
              (ii) Refusal of the registering State to submit information supporting the registration as required by § 162.153(h).
              (iii) Failure of information submitted by the State to support the State's decision to issue the registration under standards established by § 162.153.
              (2) Prior to disapproval of any State registration under this paragraph, the Administrator shall notify the registering State, in writing, of the Administrator's intent to disapprove, and of the reasons for disapproval. The notice of intent will provide a reasonable time, not less than ten days from the date the notice is received by the State, for the State to respond, and will invite the State to consult with the Administrator or his designee. If the grounds for disapproval are based on actions or omissions by the State, the notice will, if possible, also provide the State with a reasonable amount of time in which to take corrective action, not to exceed the time allowed for disapproval under paragraph (c) of this section.
              (3) The registering State may, within ten days of receipt of a notice of intent to disapprove, request that the Administrator, or his designee, consult with appropriate State officials prior to the Administrator's final decision on disapproval. The Administrator will consider any relevant information presented at such a consultation, or in any other timely and appropriate fashion, in deciding whether to withdraw the notice of intent to disapprove.
              (b) Special disapprovals. (1) The Administrator may disapprove any State registration, including a registration for a similar product, at any time, if the Administrator determines that use of the product under the State registration:
              (i) Would constitute an imminent hazard.

              (ii) May result in a residue on food or feed exceeding, or not covered by, a tolerance, exemption, or other clearance under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a et seq.).
              (2) If the Administrator disapproves a registration under this paragraph, the Administrator shall provide the registering State with written notification of disapproval, in accordance with paragraph (c) of this section, as soon thereafter as practicable. Such notification will specify the grounds for disapproval and invite the State to comment on the decision.
              (3) If requested by the State within ten days of its receipt of a notice of disapproval, the Administrator, or his designee, will consult with appropriate State officials. The Administrator may consider any information presented at such a consultation, or in any other appropriate fashion, in determining whether the disapproval should be rescinded.
              (c) Decision and notification of disapproval. Except as provided in paragraph (b)(1) of this section, the Administrator will make a final decision on disapproval of a State registration, and provide written notification thereof to the State, within 90 days of the effective date of the registration; provided that, if the State does not notify the Agency of a registration within ten days of its effective date, then the Administrator will make a final decision on disapproval within 90 days of the date on which EPA receives notification of the State registration. The notice of disapproval will specify an appropriate date on which the disapproval will become effective. Disapproval may become effective immediately, or at anytime within the period allowed for the Administrator to make a final decision on disapproval. The notice of disapproval will also, when appropriate, give instructions for use or disposal of the pesticide. Each notice of disapproval will be published in the Federal Register.

              (d) Effect of disapproval. If a registration issued by a State is disapproved by the Administrator, that registration will not be valid for any purpose under FIFRA, as of the date the disapproval becomes effective. Thereafter, distribution or sale of the pesticide, in either interstate or intrastate commerce, for uses subject to the disapproval will be a violation of sec. 12(a)(1) of FIFRA.
              (e) Rescission of disapproval. If the Administrator determines, after consultation with the State lead agency, that a registration, previously issued by the State and disapproved by the Administrator, should not have been disapproved under FIFRA, then the Administrator shall rescind the disapproval. The Administrator shall send written notification of the rescission to the State. In addition, the Administrator shall publish notice of any rescission of disapproval in the Federal Register.

              (f) Notification of registrants. Any State that issues a registration which has been disapproved, or which is subject to a notice of intent to disapprove, shall be responsible for notifying the affected registrant of any such notice of intent or disapproval, and of any recession of disapproval by the Administrator.

              § 162.155
              Suspension of State registration authority.
              (a) General. (1) If the Administrator finds that a State is not capable of exercising, or has failed to exercise, adequate control over its registration program, so that the State cannot ensure that registrations issued by it will be in accord with the purposes of FIFRA, then the Administrator may suspend the State's authority to register pesticides under sec. 24(c) of the Act. Registrations issued by the State after suspension of its authority will not be considered valid under FIFRA. Registrations issued by the State prior to suspension will not be affected by the suspension.
              (2) The Administrator may suspend all or any part of a State's registration authority, as appropriate.
              (b) Grounds for suspension. (1) The Administrator may suspend a State's registration authority due to lack of, or failure to exercise, adequate control by the State over its sec. 24(c) registration program. Adequate control includes, but is not limited to, all of the following:
              (i) Access to appropriate scientific and technical personnel to review data and make determinations as required by § 162.153.
              (ii) Registration procedures satisfying § 162.153.
              (iii) Complete and accurate records of State registrations.
              (iv) Adequate legal authority. (A) To deny, suspend, revoke, or amend a State registration when the registration is not in compliance with FIFRA, this subpart, or State law, or when necessary to prevent unreasonable adverse effects on the environment.
              (B) To enter, at reasonable times, by consent, warrant, or other legal means, any establishment where pesticides are produced or held for distribution or sale, to inspect, sample, and observe whether pesticides are being produced or distributed in compliance with FIFRA, this subpart, State law, and the terms of any State registration.
              (2) The Administrator may suspend a State's registration authority if the State fails to exercise the controls specified in paragraph (b)(1) of this section, or if the State refuses to correct within a reasonable time any other significant deficiencies in its regulatory program, as specified by the Administrator in a notice of intent to suspend.
              (c) Procedures for suspension. (1) Prior to suspending the registration authority of any State, the Administrator will notify the State lead agency, in writing, of the Administrator's intent to suspend, and of the specific grounds for suspension. The notice of intent will specify whether the suspension will be complete or partial, and will provide the State an opportunity to respond and a reasonable amount of time, not less than 30 days from the date the notice is received, in which to correct the deficiencies specified in the notice. If the State does not correct the specified deficiencies within the reasonable time allowed by the notice, or if the Administrator has not withdrawn the notice of intent before that time, the notice of intent will be published in the Federal Register, and the public given an opportunity to comment thereon.

              (2) If requested by the affected State lead agency within 30 days of receipt of the notice of intent to suspend, an informal consultation between appropriate State and EPA officials will be held to discuss the proposed suspension. In such a case, the Administrator shall not make a final decision on the proposed suspension until after the consultation. The Administrator shall consider all relevant information presented at the consultation, or in any other appropriate manner, in determining whether to suspend the State's authority. If the Administrator determines, on the basis of such information, that the deficiencies listed in the notice of intent no longer exist, or will be corrected in a reasonable time, then the Administrator will withdraw, in writing, the notice of intent to suspend.

              (3) Within ten days of the date a notice of intent to suspend is published in the Federal Register, a State may request a public hearing to consider the proposed suspension. If a hearing is requested, the Administrator will:
              (i) Schedule a public hearing to be held in that State.
              (ii) Publish in the Federal Register a notice announcing the date, time, and location of the hearing.
              (iii) Appoint a presiding officer who shall preside over the hearing.
              (iv) Prescribe additional, appropriate procedures for the conduct of the hearing, including procedures for the presentation of relevant material evidence from the State, EPA, or members of the public who would be affected by the outcome of the hearing. Evidence may be presented in either oral or written form, at the discretion of the Administrator.
              (4) Following the close of any hearing held under paragraph (c)(3) of this section, the presiding officer shall make a recommended decision that the State's authority to register pesticides under sec. 24(c) of FIFRA be suspended, in whole or in part, or that the State's authority not be suspended and that the notice of intent to suspend be withdrawn.
              (5) Any recommended decision made by a presiding officer under paragraph (c)(4) of this section may be appealed to the Administrator within 30 days after its issuance by the State or by EPA. Any recommended decision which is not appealed, or which the Administrator does not review on his own initiative, will become a final Agency action 30 days after its issuance.
              (6) If no hearing is requested under paragraph (c)(3) of this section, or if a recommended decision is appealed to the Administrator under paragraph (c)(5) of this section, the Administrator shall issue a final order either suspending the State's authority to register pesticides under section 24(c) of FIFRA, in whole or in part, or withdrawing the notice of intent to suspend.

              (7) Any final order suspending State registration authority, issued under paragraph (c) (5) or (6) of this section, will specify the grounds therefor and an effective date for the suspension. If the suspension is merely partial, the notice of suspension will specify the types of registrations which will not be recognized as valid under sec. 24(c). All final orders issued under paragraph (c) (5) or (6) will be published in the Federal Register.

              (d) Termination of suspension. Suspension of a State's authority will be effective for the period specified in the notice of suspension, or if no period was specified, until such time as the Administrator is satisfied that the State can and will exercise adequate control over its program. In the latter case, the Administrator will notify the State that the suspension is terminated, or that it will be terminated on a specific date. In either case, the Administrator will publish a notice of the termination of suspension in the Federal Register.

              (e) Judicial review. Any State whose authority to register pesticides has been finally suspended by the Administrator may seek judicial review of the Administrator's decision under sec. 16 of FIFRA, at any time prior to termination of the suspension. Such suspension shall remain in effect during the period of judicial review unless otherwise ordered by the Administrator.

              § 162.156
              General requirements.
              (a) Requirements for distribution and use. (1) Any product whose State registration has been issued in accordance with §§ 162.152 and 162.153 may be distributed and used in that State, subject to the following provisions of the Act and the regulations promulgated thereunder:

              (i) Sec. 12(a)(1) (A) through (E), in accordance with:
              (A) Sec. 2(q)(1) (A) through (G).
              (B) Sec. 2(q)(2) (A) through (D).
              (ii) Sec. 12(a)(2) (A) through (G) and (I) through (P).
              (2) A product or use classified by a State for restricted use under § 162.153(g) may be used only by, or under the direct supervision of, an applicator certified under a plan approved by EPA in accordance with sec. 4 of FIFRA.
              (3) State registrations which are not issued in accordance with § 162.152 (a) and (b)(2) (i), (ii) and (iii) are not authorized by section 24(c) and are not considered valid for any purposes under FIFRA. When the Administrator determines that a registration is invalid, the Administrator shall notify the registering State that the registration is invalid, and may specify the reason for the invalidity.
              (b) Establishment registration requirements. No person may produce any pesticide, including any pesticide registered by a State under section 24(c), unless the establishment in which it is produced is registered by the Administrator in accordance with sec. 7 of FIFRA and 40 CFR part 167.
              (c) Books and records requirements. All producers of pesticides, including those producers of pesticides registered by States under sec. 24(c), must maintain records in accordance with the requirements imposed under sec. 8 of FIFRA and 40 CFR part 169.

            Subpart E [Reserved]

          Pt. 164
          PART 164—RULES OF PRACTICE GOVERNING HEARINGS, UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT, ARISING FROM REFUSALS TO REGISTER, CANCELLATIONS OF REGISTRATIONS, CHANGES OF CLASSIFICATIONS, SUSPENSIONS OF REGISTRATIONS AND OTHER HEARINGS CALLED PURSUANT TO SECTION 6 OF THE ACT

              Subpart A—General
              Sec.
              164.1
              Number of words.
              164.2
              Definitions.
              164.3
              Scope and applicability of this part.
              164.4
              Arrangements for examining Agency records, transcripts, orders, and decisions.
              164.5
              Filing and service.
              164.6
              Time.
              164.7
              Ex parte discussion of proceeding.
              164.8
              Publication.

              Subpart B—General Rules of Practice Concerning Proceedings (Other Than Expedited Hearings)

                Commencement of Proceeding
                164.20
                Commencement of proceeding.
                164.21
                Contents of a denial of registration, notice of intent to cancel a registration, or notice of intent to change a classification.
                164.22
                Contents of document setting forth objections.
                164.23
                Contents of the statement of issues to accompany notice of intent to hold a hearing.
                164.24
                Response to the Administrator's notice of intention to hold a hearing.
                164.25
                Filing copies of notification of intent to cancel registration or change classification or refusal to register, and statement of issues.

                Appearances, Intervention, and Consolidation
                164.30
                Appearances.
                164.31
                Intervention.
                164.32
                Consolidation.

                Administrative Law Judge
                164.40
                Qualifications and duties of Administrative Law Judge.

                Prehearing Procedures and Discovery
                164.50
                Prehearing conference and primary discovery.
                164.51
                Other discovery.

                Motions
                164.60
                Motions.

                Subpoenas and Witness Fees
                164.70
                Subpoenas.
                164.71
                Fees of witnesses.

                The Hearings
                164.80
                Order of proceeding and burden of proof.
                164.81
                Evidence.
                164.82
                Transcripts.

                Initial or Accelerated Decision
                164.90
                Initial decision.
                164.91
                Accelerated decision.

                Appeals
                164.100
                Appeals from or review of interlocutory orders or rulings.
                164.101
                Appeals from or review of initial decisions.
                164.102
                Appeals from accelerated decisions.
                164.103
                Final decision or order on appeal or review.
                164.110
                Motion for reopening hearings; for rehearing; for reargument of any proceeding; or for reconsideration of order.
                164.111
                Procedure for disposition of motions.

              Subpart C—General Rules of Practice for Expedited Hearings
              164.120
              Notification.
              164.121
              Expedited hearing.
              164.122
              Final order and order of suspension.
              164.123
              Emergency order.

              Subpart D—Rules of Practice for Applications Under Sections 3 and 18 To Modify Previous Cancellation or Suspension Orders
              164.130
              General.
              164.131
              Review by Administrator.
              164.132
              Procedures governing hearing.
              164.133
              Emergency waiver of hearing.

            Authority:
            7 U.S.C. 136d.

            Source:
            38 FR 19371, July 20, 1973, unless otherwise noted.

            Subpart A—General

              § 164.1
              Number of words.
              As used in this part, a word in the singular form shall be deemed to import the plural, and vice versa, as the case may require.

              § 164.2
              Definitions.
              For the purposes of this part, the following terms shall be defined, as listed below:
              (a) The term Act means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 973) and other legislation supplementary thereto and amendatory thereof.
              (b) The term Administrative Law Judge means an Administrative Law Judge appointed pursuant to 5 U.S.C. 3105 (see also 5 CFR part 930, as amended), and such term is synonymous with the term “Hearing Examiner” as used in the Act or in the United States Code.
              (c) The term Administrator means the Administrator of the United States Environmental Protection Agency.
              (d) The term Agency, unless otherwise specified, means the United States Environmental Protection Agency.
              (e) The term Applicant means any person who has made application to have a pesticide registered or classified pursuant to the provisions of the Act.
              (f) The term Committee means a group of qualified scientists designated by the National Academy of Sciences according to agreement under the Act to submit an independent report to the Administrative Law Judge on questions of scientific fact referred from a hearing under subpart B of this part.
              (g) Environmental Appeals Board shall mean the Board within the Agency described in § 1.25 of this title. The Administrator delegates authority to the Environmental Appeals Board to issue final decisions in appeals filed under subparts B and C of this part. An appeal directed to the Administrator, rather than to the Environmental Appeals Board, will not be considered. This delegation does not preclude the Environmental Appeals Board from referring an appeal or a motion under subparts B and C to the Administrator when the Environmental Appeals Board, in its discretion, deems it appropriate to do so. When an appeal or motion is referred to the Administrator, all of the parties shall be so notified and the rules in subparts B and C referring to the Environmental Appeals Board shall be interpreted as referring to the Administrator.
              (h) The term Expedited Hearing means a hearing commenced as the result of the issuance of a notice of intention to suspend or the suspension of a registration of a pesticide by an emergency order, and is limited to a consideration as to whether a pesticide presents an imminent hazard which justifies such suspension.
              (i) The term Hearing means a public hearing which is conducted pursuant to the provisions of chapter 5, subchapter II of title 5 of the United States Code and the regulations of this part.
              (j) The term Hearing Clerk means the Hearing Clerk, Environmental Protection Agency, Washington, DC 20460.
              (k) The term Initial Decision means the decision of the Administrative Law Judge supported by findings of fact and conclusions regarding all material issues of law, fact, or discretion, as well as reasons therefor. Such decision shall become the final decision and order of the Administrator without further proceedings unless an appeal therefrom is taken or the Administrator orders review thereof as herein provided.
              (l) The term Judicial Officer means an officer or employee of the Agency designated as a judicial officer, pursuant to these rules, who shall meet the qualifications and perform functions as herein provided.
              (1) Office. There may be designated for the Agency one or more judicial officers, one of whom may be Chief Judicial Officer. As work requires, there may be a judicial officer designated to act for the purpose of a particular case. All prior designations of judicial officer shall stay in force until further notice.
              (2) Qualification. A judicial officer shall be a permanent or temporary employee or officer of the Agency who may perform other duties for the Agency. Such judicial officer shall not be employed by the Office of Chemical Safety and Pollution Prevention or have any connection with the preparation or presentation of evidence for a hearing.
              (3) Functions. The Administrator may delegate any or part of his authority to act in a given case under subparts B and C of this part to a judicial officer. The Administrator can separately delegate his authority to rule on interlocutory orders and motions, and may also delegate his authority to make findings of fact and draw conclusions of law in a particular proceeding, providing that this delegation shall not preclude the Judicial Officer from referring any motion or case to the Administrator when the Judicial Officer determines such referral to be appropriate. The Administrator, in deciding a case himself, may consult with and assign the preliminary drafting of conclusions of law and findings of fact to any judicial officer.
              (m) The term Party means any person, group, organization, or Federal agency or department that participates in a hearing.
              (n) The term Person includes any individual, partnership, association, corporation, and any organized group of persons, whether incorporated or not.
              (o) The term Petitioner means any person adversely affected by a notice of the Administrator who requests a public hearing.
              (p) The term Presiding Officer means any person designated by the Administrator to conduct an expedited hearing.
              (q) The term Recommended Decision means the recommended findings and conclusions of the Presiding Officer in an expedited hearing.
              (r) The term Registrant means any person who has registered a pesticide pursuant to the provisions of the Act.
              (s) The term Respondent means the Assistant Administrator of the Office of Chemical Safety and Pollution Prevention.
              Terms defined in the act and not explicitly defined herein are used herein with the meanings given in the act.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992; 57 FR 30657, July 10, 1992; 73 FR 75597, Dec. 12, 2008; 77 FR 46292, Aug. 3, 2012]

              § 164.3
              Scope and applicability of this part.
              The provisions of subpart B of this part shall govern proceedings, conducted pursuant to the provisions of the Act, concerning refusals to register, cancellations of registration, changes of classifications or hearings called by the Administrator; the provisions of subpart C of this part shall govern suspension proceedings conducted pursuant to the provisions of the Act.

              § 164.4
              Arrangements for examining Agency records, transcripts, orders, and decisions.
              (a) Reporting of orders, decisions, and other signed documents. All orders, decisions, or other signed documents required by the rules in this part, whether issued by the Environmental Appeals Board or the Presiding Officer shall be made available to the public.
              (b) Establishment of an Agency repository. In addition, all transcripts and docket entries shall become part of the official docket and shall be retained by the hearing clerk. At least two copies of all final orders, decisions and a notification of any appeals taken therefrom shall be retained by the hearing clerk and filed chronologically and shall be periodically bound and indexed. All the above documents shall be made available to the public for reasonable inspections during Agency business hours.

              (c) Whenever any information or data is required to be produced or examined and any party to the proceeding claims that such information is a trade secret or commercial or financial information, other than information relating to the formulas of a pesticide, the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board may require production or testimony in camera and sealed to all but the parties.
              (d) All orders, decisions, or other documents made or signed by the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board shall be filed with the hearing clerk. The hearing clerk shall immediately serve all parties with a copy of such order, decision, or other document.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]

              § 164.5
              Filing and service.
              (a) All documents or papers required or authorized to be filed, shall be filed with the hearing clerk, except as provided otherwise in this part. At the same time that a party files documents or papers with the clerk, it shall serve upon all other parties copies thereof, with a certificate of service on each document or paper, including those filed with the hearing clerk. If filing is accomplished by mail addressed to the clerk, filing shall be deemed timely if the papers are postmarked on the due date except as to initial filings requesting a public hearing or responding to a notice of intent to hold a hearing, in which case such filings must be received by the hearing clerk either within the time required by statute or by the notice of intent to hold a hearing.
              (b) Each document filed, other than papers commencing a proceeding, shall contain the FIFRA docket number and, if the document affects less than all of the registrations included under that docket number, the registration number or file symbol of each product which is the subject of the document.
              (c) In addition to copies served on all other parties, each party shall file an original and two copies of all papers with the hearing clerk.

              § 164.6
              Time.
              (a) Computation. In computing any period of time prescribed or allowed by these rules, except as otherwise provided, the day of the act, event, or default from which the designated period of time begins to run shall not be included. Saturdays, Sundays, and legal holidays shall be included in computing the time allowed for the filing of any document or paper, except that when such time expires on a Saturday, Sunday, or legal holiday, such period shall be extended to include the next following business day.
              (b) Enlargement. When by these rules or by order of the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board, an act is required or allowed to be done at or within a specified time, the Administrative Law Judge (before his initial decision is filed), or the Presiding Officer (before his recommended decision is filed), or the Environmental Appeals Board (after the Administrative Law Judge's initial decision or the presiding officer's recommended decision is filed), for cause shown may at any time in their discretion: with or without motion or notice, order the period enlarged if request therefor, which may be made ex parte, is made before the expiration of the period originally prescribed or as extended by a previous order; or on motion made after the expiration of the specified period, permit the act to be done where the failure to act was the result of excusable neglect. In this connection, consideration shall be given to the fact that, under the provisions of the act, the Administrator must issue his order not later than 90 days after the completion of the hearing, unless all parties agree by stipulation to extend this period of time pursuant to § 164.103.
              (c) Additional time after service by mail. A prescribed period of time within which a party is required or permitted to do an act shall be computed from the time of service, except that when the service is made by mail, 3 days shall be added to the prescribed period. Such addition for service by mail shall not apply in the case of filing initial requests for hearings or responding to a notice of intent to hold a hearing, in which cases statutory filing times will run from the date of the return receipt pursuant to § 164.8.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]

              § 164.7
              Ex parte discussion of proceeding.

              At no stage of a proceeding shall the Administrator, the members of the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge discuss ex parte the merits of the proceeding with any party or with any person who has been connected with the preparation or presentation of the proceeding as an advocate, or in an investigative or expert capacity, or with any representative of such person, Provided, That the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge may discuss the merits of the case with any such person if all parties to the proceeding, or their representatives, have been given reasonable notice and opportunity to be present. Any memorandum or other communication addressed to the Administrator, the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge during the pendency of the proceeding, and relating to the merits thereof, by or on behalf of any party, shall be regarded as an argument made in the proceeding. The Administrator, the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge shall cause any such communication to be filed with the hearing clerk and served upon all other parties to the proceeding who will be given the opportunity to file an answer thereto.
              [57 FR 5342, Feb. 13, 1992]

              § 164.8
              Publication.

              All notices of intention to cancel a registration, all notices of intention to change a classification, and all denials of registrations, all together with the reasons (including the factual basis therefor), and all notices of intention by the Administrator to hold a hearing, together with the statement of issues as provided by § 164.20(b) shall be sent to the registrant or applicant by registered or certified mail (return receipt requested), and published by appropriate announcement in the Federal Register by the Administrator. The Administrative Law Judge shall cause to be published in the Federal Register by appropriate announcement, a notice of the filing of any objections, pursuant to § 164.20(b) or responses pursuant to § 164.24, and a notice of the public hearing as provided by § 164.80 et seq. Said notice of public hearing shall designate the place where the hearing will be held and specify the time when the hearing will commence. The hearing shall convene at the place and time announced in the notice, unless amended by subsequent notice published in the Federal Register, but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof at the hearing.

            Subpart B—General Rules of Practice Concerning Proceedings (Other Than Expedited Hearings)

              Commencement of Proceeding

                § 164.20
                Commencement of proceeding.
                (a) A proceeding shall be commenced whenever a hearing is requested by any person adversely affected by a notice of the Administrator of his refusal to register or of his intent to cancel the registration or to change the classification of a pesticide. A proceeding shall likewise be commenced whenever the Administrator decides to call a hearing to determine whether or not the registration of a pesticide should be canceled or its classification changed. Such request or notice of intent to hold a hearing shall be timely filed with the hearing clerk, and the matter shall be docketed and assigned a FIFRA docket number.

                (b) If a request for a hearing is filed, the person filing the request shall, at the same time, file a document stating his objections to the Administrator's refusal to register or his intent to cancel the registration or to change the classification of a pesticide. If a notice of intent to hold a hearing is filed by the Administrator, he shall, at the same time, file a statement of issues.
                (c) Upon the filing of any objections or notice of intent to hold a hearing, the proceeding shall be referred to the Chief Administrative Law Judge by the hearing clerk. The Chief Administrative Law Judge shall refer the proceeding to himself or another Administrative Law Judge who shall thereafter be in charge of all further matters concerning the proceedings, except as otherwise provided for by order of the Chief Administrative Law Judge, the Administrator, or the Environmental Appeals Board.
                [38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992]

                § 164.21
                Contents of a denial of registration, notice of intent to cancel a registration, or notice of intent to change a classification.
                (a) Contents. The denial of registration or a notice of intent to cancel a registration or to change a classification shall be accompanied by the reasons (including the factual basis) for the action.
                (b) Amendments to contents of denials and notices. Such documents under this section may be amended or enlarged by the Administrator at any time prior to the commencement of the public hearing. If the Administrative Law Judge determines that additional time is necessary to permit a party to prepare for matters raised by such amendments, the commencement of the hearing shall be delayed for an appropriate period.

                § 164.22
                Contents of document setting forth objections.
                (a) Concise statement required. Any document containing objections to an order of the Administrator of his refusal to register, or his intent to cancel the registration, or change the classification of a pesticide, shall clearly and concisely set forth such objections and the basis for each objection, including relevant allegations of fact concerning the pesticide under consideration. The document shall indicate the registration number of the pesticide, if applicable, a copy of the currently accepted and/or proposed labeling and a list of the currently registered or proposed uses of said pesticide.
                (b) Amendments to objections byleave. Objections may be amended at any time prior to the commencement of the public hearing by leave of the Administrative Law Judge or by written consent of all parties. The Administrative Law Judge shall freely grant such leave when justice so requires. If the Administrative Law Judge determines that additional time is necessary to permit a party to prepare for matters raised by amendments to objections, the commencement of the hearing shall be delayed for an appropriate period. This subsection shall not permit the addition, beyond the statutory deadline, of registered pesticides which are not included in the objections filed pursuant to paragraph (a) of this section.
                (c) Amendments to objections as a matter of right. Objections may be amended as a matter of right within 30 days, or in such time as the Administrator shall designate, after the Administrator amends his notice of intent to cancel a registration, change a classification, or his refusal to register a pesticide.

                § 164.23
                Contents of the statement of issues to accompany notice of intent to hold a hearing.
                (a) Concise statement required. The statement of issues by the Administrator shall set a time in which any person wishing to participate in the hearing shall file a written response to the statement of issues as provided by § 164.24. The statement of issues shall include questions as to which evidence shall be taken at the hearing. Those questions may include questions concerning whether a pesticide's registration should be canceled or its classification changed, whether its composition is such as to warrant the claims for it, whether its labeling and other material submitted comply with the requirements of the Act, whether it will perform its intended function without unreasonable adverse effects on the environment, and whether, when used in accordance with widespread and commonly recognized practice, it will or will not generally cause unreasonable adverse effects on the environment.
                (b) Amendment to statement of issues. The statement of issues may be amended or enlarged by the Administrator at any time prior to the commencement of the public hearing. If the Administrative Law Judge determines that additional time is necessary to permit a party to prepare for matters raised by amendments or enlargements to the statement of issues, the commencement of the hearing shall be delayed for an appropriate period.

                § 164.24
                Response to the Administrator's notice of intention to hold a hearing.
                Any person wishing to participate in any proceeding commenced pursuant to any notice by the Administrator of intention to hold a hearing, shall file with the hearing clerk, within the time set by the Administrator in the notice (in no case less than 30 days from the date of the notice), a written response to the statement of issues which shall include the position and interest of such person with respect thereto. If any such person is a registrant or an applicant for registration, he shall also file the registration number of the pesticide, if applicable, a copy of the currently accepted and/or proposed labeling and a list of the currently registered or proposed uses of said pesticide.

                § 164.25
                Filing copies of notification of intent to cancel registration or change classification or refusal to register, and statement of issues.
                After a copy of the document setting forth the objections and requesting a public hearing is filed with the hearing clerk or a response to the statement of issues is filed, the hearing clerk shall serve a copy of the document upon Respondent and the Office of the General Counsel of the Agency, Respondent shall, by counsel, thereupon file with the hearing clerk a copy of the appropriate notice of intention to cancel, the notice of intention to change the classification or the registration refusal order.

              Appearances, Intervention, and Consolidation

                § 164.30
                Appearances.

                  Representatives. Parties may appear in person or by counsel or other representative. Persons who appear as counsel or in a representative capacity must conform to the standards of ethical conduct required of practitioners before the courts of the United States.

                § 164.31
                Intervention.
                (a) Motion. Any person may file a motion for leave to intervene in a hearing conducted under this subpart. A motion must set forth the grounds for the proposed intervention, the position and interest of the movant in the proceeding and the documents proposed to be filed pursuant to either § 164.22 or § 164.24.
                (b) When filed. A motion for leave to intervene in a hearing must ordinarily be filed prior to the commencement of the first prehearing conference. Any motion filed after that time must contain, in addition to the information set forth in paragraph (a) of this section, a statement of good cause for the failure to file the motion prior to the commencement of the first prehearing conference, and shall be granted only upon a finding (1) that extraordinary circumstances justify the granting of the motion, or (2) that the intervenor shall be bound by agreements, arrangements, and other matters previously made in the proceeding.
                (c) Disposition. Leave to intervene will be freely granted but only insofar as such leave raises matters which are pertinent to and do not unreasonably broaden the issues already presented. If leave is granted, the movant shall thereby become a party with the full status of the original parties to the proceedings. If leave is denied, the movant may request that the ruling be certified to the Environmental Appeals Board, pursuant to § 164.100 for a speedy appeal.
                (d) Amicus curiae. Persons not parties to the proceedings wishing to file briefs may do so by leave of the Administrative Law Judge granted on motion. A motion for leave shall identify the interest of the applicant and shall state the reasons why the proposed amicus brief is desirable. Unless all parties otherwise consent, an amicus curiae shall file its brief within the time allowed the party whose position the brief will support. Upon a showing of good cause, the Administrator or Administrative Law Judge may grant permission for later filing.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]

                § 164.32
                Consolidation.
                The Chief Administrative Law Judge, by motion or sua sponte, may consolidate two or more proceedings whenever it appears that this will expedite or simplify consideration of the issues. Consolidation shall not affect the right of any party to raise issues that could have been raised if consolidation had not occurred. At the conclusion of proceedings consolidated under this section, the Administrative Law Judge shall issue one decision under § 164.90 unless one or more of the consolidated proceedings have been dismissed pursuant to § 164.91.

              Administrative Law Judge

                § 164.40
                Qualifications and duties of Administrative Law Judge.
                (a) Qualifications. The Administrative Law Judge shall have the qualifications required by statute. He shall not decide any matter in connection with a proceeding where he has a financial interest in any of the parties or a relationship with a party that would make it otherwise inappropriate for him to act.
                (b) Disqualification of the Administrative Law Judge. (1) Any party may, by motion made to the Administrative Law Judge, as soon as practicable, request that he disqualify himself and withdraw from the proceeding. The Administrative Law Judge shall then rule upon the motion and, upon request of the movant, shall certify an adverse ruling for appeal.
                (2) Withdrawal sua sponte. The Administrative Law Judge may at any time withdraw from any proceedings in which he deems himself disqualified for any reason.
                (c) Conduct. The Administrative Law Judge shall conduct the proceeding in a fair and impartial manner subject to the precepts of the Canons of Judicial Ethics of the American Bar Association.
                (d) Power. Subject to review, as provided elsewhere in this part, the Administrative Law Judge shall have power to take actions and decisions in conformity with statute or in the interests of justice. The Administrative Law Judge shall not interrupt the recording of the proceedings on the record over the objection of any party.
                (e) Absence or change of the Administrative Law Judge. In the case of the absence or unavailability of the Administrative Law Judge, or his inability to act, or his removal by disqualification or withdrawal, the powers and duties to be performed by him under this part in connection with a hearing assigned to him may, unless otherwise directed by the Administrator, be assigned to another Administrative Law Judge so designated to act by the Chief Administrative Law Judge, the Administrator or the Environmental Appeals Board.
                [38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992]

              Prehearing Procedures and Discovery

                § 164.50
                Prehearing conference and primary discovery.
                (a) Purpose of the prehearing conference. Except as otherwise provided in paragraph (d) of this section, the Administrative Law Judge shall, prior to the commencement of the hearing and for the purpose of expediting the hearing, file with the hearing clerk an order for a prehearing conference. More than one such conference may be held. Such order or orders shall direct the parties or their counsel to appear at a specified time and place to consider:
                (1) The simplification of issues including listing of specific uses to be contested;
                (2) The necessity or desirability of amendments to the objections or statement of issues, or any document filed in response thereto;
                (3) The possibility of obtaining stipulations of fact and documents which will avoid unnecessary delay;

                (4) Matters of which official notice may be taken;

                (5) The limitation of the number of expert and other witnesses;
                (6) Procedure at the hearing except as so provided in § 164.80(a);
                (7) The use of verified written statements in lieu of oral direct testimony;
                (8) The intent of any party to request a scientific advisory committee as defined in § 164.2(f);
                (9) The issuance of subpoenas and subpoenas duces tecum for discovery and hearing purposes;

                (10) A setting of a time and place for the public hearing, after giving careful consideration to the convenience of all the parties, the witnesses, the public interest and the necessity for notice in the Federal Register as provided by § 164.8; and
                (11) Any other matter that may expedite the hearing or aid in the disposition of the proceeding.
                (b) Primary discovery (Exchange of witness lists and documents). At a prehearing conference or within some reasonable time set by the Administrative Law Judge prior to the hearing, each party shall make available to the other parties the names of the expert and other witnesses the party expects to call, together with a brief narrative summary of their expected testimony and a list of all documents and exhibits which the party expects to introduce into evidence. Thereafter, witnesses, documents, or exhibits may be added and narrative summaries of expected testimony amended upon motion by a party.
                (c) Record of the prehearing conference. No transcript of any prehearing conference shall be made unless a request therefor by one of the parties is granted by the Administrative Law Judge. Such party shall bear the cost of the taking of the transcript unless otherwise ordered by the Administrative Law Judge. The Administrative Law Judge shall prepare and file for the record a written report of the action taken at each conference, which shall incorporate any stipulations or agreements made by the parties at or as a result of such conference, all rulings upon matters considered at such conference and appropriate orders.
                (d) Unavailability of a prehearing conference. Upon a finding that circumstances render a prehearing conference unnecessary, or impracticable, or upon a finding that a prehearing conference would serve primarily to delay the proceedings rather than to expedite them, the Administrative Law Judge, on motion or sua sponte, may order that the prehearing conference not be held. In these circumstances he may request the parties to correspond with him for the purpose of accomplishing any of the objectives set forth in this section. Such correspondence shall not be made a part of the record, but the Administrative Law Judge shall submit a written summary for the record if any action is taken.
                (e) Submission of questions to an advisory committee—(1) General. At any prehearing conference, or if none is held prior to the public hearing, except as herein provided, the Administrative Law Judge shall determine whether any party desires that questions of scientific fact be referred to a committee designated by the National Academy of Sciences.
                (2) Preparation of questions. On determining an affirmative intent, the Administrative Law Judge shall direct all parties to file and serve, within a time period subject to his discretion, proposed questions of scientific fact accompanied by reasons supporting their submission to said committee. Within 10 days of the service of such proposed questions, together with their supporting reasons, any party may respond in writing to the proposed submission of the questions to the said committee. The Administrative Law Judge shall determine whether or not a reference of questions of scientific fact to said committee is necessary or desirable. In the event he decides such reference is necessary or desirable, he shall so inform the National Academy in writing, and shall prepare in his discretion appropriate questions. If any of the questions prepared are not in substance based upon the submissions of the parties, the Administrative Law Judge shall permit any party 10 days after their preparation to respond in writing to the proposed submission of said question or questions. He shall then determine whether such questions should be referred to the committee.

                (3) Reference and report. Not less than 30 days after he has informed the National Academy that questions of scientific fact will be referred to it, the Administrative Law Judge shall refer the questions of scientific fact as prepared. The committee shall report in writing to the Administrative Law Judge within 60 days after such referral on these questions of scientific fact and the report, its record and any other matter transmitted as provided for by the Administrator's agreement with the National Academy of Sciences shall be made public and considered as part of the hearing record.
                (4) Request and submission subsequent to prehearing conference. At any time before the hearing is closed, the Administrative Law Judge or a party by motion may request that questions of scientific fact not previously referred be referred, or that questions previously referred be amended or expanded. The Administrative Law Judge may refer such questions if he finds that good cause exists and that reference of such questions is necessary or desirable.
                [38 FR 19371, July 20, 1973, as amended at 39 FR 11884, Apr. 1, 1974]

                § 164.51
                Other discovery.
                (a) General. Except as so provided by § 164.50(b) supra, further discovery, under this subpart, shall be permitted only upon determination by the Administrative Law Judge (1) that such discovery shall not in any way unreasonably delay the proceeding, (2) that the information to be obtained is not otherwise obtainable and (3) that such information has significant probative value. The Administrative Law Judge shall be guided by the procedures set forth in the Federal Rules of Civil Procedure, where practicable, and the precedents thereunder, except that no discovery shall be undertaken except upon order of the Administrative Law Judge or upon agreement of the parties.
                (b) Depositions upon oral questions. The Administrative Law Judge shall order depositions upon oral questions only upon a showing of good cause and upon a finding that (1) the information sought cannot be obtained by alternative methods, or (2) there is a substantial reason to believe that relevant and probative evidence may otherwise not be preserved for presentation by a witness at the hearing.
                (c) Procedure. (1) Any party to the proceeding desiring discovery shall make a motion or motions therefor. Such a motion shall set forth (i) the circumstances warranting the taking of the discovery, (ii) the nature of the information expected to be discovered and (iii) the proposed time and place where it will be taken.
                (2) If the Administrative Law Judge determines the motion should be granted, he shall issue an order and appropriate subpoenas, if necessary, for the taking of such discovery together with the conditions and terms thereof.

              Motions

                § 164.60
                Motions.
                (a) General. All motions, except those made orally during the course of a public hearing or as otherwise provided by this part, shall be in writing and shall state with particularity the grounds therefor, shall set forth the relief or order sought, and shall be filed with the hearing clerk and served on all parties.
                (b) Response to motions. Within 10 days after service of any motion filed pursuant to this part, or within such other time as may be fixed by the Administrator, his designee, or the Administrative Law Judge, any party may serve and file an answer to the motion. The movant shall, if requested by the Administrator, his designee, or the Administrative Law Judge, serve and file reply papers within the time set by the request.
                (c) Decision. The Administrative Law Judge shall rule upon all motions filed or made prior to the filing of his initial or accelerated decision at the time of filing on ex parte motions or where the movant has stated that no party objects to the granting of such motion. Otherwise, such decision shall await the answering papers and reply papers if permitted. The Environmental Appeals Board shall rule upon all motions filed after the filing of the initial or accelerated decision. Oral argument of motions will be permitted only if the Administrative Law Judge or the Environmental Appeals Board deems it necessary.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

              Subpoenas and Witness Fees

                § 164.70
                Subpoenas.
                (a) The attendance of witnesses or the production of documentary evidence may, by subpoena, be required at any designated place of hearing or place of discovery. Subpoenas may be issued by the Administrative Law Judge sua sponte or upon a showing by an applicant that evidence sought for hearing is relevant and material to the issues involved in the hearing or that the sought discovery pursuant to § 164.51 meets the standards set forth therein. The Administrative Law Judge shall be guided by the principles of the Federal Rules of Civil Procedure in making any order for the protection of a witness or the content of the documents produced.
                (b) Motion for subpoena duces tecum. Subpoenas for the production of documentary evidence, unless issued by the Administrative Law Judge sua sponte, shall be issued only upon a written motion. Such motion shall specify, as exactly as possible, the documents desired.
                (c) Service of subpoenas. Subpoenas shall be served as provided by the Federal Rules of Civil Procedure.

                § 164.71
                Fees of witnesses.
                Witnesses summoned before the Administrative Law Judge shall be paid the same fees and mileage that are paid witnesses in the courts of the United States, and persons whose depositions are taken, and the persons taking the same, shall be entitled to the same fees as are paid for like services in the courts of the United States. Fees shall be paid by the party at whose instance the witness appears or the deposition is taken.

              The Hearings

                § 164.80
                Order of proceeding and burden of proof.
                (a) At the hearing, the proponent of cancellation or change in classification has the burden of going forward to present an affirmative case for the cancellation or change in classification of the registration. In the case of the denial of an application for registration, the applicant shall have the burden of going forward. In the case of a hearing called by the Administrator, the Respondent has the burden of going forward to present an affirmative case as to the statement of issues. The party having the burden of going forward shall have the opportunity to submit evidence on rebuttal.
                (b) On all issues arising in connection with the hearing, the ultimate burden of persuasion shall rest with the proponent of the registration.

                (c) If any party, other than Respondent, after being duly notified, fails to appear at the hearing, he shall be deemed to have authorized the Administrative Law Judge to dismiss the proceeding with or without prejudice, as the Administrative Law Judge may determine, unless a motion excusing the failure to appear has been made and granted. In the event that a party appears at the hearing and no representative of the Agency appears, the Administrative Law Judge shall proceed ex parte to hear the evidence of the party: Provided, That failure on the part of Respondent to appear at a hearing shall not be deemed to be a waiver of Respondent's right to file proposed findings of fact, conclusions of law and orders, to be served with a copy of the Administrative Law Judge's initial or accelerated decision, and to file exceptions with and to submit argument before the Administrator with respect thereto.

                § 164.81
                Evidence.
                (a) General. The Administrative Law Judge shall admit all relevant, competent and material evidence, except evidence that is unduly repetitious. Relevant, competent and material evidence may be received at any hearing even though inadmissible under the rules of evidence applicable to judicial proceedings. The weight to be given evidence shall be determined by its reliability and probative value. In all hearings the testimony of witnesses shall be taken orally, except as otherwise provided by these rules or by the Administrative Law Judge. Parties, however, shall have the right to cross-examine a witness who appears at the hearing, provided that such cross examination is not unduly repetitious.
                (b) Report of a committee of the National Academy of Sciences. If questions have been submitted to a committee designated by the National Academy pursuant to § 164.50(e), the report of the committee, other material that may be required by the Administrator and a list of witnesses and evidence relied upon shall be received into evidence and made part of the record of the hearing. Objections to the report may also be made part of the record and go to the weight of its evidentiary value.
                (c) Objections. If a party objects to the admission or rejection of any evidence or the limitation of the scope of any examination or cross-examination, he shall state briefly the grounds for such objection. The transcript shall include any argument or debate thereon, unless the Administrative Law Judge, with the consent of all parties, orders that such argument not be transcribed. The ruling and the reasons given therefor by the Administrative Law Judge on any objection shall be a part of the transcript. An automatic exception to that ruling will follow.
                (d) Exhibits. Except where the Administrative Law Judge finds that the furnishing of copies is impracticable, a copy of each exhibit filed with the Administrative Law Judge shall be furnished to each other party. A true copy of an exhibit may, in the discretion of the Administrative Law Judge, be substituted for the original.
                (e) Official Notice. Official notice may be taken of Agency proceedings, any matter judicially noticed in the Federal courts, and of other facts within the specialized knowledge and experience of the Agency. Any active party shall be given adequate opportunity to show that such facts are erroneously noticed by presenting evidence to the contrary.
                (f) Offer of proof. Whenever evidence is deemed inadmissible, the party offering such evidence may make an offer of proof, which shall be included in the transcript. The offer of proof for excluded oral testimony shall consist of a brief statement describing the nature of the evidence excluded. If the evidence consists of a document or exhibit, it shall be inserted in the record in total. In the event the Environmental Appeals Board decides that the Administrative Law Judge's ruling in excluding the evidence was erroneous and prejudicial, the hearings may be reopened to permit the taking of such evidence, or where appropriate, the Environmental Appeals Board may evaluate the evidence and proceed to a final decision.
                (g) Verified statements. With the approval of the Administrative Law Judge, a witness may insert into the record, as his testimony, statements of fact or opinion prepared by him or written answers to interrogatories of counsel, or may submit as an exhibit his prepared statement, provided that such statements or answers must not include legal argument. Before any such statement or answer is read or admitted into evidence the witness shall deliver to the Administrative Law Judge, the reporter, and opposing counsel a copy of such. The admissibility of the evidence contained in such statement shall be subject to the same rules as if such testimony were produced in the usual manner and the witness shall be subject to oral cross-examination on the contents of such statements. Approval for such a procedure may be denied when it appears to the Administrative Law Judge that the memory or the demeanor of the witness is of importance.
                [38 FR 19371, July 20, 1973, as amended at 40 FR 25815, June 19, 1975; 57 FR 5343, Feb. 13, 1992]

                § 164.82
                Transcripts.
                (a) Filing and certification. Hearings shall be stenographically reported, transcribed and made available to the public as required by statute or Agency regulations. As soon as practicable after the taking of the last evidence, the Administrative Law Judge shall certify (1) that the original transcript is a true transcript of the testimony offered or received at the hearing, except in such particulars as he shall specify and (2) that the exhibits accompanying the transcript are all the exhibits introduced at the hearing, with such exceptions as he shall specify. A copy of such certificate shall be attached to each of the copies of the transcript.
                (b) [Reserved]

              Initial or Accelerated Decision

                § 164.90
                Initial decision.
                (a) Proposed findings of fact, conclusions, and order. Within 20 days after the last evidence is taken in a hearing, each party may file with the hearing clerk proposed orders, findings of fact, and conclusions of law based solely on the record, and a brief in support thereof. Within 10 days thereafter, each party may file a reply brief. The Administrative Law Judge may, in his discretion, extend the total time period for filing any proposed findings, conclusions, orders or briefs for an additional 30 days. In such instances, briefs and replies shall be due at such time as the Administrative Law Judge may fix by order. The hearing shall be deemed closed at the conclusion of the briefing period.
                (b) Initial decision. The Administrative Law Judge, within 25 days after the close of the hearing, shall evaluate the record before him, and prepare and file his initial decision with the hearing clerk. A copy of the initial decision shall be served upon each of the parties, and the hearing clerk shall immediately transmit a copy to the Environmental Appeals Board. The initial decision shall become the decision of the Environmental Appeals Board without further proceedings unless an appeal is taken from it or the Environmental Appeals Board orders review of it, pursuant to § 164.101.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                § 164.91
                Accelerated decision.
                (a) General. The Administrative Law Judge, in his discretion, may at any time render an accelerated decision in favor of Respondent as to all or any portion of the proceeding, including dismissal without further hearing or upon such limited additional evidence such as affidavits as he may receive, under any of the following conditions:
                (1) Untimely or insufficient objections filed pursuant to § 164.20;
                (2) Failure to comply with discovery orders;
                (3) Failure to comply with prehearing orders;
                (4) Failure to appear or to proceed at prehearing conferences;
                (5) Failure to appear at the hearing;
                (6) Failure to state a claim upon which relief can be granted, or direct or collateral estoppel.
                (7) Theat there is no genuine issue of any material fact and that the respondent is entitled to judgment as a matter of law; or
                (8) Such other and further reasons as are just.
                (b) Effect. A decision rendered under this section shall have the same force and effect as an initial decision entered under § 164.90.

              Appeals

                § 164.100
                Appeals from or review of interlocutory orders or rulings.

                Except as provided herein, appeals as a matter of right shall lie to the Environmental Appeals Board only from an initial or accelerated decision of the Administrative Law Judge. Appeals from other orders or rulings shall, except as provided in this section, lie only if the Administrative Law Judge certifies such orders or rulings for appeal, or otherwise as provided. The Administrative Law Judge may certify an order or ruling for appeal to the Environmental Appeals Board when: (a) The order or ruling involves an important question of law or policy about which there is substantial ground for difference of opinion; and (b) either (1) an immediate appeal from the order and ruling will materially advance the ultimate termination of the proceeding or (2) review after the final judgment is issued will be inadequate or ineffective. The Administrative Law Judge shall certify orders or rulings for appeal only upon the request of a party. If the Environmental Appeals Board determines that certification was improvidently granted, or takes no action within thirty (30) days of the certification, the appeal shall be deemed dismissed. When an order or ruling is not certified by the Administrative Law Judge, it shall be reviewed by the Environmental Appeals Board only upon appeal from the initial or accelerated decision except when the Environmental Appeals Board determines, upon request of a party and in exceptional circumstances, that delaying review would be deleterious to vital public or private interests. Except in extraordinary circumstances proceedings will not be stayed pending an interlocutory appeal; where a stay is granted, a stay of more than 30 days must be approved by the Environmental Appeals Board. Ordinarily, the interlocutory appeal will be decided on the basis of the submission made to the Administrative Law Judge, but the Environmental Appeals Board may allow further briefs and oral argument.
                [57 FR 5343, Feb. 13, 1992]

                § 164.101
                Appeals from or review of initial decisions.
                (a) Exceptions and request for oral argument. (1) Within 20 days after the filing of the Administrative Law Judge's initial decision, each party may take exception to any matter set forth in such decision or to any adverse order or ruling to which he objected during the hearing and may appeal such exceptions to the Environmental Appeals Board for decision by filing them in writing with the hearing clerk, including a section containing proposed findings of fact, conclusions, orders, or rulings. Within the same period of time each party filing exceptions and amicus curiae shall file with the hearing clerk a brief concerning each of the exceptions being appealed. The party shall include, in its brief, page references to the relevant portions of the record and to the Administrative Law Judge's initial decision.
                (2) Within 7 days of the service of exceptions, and of a brief under paragraph (a)(1) of this section, any other party or amicus curiae may file and serve a brief responding to exceptions or arguments raised by any other party. Such brief shall include references to the relevant portions of the record. Such brief shall not, however, raise additional exceptions.
                (3) Five copies of all material filed under this section shall be filed with the hearing clerk.
                (b) Review by Administrator when no exceptions are filed. If no exceptions are filed within the time provided, the hearing clerk shall notify the Administrator 30 days from the date of filing of the Administrative Law Judge's initial decision. Within 10 days after said notification, the Environmental Appeals Board shall issue an order either declining review of the initial decision or expressing its intent to review said initial decision. Such order may include a statement of issues to be briefed by the parties and a time schedule concerning service and filing of briefs adequate to allow the Environmental Appeals Board to issue a final order within 90 days from the close of the hearing.
                (c) Argument before the Environmental Appeals Board. (1) A party, if he files exceptions and a brief, shall state in writing whether he desires to make an oral argument thereon before the Environmental Appeals Board; otherwise, he shall be deemed to have waived such oral argument. The Environmental Appeals Board shall, however, on its own initiative, have the right to set an appeal for oral argument.
                (2) If the Environmental Appeals Board determines that additional exceptions should be argued, counsel for the parties shall be given reasonable written notice of such determination so as to permit preparation of adequate argument on all of the exceptions to be argued.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                § 164.102
                Appeals from accelerated decisions.
                (a) Within 20 days after filing of an accelerated decision by the Administrative Law Judge, any party may file exceptions and a supporting brief with the hearing clerk, stating with particularity the grounds upon which he asserts that the decision is incorrect. The party shall include in its brief page references to the relevant portions of the record, if applicable.
                (b) Within 7 days of the service of exceptions and brief under paragraph (a) of this section, any other party or amicus curiae may file and serve a brief responding thereto, with appropriate page references to the relevant portions of the record, if applicable.

                (c) Ordinarily, the appeal from an accelerated decision will be decided on the basis of the submission of briefs, but the Environmental Appeals Board may allow additional briefs and oral argument.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                § 164.103
                Final decision or order on appeal or review.
                Within 90 days after the close of the hearing or within 90 days from the filing of an accelerated decision, unless otherwise stipulated by the parties, the Environmental Appeals Board shall, on appeal or review from an initial or accelerated order of the Administrative Law Judge, issue its final decision and order, including its rulings on any exceptions filed by the parties; such final order may accept or reject all or part of the initial or accelerated decision of the Administrative Law Judge even if acceptable to the parties.
                [57 FR 5343, Feb. 13, 1992]

                § 164.110
                Motion for reopening hearings; for rehearing; for reargument of any proceeding; or for reconsideration of order.
                (a) Filing; service. A motion for reopening the hearing to take further evidence, or for rehearing or reargument of any proceeding or for reconsideration of the order, must be made by motion to the Environmental Appeals Board filed with the hearing clerk. Every such motion must state specifically the grounds relied upon.
                (b) Motion to reopen hearings. A motion to reopen a hearing to take further evidence may be filed at any time prior to the issuance of the Administrator's final order. Every such motion shall state briefly the nature and purpose of the evidence to be adduced, shall show that such evidence is not merely cumulative, and shall set forth good reason why such evidence was not adduced at a hearing.
                (c) Motions to rehear or reargue proceedings, or to reconsider final orders. A motion to rehear or reargue the proceeding or to reconsider the final order shall be filed within 10 days after the date of service of the final order. Every such motion must state specifically the matters claimed to have been erroneously decided, and alleged errors must be briefly stated. Motions to rehear or reargue proceedings or to reconsider final orders shall be directed to, and heard by, the Environmental Appeals Board. Motions under this section directed to the Administrator will not be considered, except in cases that the Environmental Appeals Board has referred to the Administrator pursuant to § 164.2(g) and in which the Administrator has issued the final order. A motion for reconsideration shall not stay the effective date of the final order unless specifically so ordered by the Environmental Appeals Board.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                § 164.111
                Procedure for disposition of motions.
                Within 7 days following the service of any motion provided for in § 164.110, any other party to the proceeding may file with the hearing clerk an answer thereto. As soon as practicable thereafter, the Environmental Appeals Board shall announce its decision whether to grant or to deny the motion. Unless the Environmental Appeals Board shall determine otherwise, operation of the order shall not be stayed pending the decision to grant or to deny the motion. In the event that any such motion is granted by the Environmental Appeals Board, the applicable rules of practice, as set out elsewhere herein, shall be followed.
                [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]

            Subpart C—General Rules of Practice for Expedited Hearings

              § 164.120
              Notification.
              (a) Whenever the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, but that the hazard does not constitute an emergency, he shall notify the registrant of his intention to suspend registration of the pesticide at issue.
              (b) Such notice shall include findings pertaining to the question of imminent hazard and shall either be personally served on the registrant or be sent to the registrant by registered or certified mail, return receipt requested, and filed with the hearing clerk.

              § 164.121
              Expedited hearing.
              (a) Request. (1) An expedited hearing shall be held whenever the Administrator has received from the registrant a timely request for such hearing in response to the Administrator's notice of intention to suspend.
              (2) A request for an expedited hearing is timely if made in writing or by telegram and filed with the office of the hearing clerk within 5 days of the registrant's receipt of the notice of intention to suspend.
              (3) At the time of filing a request for an expedited hearing, the registrant shall also file a document setting forth objections to the Administrator's notice of intention to suspend and its findings pertaining to the question of imminent hazard. Such objections shall conform to the requirements of § 164.21.
              (b) Presiding officer. (1) An expedited hearing shall be conducted by a presiding officer appointed by the Administrator, and such officer need not be an Administrative Law Judge.
              (2) The presiding officer shall not have the authority to make an initial decision on the merits but shall make a recommended decision only.
              (c) The issue. The expedited hearing shall address only the issue of whether an imminent hazard exists.
              (d) Time of hearing. The hearing shall commence within 5 days after the filing of the request with the office of the hearing clerk unless the registrant and respondent agree that it shall commence at a later time. As soon as possible, the presiding officer shall publish in the Federal Register notice of such hearing.
              (e) Intervention. Any person adversely affected by the Administrator's notice may move to intervene within 5 days after the receipt by the registrant of said notice or at any time prior to the conclusion of the presentation of the evidence, upon good cause found, except
              (1) Leave to intervene will be granted only if the motion to intervene meets the standards of § 164.31 and, in addition, indicates that the movant would raise matters or introduce evidence pertinent to the issue of imminent hazard which would substantially assist in its resolution.
              (2) A movant denied permission to intervene under this section but who otherwise meets the standards of § 164.31 and who is adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding, for all purposes of its further review.
              (3) When an “emergency order” is issued pursuant to § 164.123, no person other than the respondent and the registrant shall participate in the hearing except that any person adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding for all purposes of its further review.
              (f) Appearances and consolidation. The provisions of §§ 164.30 and 164.32 apply to an expedited hearing insofar as may be practicable.
              (g) Order of proceeding and burden of proof. At the hearing, the proponent of suspension shall have the burden of going forward to present an affirmative case for the suspension. However, the ultimate burden of persuasion shall rest with the proponent of the registration.
              (h) Evidence. The provisions of § 164.81, where applicable, apply to an expedited hearing.
              (i) Transcripts. The presiding officer shall make provision for daily transcripts and otherwise comply with the provisions of § 164.82.
              (j) Proposed findings or conclusions; recommended decision. (1) Within 4 days of the conclusion of the presentation of evidence, the parties may propose findings and conclusions to the Presiding Officer. Such proposed findings and conclusions shall be accompanied by a brief with supporting reasons.

              (2) Within 8 days of the conclusion of the presentation of evidence, the Presiding Officer shall submit to the parties his proposed recommended findings and conclusions and a statement of the reasons on which they are based.

              (3) Within 10 days of the conclusion of the presentation of evidence the Presiding Officer shall submit to the Environmental Appeals Board his recommended findings and conclusions, together with the record.
              (4) Within 12 days of the conclusion of the presentation of evidence the parties shall submit to the Environmental Appeals Board their objections to the Presiding Officer's recommended findings and conclusions and written briefs in support thereof.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]

              § 164.122
              Final order and order of suspension.
              (a) Final order. Within 7 days of receipt of the record and of the Presiding Officer's recommended findings and conclusions, the Environmental Appeals Board shall issue a final decision and order. Such final order may accept or reject in whole or in part the recommendations of the Presiding Officer.
              (b) Order of suspension. No final order of suspension shall be issued unless the Environmental Appeals Board has issued or at the same time issues a notice of its intention to cancel the registration or change the classification of the pesticide. Such notice shall be given as provided in § 164.8.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]

              § 164.123
              Emergency order.
              (a) Whenever the Environmental Appeals Board determines that an emergency exists that does not permit him to hold a hearing before suspension, the Environmental Appeals Board may issue a suspension order in advance of notification to the registrant.
              (b) The Environmental Appeals Board shall immediately notify the registrant of the suspension order. The registrant may then request a hearing in accordance with §§ 164.121 and 164.122, but the suspension order shall remain in effect during the hearing pending the issuance of a final order on suspension.
              [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]

            Subpart D—Rules of Practice for Applications Under Sections 3 and 18 To Modify Previous Cancellation or Suspension Orders

              Authority:
              Sec. 25(a) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by the Federal Environmental Pesticide Control Act of 1972 (86 Stat. 997).

              Source:
              40 FR 12265, Mar. 18, 1975, unless otherwise noted.

              § 164.130
              General.
              EPA has determined that any application under section 3 or section 18 of the Act to allow use of a pesticide at a site and on a pest for which registration has been finally cancelled or suspended by the Administrator constitutes a petition for reconsideration of such order. Because of the extensive notice and hearing opportunities mandated by FIFRA and the Administrative Procedures Act before a final cancellation or suspension order may be issued, EPA has determined that such orders may not be reversed or modified without affording interested parties—who may in fact have participated in lengthy cancellation proceedings—similar notice and hearing opportunities. The procedures set forth in this subpart D shall govern all such applications.

              § 164.131
              Review by Administrator.

              (a) The Administrator will review applications subject to this subpart D and supporting data submitted by the applicant to determine whether reconsideration of the Administrator's prior cancellation or suspension order is warranted. The Administrator shall determine that such reconsideration is warranted when he finds that: (1) The applicant has presented substantial new evidence which may materially affect the prior cancellation or suspension order and which was not available to the Administrator at the time he made his final cancellation or suspension determination and (2) such evidence could not, through the exercise of due diligence, have been discovered by the parties to the cancellation or suspension proceeding prior to the issuance of the final order.

              (b) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is not warranted, then the application will be denied without requirement for an administrative hearing. The Administrator shall publish notice in the Federal Register of the denial briefly describing the basis for his determination as soon as practicable. Such denial shall constitute final agency action.

              (c) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is warranted, he will then publish notice in the Federal Register setting forth his determination and briefly describing the basis for the determination. Such notice shall announce that a formal public hearing will be held in accordance with 5 U.S.C. section 554. The notice shall specify: (1) The date on which the hearing will begin and end, (2) the issues of fact and law to be adjudicated at the hearing, (3) the date on which the presiding officer shall submit his recommendations, including findings of fact and conclusions, to the Administrator, and (4) the date on which a decision by the Administrator is anticipated.

              § 164.132
              Procedures governing hearing.
              (a) The burden of proof in the hearing convened pursuant to § 164.131 shall be on the applicant and he shall proceed first. The issues in the hearing shall be whether: (1) Substantial new evidence exists and (2) such substantial new evidence requires reversal or modification of the existing cancellation or suspension order. The determination of these issues shall be made taking into account the human and environmental risks found by the Administrator in his cancellation or suspension determination and the cumulative effect of all past and present uses, including the requested use, and uses which may reasonably be anticipated to occur in the future as a result of granting the requested reversal or modification. The granting of a particular petition for use may not in itself pose a significant risk to man or the environment, but the cumulative impact of each additional use of the cancelled or suspended pesticide may re-establish, or serve to maintain, the significant risks previously found by the Administrator.
              (b) The presiding officer shall make recommendations, including findings of fact and conclusions and to the extent feasible, as determined by the presiding officer, the procedures at the hearing shall follow the Rules of Practice, set forth in subparts A and B of this part 164.

              § 164.133
              Emergency waiver of hearing.
              (a) In the case of an application subject to this subpart D which is filed under section 18 of FIFRA, and regulations thereunder, and for which a hearing is required pursuant to § 164.131, the Administrator may dispense with the requirement of convening such a hearing in any case in which he determines:
              (1) That the application presents a situation involving need to use the pesticide to prevent an unacceptable risk: (i) To human health, or (ii) to fish or wildlife populations when such use would not pose a human health hazard; and
              (2) That there is no other feasible solution to such risk; and
              (3) That the time available to avert the risk to human health or fish and wildlife is insufficient to permit convening a hearing as required by § 164.131; and
              (4) That the public interest requires the granting of the requested use as soon as possible.

              (b) Notice of any determination made by the Administrator pursuant to paragraph (a) of this section shall be published in the Federal Register as soon as practicable after granting the requested use and shall set forth the basis for the Administrator's determination.

          Pt. 165
          PART 165—PESTICIDE MANAGEMENT AND DISPOSAL

              Subpart A—General
              Sec.
              165.1
              Scope.
              165.3
              Definitions.
              165.4-165.19
              [Reserved]

              Subpart B—Nonrefillable Container Standards: Container Design and Residue Removal
              165.20
              General provisions.
              165.23
              Scope of pesticide products included.
              165.25
              Nonrefillable container standards.
              165.27
              Reporting and recordkeeping.
              165.28-165.39
              [Reserved]

              Subpart C—Refillable Container Standards: Container Design
              165.40
              General provisions.
              165.43
              Scope of pesticide products included.
              165.45
              Refillable container standards.
              165.47
              What information must I report about my refillable containers?
              165.48-165.59
              [Reserved]

              Subpart D—Standards for Repackaging Pesticide Products into Refillable Containers
              165.60
              General provisions.
              165.63
              Scope of pesticide products included.
              165.65
              Registrants who distribute or sell pesticide products in refillable containers.
              165.67
              Registrants who distribute or sell pesticide products to refillers for repackaging.
              165.70
              Refillers who are not registrants.
              165.71-165.79
              [Reserved]

              Subpart E—Standards for Pesticide Containment Structures
              165.80
              General provisions.
              165.81
              Scope of stationary pesticide containers included.
              165.82
              Scope of pesticide dispensing areas included.
              165.83
              Definition of new and existing structures.
              165.85
              Design and capacity requirements for new structures.
              165.87
              Design and capacity requirements for existing structures.
              165.90
              Operational, inspection and maintenance requirements for all new and existing containment structures.
              165.92
              What if I need both a containment pad and a secondary containment unit?
              165.95
              What recordkeeping do I have to do as a facility owner or operator?
              165.97
              States with existing containment programs.

            Authority:
            7 U.S.C. 136 through 136y.

            Source:
            71 FR 47422, Aug. 16, 2006, unless otherwise noted.

            Subpart A—General

              § 165.1
              Scope.
              The part 165 regulations establish standards and requirements for pesticide containers, repackaging pesticides, and pesticide containment structures.

              § 165.3
              Definitions.
              Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this part, the following terms shall have the meanings set forth below.

                Act means the Federal Insecticide, Fungicide, and Rodenticide Act.

                Agricultural pesticide means any pesticide product labeled for use in or on a farm, forest, nursery, or greenhouse.

                Appurtenance means any equipment or device which is used for the purpose of transferring a pesticide from a stationary pesticide container or to any refillable container, including but not limited to, hoses, fittings, plumbing, valves, gauges, pumps and metering devices.

                Capacity means, as applied to containers, the rated capacity of the container.

                Container means any package, can, bottle, bag, barrel, drum, tank, or other containing-device (excluding any application tanks) used to enclose a pesticide. Containers that are used to sell or distribute a pesticide product and that also function in applying the product (such as spray bottles, aerosol cans and containers that become part of a direct injection system) are considered to be containers for the purposes of this part.

                Containment pad means any structure that is designed and constructed to intercept and contain pesticides, rinsates, and equipment wash water at a pesticide dispensing area.

                Containment structure means either a secondary containment unit or a containment pad.

                Custom blending means the service of mixing pesticides to a customer's specifications, usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture, when:
              (1) The blend is prepared to the order of the customer and is not held in inventory by the blender;
              (2) The blend is to be used on the customer's property (including leased or rented property);
              (3) The pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the product in such a blend;
              (4) The blend is prepared from registered pesticides; and
              (5) The blend is delivered to the end-user along with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of the mixture.

                Dilutable means that the pesticide product's labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application or use.

                Dry pesticide means any pesticide that is in solid form and that has not been combined with liquids; this includes formulations such as dusts, wettable powders, dry flowables, water-soluble powders, granules, and dry baits.

                Establishment means any site where a pesticidal product, active ingredient, or device is produced, regardless of whether such site is independently owned or operated, and regardless of whether such site is domestic and producing a pesticidal product for export only, or whether the site is foreign and producing any pesticidal product for import into the United States.

                Facility means all buildings, equipment, structures, and other stationary items which are located on a single site or on contiguous or adjacent sites and which are owned or operated by the same person (or by any person who controls, who is controlled by, or who is under common control with such person).

                Nonrefillable container means a container that is not a refillable container and that is designed and constructed for one-time use and is not intended to be filled again with a pesticide for sale or distribution. Reconditioned containers are considered to be nonrefillable containers.

                One-way valve means a valve that is designed and constructed to allow virtually unrestricted flow in one direction and no flow in the opposite direction, thus allowing the withdrawal of material from, but not the introduction of material into, a container.

                Operator means any person in control of, or having responsibility for, the daily operation of a facility at which a containment structure is located.

                Owner means any person who owns a facility at which a containment structure is required.

                Pesticide compatible as applied to containers means that the container construction materials will not chemically react with the formulation. A container is not compatible with the formulation if, for example, the formulation:
              (1) Is corrosive to the container;
              (2) Causes softening, premature aging, or embrittlement of the container;
              (3) Otherwise causes the container to weaken or to create the risk of discharge;
              (4) Reacts in a significant chemical, electrolytic, or galvanic manner with the container, or
              (5) Interacts in a way, such as the active ingredient permeating the container wall, that would cause the formulation to differ from its composition as described in the statement required in connection with its registration under FIFRA section 3.

                Pesticide compatible as applied to containment means that the containment construction materials are able to withstand anticipated exposure to stored or transferred substances without losing the capability to provide the required containment of the same or other substances within the containment area.

                Pesticide dispensing area means an area in which pesticide is transferred out of or into a container.

                Portable pesticide container means a refillable container that is not a stationary pesticide container.

                Produce means to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to section 5 of the Act, and any active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.

                Producer means any person, as defined by the Act, who produces any pesticide, active ingredient, or device (including packaging, repackaging, labeling and relabeling).

                Refillable container means a container that is intended to be filled with pesticide more than once for sale or distribution.

                Refiller means a person who engages in the activity of repackaging pesticide product into refillable containers. This could include a registrant or a person operating under contract to a registrant.

                Refilling establishment means an establishment where the activity of repackaging pesticide product into refillable containers occurs.

                Repackage means, for the purposes of this part, to transfer a pesticide formulation from one container to another without a change in the composition of the formulation, the labeling content, or the product's EPA registration number, for sale or distribution.

                Rinsate means the liquid resulting from the rinsing of the interior of any equipment or container that has come in direct contact with any pesticide.

                Runoff means surface water leaving the target site.

                Secondary containment unit means any structure, including rigid diking, that is designed and constructed to intercept and contain pesticide spills and leaks and to prevent runoff and leaching from stationary pesticide containers.

                Stationary pesticide container means a refillable container that is fixed at a single facility or establishment or, if not fixed, remains at the facility or establishment for at least 30 consecutive days, and that holds pesticide during the entire time.

                Suspension concentrate means a stable suspension of solid particulate active ingredients in a liquid intended for dilution with water before use.

                Tamper-evident device means a device which can be visually inspected to determine if a container has been opened.

                Transport vehicle means a cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode.

                Washwater means the liquid resulting from the rinsing of the exterior of any equipment or containers that have or may have come in direct contact with any pesticide or system maintenance compound, such as oil or antifreeze.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

              §§ 165.4-165.19
              [Reserved]

            Subpart B—Nonrefillable Container Standards: Container Design and Residue Removal

              § 165.20
              General provisions.
              (a) What is the purpose of the regulations in this subpart? The regulations in this subpart establish design and construction requirements for nonrefillable containers used for the distribution or sale of some pesticide products.
              (b) Do I have to comply with the regulations in this subpart? You must comply with the regulations in this subpart if you are a registrant who distributes or sells a pesticide product in nonrefillable containers. If your pesticide product is subject to the regulations in this subpart as set out in § 165.23, your pesticide product must be distributed or sold in a nonrefillable container that meets the standards of these regulations.
              (c) When do I have to comply? Any pesticide product packaged in a nonrefillable container and released for shipment by you after August 16, 2009 must be packaged in a nonrefillable container that complies with the regulations of this subpart.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]

              § 165.23
              Scope of pesticide products included.
              (a) Are manufacturing use products subject to the regulations in this subpart? No, the regulations in this subpart do not apply to manufacturing use products, as defined in § 158.153(h) of this chapter.
              (b) Are plant-incorporated protectants subject to the regulations in this subpart? No, the regulations in this subpart do not apply to plant-incorporated protectants, as defined in § 174.3 of this chapter.
              (c) Which antimicrobial pesticide products are not subject to the regulations in this subpart? The regulations in this subpart do not apply to a pesticide product if it satisfies all of the following conditions:
              (1) The pesticide product meets one of the following two criteria:
              (i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
              (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
              (B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
              (2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
              (3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
              (4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (d) of this section.
              (d) How will EPA determine if an antimicrobial pesticide product otherwise exempted must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment? (1) EPA may determine that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the nonrefillable container regulations in this subpart to prevent an unreasonable adverse effect on the environment if all of the following conditions exist:
              (i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
              (ii) The information, data or other evidence is reliable and factual.
              (iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
              (iv) Complying with the container regulations could reasonably be expected to eliminate the problem.
              (2) If EPA determines that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the nonrefillable container regulations in this subpart to prevent an unreasonable adverse effect on the environment, EPA may require, by rule, that the product be distributed or sold in nonrefillable containers that comply with all or some of the requirements in this subpart. Alternatively, EPA may notify the applicant or registrant of its intent to make such a determination. After allowing the applicant or registrant a reasonable amount of time to reply, EPA may require, by notification and as a condition of registration, that the product be distributed or sold in nonrefillable containers that comply with all or some of the requirements in this subpart. For the purpose of the previous sentence, 60 days would be a reasonable amount of time to reply, although EPA may, in its discretion, provide more time. EPA may deny registration or initiate cancellation proceedings if the registrant fails to comply with the nonrefillable container regulations within the time frames established by EPA in the rule or in its notification.
              (e) What other pesticide products are subject to the regulations in this subpart? (1) Except for manufacturing use products, plant-incorporated protectants, and antimicrobial products that are exempt under paragraph (c) of this section, all of the regulations in this subpart apply to a pesticide product if it satisfies at least one of the following criteria:
              (i) The pesticide product meets the criteria of Toxicity Category I as set out in § 156.62 of this chapter.
              (ii) The pesticide product meets the criteria of Toxicity Category II as set out in § 156.62 of this chapter.
              (iii) The pesticide product is classified for restricted use as set out in §§ 152.160 - 152.175 of this chapter.
              (2) Except for manufacturing use products, plant-incorporated protectants, antimicrobial products that are exempt under (c) of this section, and other pesticide products that are regulated under paragraph (e)(1) of this section, a pesticide product must be packaged in compliance with 49 CFR 173.24. If the pesticide product meets the definition of a hazardous material in 49 CFR 171.8, the Department of Transportation requires it to be packaged according to 49 CFR parts 171-180.
              (f) What does “pesticide product” or “pesticide” mean in the rest of this subpart? In §§ 165.25 through 165.27, the term “pesticide product” or “pesticide” refers only to a pesticide product or a pesticide that is subject to the regulations in this subpart as described in paragraphs (a) through (e) of this section.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]

              § 165.25
              Nonrefillable container standards.
              (a) What Department of Transportation (DOT) standards do my nonrefillable containers have to meet under this part if my pesticide product is not a DOT hazardous material? A pesticide product that does not meet the definition of a hazardous material in 49 CFR 171.8 must be packaged in a nonrefillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR 173.4, 173.5, 173.6, 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213, 173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180 that are applicable to a Packing Group III material, or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B. The requirements in this paragraph apply to the pesticide product as it is packaged for transportation in commerce.
              (b) What DOT standards do my nonrefillable containers have to meet under this part if my pesticide product is a DOT hazardous material? (1) If your pesticide product meets the definition of a hazardous material in 49 CFR 171.8, the DOT requires your pesticide product to be packaged according to 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B.
              (2) For the purposes of these regulations, a pesticide product that meets the definition of a hazardous material in 49 CFR 171.8 must be packaged in a nonrefillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B. The requirements in this paragraph apply to the pesticide product as it is packaged for transportation in commerce.
              (c) What will EPA do if DOT proposes to change any of the cross-referenced regulations? If the DOT proposes to change any of the regulations that are incorporated in paragraphs (a) and (b) of this section, EPA will provide notice of the proposed changes and an opportunity to comment in the Federal Register. Following notice and comment, EPA will take final action regarding whether or not to revise its rules, and the extent to which any such revision will correspond with revised DOT regulations.
              (d) What standards for closures do my nonrefillable containers have to meet? If your nonrefillable container is a rigid container with a capacity equal to or greater than 3.0 liters (0.79 gallons), if the container is not an aerosol container or a pressurized container, and if the container is used to distribute or sell a liquid agricultural pesticide, each nonrefillable container must have at least one of the following standard closures:

              (1) Bung, 2 inch pipe size (2.375 inches in diameter), external threading, 11.5 threads per inch, National Pipe Straight (NPS) standard.
              (2) Bung, 2 inch pipe size (2.375 inches in diameter), external threading, 5 threads per inch, buttress threads.
              (3) Screw cap, 63 millimeters, at least one thread revolution at 6 threads per inch.
              (4) Screw cap, 38 millimeters, at least one thread revolution at 6 threads per inch. The cap may fit on a separate rigid spout or on a flexible pull-out plastic spout.
              (e) What standards for dispensing do my nonrefillable containers have to meet? If your nonrefillable container has a capacity of 5 gallons (18.9 liters) or less, if the container is not an aerosol container, a pressurized container, or a spray bottle, and if the container holds a liquid pesticide, your nonrefillable container must do both of the following:
              (1) Allow the contents of the nonrefillable container to pour in a continuous, coherent stream.
              (2) Allow the contents of the nonrefillable container to be poured with a minimum amount of dripping down the outside of the container.
              (f) What standards for residue removal do my nonrefillable containers have to meet? Each nonrefillable container and pesticide formulation combination must meet the applicable residue removal standard of this section.
              (1) If the nonrefillable container is rigid and has a capacity less than or equal to 5 gallons (18.9 liters) for liquid formulations or 50 pounds (22.7 kilograms) for solid formulations and if the pesticide product's labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application (that is, if the pesticide is dilutable), each container/formulation combination must be capable of attaining at least 99.99 percent removal of each active ingredient when tested using the EPA test procedure “Rinsing Procedures for Dilutable Pesticide Products in Rigid Containers.”
              (2) The test must be conducted only if the pesticide product is a suspension concentrate or if EPA specifically requests the records on a case by case basis.

              (3) For the rigid container/dilutable product standard in paragraph (f)(1) of this section, percent removal represents the percent of the original concentration of the active ingredient in the pesticide product when compared to the concentration of that active ingredient in the fourth rinse. Percent removal is calculated by the formula:

              percent removal = [1.0 - RR] x 100.0, where

                RR = rinsate ratio = Active ingredient concentration in fourth rinsate/Original concentration of active ingredient in the product

              (g) Can I obtain a waiver from or a modification to any of the nonrefillable container standards? Yes, it is possible for you to obtain a waiver from or a modification to the nonrefillable container standards, as follows:
              (1) EPA may waive or modify the requirements of paragraph (a) of this section regarding the DOT standards for pesticide products that are not DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (a) of this section.
              (2) EPA may waive or modify the requirements of paragraph (b) of this section regarding the DOT standards for pesticide products that are DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (b) of this section. EPA will modify or waive the requirements of paragraph (b) of this section only after consulting with DOT to ensure consistency with DOT regulations and exemptions.
              (3) EPA may approve a non-standard closure (that is, a closure not listed in paragraph (d) of this section) if EPA determines that both of the following conditions are satisfied:
              (i) The non-standard closure is necessary for the proper mixing, loading, or application of the pesticide product.

              (ii) The non-standard closure offers exposure protection to handlers during mixing and loading that is the same or greater than that provided by the standard closures.

              (4) EPA may waive or modify the container dispensing capability standards in paragraph (e) of this section if EPA determines that at least one of the following conditions is satisfied:
              (i) The product is typically removed from the container by a method other than pouring.
              (ii) Compliance with the container dispensing capability standards would increase exposure to the pesticide container handler.
              (5) EPA may waive or modify the requirements of paragraph (f) of this section regarding the residue removal standard if EPA determines that both of the following conditions are satisfied:
              (i) The residue remaining in the container would not cause an unreasonable adverse effect on the environment; and
              (ii) The product offers significant benefits and cannot be economically reformulated or repackaged.
              (h) How do I obtain a waiver from or a modification to any of the nonrefillable container standards? To obtain a waiver from or a modification to any of the nonrefillable container standards, you must submit a written request for a waiver or a modification to the EPA to the following address: Office of Pesticide Programs (7504P); U.S. Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the pesticide product in a nonrefillable container that does not comply with all of the nonrefillable container standards unless and until EPA approves the request for the waiver or modification in writing. You must include two copies of the following information (which may be part of an application for registration or amended registration) with your written request:
              (1) The name and address of the registrant; the date; and the name, title, signature, and phone number of the company official making the request.
              (2) The name and EPA registration number of the pesticide product for which the waiver or modification is requested.
              (3) A statement specifying the requirement or requirements from which you are requesting a waiver or a modification.
              (4) A description of the nonrefillable container or containers for which the waiver or modification is requested.
              (5) Documentation or justification to demonstrate that the applicable waiver or modification criteria in paragraph (g) of this section are satisfied.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]

              § 165.27
              Reporting and recordkeeping.
              (a) What information must I report about my nonrefillable containers? You are not required to report to EPA with information about your nonrefillable containers under the regulations in this subpart. You should refer to the reporting standards in part 159 of this chapter to determine if information on container failures or other incidents involving pesticide containers must be reported to EPA under FIFRA section 6(a)(2) (7 U.S.C. 136d(a)(2)).
              (b) What recordkeeping do I have to do for my nonrefillable containers? For each pesticide product that is subject to §§ 165.25 through 165.27 and is distributed or sold in nonrefillable containers, you must maintain the records listed in this section for as long as a nonrefillable container is used to distribute or sell the pesticide product and for 3 years after that. You must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe. You must keep the following records:
              (1) The name and EPA registration number of the pesticide product.
              (2) A description of the nonrefillable container(s) in which the pesticide product is distributed or sold.
              (3) At least one of the following records to document compliance with the requirement for closures in § 165.25(d) for each nonrefillable container used to distribute or sell the pesticide product that must comply with § 165.25(d):
              (i) A letter or document from the container supplier that describes the closure.

              (ii) A specification about the closure in the contract between the registrant or applicant and the container supplier.

              (iii) A copy of EPA's approval of any non-standard closure.
              (4) At least one of the following records pertaining to the container dispensing capability requirements in § 165.25(e) for each nonrefillable container used to distribute or sell the pesticide product that must comply with § 165.25(e):
              (i) Test data or documentation demonstrating that the nonrefillable container meets the standards in § 165.25(e) when it contains the pesticide product.
              (ii) Test data or documentation demonstrating that a different nonrefillable container meets the standards in § 165.25(e) when it contains the pesticide product or even a different pesticide product and a written explanation of why such data or documentation demonstrates that the container meets the standards in § 165.25(e) for the pesticide product.
              (iii) A copy of EPA's approval of a request for a waiver from the container dispensing requirement.
              (5) At least one of the following records pertaining to the nonrefillable container residue removal requirement in § 165.25(f) if the pesticide product is a suspension concentrate or if EPA specifically requests the records on a case-by-case basis:
              (i) Test data showing that the nonrefillable container and pesticide formulation meet the standard in § 165.25(f) .
              (ii) Test data showing that a different nonrefillable container with the same or a different pesticide formulation meets the standard in § 165.25(f), together with a written explanation of why such data demonstrate that the nonrefillable container and pesticide formulation meet the standard in § 165.25(f).
              (iii) A copy of EPA's approval of a request for a waiver from the residue removal standard requirement.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]

              §§ 165.28-165.39
              [Reserved]

            Subpart C—Refillable Container Standards: Container Design

              § 165.40
              General provisions.
              (a) What is the purpose of the regulations in this subpart? The regulations in this subpart establish design and construction requirements for refillable containers used for the distribution or sale of some pesticide products.
              (b) Do I have to comply with the regulations in this subpart? (1) You must comply with all of the regulations in this subpart if you are a registrant who distributes or sells a pesticide product in refillable containers. If your pesticide product is subject to the regulations in this subpart as set out in § 165.43, your pesticide product must be distributed or sold in a refillable container that meets the standards of these regulations. This includes your pesticide products that are repackaged according to subpart D of this part.
              (2) You must comply with the regulations in § 165.45(f) for stationary pesticide containers if you are a refiller of a pesticide product and you are not the registrant of the pesticide product. If the pesticide product is subject to the regulations in this subpart as set out in § 165.43, the stationary pesticide containers used to distribute or sell the product must meet the standards of § 165.45(f).
              (3) If you are a refiller of a pesticide product and you are not a registrant of the pesticide product, § 165.45(a)(2) provides an exemption from some of the requirements in § 165.45(a)(1) .
              (c) When do I have to comply? Any pesticide product packaged in a refillable container and released for shipment by you after August 16, 2011 must be packaged in a refillable container that complies with the regulations of this subpart.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]

              § 165.43
              Scope of pesticide products included.
              (a) Are manufacturing use products subject to the regulations in this subpart? No, the regulations in this subpart do not apply to manufacturing use products, as defined in § 158.153(h) of this chapter.
              (b) Are plant-incorporated protectants subject to the regulations in this subpart? No, the regulations in this subpart do not apply to plant-incorporated protectants, as defined in § 174.3 of this chapter.
              (c) Which antimicrobial pesticide products are not subject to the regulations in this subpart? The regulations in this subpart do not apply to a pesticide product if it satisfies all of the following conditions:
              (1) The pesticide product meets one of the following two criteria:
              (i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
              (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
              (B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
              (2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
              (3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
              (4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (e) of this section.
              (d) Which requirements must an antimicrobial swimming pool product comply with if it is not exempt from these regulations? An antimicrobial swimming pool product that is not exempt by paragraph (a), (b), or (c) of this section must comply with all of the regulations in this subpart except § 165.45(d) regarding marking and § 165.45(e) regarding openings. For the purposes of this subpart, an antimicrobial swimming pool product is a pesticide product that satisfies both of the following conditions:
              (1) The pesticide product is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
              (2) The labeling of the pesticide product includes directions for use on only a site or sites in the antimicrobial product use category of swimming pools.
              (e) How will EPA determine if an antimicrobial pesticide product otherwise exempted must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment? (1) EPA may determine that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the refillable container regulations in this subpart to prevent an unreasonable adverse effect on the environment if all of the following conditions exist:
              (i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
              (ii) The information, data or other evidence is reliable and factual.
              (iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
              (iv) Complying with the container regulations could reasonably be expected to eliminate the problem.

              (2) If EPA determines that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the refillable container regulations in this subpart to prevent an unreasonable adverse effect on the environment, EPA may require, by rule, that the product be distributed or sold in refillable containers that comply with all or some of the requirements in this subpart. Alternatively, EPA may notify the applicant or registrant of its intent to make such a determination. After allowing the applicant or registrant a reasonable amount of time to reply, EPA may require, by notification and as a condition of registration, that the product be distributed or sold in refillable containers that comply with all or some of the requirements in this subpart. For the purpose of the previous sentence, 60 days would be a reasonable amount of time to reply, although EPA may, in its discretion, provide more time. EPA may deny registration or initiate cancellation proceedings if the registrant fails to comply with the refillable container regulations within the time frames established by EPA in the rule or in its notification.
              (f) What other pesticide products are subject to the regulations in this subpart? The regulations in this subpart apply to all pesticide products other than manufacturing use products, plant-incorporated protectants, and antimicrobial products that are exempt by paragraph (c) of this section. Antimicrobial products covered under paragraph (d) of this section are subject to the regulations indicated in paragraph (d) of this section.
              (g) What does “pesticide product” or “pesticide” mean in the rest of this subpart? In § 165.43(h) through § 165.47, the term “pesticide product” or “pesticide” refers only to a pesticide product or a pesticide that is subject to the regulations in this subpart as described in paragraphs (a) through (f) of this section.
              (h) Are there any other exceptions? (1) The regulations in this subpart do not apply to transport vehicles that contain pesticide in pesticide-holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide.
              (2) The regulations in this subpart do not apply to containers that hold pesticides that are gaseous at atmospheric temperature and pressure.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]

              § 165.45
              Refillable container standards.
              (a) What Department of Transportation (DOT) standards do my refillable containers have to meet under this part if my pesticide product is not a DOT hazardous material? (1) A pesticide product that does not meet the definition of a hazardous material in 49 CFR 171.8 must be packaged in a refillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR 173.4, 173.5, 173.6, 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 173.213, 173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and part 180 that are applicable to a Packing Group III material, or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B. The requirements in this paragraph apply to the pesticide product as it is packaged for transportation in commerce.
              (2) A refiller is not required to comply with 49 CFR 173.28(b)(2) for pesticide products that are not DOT hazardous materials if the refillable container to be reused complies with the refillable container regulations in this subpart and the refilling is done in compliance with the repackaging regulations in subpart D of this part.
              (b) What DOT standards do my refillable containers have to meet under this part if my pesticide product is a DOT hazardous material? (1) If your pesticide product meets the definition of a hazardous material in 49 CFR 171.8, the DOT requires your pesticide product to be packaged according to 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B.

              (2) For the purposes of these regulations, a pesticide product that meets the definition of a hazardous material in 49 CFR 171.8 must be packaged in a refillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B. The requirements in this paragraph apply to the pesticide product as it is packaged for transportation in commerce.
              (c) What will EPA do if DOT proposes to change any of the cross-referenced regulations? If the DOT proposes to change any of the regulations that are incorporated in paragraphs (a) and (b) of this section, EPA will provide notice of the proposed changes and an opportunity to comment in the Federal Register. Following notice and comment, EPA will take final action regarding whether or not to revise its rules, and the extent to which any such revision will correspond with revised DOT regulations.
              (d) What standards for marking do my refillable containers have to meet? Each refillable container must be marked in a durable and clearly visible manner with a serial number or other identifying code that will distinguish the individual container from all other containers. Durable marking includes, but is not limited to, etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, and marking with durable ink. The serial number or other identifying code must be located on the outside part of the container except on a closure. Placement on the label or labeling is not sufficient unless the label is an integral, permanent part of or permanently stamped on the container.
              (e) What standards for openings do my refillable containers have to meet? If your refillable container is a portable pesticide container that is designed to hold liquid pesticide formulations and is not a cylinder that complies with the DOT Hazardous Materials Regulations in 49 CFR parts 171-180, each opening of the container other than a vent must have a one-way valve, a tamper-evident device or both. A one-way valve may be located in a device or system separate from the container if the device or system is the only reasonably foreseeable way to withdraw pesticide from the container. A vent must be designed to minimize the amount of material that could be introduced into the container through it.
              (f) What standards do my stationary pesticide containers have to meet? If a stationary pesticide container designed to hold undivided quantities of pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide is located at the refilling establishment of a refiller operating under written contract to you, the stationary pesticide container must meet the following standards:
              (1) Except during a civil emergency or any unanticipated grave natural disaster or other natural phenomenon of an exceptional, inevitable and irresistible character, the effects of which could not have been prevented or avoided by the exercise of due care or foresight, each stationary pesticide container (for liquid and dry pesticides) and its appurtenances must meet both of the following standards:
              (i) Each stationary pesticide container and its appurtenances must be resistant to extreme changes in temperature and constructed of materials that are adequately thick to not fail and that are resistant to corrosion, puncture, or cracking.
              (ii) Each stationary pesticide container must be capable of withstanding all operating stresses, taking into account static heat, pressure buildup from pumps and compressors, and any other foreseeable mechanical stresses to which the container may be subjected in the course of operations.
              (2) Each stationary container of liquid pesticides must meet all of the following standards:
              (i) Each stationary container of liquid pesticides must be equipped with a vent or other device designed to relieve excess pressure, prevent losses by evaporation, and exclude precipitation.
              (ii) External sight gauges, which are pesticide-containing hoses or tubes that run vertically along the exterior of the container from the top to the bottom, are prohibited on stationary containers of liquid pesticides.

              (iii) Each connection on a stationary container of liquid pesticides that is below the normal liquid level must be equipped with a shutoff valve which is capable of being locked closed. A shutoff valve must be located within a secondary containment unit if one is required by subpart E of this part.

              (g) Can I obtain a waiver from or a modification to any of the refillable container standards? Yes, it is possible for you to obtain a waiver from or a modification to some of the refillable container standards, as follows:
              (1) EPA may waive or modify the requirements of paragraph (a) of this section regarding the DOT standards for pesticide products that are not DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (a) of this section.
              (2) EPA may waive or modify the requirements of paragraph (b) of this section regarding the DOT standards for pesticide products that are DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (b) of this section. EPA will modify or waive the requirements of paragraph (b) of this section only after consulting with DOT to ensure consistency with DOT regulations and exemptions.
              (h) How do I obtain a waiver from or a modification to any of the refillable container standards? To obtain a waiver from or a modification to any of the refillable container standards, you must submit a written request for a waiver or a modification to the EPA to the following address: Office of Pesticide Programs (7504P); U.S. Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the pesticide product in a refillable container that does not comply with all of the refillable container standards unless and until EPA approves the request for the waiver or modification in writing. You must include two copies of the following information (which may be part of an application for registration or amended registration) with your written request:
              (1) The name and address of the registrant; the date; and the name, title, signature, and phone number of the company official making the request.
              (2) The name and EPA registration number of the pesticide product for which the waiver or modification is requested.
              (3) A statement specifying the requirement or requirements from which you are requesting a waiver or a modification.
              (4) A description of the refillable container or containers for which the waiver or modification is requested.
              (5) Documentation or justification to demonstrate that the applicable waiver or modification criteria in paragraph (g) of this section are satisfied.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]

              § 165.47
              What information must I report about my refillable containers?
              You are not required to report to EPA with information about your refillable containers under the regulations in this subpart. You should refer to the reporting standards in part 159 of this chapter to determine if information on container failures or other incidents involving pesticide containers must be reported to EPA under FIFRA section 6(a)(2) (7 U.S.C. 136d(a)(2)).

              §§ 165.48-165.59
              [Reserved]

            Subpart D—Standards for Repackaging Pesticide Products into Refillable Containers

              § 165.60
              General provisions.
              (a) What is the purpose of the regulations in this subpart? The regulations in this subpart establish requirements for repackaging some pesticide products into refillable containers for distribution or sale.
              (b) Do I have to comply with the regulations in this subpart? You must comply with the regulations in this subpart if you are a registrant who distributes or sells a pesticide product in refillable containers, if you are a registrant who distributes or sells pesticide products to a refiller (that is not part of your company) for repackaging into refillable containers, or if you are a refiller of a pesticide product and you are not the registrant of the pesticide product. Each pesticide product that is subject to the regulations in this subpart as set out in § 165.63 and that is distributed or sold in a refillable container must be distributed or sold in compliance with the standards of these regulations.
              (c) When do I have to comply? Any pesticide product repackaged into a refillable container and released for shipment by you after August 16, 2011 must be repackaged in compliance with the regulations of this subpart.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.63
              Scope of pesticide products included.
              (a) Are manufacturing use products subject to the regulations in this subpart? No, the regulations in this subpart do not apply to manufacturing use products, as defined in § 158.153(h) of this chapter.
              (b) Are plant-incorporated protectants subject to the regulations in this subpart? No, the regulations in this subpart do not apply to plant-incorporated protectants, as defined in § 174.3 of this chapter.
              (c) Which antimicrobial pesticide products are not subject to the regulations in this subpart? The regulations in this subpart do not apply to a pesticide product if it satisfies all of the following conditions:
              (1) The pesticide product meets one of the following two criteria:
              (i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
              (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
              (B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
              (2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
              (3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
              (4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (e) of this section.
              (d) Which requirements must an antimicrobial swimming pool product comply with if it is not exempt from these regulations? (1) An antimicrobial swimming pool product that is not exempt by paragraph (a), (b), or (c) of this section must comply with all of the regulations in this subpart except for the following requirements:

                  Requirement
                  Requirement for registrants who distribute or sell directly in refillable containers
                  Requirement for refillers who are not registrants

                  Recordkeeping specific to each instance of repackaging
                  § 165.65(i)(2)
                  § 165.70(j)(2)

                  Container inspection: criteria regarding a serial number or other identifying code
                  § 165.65(e)(2)
                  § 165.70(f)(2)

                  Container inspection: criteria regarding one-way valve or tamper-evident device
                  § 165.65(e)(3)
                  § 165.70(f)(3)

                  Cleaning requirement: criteria regarding one-way valve or tamper-evident device
                  § 165.65(f)(1)
                  § 165.70(g)(1)

                  Cleaning if the one-way valve or tamper-evident device is not intact
                  § 165.65(g)
                  § 165.70(h)

              (2) For the purposes of this subpart, an antimicrobial swimming pool product is a pesticide product that satisfies both of the following conditions:
              (i) The pesticide product is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
              (ii) The labeling of the pesticide product includes directions for use on only a site or sites in the antimicrobial product use category of swimming pools.
              (e) How will EPA determine if an antimicrobial pesticide product otherwise exempted must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment? (1) EPA may determine that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the repackaging regulations in this subpart to prevent an unreasonable adverse effect on the environment if all of the following conditions exist:
              (i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
              (ii) The information, data or other evidence is reliable and factual.
              (iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
              (iv) Complying with the container regulations could reasonably be expected to eliminate the problem.
              (2) If EPA determines that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the repackaging regulations in this subpart to prevent an unreasonable adverse effect on the environment, EPA may require, by rule, that the product be repackaged in compliance with all or some of the requirements in this subpart. Alternatively, EPA may notify the applicant or registrant of its intent to make such a determination. After allowing the applicant or registrant a reasonable amount of time to reply, EPA may require, by notification and as a condition of registration, that the product be repackaged in compliance with all or some of the requirements in this subpart. For the purpose of the previous sentence, 60 days would be a reasonable amount of time to reply, although EPA may, in its discretion, provide more time. EPA may deny registration or initiate cancellation proceedings if the registrant fails to comply with the repackaging regulations within the time frames established by EPA in the rule or in its notification.
              (f) What other pesticide products are subject to the regulations in this subpart? The regulations in this subpart apply to all pesticide products other than manufacturing use products, plant-incorporated protectants, and antimicrobial products that are exempt paragraph (c) of this section. Antimicrobial products covered under paragraph (d) of this section are subject to the regulations indicated in that section.
              (g) What does “pesticide product” or “pesticide” mean in the rest of this subpart? In §§ 165.63(h) through 165.70, the term “pesticide product” or “pesticide” refers only to a pesticide product or a pesticide that is subject to the regulations in this subpart as described in paragraphs (a) through (f) of this section.
              (h) Are there any other exceptions? (1) The regulations in this subpart do not apply to transport vehicles that contain pesticide in pesticide-holding tanks that are an integral part of the transport vehicle and that are the primary containment for the pesticide.
              (2) Custom blending is not subject to the regulations in this subpart.
              (3) The regulations in this subpart do not apply to containers that hold pesticides that are gaseous at atmospheric temperature and pressure.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.65
              Registrants who distribute or sell pesticide products in refillable containers.
              (a) Must I comply with the standards in this section? You must comply with the standards in this section if you are a registrant who distributes or sells pesticide products in refillable containers. This means that you conduct all of the repackaging for a pesticide product and that you do not distribute or sell the pesticide product to a refiller that is not part of your company for repackaging into refillable containers. If you are a registrant that repackages a product directly into refillable containers for sale or distribution and you also sell or distribute other quantities of that product to an independent refiller for repackaging, then you must meet the requirements in this section for those quantities you distribute or sell directly and the requirements in § 165.67 for those quantities that you distribute or sell to an independent refiller.
              (b) Am I responsible for product integrity? Yes, you are responsible for the pesticide product that you distribute or sell in refillable containers not being adulterated or different from the composition described in its confidential statement of formula that is required under FIFRA section 3.
              (c) What information must I develop? For each pesticide product distributed or sold in refillable containers, you must develop both of the following documents in writing.
              (1) You must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.
              (i) The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under FIFRA section 3.
              (ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under “Directions for Use,” or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable Federal and State regulations.
              (2) You must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.
              (i) An acceptable container is one that you have determined meets the standards in subpart C of this part and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.
              (ii) You must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in subpart C of this part.
              (d) What requirements must my individual establishments follow regarding repackaging a pesticide product into refillable containers? A refiller at your individual establishment that repackages a pesticide product into refillable containers for distribution or sale must comply with all of the following provisions.
              (1) The establishment must be registered with EPA as a producing establishment as required by § 167.20 of this chapter.
              (2) The refiller must not change the pesticide formulation unless the refiller has a registration for the new formulation.
              (3) The refiller must repackage a pesticide product only into a refillable container that is identified on your description of acceptable containers for that pesticide product.
              (4) The refiller may repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. In addition, there are no general limits on the size of the refillable containers that the refiller can use.
              (5) The refiller must have all of the following items at the establishment before repackaging a pesticide product into any refillable container for distribution or sale:
              (i) The pesticide product's label and labeling.

              (ii) The written refilling residue removal procedure for the pesticide product.

              (iii) The written description of acceptable containers for the pesticide product.
              (6) Before repackaging a pesticide product into any refillable container for distribution or sale, the refiller must identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with paragraph (f) of this section. The refiller may identify the previous pesticide product by referring to the label or labeling.
              (7) The refiller must inspect each refillable container according to paragraph (e) of this section.
              (8) The refiller must clean each refillable container according to paragraph (f) or (g) of this section, if required by either paragraph.
              (9) The refiller must ensure that each refillable container is properly labeled according to paragraph (h) of this section.
              (10) The establishment must maintain records in accordance with paragraph (i) of this section.
              (11) The establishment must maintain records as required by part 169 of this chapter.
              (12) The establishment must report as required by part 167 of this chapter.
              (e) How must my individual establishments inspect refillable containers? Before repackaging a pesticide product into any refillable container, a refiller at your establishment must visually inspect the exterior and (if possible) the interior of the container and the exterior of appurtenances. The purpose of the inspection is to determine whether the container meets the necessary criteria with respect to continued container integrity, required markings, and openings. If the condition in paragraph (e)(1) of this section exists, the container fails the inspection and must not be refilled unless the container is repaired, reconditioned, or remanufactured in compliance with the relevant DOT requirement. If the condition in paragraph (e)(2) or (e)(3) of this section exists (or both), the container fails the inspection and must not be refilled until the container meets the standards specified in subpart C of this part. The conditions are:
              (1) The integrity of the container is compromised in at least one of the following ways:
              (i) The container shows signs of rupture or other damage which reduces its structural integrity.
              (ii) The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects.
              (iii) The container has cracks, warpage, corrosion or any other damage which might render it unsafe for transportation.
              (iv) There is damage to the fittings, valves, tamper-evident devices or other appurtenances that may cause failure of the container.
              (2) The container does not bear the markings required by § 165.45(a), (b) and (d), or such markings are not legible.
              (3) The container does not have an intact and functioning one-way valve or tamper-evident device on each opening other than a vent, if required.
              (f) How must my individual establishments clean refillable containers? A refiller at your establishment must clean each refillable container by conducting the pesticide product's refilling residue removal procedure before repackaging the pesticide product into the refillable container, unless the conditions in paragraph (f)(1) of this section and either paragraph (f)(2) or (f)(3) of this section are satisfied:
              (1) If required, each tamper-evident device and one-way valve is intact.
              (2) The refillable container is being refilled with the same pesticide product.
              (3) Both of the following conditions are satisfied:
              (i) The container previously held a pesticide product with a single active ingredient and is being used to repackage a pesticide product with the same single active ingredient.

              (ii) There is no change that would cause the composition of the product being repackaged to differ from the composition described in its confidential statement of formula that is required under FIFRA section 3. Examples of unallowable changes include the active ingredient concentration increasing or decreasing beyond the limits established by the confidential statement of formula or a reaction or interaction between the pesticide product being repackaged and the residue remaining in the container.
              (g) How must my individual establishments clean a refillable container that has a broken (non-intact) tamper-evident device or one-way valve? As required in paragraph (f) of this section, a refiller at your establishment must clean each refillable container that has a tamper-evident device or one-way valve that is not intact by conducting the pesticide product's refilling residue removal procedure before repackaging the pesticide product into the refillable container. In addition, other procedures may be necessary to assure that product integrity is maintained in such cases.
              (h) How must my individual establishments label refillable containers? Before distributing or selling a pesticide product in a refillable container, a refiller at your establishment must ensure that the label of the pesticide product is securely attached to the refillable container such that the label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. The label and labeling must comply in all respects with the requirements of part 156 of this chapter. In particular, the refiller at your establishment must ensure that the net contents statement and EPA establishment number appear on the label.
              (i) What recordkeeping must my individual establishments do? Each of your individual establishments that repackages a pesticide product into refillable containers for distribution or sale must maintain all of the records listed in this section in addition to the applicable records identified in parts 167 and 169 of this chapter. The establishment must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe.
              (1) For each pesticide product distributed or sold in refillable containers, both of the following records must be maintained for the current operating year and for 3 years after that:
              (i) The written refilling residue removal procedure for the pesticide product.
              (ii) The written description of acceptable containers for the pesticide product.
              (2) Each time a refiller at your establishment repackages a pesticide product into a refillable container and distributes or sells the product, the following records must be generated and maintained for at least 3 years after the date of repackaging:
              (i) The EPA registration number of the pesticide product distributed or sold in the refillable container.
              (ii) The date of the repackaging.
              (iii) The serial number or other identifying code of the refillable container.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.67
              Registrants who distribute or sell pesticide products to refillers for repackaging.
              (a) Must I comply with the standards in this section? You must comply with the standards in this section if you are a registrant who distributes or sells pesticide products to a refiller that is not part of your company for repackaging into refillable containers.
              (b) Under what conditions can I allow a refiller to repackage my pesticide product into refillable containers? You may allow a refiller to repackage your pesticide product into refillable containers and to distribute or sell such repackaged product under your existing registration if all of the following conditions are satisfied:
              (1) The repackaging results in no change to the pesticide formulation.
              (2) One of the following conditions regarding a registered refilling establishment is satisfied:
              (i) The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter.
              (ii) The pesticide product is repackaged by a refilling establishment registered with EPA as required by § 167.20 of this chapter at the site of a user who intends to use or apply the product.
              (3) You have entered into a written contract with the refiller to repackage the pesticide product and to use the label of your pesticide product.

              (4) The pesticide product is repackaged only into refillable containers that meet the standards of subpart C of this part.
              (5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refiller's EPA establishment number.
              (c) What violations are applicable to illegal repackaging? Repackaging a pesticide product for distribution or sale without either obtaining a registration or meeting all of the conditions in paragraph (b) of this section is a violation of section 12 of the Act. Both you and the refiller that is repackaging your pesticide product under written contract with you may be liable for violations pertaining to the repackaged product.
              (d) When must I provide the written contract to the refiller? If you allow a refiller to repackage your product as specified in paragraph (b) of this section you must provide the written contract referred to in paragraph (b)(3) of this section to the refiller before you distribute or sell the pesticide product to the refiller.
              (e) Am I responsible for product integrity? Yes, for a product that you distribute or sell to a refiller that is not part of your company for repackaging into refillable containers, you are responsible for the pesticide product not being adulterated or different from the composition described in its confidential statement of formula that is required under FIFRA section 3.
              (f) What information must I develop? For each pesticide product distributed or sold in refillable containers, you must develop both of the following documents in writing.
              (1) You must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.
              (i) The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under FIFRA section 3.
              (ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under “Directions for Use,” or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable Federal and State regulations.
              (2) You must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.
              (i) An acceptable container is one that you have determined meets the standards in subpart C of this part and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.
              (ii) You must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in subpart C of this part.
              (g) When must I provide the information to the refiller? You must provide the refiller with all of the following information and documentation before or at the time of distribution or sale of your pesticide product to the refiller:
              (1) Your written refilling residue removal procedure for the pesticide product.
              (2) Your written description of acceptable containers for the pesticide product.
              (3) The pesticide product's label and labeling.
              (h) What recordkeeping must I do? You must maintain all of the records listed in this section for the current operating year and for 3 years after that. You must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe:

              (1) Each written contract entered into with a refiller for repackaging your pesticide product into refillable containers.

              (2) Your written refilling residue removal procedure for the pesticide product.
              (3) Your written description of acceptable containers for the pesticide product.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.70
              Refillers who are not registrants.
              (a) Must I comply with the standards in this section? You must comply with the standards in this section if you are a refiller of a pesticide product and you are not the registrant of the pesticide product.
              (b) Under what conditions can I repackage a registrant's pesticide product into refillable containers? A registrant may allow you to repackage the registrant's pesticide product into refillable containers and to distribute or sell such repackaged product under the registrant's existing registration if all of the following conditions are satisfied:
              (1) The repackaging results in no change to the pesticide formulation.
              (2) One of the following conditions regarding a registered refilling establishment is satisfied:
              (i) The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter.
              (ii) The pesticide product is repackaged by a refilling establishment registered with EPA as required by § 167.20 of this chapter at the site of a user who intends to use or apply the product.
              (3) The registrant has entered into a written contract with you to repackage the pesticide product and to use the label of the registrant's pesticide product.
              (4) The pesticide product is repackaged only into refillable containers that meet the standards of subpart C of this part.
              (5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refillers EPA establishment number.
              (c) What violations are applicable to illegal repackaging? Repackaging a pesticide product for distribution or sale without either obtaining a registration or meeting all of the conditions in paragraph (b) of this section is a violation of section 12 of the Act. Both you and the pesticide product's registrant may be liable for violations pertaining to the repackaged product.
              (d) Am I responsible for product integrity? Yes, you are responsible for the pesticide product that you distribute or sell in refillable containers not being adulterated or different from the composition described in its confidential statement of formula that is required under FIFRA section 3.
              (e) What requirements must I follow regarding repackaging a pesticide product into refillable containers? You must comply with all of the following provisions.
              (1) Your establishment must be registered with EPA as a producing establishment as required by § 167.20 of this chapter.
              (2) You must not change the pesticide formulation unless you have a registration for the new formulation.
              (3) You must repackage a pesticide product only into a refillable container that is identified on the description of acceptable containers for that pesticide product provided by the registrant.
              (4) You may repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. In addition, there are no general limits on the size of the refillable containers that you can use.
              (5) You must have all of the following items at your establishment before repackaging a pesticide product into any refillable container for distribution or sale:
              (i) The written contract referred to in paragraph (b)(3) of this section from the pesticide product's registrant.
              (ii) The pesticide product's label and labeling.
              (iii) The registrant's written refilling residue removal procedure for the pesticide product.
              (iv) The registrant's written description of acceptable containers for the pesticide product.

              (6) Before repackaging a pesticide product into any refillable container for distribution or sale, you must identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with paragraph (g) of this section. You may identify the previous pesticide product by referring to the label or labeling.
              (7) You must inspect each refillable container according to paragraph (f) of this section.
              (8) You must clean each refillable container according to paragraph (g) or (h) of this section, if required by either paragraph.
              (9) You must ensure that each refillable container is properly labeled according to paragraph (i) of this section.
              (10) You must maintain records in accordance with paragraph (j) of this section.
              (11) You must maintain records as required by part 169 of this chapter.
              (12) You must report as required by part 167 of this chapter.
              (13) The stationary pesticide containers at your establishment must meet the standards in § 165.45(f).
              (14) You may be required to comply with the containment standards in subpart E of this part.
              (f) How must I inspect refillable containers? Before repackaging a pesticide product into any refillable container, you must visually inspect the exterior and (if possible) the interior of the container and the exterior of appurtenances. The purpose of the inspection is to determine whether the container meets the necessary criteria with respect to continued container integrity, required markings, and openings. If the condition in paragraph (f)(1) of this section exists, the container fails the inspection and must not be refilled unless the container is repaired, reconditioned, or remanufactured in compliance with the relevant DOT requirement. If the condition in paragraph (f)(2) or (f)(3) of this section exists (or both), the container fails the inspection and must not be refilled until the container meets the standards specified in subpart C of this part. The conditions are:
              (1) The integrity of the container is compromised in at least one of the following ways:
              (i) The container shows signs of rupture or other damage which reduces its structural integrity.
              (ii) The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects.
              (iii) The container has cracks, warpage, corrosion or any other damage which might render it unsafe for transportation.
              (iv) There is damage to the fittings, valves, tamper-evident devices or other appurtenances that may cause failure of the container.
              (2) The container does not bear the markings required by § 165.45(a), (b) and (d), or such markings are not legible.
              (3) The container does not have an intact and functioning one-way valve or tamper-evident device on each opening other than a vent, if required.
              (g) How must I clean refillable containers? You must clean each refillable container by conducting the pesticide product's refilling residue removal procedure before repackaging the pesticide product into the refillable container, unless the conditions in paragraph (g)(1) of this section and either paragraph (g)(2) or (g)(3) of this section are satisfied:
              (1) If required, each tamper-evident device and one-way valve is intact.
              (2) The refillable container is being refilled with the same pesticide product.
              (3) Both of the following conditions are satisfied.
              (i) The container previously held a pesticide product with a single active ingredient and is being used to repackage a pesticide product with the same single active ingredient.
              (ii) There is no change that would cause the composition of the product being repackaged to differ from the composition described in its confidential statement of formula that is required under FIFRA section 3. Examples of unallowable changes include the active ingredient concentration increasing or decreasing beyond the limits established by the confidential statement of formula or a reaction or interaction between the pesticide product being repackaged and the residue remaining in the container.
              (h) How must I clean a refillable container that has a broken (non-intact) tamper-evident device or one-way valve? As required in paragraph (g) of this section, you must clean each refillable container that has a tamper-evident device or one-way valve that is not intact by conducting the pesticide product's refilling residue removal procedure before repackaging the pesticide product into the refillable container. In addition, other procedures may be necessary to assure that product integrity is maintained in such cases.
              (i) How must I label refillable containers? Before distributing or selling a pesticide product in a refillable container, you must ensure that the label of the pesticide product is securely attached to the refillable container such that the label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. The label and labeling must comply in all respects with the requirements of part 156 of this chapter. In particular, you must ensure that the net contents statement and EPA establishment number appear on the label.
              (j) What recordkeeping must I do? You must maintain all of the records listed in this section in addition to the applicable records identified in parts 167 and 169 of this chapter. You must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe.
              (1) For each pesticide product distributed or sold in refillable containers, all of the following records must be maintained for the current operating year and for 3 years after that:
              (i) The written contract from the pesticide product's registrant for the pesticide product.
              (ii) The written refilling residue removal procedure for the pesticide product.
              (iii) The written description of acceptable containers for the pesticide product.
              (2) Each time you repackage a pesticide product into a refillable container and distribute or sell the product, the following records must be generated and maintained for at least 3 years after the date of repackaging:
              (i) The EPA registration number of the pesticide product distributed or sold in the refillable container.
              (ii) The date of the repackaging.
              (iii) The serial number or other identifying code of the refillable container.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              §§ 165.71-165.79
              [Reserved]

            Subpart E—Standards for Pesticide Containment Structures

              § 165.80
              General provisions.
              (a) What is the purpose of the regulations in this subpart? The purpose of the containment regulations in this subpart is to protect human health and the environment from exposure to agricultural pesticides which may spill or leak from stationary pesticide containers. This protection is achieved by the construction of secondary containment units or pads at certain facilities handling agricultural pesticides. These regulations will also reduce waste generation associated with:
              (1) Storage and handling of large quantities of pesticide products.
              (2) Pesticide dispensing and container-refilling operations.
              (b) Do I have to comply with the regulations in this subpart? You must comply with the regulations in this subpart if you are an owner or operator of one of the following businesses and if you also have a stationary pesticide container or a pesticide dispensing (including container refilling) area:

              (1) Refilling establishments who repackage agricultural pesticides and whose principal business is retail sale (i.e., more than 50% of total annual revenue comes from retail operations).
              (2) Custom blenders of agricultural pesticides.
              (3) Businesses which apply an agricultural pesticide for compensation (other than trading of personal services between agricultural producers).
              (c) When do I have to comply? You must comply with all applicable containment regulations for new and existing structures as of August 17, 2009.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.81
              Scope of stationary pesticide containers included.
              (a) What is a stationary pesticide container? A stationary pesticide container is a refillable container that is fixed at a single facility or establishment, or, if not fixed, remains at the facility or establishment for at least 30 consecutive days, and that holds pesticide during the entire time.
              (b) What stationary pesticide containers are subject to the regulations in this subpart? Stationary pesticide containers designed to hold undivided quantities of agricultural pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide are subject to the regulations in this subpart and must have a secondary containment unit that complies with the provisions of this subpart unless any of the following conditions exists:
              (1) The container is empty, that is, all pesticide that can be removed by methods such as draining, pumping or aspirating has been removed (whether or not the container has been rinsed or washed).
              (2) The container holds only pesticide rinsates or wash waters, and is labeled accordingly.
              (3) The container holds only pesticides which would be gaseous when released at atmospheric temperature and pressure.
              (4) The container is dedicated to non-pesticide use, and is labeled accordingly.

              § 165.82
              Scope of pesticide dispensing areas included.
              (a) What pesticide dispensing areas are subject to the regulations in this subpart? A pesticide dispensing area is subject to the containment regulations in this subpart and must have a containment pad that complies with the requirements of this subpart if any of the following activities occur:
              (1) Refillable containers of agricultural pesticide are emptied, cleaned or rinsed.
              (2) Agricultural pesticides are dispensed from a stationary pesticide container designed to hold undivided quantities of agricultural pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide for any purpose, including refilling or emptying for cleaning. This applies when pesticide is dispensed from the container into any vessel, including, but not limited to:
              (i) Refillable containers;
              (ii) Service containers;
              (iii) Transport vehicles;
              (iv) Application equipment.
              (3) Agricultural pesticides are dispensed from a transport vehicle for purposes of filling a refillable container.
              (4) Agricultural pesticides are dispensed from any other container for the purpose of refilling a refillable container for sale or distribution. Containment requirements do not apply if the agricultural pesticide is dispensed from such a container for use, application or purposes other than refilling for sale or distribution.
              (b) What pesticide dispensing areas are exempt from the regulations in this subpart? A pesticide dispensing area is exempt from the regulations in this subpart if any of the following conditions exist:
              (1) The only pesticides in the dispensing area would be gaseous when released at atmospheric temperature and pressure.
              (2) The only pesticide containers refilled or emptied within the dispensing area are stationary pesticide containers which are already protected by a secondary containment unit that complies with the provisions of this subpart.
              (3) The pesticide dispensing area is used solely for dispensing pesticide from a rail car which does not remain at a facility long enough to meet the definition of a stationary pesticide container; that is, 30 days.

              § 165.83
              Definition of new and existing structures.
              (a) What is a new containment structure? A new containment structure is one whose installation began after November 16, 2006. Installation is considered to have begun if:

              (1) You, as the owner or operator, have obtained all Federal, State, and local approvals or permits necessary to begin physical construction of the containment structure; AND
              (2) You have either begun a continuous on-site physical construction or installation program OR you have entered into contractual obligations. The contract must be such that it cannot be canceled or modified without substantial loss, and must be for the physical construction or installation of the containment structure within a specific and reasonable time frame.
              (b) What is an existing containment structure? An existing containment structure is defined as one whose installation began on or before November 16, 2006.

              § 165.85
              Design and capacity requirements for new structures.
              (a) For all new containment structures, what construction materials must I use? These are the material specifications for a new containment structure:
              (1) The containment structure must be constructed of steel, reinforced concrete or other rigid material capable of withstanding the full hydrostatic head, load and impact of any pesticides, precipitation, other substances, equipment and appurtenances placed within the structure. The structure must be liquid-tight with cracks, seams and joints appropriately sealed.
              (2) The structure must not be constructed of natural earthen material, unfired clay, or asphalt.
              (3) The containment structure must be made of materials compatible with the pesticides stored. In this case, compatible means able to withstand anticipated exposure to stored or transferred substances and still provide containment of those same or other substances within the containment area.
              (b) For all new containment structures, what are the general design requirements? These are the general design requirements for new containment structures:
              (1) You must protect appurtenances and pesticide containers against damage from operating personnel and moving equipment. Means of protection include, but are not limited to, supports to prevent sagging, flexible connections, the use of guard rails, barriers, and protective cages.
              (2) Appurtenances, discharge outlets or gravity drains must not be configured through the base or wall of the containment structure, except for direct interconnections between adjacent containment structures which meet the requirements of this subpart. Appurtenances must be configured in such a way that spills or leaks are easy to see.
              (3) The containment structure must be constructed with sufficient freeboard to contain precipitation and prevent water and other liquids from seeping into or flowing onto it from adjacent land or structures.
              (4) Multiple stationary pesticide containers may be protected within a single secondary containment unit.
              (c) For new secondary containment units for stationary containers of liquid pesticides and new containment pads in pesticide dispensing areas, what are the capacity requirements? These are the capacity requirements:
              (1) New secondary containment units for stationary containers of liquid pesticides, if protected from precipitation, must have a capacity of at least 100 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
              (2) New secondary containment units for stationary containers of liquid pesticides, if exposed to or unprotected from precipitation, must have a capacity of at least 110 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
              (3) New containment pads in pesticide dispensing areas which have a pesticide container or pesticide-holding equipment with a volume of 750 gallons or greater must have a holding capacity of at least 750 gallons.
              (4) New containment pads in pesticide dispensing areas which do not have a pesticide container or pesticide-holding equipment with a volume of at least 750 gallons must have a holding capacity of at least 100 percent of the volume of the largest pesticide container or pesticide-holding equipment used on the pad.
              (d) For new secondary containment units for stationary containers of liquid pesticides, what are the specific design requirements? You must either anchor or elevate each stationary container of liquid pesticides protected by a new secondary containment unit to prevent flotation in the event that the secondary containment unit fills with liquid.
              (e) For new containment pads in pesticide dispensing areas, what are the specific design requirements? Each new containment pad in a pesticide dispensing area must:
              (1) Be designed and constructed to intercept leaks and spills of pesticides which may occur in the pesticide dispensing area.
              (2) Have enough surface area to extend completely beneath any container on it, with the exception of transport vehicles dispensing pesticide for sale or distribution to a stationary pesticide container. For such vehicles, the surface area of the containment pad must accommodate at least the portion of the vehicle where the delivery hose or device couples to the vehicle. This exception does not apply to transport vehicles that are used for prolonged storage or repeated on-site dispensing of pesticides.
              (3) Allow, in conjunction with its sump, for removal and recovery of spilled, leaked, or discharged material and rainfall, such as by a manually activated pump. Automatically-activated pumps which lack automatic overflow cutoff switches for the receiving container are prohibited.
              (4) Have its surface sloped toward an area where liquids can be collected for removal, such as a liquid-tight sump or a depression, in the case of a single-pour concrete pad.
              (f) For new secondary containment units for stationary containers of dry pesticides, what are the specific design requirements? These are the specific design requirements for new secondary containment units for stationary containers of dry pesticides:
              (1) The stationary containers of dry pesticides within the containment unit must be protected from wind and precipitation.
              (2) Stationary containers of dry pesticides must be placed on pallets or a raised concrete platform to prevent the accumulation of water in or under the pesticide.
              (3) The storage area for stationary containers of dry pesticides must include a floor that extends completely beneath the pallets or raised concrete platforms on which the stationary containers of dry pesticides must be stored.
              (4) The storage area for stationary containers of dry pesticides must be enclosed by a curb a minimum of 6 inches high that extends at least 2 feet beyond the perimeter of the container.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

              § 165.87
              Design and capacity requirements for existing structures.
              (a) For all existing containment structures, what construction materials must I use? These are the material specifications for an existing containment structure:
              (1) The containment structure must be constructed of steel, reinforced concrete or other rigid material capable of withstanding the full hydrostatic head, load and impact of any pesticides, precipitation, other substances, equipment and appurtenances placed within the structure. The structure must be liquid-tight with cracks, seams and joints appropriately sealed.
              (2) The structure must not be constructed of natural earthen material, unfired clay, or asphalt.
              (3) The containment structure must be made of materials compatible with the pesticides stored. In this case, compatible means able to withstand anticipated exposure to stored or transferred substances and still provide containment of those same or other substances within the containment area.
              (b) For all existing containment structures, what are the general design requirements? These are the general design requirements for existing containment structures:
              (1) You must protect appurtenances and pesticide containers against damage from operating personnel and moving equipment. Means of protection include, but are not limited to, supports to prevent sagging, flexible connections, the use of guard rails, barriers, and protective cages.

              (2) You must seal all appurtenances, discharge outlets and gravity drains through the base or wall of the containment structure, except for direct interconnections between adjacent containment structures which meet the requirements of this subpart.
              (3) The containment structure must be constructed with sufficient freeboard to contain precipitation and prevent water and other liquids from seeping into or flowing onto it from adjacent land or structures.
              (4) Multiple stationary pesticide containers may be protected within a single secondary containment unit.
              (c) For existing secondary containment units for stationary containers of liquid pesticides and existing containment pads in pesticide dispensing areas, what are the capacity requirements? These are the capacity requirements:
              (1) Existing secondary containment units for stationary containers of liquid pesticides must have a capacity of at least 100 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
              (2) Existing containment pads in pesticide dispensing areas which have a pesticide container or pesticide-holding equipment with a volume of 750 gallons or greater must have a holding capacity of at least 750 gallons.
              (3) Existing containment pads in pesticide dispensing areas which do not have a pesticide container or pesticide-holding equipment with a volume of at least 750 gallons must have a holding capacity of at least 100 percent of the volume of the largest pesticide container or pesticide-holding equipment used on the pad.
              (d) For existing secondary containment units for stationary containers of liquid pesticides, what are the specific design requirements? You must either anchor or elevate each stationary container of liquid pesticides protected by an existing secondary containment unit to prevent flotation in the event that the secondary containment unit fills with liquid.
              (e) For existing containment pads in pesticide dispensing areas, what are the specific design requirements? Each existing containment pad in a pesticide dispensing area must:
              (1) Be designed and constructed to intercept leaks and spills of pesticides which may occur in the pesticide dispensing area.
              (2) Have enough surface area to extend completely beneath any container on it, with the exception of transport vehicles dispensing pesticide for sale or distribution to a stationary pesticide container. For such vehicles, the surface area of the containment pad must accommodate at least the portion of the vehicle where the delivery hose or device couples to the vehicle. This exception does not apply to transport vehicles that are used for prolonged storage or repeated on-site dispensing of pesticides.
              (3) Allow, in conjunction with its sump, for removal and recovery of spilled, leaked, or discharged material and rainfall, such as by a manually activated pump. Automatically-activated pumps which lack automatic overflow cutoff switches for the receiving container are prohibited.
              (f) For existing secondary containment units for stationary containers of dry pesticides, what are the specific design requirements? These are the specific design requirements for existing secondary containment units for stationary containers of dry pesticides:
              (1) The stationary containers of dry pesticides within the containment unit must be protected from wind and precipitation.
              (2) Stationary containers of dry pesticides must be placed on pallets or a raised concrete platform to prevent the accumulation of water in or under the pesticide.
              (3) The storage area for stationary containers of dry pesticides must include a floor that extends completely beneath the pallets or raised concrete platforms on which the stationary containers of dry pesticides must be stored.
              (4) The storage area for stationary containers of dry pesticides must be enclosed by a curb a minimum of 6 inches high that extends at least 2 feet beyond the perimeter of the container.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]

              § 165.90
              Operational, inspection and maintenance requirements for all new and existing containment structures.
              (a) What are the operating procedures required for all new and existing containment structures? As the owner or operator of a new or existing pesticide containment structure, you must:
              (1) Manage the structure in a manner that prevents pesticides or materials containing pesticides from escaping from the containment structure (including, but not limited to, pesticide residues washed off the containment structure by rainfall or cleaning liquids used within the structure.)
              (2) Ensure that pesticide spills and leaks on or in any containment structure are collected and recovered in a manner that ensures protection of human health and the environment (including surface water and groundwater) and maximum practicable recovery of the pesticide spilled or leaked. Cleanup must occur no later than the end of the day on which pesticides have been spilled or leaked except in circumstances where a reasonable delay would significantly reduce the likelihood or severity of adverse effects to human health or the environment.
              (3) Ensure that all materials resulting from spills and leaks and any materials containing pesticide residue are managed according to label instructions and applicable Federal, State and local laws and regulations.
              (4) Ensure that transfers of pesticides between containers, or between containers and transport vehicles are attended at all times.
              (5) Ensure that each lockable valve on a stationary pesticide container, if it is required by § 165.45(f), is closed and locked, or that the facility is locked, whenever the facility is unattended.
              (b) What are the inspection and maintenance requirements for all new and existing containment structures? As owner or operator of a new or existing pesticide containment structure, you must:
              (1) Inspect each stationary pesticide container and its appurtenances and each containment structure at least monthly during periods when pesticides are being stored or dispensed on the containment structure. Your inspection must look for visible signs of wetting, discoloration, blistering, bulging, corrosion, cracks or other signs of damage or leakage.
              (2) Initiate repair to any areas showing visible signs of damage and seal any cracks and gaps in the containment structure or appurtenances with material compatible with the pesticide being stored or dispensed no later than the end of the day on which damage is noticed and complete repairs within a time frame that is reasonable, taking into account factors such as the weather, and the availability of cleanup materials, trained staff, and equipment.
              (3) Not store any additional pesticide on a containment structure if the structure fails to meet the requirements of this subpart until suitable repairs have been made.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]

              § 165.92
              What if I need both a containment pad and a secondary containment unit?
              You may combine containment pads and secondary containment units as an integrated system provided the requirements set out in this subpart for containment pads and secondary containment units in §§ 165.85(a) and (b), 165.87(a) and (b) and § 165.90, and as applicable, §§ 165.85(c)-(f) and 165.87(c)-(f) are satisfied separately.

              § 165.95
              What recordkeeping do I have to do as a facility owner or operator?
              As a facility owner or operator subject to the requirements of this subpart, you must maintain the following records, and you must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe:
              (a) Records of inspection and maintenance for each containment structure and for each stationary pesticide container and its appurtenances must be kept for 3 years and must include the following information:
              (1) Name of the person conducting the inspection or maintenance;

              (2) Date the inspection or maintenance was conducted;

              (3) Conditions noted;
              (4) Specific maintenance performed.
              (b) Records for any non-stationary pesticide container designed to hold undivided quantities of agricultural pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide that holds pesticide but is not protected by a secondary containment unit meeting these regulations must be kept for 3 years. Records on these non-stationary pesticide containers must include the time period that the container remains at the same location.
              (c) Records of the construction date of the containment structure must be kept for as long as the pesticide containment structure is in use, and for 3 years afterwards.

              § 165.97
              States with existing containment programs.
              (a) What options are available to States that already have containment regulations? States that have promulgated containment regulations effective prior to August 16, 2006, and which also have primary enforcement responsibility and/or certification programs, have the option of continuing to implement their own programs in lieu of these Federal regulations.
              (b) How may a State request authority to continue implementing its State containment regulations? A State with pesticide containment regulations may request the authority to continue implementing State containment regulations by August 16, 2007 in the following manner:
              (1) The State must submit a letter and any supporting documentation to EPA. Supporting documentation must demonstrate that the State's program is providing environmental protection equivalent to or more protective than that expected to be provided by the Federal regulations in this subpart.
              (2) The State must identify any significant changes to State regulations which would be necessary in order to provide environmental protection equivalent to the EPA regulations, and develop an estimated timetable to effect these changes. The letter must be signed by the designated State Lead Agency.
              (c) How will EPA notify the State if its request is granted? EPA's Office of Pesticide Programs will review the State's correspondence and determine whether the State program is adequate to provide environmental protection equivalent to or more protective than these Federal regulations for new and existing containment structures. EPA's Office of Pesticide Programs will inform the State of its determination through a letter authorizing or declining to authorize the State to continue implementing its containment regulations and will detail any reasons for declining authorization.
              (d) How must a State inform EPA of revisions to its containment regulations? Any state that has received authorization to continue implementing its state containment regulations must inform EPA by letter signed by the designated State Lead Agency within 6 months of any revision to the State's containment regulations. EPA will inform the state by letter if it determines that the State's containment regulations are no longer adequate based on the revisions. The State's containment regulations will remain in effect, unless and until EPA sends the state a letter making this determination.
              [71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]

          Pt. 166
          PART 166—EXEMPTION OF FEDERAL AND STATE AGENCIES FOR USE OF PESTICIDES UNDER EMERGENCY CONDITIONS

              Subpart A—General Provisions
              Sec.
              166.1
              Purpose and organization.
              166.2
              Types of exemptions.
              166.3
              Definitions.
              166.7
              User notification; advertising.

              Subpart B—Specific, Quarantine, and Public Health Exemptions
              166.20
              Application for a specific, quarantine, or public health exemption.
              166.22
              Consultation with the Secretary of Agriculture and Governors of the States.
              166.24
              Public notice of receipt of application and opportunity for public comment.
              166.25
              Agency review.
              166.28
              Duration of exemption.
              166.30
              Notice of Agency decision.

              166.32
              Reporting and recordkeeping requirements for specific, quarantine, and public health exemptions.
              166.34
              EPA review of information obtained in connection with emergency exemptions.
              166.35
              Revocation or modification of exemptions.

              Subpart C—Crisis Exemptions
              166.40
              Authorization.
              166.41
              Limitations.
              166.43
              Notice to EPA and registrants or basic manufacturers.
              166.45
              Duration of crisis exemption.
              166.49
              Public notice of crisis exemptions.
              166.50
              Reporting and recordkeeping requirements for crisis exemption.
              166.53
              EPA review of crisis exemption and revocation of authority.

            Authority:
            7 U.S.C. 136p, and 136w.

            Source:
            51 FR 1902, Jan. 15, 1986, unless otherwise noted.

            Subpart A—General Provisions

              § 166.1
              Purpose and organization.
              (a) Purpose and scope. Section 18 of the Act authorizes the Administrator to exempt State and Federal agencies from any provision of the Act, if he determines that emergency conditions exist which require an exemption. The regulations in this part establish procedures whereby the Administrator may exempt a Federal or State agency from the provisions of the Act which regulate the manner in which a pesticide is made available for use or is used.
              (b) Organization. (1) The provisions in subpart A of this part describe the four types of emergency exemptions authorized by the Agency and define terms used in this part.
              (2) Subpart B of this part establishes procedures and criteria for specific, quarantine, and public health exemptions.
              (3) Subpart C of this part establishes procedures and criteria for crisis exemptions.

              § 166.2
              Types of exemptions.
              There are four types of emergency exemptions which may be authorized: specific, quarantine, public health, and crisis exemptions.
              (a) Specific exemption. A specific exemption may be authorized in an emergency condition to avert:
              (1) A significant economic loss; or
              (2) A significant risk to:
              (i) Endangered species,
              (ii) Threatened species,
              (iii) Beneficial organisms, or
              (iv) The environment.
              (b) Quarantine exemption. A quarantine exemption may be authorized in an emergency condition to control the introduction or spread of any pest that is an invasive species, or is otherwise new to or not theretofore known to be widely prevalent or distributed within and throughout the United States and its territories.
              (c) Public health exemption. A public health exemption may be authorized in an emergency condition to control a pest that will cause a significant risk to human health.
              (d) Crisis exemption. A crisis exemption may be utilized in an emergency condition when the time from discovery of the emergency to the time when the pesticide use is needed is insufficient to allow for the authorization of a specific, quarantine, or public health exemption.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4510, Jan. 27, 2006]

              § 166.3
              Definitions.
              Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:

                Act means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.

                Agency and EPA mean the U. S. Environmental Protection Agency.

                Beneficial organism means any pollinating insect, or any pest predator, parasite, pathogen or other biological control agent which functions naturally or as part of an integrated pest management program to control another pest.

                Emergency condition means an urgent, non-routine situation that requires the use of a pesticide(s) and shall be deemed to exist when:

              (1) No effective pesticides are available under the Act that have labeled uses registered for control of the pest under the conditions of the emergency; and
              (2) No economically or environmentally feasible alternative practices which provide adequate control are available; and
              (3) The situation:
              (i) Involves the introduction or dissemination of an invasive species or a pesticide new to or not theretofore known to be widely prevalent or distributed within or throughout the United States and its territories; or
              (ii) Will present significant risks to human health; or
              (iii) Will present significant risks to threatened or endangered species, beneficial organisms, or the environment; or
              (iv) Will cause significant economic loss due to:
              (A) An outbreak or an expected outbreak of a pest; or
              (B) A change in plant growth or development caused by unusual environmental conditions where such change can be rectified by the use of a pesticide(s).

                First food use means the use of a pesticide on a food or in a manner which otherwise would be expected to result in residues in a food, if no tolerance or exemption from the requirements of a tolerance for residues of the pesticide on any food has been established for the pesticide under section 408 of the Federal Food, Drug, and Cosmetic Act.

                Food means any article used for food or drink for man or animals.

                Invasive species means, with respect to a particular ecosystem, any species that is not native to that ecosystem, and whose introduction does or is likely to cause economic or environmental harm or harm to human health.

                IR-4 means the Interregional Research Project No. 4, a cooperative effort of the state land grant universities, the U.S. Department of Agriculture and EPA, to address the chronic shortage of pest control options for minor crops, which are generally of too small an acreage to provide economic incentive for registration by the crop protection industry.

                New chemical means an active ingredient not contained in any currently registered pesticide.

                Significant economic loss means that, compared to the situation without the pest emergency and despite the best efforts of the affected persons, the emergency conditions at the specific use site identified in the application are reasonably expected to cause losses meeting any of the following criteria:
              (1) For pest activity that primarily affects the current crop or other output, one or more of the following:
              (i) Yield loss greater than or equal to 20%.
              (ii) Economic loss, including revenue losses and cost increases, greater than or equal to 20% of gross revenues.
              (iii) Economic loss, including revenue losses and cost increases greater than or equal to 50% of net revenues.
              (2) For any pest activity where EPA determines that the criteria in paragraph (1) of this definition would not adequately describe the expected loss, substantial loss or impairment of capital assets, or a loss that would affect the long-term financial viability expected from the productive activity.

                Special Review means any interim administrative review of the risks and benefits of the use of a pesticide conducted pursuant to the provisions of part 154 of this chapter, or § 162.11 of this chapter prior to November 27, 1985, or any subsequent version of those rules.

                Unreasonable adverse effects on the environment means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.
              [73 FR 75597, Dec. 12, 2008]

              § 166.7
              User notification; advertising.
              (a) A State or Federal agency that obtains an exemption may notify eligible users of the availability of the exempted pesticide(s) through user groups, retail dealers, and other means. Notification may include distributing copies of the section 18 approval letter, labeling, or other information to eligible persons.

              (b) As set forth more fully in § 168.22 of this chapter, EPA interprets FIFRA sections 12(a)(1) (A) and (B) as making it unlawful for any person who distributes, sells, offers for sale, holds for sale, ships, delivers for shipment, or receives and (having so received) delivers or offers to deliver any pesticide, to advertise the pesticide for any use authorized by an emergency exemption, except for advertisements that are placed in media that address only persons in the geographical area to which the exemption applies, state the name and address of one or more retail dealers where users may buy the pesticide, and contain a prominent notice of the limitations on use under the emergency exemption. EPA may withdraw an exemption if the use of the pesticide covered by the exemption is advertised unlawfully.
              [54 FR 1125, Jan. 11, 1989]

            Subpart B—Specific, Quarantine, and Public Health Exemptions

              § 166.20
              Application for a specific, quarantine, or public health exemption.
              (a) General information required in an application for a specific, quarantine or public health exemption. An application must be submitted in writing by the head of the Federal or State agency, the Governor of the State involved, or their official designee. If a designee has been delegated authority to request exemptions, written authorization of such delegation must accompany the request or be on file with the Agency. In addition, the application must contain all applicable information specified in paragraphs (a) (1) through (11) of this section.
              (1) Identity of contact persons. (i) Unless otherwise specified, the person who submits the application will be considered the contact person for all matters relating to administration of the emergency exemption.
              (ii) Requests should identify by name and telephone number one or more qualified experts who may be contacted in case any questions arise concerning the application.
              (2) Description of the pesticide. The application shall contain a description of the pesticide(s) proposed for use under the exemption. Such information shall include:
              (i) For a federally registered pesticide product:
              (A) A copy of the label(s) if a specific product(s) is/are requested; or the formulation(s) requested if a specific product is not requested; and
              (B) A copy of any additional labeling proposed for the emergency exemption; or
              (ii) For any other pesticide products:
              (A) A confidential statement of formula or reference to one already submitted to the Agency; and
              (B) Complete labeling to be used in connection with the proposed exemption use.
              (3) Description of the proposed use. The application shall identify all of the following:
              (i) Sites to be treated, including their locations within the State;
              (ii) The method of application;
              (iii) The rate of application in terms of active ingredient and product;
              (iv) The maximum number of applications;
              (v) The total acreage or other appropriate unit proposed to be treated;
              (vi) The total amount of pesticide proposed to be used in terms of both active ingredient and product;
              (vii) All applicable restrictions and requirements concerning the proposed use which may not appear on labeling;
              (viii) The duration of the proposed use; and
              (ix) Earliest possible harvest dates.
              (4) Alternative methods of control. The application shall contain:
              (i) A detailed explanation of why the pesticide(s) currently registered for the particular use proposed in the application is not available in adequate supplies and/or effective to the degree needed to control the emergency. If the applicant states that an available registered pesticide is ineffective for the given situation, the statement must be supported by field data which demonstrate ineffectiveness of registered pesticides, or, if such data are unavailable, statements by qualified agricultural experts, extension personnel, university personnel or other persons similarly qualified in the field of pest control; and

              (ii) A detailed explanation of why alternative practices, if available, either would not provide adequate control or would not be economically or environmentally feasible.

              (5) Effectiveness of proposed use. The application shall contain data, a discussion of field trials, or other evidence which provide the basis for the conclusion that the proposed pesticide treatment will be effective in dealing with the emergency.
              (6) Discussion of residues for food uses. If the proposed use is expected to result in residues of the pesticide in or on food, the application shall list the food likely to contain such residues and shall contain an estimate of the maximum amount of the residue likely to result from the proposed use, together with the information on which such estimates are based.
              (7) Discussion of risk information. The application shall address the potential risks to human health, endangered or threatened species, beneficial organisms, and the environment expected to result from the proposed use, together with references to data and other supporting information.
              (8) Coordination with other affected State or Federal agencies. If the proposed use of the pesticide is likely to be of concern to other Federal or State agencies, the application shall indicate that such agencies have been contacted prior to submission of the application, and any comments received from such agencies shall be submitted to EPA.
              (9) Acknowledgment by registrant. The application shall contain a statement by the registrants of all pesticide products proposed for use acknowledging that a request has been made to the Agency for use of the pesticide under this section. This acknowledgment shall include a statement of support for the requested use, including the expected availability of adequate quantities of the requested product under the use scenario proposed by the applicant(s); and the status of the registration in regard to the requested use including appropriate petition numbers, or of the registrant's intentions regarding the registration of the use.
              (10) Description of proposed enforcement program. Prior to approval, the applicant shall provide an explanation of the authority of the applicant or related State or Federal agencies for ensuring that use of the pesticide under the proposed exemption would comply with any special requirements imposed by the Agency and a description of the program and procedures for assuring such compliance.
              (11) Repeated uses. Applications for the use of a pesticide at a site for which the applicant has previously been exempted under section 18 shall contain an interim report summarizing the results of the specific, quarantine, or public health exemption previously issued, if the application is submitted prior to the time the final report for the previous exemption is due. The interim report shall contain that information specified in § 166.32 to the extent available at the time the application is made.
              (b) Information required for a specific exemption. An application for a specific exemption shall provide all of the following information, as appropriate, concerning the nature of the emergency:
              (1) The scientific and common name of the pest or pest complex;
              (2) A discussion of the events which brought about the emergency condition;
              (3) A discussion of the anticipated risks to endangered or threatened species, beneficial organisms, or the environment that would be remedied by the proposed use of the pesticide; and
              (4) A discussion of the anticipated significant economic loss, together with data and other information supporting the discussion, that addresses one or more of the following, as appropriate:
              (i) Yield or utilized yield reasonably anticipated in the absence of the emergency and expected losses in quantity due to the emergency;
              (ii) The information in paragraph (b)(4)(i) of this section plus prices reasonably anticipated in the absence of the emergency and changes in prices and/or production costs due to the emergency;
              (iii) The information in paragraph (b)(4)(ii) of this section plus operating costs reasonably anticipated in the absence of the emergency;
              (iv) Any other information explaining the economic consequences of the emergency.
              (5) Re-certification of an emergency condition. Applicants for specific exemptions may submit re-certification applications relying on previously submitted information to satisfy the information requirements of paragraphs (a)(1) through (a)(10) of this section, and of paragraphs (b)(1) through (b)(4) of this section, where all of the following conditions are met:
              (i) An exemption was granted for the same pesticide at the same site to the same applicant the previous year;
              (ii) The emergency condition could reasonably be expected to continue for longer than 1 year;
              (iii) EPA has not declared the use ineligible for re-certification;
              (iv) The use is not subject to public notice pursuant to § 166.24(a)(1) through (a)(6);
              (v) The applicant certifies that all of the following are true:
              (A) The emergency condition described in the preceding year's application continues to exist;
              (B) Except as expressly identified, all information submitted in the preceding year's application is still accurate;
              (C) Except as expressly identified, the proposed conditions of use are identical to the conditions of use EPA approved for the preceding year;
              (D) Any conditions or limitations on the eligibility for re-certification identified in the preceding year's notice of approval of the emergency exemption have been satisfied;
              (E) The applicant is not aware of any alternative chemical or non-chemical practice that may offer a meaningful level of pest control, or has provided documentation that each such known practice does not provide adequate control or is not economically or environmentally feasible.
              (c) Information required for a quarantine exemption. An application for a quarantine exemption shall provide all of the following information concerning the nature of the emergency:
              (1) The scientific and common name of pest;
              (2) The origin of pest and the means of its introduction or spread if known; and
              (3) The anticipated impact of not controlling the pest.
              (d) Information required for a public health exemption. An application for a public health exemption shall provide all the following information concerning the nature of the emergency:
              (1) The scientific and common name of the pest to be controlled and, if the pest is a vector, a description of the disease it is expected to transmit;
              (2) A discussion of the magnitude of the health problems which are expected to occur without the pesticide use; and
              (3) Discussion of the availability of medical treatment for the health problem.
              [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 FR 4511, Jan. 27, 2006]

              § 166.22
              Consultation with the Secretary of Agriculture and Governors of the States.
              The Agency, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any State concerned if they request such determination.

              § 166.24
              Public notice of receipt of application and opportunity for public comment.
              (a) Publication requirement. The Administrator shall issue a notice of receipt in the Federal Register for a specific, quarantine, or public health exemption and request public comment when any one of the following criteria is met:
              (1) The application proposes use of a new chemical;
              (2) The application proposes the first food use of an active ingredient;
              (3) The application proposes any use of a pesticide if the pesticide has been subject to a suspension notice under section 6(c) of the Act;
              (4) The application proposes use of a pesticide which:
              (i) Was the subject of a notice under section 6(b) of the Act and was subsequently cancelled, and
              (ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was the subject of the notice under section 6(b);
              (5) The application proposes use of a pesticide which:

              (i) Contains an active ingredient which is or has been the subject of a Special Review, and

              (ii) Is intended for a use that could pose a risk similar to the risk posed by any use of the pesticide which is or has been the subject of the Special Review;
              (6) The application proposes use of a pesticide which:
              (i) Was voluntarily canceled under section 6(f) of the Act, and
              (ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was voluntarily canceled under section 6(f);
              (7) The application proposes use of a pesticide for a specific or public health exemption, if:
              (i) An emergency exemption has been requested or approved for that use in any 3 previous years, or any 5 previous years if the use is supported by the IR-4 program, and
              (ii) A complete application for registration of that use and/or a petition for tolerance for residues in or on the commodity has not been submitted to the Agency; or
              (8) The Administrator determines that publication of notice is appropriate.
              (b) Contents. The notice of receipt of an application for an emergency exemption shall contain the following information:
              (1) The name of the applicant;
              (2) The name of the active ingredient requested for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
              (3) The total amount of product or active ingredient proposed for use;
              (4) The geographical location where treatment is proposed;
              (5) The proposed number of acres or other appropriate units proposed to be treated;
              (6) A summary of the applicant's description of the emergency conditions including the pest and the site or crop to be treated;
              (7) A description of the major conditions of use of the pesticide as proposed by the applicant;
              (8) If the pesticide proposed for use meets the criteria of paragraph (a) (3), (4), or (5) of this section, an identification of the types of risks that were the basis for EPA's regulatory action; and
              (9) The name, telephone number, and address of a person in the Agency who can provide further information.
              (c) Length of comment period. Normally, a notice of receipt shall give the public 15 days in which to file comments on the application. The Administrator may shorten or eliminate the comment period if he determines that the time available for a decision on the application requires it and shall state reasons for such action in a notice in the Federal Register. The Administrator may extend the comment period if additional time for comment is requested and such an extension would not interfere with a timely decision on the application.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006]

              § 166.25
              Agency review.
              (a) General. The Agency will review all requests as expeditiously as possible, making every attempt to respond to requests prior to the time when the proposed use is needed. The Agency will review the application and other available data necessary to make a determination with respect to all of the following:
              (1) Whether an emergency condition exists or will exist;
              (2) The Agency's ability and intention to establish a time-limited tolerance(s) or exemption(s) from the requirement of a tolerance for any pesticide residues resulting from the authorized use, identifying the level of permissible residues in or on food or feed resulting from the proposed use;
              (3) The anticipated benefits to be derived from the proposed use; and
              (4) The potential risks to human health, endangered or threatened species, beneficial organisms, and the environment from the proposed use.
              (b) Criteria for approval. The Administrator may authorize a specific, public health, or quarantine exemption, based on the information available to the Agency, after:
              (1) He determines that:
              (i) An emergency condition exists;
              (ii) The use of the pesticide under the exemption will not cause unreasonable adverse effects on the environment;

              (iii) Registration of the pesticide use for which the exemption is requested has not been suspended under section 6(c) of the Act or cancelled following a notice under section 6(b) of the Act, unless the use is authorized in accordance with the provisions of §§ 164.130 through 164.133 of this chapter;
              (2) Giving due consideration to:
              (i) Whether the pesticide is reasonably likely to be used in compliance with the requirements imposed by the Agency under the exemption; and
              (ii) The progress which has been made toward registration of the proposed use, if a repeated specific or public health exemption is sought. It shall be presumed that if a complete application for registration of a use, which has been under a specific or public health exemption for any 3 previous years, or any 5 previous years if the use is supported for registration by the IR-4 program, has not been submitted, reasonable progress towards registration has not been made.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006]

              § 166.28
              Duration of exemption.
              (a) Specific or public health exemptions. EPA shall allow use of a pesticide under a specific or public health exemption for as long a period as is reasonably expected to be necessary but in no case for longer than 1 year.
              (b) Quarantine exemption. EPA shall allow use of a pesticide under a quarantine exemption for as long a period as is deemed necessary but in no case for longer than 3 years. Quarantine exemptions may be renewed. Interim reports containing the information specified in § 166.32(b) to the extent available shall be filed annually.

              § 166.30
              Notice of Agency decision.
              (a) Notification of applicants. The Agency shall notify an applicant of its decision to approve or deny an application request for an emergency exemption in a timely manner.
              (1) Incomplete applications. The Agency may discontinue the processing of any application that does not address all of the requirements of § 166.20 until such time the additional information is submitted by the applicant.
              (2) Complete applications—(i) Denials. The Agency shall provide the specific reasons and rationale for denying the exemption request. If the denial is based on a specific information gap, the decision shall be reconsidered in a timely manner when the information gap is filled.
              (ii) Approvals. The Agency shall provide the specific terms and conditions under which the exempted pesticide may be used.
              (b) Federal Register publication. (1) At least quarterly, the Administrator shall issue a notice in the Federal Register announcing all approvals of specific, quarantine, and public health exemptions. The notice shall contain all of the following:
              (i) The name of the applicant;
              (ii) The pesticide authorized for use;
              (iii) The crop or site to be treated; and
              (iv) The name, address, and telephone number of a person in the Agency who can provide further information.
              (2) In addition, if EPA has issued a Notice of Receipt of an application for an exemption, it will issue a notice of its final decision and the reasons for that decision.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]

              § 166.32
              Reporting and recordkeeping requirements for specific, quarantine, and public health exemptions.
              (a) Unexpected adverse effects information. Any unexpected adverse effects resulting from the use of a pesticide under a specific, quarantine, or public health exemption must be immediately reported to the Agency.
              (b) Interim and final reports. A final report summarizing the results of pesticide use under any specific, quarantine, or public health exemption must be submitted to the Agency within 6 months from the expiration of the exemption unless otherwise specified by the Agency. For quarantine exemptions granted for longer than 1 year, interim reports must be submitted annually. When an application for renewal of the exemption is submitted before the expiration of the exemption or before submission of the final report, an interim report must be submitted with the application. The information in interim and final reports shall include all of the following:

              (1) Total acreage, amount of commodity or other unit treated and the total quantity of the pesticide used;

              (2) A discussion of the effectiveness of the pesticide in dealing with the emergency condition;
              (3) A description of any unexpected adverse effects which resulted from use of the pesticide under the exemption;
              (4) The results of any monitoring required and/or carried out under the exemption;
              (5) A discussion of any enforcement actions taken in connection with the exemption;
              (6) Method(s) of disposition of a food crop, if required to be destroyed under an exemption; and
              (7) Any other information requested by the Administrator.
              (c) Records. Records for all treatments involving the first food use of a pesticide will be maintained by the agency to which the emergency exemption was granted for a minimum of 2 years following the date of expiration of the exemption. On request by the Agency these records shall be made available to the Administrator. Records will include all of the following:
              (1) Locations where the pesticide was applied;
              (2) Dates of application (range); and
              (3) Total quantity of the pesticide used.
              [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 FR 4512, Jan. 27, 2006]

              § 166.34
              EPA review of information obtained in connection with emergency exemptions.
              EPA shall review information submitted in connection with emergency exemptions and, when applicable, use it in connection with other regulatory decisions under the Act.

              § 166.35
              Revocation or modification of exemptions.
              (a) Grounds. The Administrator may revoke or modify the terms or conditions of a specific, quarantine, or public health exemption if he determines one of the following:
              (1) An emergency no longer exists;
              (2) Use of the pesticide under the exemption may cause unreasonable adverse effects on the environment;
              (3) The pesticide authorized under the exemption is not effective at controlling the pest or conditions causing the emergency; or
              (4) The terms and conditions established by the exemption and these regulations are not being complied with.
              (b) Implementation. The revocation or modification becomes effective as soon as the Administrator notifies the State or Federal agency which submitted the application. Upon notification, the applicant is required immediately to take all necessary steps to assure that further use complies with the terms and conditions of any modification or, if the exemption has been revoked, to stop further use.

            Subpart C—Crisis Exemptions

              § 166.40
              Authorization.
              The head of a Federal or State agency, the Governor of a State, or their official designee, may issue a crisis exemption in situations involving an unpredictable emergency situation when:
              (a) An unpredictable emergency condition exists;
              (b) The time element with respect to the application of the pesticide is critical, and there is not sufficient time either to request a specific, quarantine, or public health exemption or, if such a request has been submitted, for EPA to complete review of the request; and
              (c) EPA has provided verbal confirmation that, for food uses, a tolerance or exemption from the requirement of a tolerance can be established in a timely manner, responsive to the projected timeframe of use of the chemical and harvest of the commodity, and that, for any use, the Agency has no other objection.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]

              § 166.41
              Limitations.
              The crisis provisions may not be utilized to authorize a pesticide use if any of the following has occurred:
              (a) EPA has informed the head of the Federal or State agency, the Governor, or their official designee, not to issue such an exemption;

              (b) The pesticide use has been suspended under section 6(c) of the Act;

              (c) The pesticide use has been cancelled following a notice issued under section 6(b) of the Act;
              (d) The pesticide contains a new chemical; or
              (e) The application proposes the first food use of a pesticide.

              § 166.43
              Notice to EPA and registrants or basic manufacturers.
              (a) Timing of notice. (1) The State or Federal Agency issuing the crisis exemption must notify the Administrator in advance of utilization of the crisis provisions.
              (2) The State or Federal agency issuing the crisis exemption shall notify the registrant(s) or, if appropriate, the basic manufacturer(s) of the pesticide(s) being used under the crisis exemption at the same time notice is given to EPA or as soon thereafter as possible.
              (b) Contents of notice. Information required to be provided in notices shall include all of the following:
              (1) The name of the product and active ingredient authorized for use, along with the common name and CAS number if available, including a copy of the EPA registered label and use directions appropriate to the authorized use;
              (2) The site on which the pesticide is to be used or is being used;
              (3) The use pattern;
              (4) The date on which the pesticide use is to begin and the date when the use will end;
              (5) An estimate of the level of residues of the pesticide expected to result from use under the crisis exemption;
              (6) Earliest anticipated harvest date of the treated commodity;
              (7) Description of the emergency situation; and
              (8) Any other pertinent information available at the time.
              [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 FR 4512, Jan. 27, 2006]

              § 166.45
              Duration of crisis exemption.
              A crisis exemption may be authorized for:
              (a) Only as long as is necessary to control the pest or conditions causing the emergency; and
              (b) No longer than 15 days, unless an application requesting a specific, quarantine, or public health exemption for this use has been submitted to the Agency.

              § 166.49
              Public notice of crisis exemptions.
              (a) Periodic notices. At least quarterly, the Administrator shall issue a notice in the Federal Register announcing issuance of crisis exemptions. The notice shall contain all of the following:
              (1) The name of the applicant;
              (2) The pesticide authorized for use;
              (3) The crop or site to be treated; and
              (4) The name, address, and telephone number of a person in the Agency who can provide further information.
              (b) Annual reports. Annually, the Agency shall issue a notice in the Federal Register that shall summarize:
              (1) The number of crisis exemptions declared; and
              (2) The number of crisis exemptions revoked.
              [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]

              § 166.50
              Reporting and recordkeeping requirements for crisis exemption.
              (a) Adverse effects information. Any adverse effects resulting from the use of a pesticide under a crisis exemption must be immediately reported to the Agency.
              (b) Final reports. (1) A report summarizing the results of treatment under a crisis exemption will be required to be submitted to the Agency within 3 months following the last date of treatment. If a specific, quarantine, or public health exemption has been approved while the crisis exemption is in effect, however, the crisis exemption report may be incorporated into the specific, quarantine, or public health exemption final report required under § 166.32(b) and submitted at the time it is due.

              (2) Information to be included in the crisis exemption report includes the same information as required in § 166.32(b) and an explanation as to why there was a need to utilize the crisis provisions.

              (c) Records. Records will be maintained for a minimum of 2 years following the date of expiration of the exemption. On request by the Agency, these records shall be made available to the Administrator. Records will include all of the following:
              (1) Location where the pesticide was applied;
              (2) Dates of application (range); and
              (3) Total quantity of the pesticide used.
              [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]

              § 166.53
              EPA review of crisis exemption and revocation of authority.
              (a) Review. When a crisis exemption is about to be or has already been declared by a State or Federal agency, EPA will undertake an expedited review of the pesticide to determine if use of the pesticide may result in such unreasonable health or environmental risks that the crisis authority should not be exercised or the crisis exemption should be revoked.
              (b) Revocation—(1) Individual crisis exemptions. A crisis exemption for the use of a specific pesticide may be revoked if the Administrator determines that:
              (i) There are insufficient data to determine the risks posed from the use;
              (ii) Such action is necessary to protect man or the environment; or
              (iii) The State or Federal agency is not complying with the requirements of this subpart C.
              (2) State or Federal agency authority. The Administrator may revoke the authority of a State or Federal agency to issue crisis exemptions for any pesticide if he determines that:
              (i) Such action is necessary to protect man or the environment; or
              (ii) The State or Federal agency is not complying with the requirements of this subpart C.
              (c) Reason for revocation. The Agency shall provide the specific reasons for revoking an agency's authority to issue a crisis exemption and for revoking an issued crisis exemption.

          Pt. 167
          PART 167—REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS

              Subpart A—General Provisions
              Sec.
              167.3
              Definitions.

              Subpart B—Registration Requirements
              167.20
              Establishments requiring registration.

              Subparts C-D [Reserved]

              Subpart E—Recordkeeping and Reporting Requirements
              167.85
              Reporting requirements.
              167.90
              Where to obtain and submit forms.

            Authority:
            7 U.S.C. 136 (e) and (w).

            Source:
            53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, unless otherwise noted.

            Subpart A—General Provisions

              § 167.3
              Definitions.
              Terms used in this part shall have the meanings set forth for such terms in the Federal Insecticide, Fungicide, and Rodenticide Act. In addition, when used in this part, the following terms shall have the meanings stated below:

                Act means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, 7 U.S.C. 136 et seq.

                Amount of pesticidal product means quantity, expressed in weight or volume of the product, and is to be reported in pounds for solid or semi-solid pesticides and active ingredients or gallons for liquid pesticides and active ingredients, or number of individual retail units for devices.

                Current production [sales or distribution] means amount of planned production in the calendar year in which the pesticides report is submitted, including new pesticidal products not previously sold or distributed.

                Custom blender means any establishment which provides the service of mixing pesticides to a customer's specifications, usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture, when: (1) The blend is prepared to the order of the customer and is not held in inventory by the blender; (2) the blend is to be used on the customer's property (including leased or rented property); (3) the pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the product in such a blend; (4) the blend is prepared from registered pesticides; (b) the blend is delivered to the end-user along with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of mixture; and (6) no other pesticide production activity is performed at the establishment.

                Device means any device or class of devices as defined by the Act and determined by the Administrator pursuant to section 25(c) to be subject to the provisions of section 7 of the Act.

                Establishment means any site where a pesticidal product, active ingredient, or device is produced, regardless of whether such site is independently owned or operated, and regardless of whether such site is domestic and producing a pesticidal product for export only, or whether the site is foreign and producing any pesticidal product for import into the United States.

                Past year means the calendar year immediately prior to that in which the report is submitted.

                Pesticidal product means a pesticide, active ingredient, or device.

                Pesticidal product report means information showing the types and amounts of pesticidal products which were: (1) Produced in the past calendar year; (2) produced in the current calendar year; and, (3) sold or distributed in the past calendar year. For active ingredients, the pesticidal product report must include information on the types and amounts of an active ingredient for which there is actual or constructive knowledge of its use or intended use as a pesticide. This pesticidal product report also pertains to those products produced for export only which must also be reported. A positive or a negative annual report is required in order to maintain registration for the establishment.

                Produce means to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to section 5 of the Act, any active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.

                Producer means any person, as defined by the Act, who produces any pesticide, active ingredient, or device (including packaging, repackaging, labeling and relabeling).

                Sold or distributed means the aggregate amount of a pesticidal product released for shipment by the establishment in which the pesticidal product was produced.

                Type of pesticidal product refers to each individual product as identified by: the product name; EPA Registration Number (or EPA File Symbol, if any, for planned products, or Experimental Permit Number, if the pesticide is produced under an Experimental Use Permit); active ingredients; production type (technical, formulation, repackaging, etc.); and, market for which the product was produced (domestic, foreign, etc.). In cases where a pesticide is not registered, registration is not applied for, or the pesticide is not produced under an Experimental Use Permit, the term shall also include the chemical formulation.

            Subpart B—Registration Requirements

              § 167.20
              Establishments requiring registration.
              (a) Who must register. (1) Any establishment where a pesticidal product is produced must be registered with the Agency. This requirement does not apply to custom blenders as defined in this part.
              (2) Any establishment where a substance is produced must be registered with the Agency if the producer intends the substance to be used as an active ingredient of a pesticide, or has actual or constructive knowledge that the substance will be used by any person as an active ingredient of a pesticide.

              (3) Any domestic establishment producing a pesticidal product for export, or any unregistered pesticide, or any foreign establishment producing a pesticidal product for import into the United States must be registered. Also, any establishment, either foreign or domestic, which produces a pesticidal product for use under an Experimental Use Permit, FIFRA section 18 Emergency Exemption or section 24(c) Special Local Needs registration, must be registered.
              (b) Information required. An applicant for establishment registration must submit the following information:
              (1) Name and address of the company.
              (2) The type of ownership (individual, partnership, cooperative association, corporation, or any organized group of persons whether incorporated or not).
              (3) The name and address of each producing establishment for which registration is sought.
              (c) When to apply. An application for establishment registration must be submitted, and an establishment registration number must be assigned by the Agency, before any production may occur at an establishment. In the case of an establishment which has not previously been required to be registered and is not currently registered, the producer must apply for establishment registration by submitting an application within 180 days after the effective date of this regulation.
              (d) Assignment of establishment registration number. The Agency will return incomplete or inaccurately completed applications to the applicant. If the application is complete and accurate, the Agency will register the establishment and assign a registration number to the establishment. The establishment registration number will be entered on the application, and a copy of the application will be returned to the applicant.
              (e) Amendment. If at any time after the first report there is a change in the information required to be submitted under paragraph (b) of this section, that new information must be reported to EPA, in writing on letterhead stationery or on forms supplied by the Agency, within 30 days after such change occurs.
              (f) Duration of registration. Establishment registration will remain effective provided pesticide reports are submitted annually pursuant to the requirements of this part. Failure to submit a report may result in termination of establishment registration, civil and/or criminal penalty assessments.
              [53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 FR 34203, June 23, 1993]

            Subparts C-D [Reserved]

            Subpart E—Recordkeeping and Reporting Requirements

              § 167.85
              Reporting requirements.
              (a) Who must report. Each producer operating an establishment must submit the reports required by this section concerning any pesticide, active ingredient, or device produced at each establishment. Custom blenders are not required to report production to the Agency.
              (b) Information required. The pesticide report shall include the following: (1) Name and address of the establishment; (2) amount of each pesticidal product: (i) Produced during the past year; (ii) sold or distributed during the past year; (iii) estimated to be produced during the current year. The report shall only include those pesticidal products actually produced at the reporting establishment. Reports submitted by foreign-producing establishments shall cover only those pesticidal products exported to the United States.
              (c) How to report. The reports required by this section must be made on forms supplied by the Agency. It is the ultimate responsibility of companies to obtain, complete, and submit the form each year.
              (d) When to report. A producer operating an establishment must submit an initial report no later than 30 days after the first registration of each establishment the producer operates. Thereafter, the producer must submit an annual report on or before March 1 of each year, even if the producer has produced no pesticidal product for that reporting year.
              [53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 FR 34203, June 23, 1993]

              § 167.90
              Where to obtain and submit forms.
              (a) Where to obtain forms. Any person may obtain blank forms for the applications and reports required by this part from any EPA Regional Office, or from the address listed in paragraph (b) of this section.
              (b) Where to submit applications and reports. Each producer operating an establishment, with the exception of those establishments not found at the same location as their company headquarters, must submit applications and reports required by this part to the EPA Regional Office which serves the area where the establishment is located. The list of Regional Office addresses is found in 40 CFR 1.7. Applications and reports for those establishments not found at the same location as their company headquarters to be submitted by the company headquarters to the Regional Office having jurisdiction over the State in which the company headquarters is located. A foreign producer who exports any pesticide product, device, or active ingredient to the United States must submit all applications and reports to:

                U.S. Environmental Protection Agency, Office of Enforcement and Compliance Assurance, Office of Compliance, Agriculture and Ecosystems Division (2225A), Ariel Rios Building, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460, ATTN: FIFRA Foreign Establishment Registration Contact.

              [53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 62 FR 49620, Sept. 23, 1997; 65 FR 4577, Jan. 31, 2000]

          Pt. 168
          PART 168—STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS

              Subpart A—General Provisions [Reserved]

              Subpart B—Advertising
              Sec.
              168.22
              Advertising of unregistered pesticides, unregistered uses of registered pesticides and FIFRA section 24(c) registrations.

              Subpart C [Reserved]

              Subpart D—Export Policy and Procedures for Exporting Pesticides
              168.65
              Applicability.
              168.66
              Labeling of pesticide products and devices for export.
              168.67
              Definitions.
              168.68
              [Reserved]
              168.69
              Registered export pesticide products.
              168.70
              Unregistered export pesticide products.
              168.71
              Export pesticide devices.
              168.75
              Procedures for exporting unregistered pesticides—purchaser acknowledgement statements.
              168.85
              Other export requirements.

            Authority:
            7 U.S.C. 136-136y.

            Source:
            54 FR 1125, Jan. 11, 1989, unless otherwise noted.

            Subpart A—General Provisions [Reserved]

            Subpart B—Advertising

              § 168.22
              Advertising of unregistered pesticides, unregistered uses of registered pesticides and FIFRA section 24(c) registrations.
              (a) FIFRA sections 12(a)(1) (A) and (B) make it unlawful for any person to “offer for sale” any pesticide if it is unregistered, or if claims made for it as part of its distribution or sale differ substantially from any claim made for it as part of the statement required in connection with its registration under FIFRA section 3. EPA interprets these provisions as extending to advertisements in any advertising medium to which pesticide users or the general public have access.
              (b) EPA regards it as unlawful for any person who distributes, sells, offers for sale, holds for sale, ships, delivers for shipment, or receives and (having so received) delivers or offers to deliver any pesticide, to place or sponsor advertisements which recommend or suggest the purchase or use of:
              (1) Any pesticide for a use authorized under a FIFRA section 5 experimental use permit (EUP).
              (2) Any pesticide for a use authorized under a FIFRA section 18 emergency exemption, except for advertisements that:

              (i) Are placed in media which address primarily persons in the geographical area to which the exemption applies.

              (ii) State the name and address of one or more retail dealers who stock the pesticide.
              (iii) Contain a prominent notice of the limitations on use under the section 18 emergency exemption.
              (3) Any pesticide for any use authorized only by a FIFRA section 24(c) special local need registration, unless the advertisement contains a prominent notice of the limitations on use under the section 24(c) registrations.
              (4) Any unregistered pesticide for any use unless the advertisement is one permitted by paragraph (b) (2) or (3) of this section.
              (5) A registered pesticide product for an unregistered use, unless the advertisement is one permitted by paragraph (b) (2) or (3) of this section. However, as a matter of policy, the Agency will not regard as unlawful the advertisement of uses permitted by FIFRA section 2(ee) provided the product is not an antimicrobial pesticide targeted against human pathogens (see 51 FR 19174; May 28, 1986).
              (c) For purposes of paragraph (b) of this section, a “prominent notice of the limitations on use” is one which sets forth the limitations on use in a manner reasonably likely to be understood by persons to whom the advertisement is addressed. For printed advertising, this criterion will be met by a legend in 6-point or larger type.

            Subpart C [Reserved]

            Subpart D—Export Policy and Procedures for Exporting Pesticides

              Source:
              58 FR 9085, Feb. 18, 1993, unless otherwise noted.

              § 168.65
              Applicability.
              (a) This subpart describes the labeling requirements applicable to pesticide products and devices that are intended solely for export from the United States under the provisions of FIFRA section 17(a).
              (b) This subpart applies to all export pesticide products and export pesticide devices that are exported for any purpose, including research.
              (c) Export pesticide products and export pesticide devices are also subject to requirements for pesticide production reporting, recordkeeping and inspection, and purchaser acknowledgement provisions that can be found in the following parts:
              (1) Pesticide production reporting requirements under FIFRA section 7 are located in part 167 of this chapter (as referenced in § 168.85(b)).
              (2) Recordkeeping and inspection requirements under FIFRA section 8 are located in part 169 of this chapter (as referenced in § 168.85(a)).
              (3) Purchaser acknowledgement statement provisions under FIFRA section 17(a) are located in § 168.75.
              [80 FR 75754, Dec. 19, 2014]

              § 168.66
              Labeling of pesticide products and devices for export.
              Any label and labeling information requirements in §§ 168.69, 168.70, and 168.71 that are not met fully on the product label attached to the immediate product container may be met by collateral labeling that is either:
              (a) Attached to the immediate product (container label); or
              (b) Attached to or accompanies the shipping container of the export pesticide or export device at all times when it is shipped or held for shipment in the United States.
              [80 FR 75754, Dec. 19, 2014]

              § 168.67
              Definitions.
              Terms used in this subpart have the same meanings as in the Act and as in § 152.3 of this chapter, unless otherwise defined in this section.

                Export pesticide device means a device, as defined in FIFRA section 2(h), that is intended solely for export from the United States to another country.

                Export pesticide product means a pesticide product, as defined in § 152.3 of this chapter, that is intended solely for export from the United States to another country.
              [78 FR 4077, Jan. 18, 2013]

              § 168.68
              [Reserved]

              § 168.69
              Registered export pesticide products.
              (a) Each export pesticide product that is registered under FIFRA section 3 or FIFRA section 24(c) must bear labeling approved by EPA for its registration or collateral labeling in compliance with § 168.66.
              (b) For the purposes of this subpart, a registered export pesticide product is considered to be any of the following:
              (1) A pesticide product of composition, packaging and labeling as described in its registration under FIFRA section 3;
              (2) A pesticide product that has been modified in compliance with the notification or non-notification provisions of § 152.46 of this chapter, and any associated procedures issued under § 156.10(e) of this chapter, regardless of whether such modification has been made for the pesticide product's registration under FIFRA section 3;
              (3) A pesticide product initially registered by a State under FIFRA section 24(c), and whose Federal registration has not been disapproved by EPA under § 162.164 of this chapter.
              (c) The text of the labeling of the export pesticide product must be provided in English and, if applicable, the following foreign languages:
              (1) The predominant or official language of the country of final destination, if known; and
              (2) The predominant or official language of the importing country.
              [78 FR 4077, Jan. 18, 2013, as amended at 79 FR 75754, Dec. 19, 2014]

              § 168.70
              Unregistered export pesticide products.
              (a) Any export pesticide product that does not meet the terms of § 168.69 is an unregistered export pesticide product for purposes of this subpart.
              (b) Each unregistered export pesticide product must bear labeling that complies with all requirements of this section or collateral labeling in compliance with § 168.66.
              (1) The labeling must comply with all of the prominence and legibility requirements of § 156.10(a)(2) of this chapter.
              (2) The labeling must comply with all the language requirements in §§ 168.69(c) and 156.10(a)(3) of this chapter.
              (3) The labeling must bear the following information:
              (i) The name and address of the producer, in accordance with the requirements of § 156.10(c) of this chapter;
              (ii) The net weight or measure of contents, in accordance with the requirements of § 156.10(d) of this chapter;
              (iii) The pesticide producing establishment number, in accordance with the requirements of § 156.10(f) of this chapter;
              (iv) An ingredients statement, in accordance with the requirements of § 156.10(g) of this chapter, except that:
              (A) The ingredients statement need not appear in a second language besides English if English is the official or predominant language in the importing country and the country of final destination, if known; and
              (B) An export pesticide product intended solely for research and development purposes, (and which bears the statement “For research and development purposes only. Not for distribution, sale, or use,” or similar language) may bear coded ingredient information to protect confidentiality.
              (v) Human hazard and precautionary statements in accordance with the requirements of subpart D of part 156 of this chapter. The statements must be true and accurate translations of the English statements.
              (vi) The statement “Not Registered for Use in the United States of America,” which may be amplified by additional statements accurately describing the reason(s) why the export pesticide product is not registered in the United States, or is not registered for particular uses in the United States.
              (c) This section also applies to all unregistered pesticide products and devices that are intended solely for export and that are transferred, distributed, or sold between registered establishments operated by the same producer according to § 152.30(a) of this chapter if:

              (1) The transfer, distribution or sale occurs between a point in the United States and a point outside the United States, or

              (2) The transfer occurs within the United States solely for the purpose of export from the United States.
              [78 FR 4077, Jan. 18, 2013, as amended at 79 FR 75754, Dec. 19, 2014]

              § 168.71
              Export pesticide devices.
              (a) Each export pesticide device sold or distributed anywhere in the United States must bear labeling that complies with all requirements of this section or collateral labeling in compliance with § 168.66.
              (b) The labeling of each export pesticide device must meet all of the prominence and legibility requirements of § 156.10(a)(2) of this chapter.
              (c) The labeling must also comply with all the language requirements in § 168.69(c) and § 156.10(a)(3) of this chapter.
              (d) The labeling must bear the following information:
              (1) The name and address of the producer, meeting the requirements of § 156.10(c) of this chapter;
              (2) The producing establishment number, meeting the requirements of § 156.10(f) of this chapter;
              (3) The statement “Not Registered for Use in the United States of America,” which may be amplified by additional statements describing the reason why the export pesticide device is not registered in the United States, such as “because pesticide devices are not required to be registered in the United States.”
              (e) An export pesticide device is not required to bear an ingredients statement.
              [78 FR 4077, Jan. 18, 2013, as amended at 79 FR 75754, Dec. 19, 2014]

              § 168.75
              Procedures for exporting unregistered pesticides—purchaser acknowledgement statements.
              This section describes how EPA interprets and will enforce requirements of FIFRA section 17(a)(2). Section 17(a)(2) provides that any person exporting a pesticide other than a pesticide registered for use under FIFRA section 3 or sold under FIFRA section 6(a)(1), shall obtain a statement signed by the foreign purchaser prior to export, acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States. Section 17(a)(2) requires that a copy of the statement be transmitted to an appropriate official of the government of the importing country.
              (a) Products subject to the requirement. EPA will not consider an exporter of an unregistered pesticide to be in violation of FIFRA section 17(a)(2) if, prior to export of the pesticide, the exporter submits to EPA a statement signed by the foreign purchaser which affirms that the purchaser is aware that the pesticide is not registered for use in the United States and cannot be sold for use in the United States. The exporter must also include with the submission of the purchaser acknowledgement statement to EPA, a certification signed by the exporter affirming that the export did not occur until the statement signed by the foreign purchaser was obtained by the exporter. Except as provided in paragraph (b) of this section, all pesticide products produced for export which cannot be sold for use in the United States in the form that they are produced for export, are considered to be unregistered pesticides. This includes pesticides which are of a different formulation, including composition (except for variation within certified limits), or type of formulation, and pesticides which are packaged for use patterns for which they are not registered, which may be evidenced by package type or label use statements. This also includes unregistered products which are under development as pesticidal products and which are being exported for research testing.
              (b) Exceptions. Under the specific circumstances discussed below, EPA will not treat a registered product which has been modified slightly for export purposes, as unregistered for the purposes of the purchaser acknowledgement statement requirement. Any changes to the registered product for export purposes must be documented in accordance with the record-keeping requirements at § 169.2 of this chapter and this policy.
              (1) Labeling on immediate product. EPA will not treat as unregistered for the purposes of section 17(a)(2), a registered pesticide product which cannot be sold or distributed for use in the United States because its immediate product container does not bear a label approved under a FIFRA section 3 registration, but which could be sold or distributed in the United States with the approved label attached to the immediate product container, provided that the label and labeling approved under a current FIFRA section 3 registration for the product is either attached to the immediate product container or accompanies the product at all times as supplemental labeling as provided in paragraph (c) of this section.
              (2) Packaging. (i) Certain changes may be made to a product's labeling or packaging without affecting the registration status of the product, as specified in § 152.46(b) of this chapter and this policy. These changes include any changes in package size and label net contents, provided no change in use directions or requirement for child-resistant packaging would be necessary for the product to be registered for use in the United States. For example, if child-resistant packaging is required for a particular pesticide product in the United States, and the product will be exported without child-resistant packaging, the product would be considered unregistered and therefore subject to all the requirements of FIFRA section 17(a), as described in § 168.75 of this chapter including the requirement for a purchaser acknowledgement statement.
              (ii) If an exporter needed to repackage a product in a size to meet a foreign purchaser's specifications, that modification would not affect the registration status of the export product. Other modifications to the label used for export purposes which will not affect the export product's registration status are: the use of metric units for net contents, dosages, and other numeric expressions; the use of a different format for the label, provided that the information does not contradict the U.S. label; revision of non-mandatory U.S. label statements, consistent with 40 CFR part 156, including additions or changes required by other Federal statutes or regulations; a change of the name or address of the registrant, except for a change resulting from transfer of ownership, which requires that a registrant keep his name and address current with the Agency; and any correction of typographical or printing errors that appeared on the U.S. labeling. (See § 152.46(b)).
              (3) Labeling statements. The following statements which appear on any of the product labels or labeling will not affect the status of the product, provided that they do not contradict the approved FIFRA section 3 labeling:
              (i) It is permissible to add explanatory language which accurately explains the meaning of a use classification. For example, the statement “restricted use pesticide” may be expanded to read: “Restricted in the United States of America to use by certified applicators” or “Restricted Use Pesticide. In The United States this product is restricted to use by applicators determined by each state to be competent in pesticide application and the human health and environmental consequences of misuse.” If the explanatory language falsely represents or is misleading regarding the U.S. use classification, the product will be considered misbranded. In addition, a use classification can only be listed if one has been assigned pursuant to the U.S. registration.

              (ii) An exporter who is also the manufacturer of a U.S. registered pesticide may add new uses to the label of that product for export purposes, without triggering the requirements of section 17(a)(2), as long as the new uses are within the same general use patterns as those for the registered product. The general pesticide use patterns are: terrestrial food crop and terrestrial non-food crop; greenhouse food crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood crop' indoor use' and forestry use. Adding new uses to the label which change the use pattern, such as changes from nonfood to food use, outdoor to indoor use, or terrestrial to aquatic use, render the product unregistered and subject to the requirements of section 17 for unregistered products. If the new use added to the label is a food or feed use, a tolerance must already be established for the use of that pesticide in or on that commodity.

              (4) Composition. EPA will not treat a registered product as unregistered for the purposes of the purchaser acknowledgement statement requirement under the following specific circumstances:
              (i) The formula of the exported product is within certified limits of the formula of the U.S. registered product.
              (ii) An exporter, who is also the manufacturer of a U.S. registered pesticide, may decrease the percentage of the active ingredient(s) of that product by adding a List 4 inert ingredient, without causing the product to be treated as “unregistered” and triggering the requirement to obtain a purchaser acknowledgement statement as a condition for export. In EPA's Policy Statement on Inert Ingredients in Pesticide Products, EPA included inert ingredients on List 4-a list of inert ingredients posing minimal hazard or risk-if the inert ingredients were generally regarded as innocuous. The provisions of this paragraph do not apply to those pesticide products intended for public health uses which are required or conditionally required to submit efficacy data pursuant to § 158.400 or § 161.640 of this chapter, as applicable. Any differences in formula or composition caused by adding a List 4 inert must be reflected in records which show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.
              (iii) A change in the color or fragrance of the export product will not affect the product's registration status as long as the following conditions are met. The change in color must result only from the addition of a dye included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the dye must not be a List 1 inert. (List 1 inerts are those inerts which the Agency has identified as presenting toxicological concerns. The classification of inerts is explained in EPA's Policy Statement on Inert Ingredients in Pesticide Products. The change in fragrance must result only from the addition of a chemical included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must not be a List 1 inert. The change in fragrance must not result in a pesticide product containing a food or food-like fragrance. (See “Food Fragrances in Pesticide Formulations,” EPA's Office of Pesticide Programs Policy and Criteria Notice number 2155.1, November 20, 1975.) Any difference in color or fragrance of the export product in accordance with this section must be reflected in records which show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.
              (5) Research and development products. An unregistered pesticide product exported only for research and development purposes is subject to the notification requirements of this section, unless its use fits within the criteria described in this paragraph.
              (i) An unregistered pesticide product exported solely for research and development purposes will not be considered to be in violation of the notification requirements if the export of the research and development product:
              (A) Would not involve land uses of more than 10 acres (4.05 hectares), or be used on or affect food or feed crops which are intended for consumption.
              (B) Would not involve aquatic uses of more than 1 acre (0.405 hectares), or any aquatic uses which involve water used for irrigation, drinking or recreation, or be used on or affect plants or animals taken for food or feed from such waters.
              (C) Would not involve tests on animals intended for food or feed.
              (ii) Shipments to different purchasers, to different countries of final destination, or which occur more than a calendar year apart will be evaluated separately. When determining whether total shipments exceed the criteria described in this paragraph, EPA will evaluate the total amount of shipments by a single exporter during a calendar year for use in a particular country.

              (iii) An exporter bears the burden of demonstrating that the product meets these criteria before the research product is shipped. This may be met by documenting before the product is shipped and maintaining records for the time period required by § 169.2(h) of this chapter from the date of the last shipment relevant to such records. The records to be maintained consist of:
              (A) The identity of the purchaser and country of intended use of the research product.
              (B) The amount shipped.
              (C) The intended research use by the purchaser, including the type of application site, rate of application, and measures taken for protection of humans from direct or dietary exposure.
              (c) Procedures. An exporter of an unregistered pesticide product must submit a purchaser acknowledgement statement to EPA containing the information stated in paragraph (c)(1) of this section, and a statement signed by the exporter certifying that the exportation did not occur until the signed acknowledgement statement had been obtained from the purchaser. If the foreign purchaser signs a purchaser acknowledgement statement in their own language, it must be accompanied by an English translation when it is submitted to EPA by the exporter. These statements shall be submitted in accordance with one of the two options for submission described in paragraph (c)(2) of this section.
              (1) Contents of the purchaser acknowledgement statements. The purchaser acknowledgement statement must include the following information in a format that is clearly understandable:
              (i) Name, address, and EPA identification number, if applicable, of the exporter.
              (ii) Name and address of the foreign purchaser.
              (iii) Identity of the product and the active ingredient(s), including:
              (A) The Chemical Abstract Services (CAS) Registry number for each active ingredient.
              (B) The chemical nomenclature for each active ingredient as used by the International Union of Pure and Applied Chemists (IUPAC).
              (C) Other known chemical or common names; or if the export involves a research product, a code name or identification number that can be used by EPA to identify the product from the exporter's records. If a code name or identification number is used, additional information must be attached to the certification statement submitted with the purchaser acknowledgement statement which will enable EPA to identify the product. This attached information may be claimed as confidential, and EPA will not forward this information with the purchaser acknowledgement statement to foreign governments.

              (iv) If known or reasonably ascertainable, the country or countries of final destination of the export shipment, i.e., where the exported pesticide is intended to be used, if different from the country of the foreign purchaser's address.
              (v) A statement that indicates that the foreign purchaser understands that the product is not registered for use in the United States and cannot be sold in the United States.
              (vi) The signature of the foreign purchaser.
              (vii) The date of the foreign purchaser's signature.
              (2) Reporting options. At the discretion of the exporter, the requirements of paragraph (c)(1) of this section may be met on a per-shipment or annual basis, as stated in paragraphs (c)(2)(i) and (c)(2)(ii) of this section. If the procedures in paragraph (c)(2)(ii) of this section are not followed, EPA will consider paragraph (c)(2)(i) of this section, requiring pershipment purchaser acknowledgement statements, to be applicable in full. Where paragraph (c)(2)(i) of this section is applicable, each shipment which does not meet the requirements of that paragraph will be considered to be a separate violation of FIFRA.
              (i) Per-shipment purchaser acknowledgment statement. Unless the exporter chooses to follow the procedures described in paragraph (c)(2)(ii) of this section for the annual reporting procedures, the exporter must obtain and submit to EPA, a signed purchaser acknowledgement statement prior to each shipment of an unregistered pesticide according to the following procedures:

              (A) Prior to each shipment in a calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement statement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States until the exporter has received from the foreign purchaser a properly completed, signed, and dated acknowledgment statement.
              (B) The exporter must obtain, prior to each shipment in a calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, a signed purchaser acknowledgment statement which contains the information set forth in paragraph (c)(1) of this section.
              (C) The exporter must sign a statement certifying that export did not take place until a signed purchaser acknowledgement statement was received. The exporter must also specify the chemical identity of any research product which is referred to by code in the purchaser acknowledgement statement. The information regarding the specific identity of research products, which may be included in the statement or consist of an attachment to the certification, may be claimed as confidential.
              (D) The exporter must submit the signed acknowledgement statement from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter's receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This information must be transmitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Purchaser Acknowledgement Statement.
              (ii) Annual reporting procedures. Unless the exporter chooses to follow the per-shipment reporting option described in paragraph (c)(2)(i) of this section, the exporter must follow the procedures for annual summary reporting which include the requirement of a purchaser acknowledgement statement for the first shipment each calendar year of an unregistered pesticide product to a particular purchaser, and an annual summary of shipments to that purchaser. The annual summary reporting procedures are as follows:
              (A) Prior to the first shipment each calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement statement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States until the exporter has received from the foreign purchaser a properly completed, signed, and dated purchaser acknowledgement statement.
              (B) The exporter must obtain, prior to the first shipment each calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, a signed purchaser acknowledgement statement which contains the information set forth in paragraph (c)(1) of this section.
              (C) The exporter must sign a statement certifying that export did not take place until a signed purchaser acknowledgement statement was received, indicating that this statement is for the first shipment to a particular purchaser in a specific country for that calendar year, and that the exporter will meet all the purchaser acknowledgement statement requirements as described in this paragraph (c)(2)(ii) of this section. The exporter must also specify the chemical identity of any research product which is referred to by code in the purchaser acknowledgement statement. The information regarding the specific identity of research products, which may be included in the statement or consist of an attachment to the certification, may be claimed as confidential.

              (D) The exporter must submit the signed acknowledgement statement from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter's receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This information must be transmitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Purchaser Acknowledgement Statement.

              (E) The exporter, who has chosen to comply with the requirements of this paragraph instead of providing per-shipment purchaser acknowledgement statements in accordance with paragraph (c)(2)(i) of this section, must submit an annual summary report to EPA. An annual summary report is required for each unregistered pesticide exported within the preceding calendar year. The report must be in writing, signed by the exporter, and include the following information:
              (1) Name, address, and EPA identification number if applicable, of the exporter.
              (2) Name and address of the foreign purchaser, and the date the purchaser acknowledgement statement, submitted to EPA during the previous calendar year, was signed by the purchaser.
              (3) The identity of the product and the active ingredients, including: the Chemical Abstract Services (CAS) registry number for each active ingredient, the chemical nomenclature for each active ingredient used by the International Union of Pure and Applied Chemists (IUPAC), and other known chemical or common names, or if the export involves a research product, the code name or identification number that can be used by EPA to identify the product from the exporter's records.
              (4) The dates of each shipment of the pesticide exported to the foreign purchaser during that calendar year.
              (5) If known, or reasonably ascertainable, the country or countries of final destination of the export shipments, i.e., where the exported pesticide was intended to be used, if different from the foreign purchaser's address.
              (F) The exporter shall submit the annual summary no later than March 1st of the following calendar year. The annual summary shall be sent to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Annual Summary of Exports.
              (iii) Confidentiality claims. Persons submitting the information specified in the purchaser acknowledgement statement may assert a claim of business confidentiality by marking the information claimed confidential as “FIFRA Confidential Business Information.” Information so claimed will not be disclosed, with the exception of disclosure to the foreign governments, except in accordance with the procedures set forth in 40 CFR part 2, 7 U.S.C. 136(h), and this policy statement. If such claim is not asserted, EPA may disclose the information to the public without providing further notice prior to disclosure or an opportunity to object. Notwithstanding any claim of confidentiality, the purchaser acknowledgement statement will continue to be forwarded to the appropriate foreign government officials in its entirety, as required by section 17(a)(2).
              (3) Recordkeeping. Except as specifically stated, the requirement to retain records under part 169 of this chapter applies to all pesticide producers, regardless of whether a particular product is intended for export. All records shall be maintained in accordance with the time period required by § 169.2(h) of this chapter. Producers must also maintain certain records pertaining to pesticide products intended for export. In addition to the requirement that a copy of the purchaser acknowledgement statement be kept, as stated at § 169.2(h)(3) of this chapter, the following records must be maintained:
              (i) Copies of the instructions provided to foreign purchasers in accordance with paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this section.
              (ii) Copies of signed purchaser acknowledgement statements obtained according to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of this section.
              (iii) Copies of the certification from the exporter; and copies of any accompanying information regarding the identity of coded R&D products.
              (d) Agency transmission of purchaser acknowledgement statements. EPA will transmit a copy of each purchaser acknowledgement statement to the appropriate government official in each of the intended destination countries. After receipt of the Annual Summary the following calendar year, EPA will also transmit a copy of that document to the appropriate government official in each of the intended destination countries. In the case that no Annual Summary has been received within 30 days of the date at which such summary is required to be submitted, EPA will send written notification to the appropriate government official indicating that no summary was submitted, and may also take enforcement action against the exporter.
              [58 FR 9085, Feb. 18, 1993, as amended at 69 FR 23117, Apr. 28, 2004; 71 FR 35546, June 21, 2006; 72 FR 61029, Oct. 26, 2007]

              § 168.85
              Other export requirements.
              This section describes other requirements found in regulations that apply to exporters of pesticides, devices, and active ingredients used in producing a pesticide.
              (a) Recordkeeping and inspection. Exporters of pesticides, devices and active ingredients must keep records and permit inspections of those records in accordance with part 169 of this chapter. Exporters must keep records of the product labeling used, including the EPA registered labeling, any foreign labeling on or attached to the product when shipped, and, as applicable, any supplemental labeling used. Producers of pesticides for export shall maintain these records in a manner that shows exactly which labels and labeling accompanied each shipment of a pesticide product to a foreign country. As stated at § 168.75(c), when research product identity information appears on the labeling in an encoded manner, information translating the code shall be maintained in records. These records shall be maintained for the time period required by § 169.2(h) of this chapter following the last export of such pesticides. All records required by part 169 of this chapter shall be made available for inspection and copying by EPA or its duly authorized representatives.
              (b) Pesticide production establishment requirements. Exporters of pesticides, devices, and active ingredients must submit annual reports to EPA in accordance with part 167 of this chapter, concerning those products that are exported. All products required to be labeled “Not Registered for Use in the United States of America” must be reported as unregistered production regardless of whether a purchaser acknowledgement statement is required.

          Pt. 169
          PART 169—BOOKS AND RECORDS OF PESTICIDE PRODUCTION AND DISTRIBUTION

            Sec.
            169.1
            Definitions.
            169.2
            Maintenance of records.
            169.3
            Inspection.

            Authority:
            7 U.S.C. 136f and 136w.

            Source:
            45 FR 54338, Aug. 15, 1980, unless otherwise noted.

            § 169.1
            Definitions.
            Terms used in this part shall have the meanings set forth for such terms in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, as used in this part, the following terms shall have the meanings set forth below:
            (a) Amount of pesticide or active ingredient. The term “amount of pesticide or active ingredient” means the weight or volume of the pesticide or active ingredient used in producing a pesticide expressed as weight for solid or semi-solid products and as weight or volume of liquid products.
            (b) Batch. The term “batch” means a quantity of a pesticide product or active ingredient used in producing a pesticide made in one operation or lot or if made in a continuous or semi-continuous process or cycle, the quantity produced during an interval of time to be specified by the producer.
            (c) Device. The term “device” means any device or class of device as defined by the Act and determined by the Administrator to be subject to the provisions of the Act.
            (d) Inability. The term “inability” means the incapacity of any person to maintain, furnish or permit access to any records under this Act and regulations, where such incapacity arises out of causes beyond the control and without the fault or negligence of such person. Such causes may include, but are not restricted to acts of God or of the public enemy, fires, floods, epidemics, quarantine restrictions, strikes, and unusually severe weather, but in every case, the failure must be beyond the control and without the fault or negligence of said person.
            (e) Producer. The term “producer” means the person, as defined by the Act, who produces or imports any pesticide or device or active ingredient used in producing a pesticide.

            § 169.2
            Maintenance of records.
            All producers of pesticides, devices, or active ingredients used in producing pesticides subject to this Act, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall maintain the following records:
            (a) Records showing the product name, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batch and batch identification (numbers, letters, etc.) of all pesticides produced. In cases where the product is an active ingredient used in producing a pesticide or where the product is a pesticide which is not registered, is not the subject of an application for registration, or is not produced under an Experimental Use Permit, the records shall also show the complete formula. The batch identification shall appear on all production control records. These records shall be retained for a period of two (2) years.
            (b) Records showing the brand names and quantities of devices produced. These records shall be retained for a period of two (2) years.
            (c) Records showing the following information regarding the receipt, by the producer, of all pesticides, devices, and active ingredients used in producing pesticides:
            (1) Brand name of the pesticide or device, or common or chemical name of the pesticide active ingredient;
            (2) Name and address of shipper;
            (3) Name of delivering carrier;
            (4) Date received; and
            (5) Quantities received.
            These records are not intended to cover receipt of pesticides used for in-plant maintenance, extermination, or sanitation programs, etc. Shipping and receiving documents such as invoices, freight bills, receiving tickets, etc., which provide the required information will be considered satisfactory for the purposes of this section. These records shall be retained for a period of two (2) years.
            (d) Records showing the following information regarding the shipment of all pesticides, devices, and active ingredients used in producing pesticides:
            (1) Brand name of pesticide or device, or the common or chemical name of the pesticide active ingredient;
            (2) Name and address of consignee;
            (3) Where the pesticide is produced pursuant to an experimental use permit (FIFRA section 5), a special exemption (section 18), or a special local need (section 24), the information required under these sections and any regulations promulgated thereto regarding the distribution of such pesticides;
            (4) Name of originating carrier;
            (5) Date shipped or delivered for shipment; and
            (6) Quantities shipped or delivered for shipment.
            Such records are required regardless of whether any shipment or receipt of shipment is between plants owned or otherwise controlled by the same person. Shipping and receiving documents such as invoices, freight bills, receiving tickets, etc., which provide the required information will be considered satisfactory for purposes of this section. These records shall be retained for a period of two (2) years.
            (e) Inventory records with respect to the types and amounts of pesticides or pesticide active ingredients, or quantities of devices in stock which he has produced. These records may be disposed of when a more current inventory record is prepared.
            (f) Copies of all domestic advertising of the restricted uses of any pesticide registered for restricted use which the producer caused to have prepared, including any radio or television scripts for all such pesticides. These records shall be retained for a period of two (2) years.
            (g) Copies of all guarantees given pursuant to section 12(a)(2)(C) of the Act. These records shall be retained for a period of one (1) year after expiration of the guarantee.
            (h) In the case of all pesticides, devices, and active ingredients used in producing pesticides intended solely for export to any foreign country:

            (1) Copies of the specification or directions of the foreign purchaser for the production of such pesticides, devices, or pesticide active ingredients;
            (2) Copies of labels or labeling required to comply with section 17(a)(1) of the Act; and
            (3) For any pesticide other than a pesticide registered under section 3 or sold under section 6(a)(1) of the Act, copies of a statement signed by the foreign purchaser of the pesticide acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States under this Act.
            These records shall be retained for a period of 2 years after expiration of the contract.
            (i) Records on the method of disposal (burial, incineration, etc.) date or dates of disposal, location of the disposal sites, and the types and amounts of pesticides or pesticide active ingredients disposed of by the producer or his contractor. With regard to the disposal of containers accumulated during production, the Agency will consider satisfactory a statement, attested to by a responsible firm official, describing in general terms the method and location of disposal, e.g., all containers are taken periodically to a certain site. Records of deviations from normal practice must be maintained. In addition, any records on the disposal of pesticides or pesticide active ingredients and/or containers specified pursuant to section 19 of the Act and any regulations promulgated thereto shall also be maintained. The above requirements apply to those products bearing label instructions for disposal and to any other products specified under any regulations promulgated pursuant to section 19. These records shall be retained for twenty (20) years or may be forwarded after three (3) years to the Environmental Protection Agency Regional Administrator for maintenance. Notwithstanding these record keeping requirements, whenever any producer of pesticides or pesticide active ingredients is complying with a rule promulgated under the authority of the Resource Conservation and Recovery Act of 1976 (RCRA) (Pub. L. 94-580, 90 Stat. 2795, October 21, 1976), for the handling or disposal of hazardous wastes, as defined by RCRA or any regulations promulgated thereunder, such producer will no longer be required to maintain records in accordance with this subsection.
            (j) Records of any tests conducted on human beings whether performed by the producer himself or authorized and/or paid for by the producer. Such records shall include: The names and addresses of subjects tested, dates of tests, types of tests, written consent of subjects to test, and all information and instructions given to the subjects regarding the nature and purpose of the tests and of any physical and mental health consequences which were reasonably foreseen therefrom, and any adverse effects of the test on the subjects, including any such effects coming to the attention of the producer after completion of the tests. These records shall be retained for twenty (20) years or may be forwarded after three (3) years to the Environmental Protection Agency Regional Administrator for maintenance.

            (k) Records containing research data relating to registered pesticides including all test reports submitted to the Agency in support of registration or in support of a tolerance petition, all underlying raw data, and interpretations and evaluations thereof, whether in the possession of the producer or in the possession of the independent testing facility or laboratory (if any) which performed such tests on behalf of the producer. These records shall be retained as long as the registration is valid and the producer is in business.
            [45 FR 54338, Aug. 15, 1980, as amended at 58 FR 9090, Feb. 18, 1993]

            § 169.3
            Inspection.
            (a) Producers. Any producer of any pesticide, device, or active ingredient used in producing a pesticide which is subject to this Act shall, upon request of any officer or employee of the Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person at all reasonable times to have access to and to copy all records required to be maintained by this part, including records in the possession of an independent testing facility or laboratory which performed tests on behalf of the producer. Such inspection will be conducted in accordance with procedures detailed in section 8(b) of the Act.
            (b) Distributors, carriers, dealers, etc. Any distributor, carrier, dealer, or any other person who sells or offers for sale, delivers or offers for delivery any pesticide, device, or active ingredient used in producing a pesticide which is subject to this Act, shall, upon request of any officer or employee of the Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person at all reasonable times to have access to and copy all records showing the delivery or holding of such pesticide, device, or active ingredient used in producing a pesticide, including the quantity, the date of shipment and receipt, and the name and address of the consignor and consignee, and any guarantee received pursuant to section 12(b)(1) of the Act.
            (c) Confidentiality. Any record which is subject to the regulations under this part, and which may be confidential, shall be treated in accordance with the provisions of section 10 of the Act. The availability to the public of information provided to, or otherwise obtained by, the Administrator under this part shall be governed by part 2 of this chapter.
            (d) Inability. (1) In the event of the inability of any person to produce records containing the information required to be maintained, furnished for inspection, or given access to, all other records and information regarding the same shall be provided.
            (2) Where no such inability exists and any such person fails to give access to and permit copying of such records as required, such failure shall be deemed a refusal to keep records required or a refusal to allow the inspection of any such records or both.

          Pt. 170
          PART 170—WORKER PROTECTION STANDARD

              Subpart A—General Provisions
              Sec.
              170.1
              Scope and purpose.
              170.2
              Implementation and expiration dates.
              170.3
              Definitions.
              170.7
              General duties and prohibited actions.
              170.9
              Violations of this part.

              Subpart B—Standard for Workers
              170.102
              Applicability of this subpart.
              170.103
              Exceptions.
              170.104
              Exemptions.
              170.110
              Restrictions associated with pesticide applications.
              170.112
              Entry restrictions.
              170.120
              Notice of applications.
              170.122
              Providing specific information about applications.
              170.124
              Notice of applications to handler employers.
              170.130
              Pesticide safety training for workers.
              170.135
              Posted pesticide safety information.
              170.150
              Decontamination.
              170.160
              Emergency assistance.

              Subpart C—Standard for Pesticide Handlers
              170.202
              Applicability of this subpart.
              170.203
              Exceptions.
              170.204
              Exemptions.
              170.210
              Restrictions during applications.
              170.222
              Providing specific information about applications.
              170.224
              Notice of applications to agricultural employers.
              170.230
              Pesticide safety training for handlers.
              170.232
              Knowledge of labeling and site-specific information.
              170.234
              Safe operation of equipment.
              170.235
              Posted pesticide safety information.
              170.240
              Personal protective equipment.
              170.250
              Decontamination.
              170.260
              Emergency assistance.

              Subpart D—General Provisions
              § 170.301
              Scope and purpose.
              § 170.303
              Applicability of this part.
              § 170.305
              Definitions.
              § 170.309
              Agricultural employer duties.
              § 170.311
              Display requirements for pesticide safety information and pesticide application and hazard information.
              § 170.313
              Commercial pesticide handler employer duties.
              § 170.315
              Prohibited actions.
              § 170.317
              Violations of this part.

              Subpart E—Requirements for Protection of Agricultural Workers
              § 170.401
              Training requirements for workers.
              § 170.403
              Establishment-specific information for workers.
              § 170.405
              Entry restrictions associated with pesticide applications.
              § 170.407
              Worker entry restrictions after pesticide applications.
              § 170.409
              Oral and posted notification of worker entry restrictions.
              § 170.411
              Decontamination supplies for workers.

              Subpart F—Requirements for Protection of Agricultural Pesticide Handlers
              § 170.501
              Training requirements for handlers.
              § 170.503
              Knowledge of labeling, application-specific, and establishment-specific information for handlers.
              § 170.505
              Requirements during applications to protect handlers, workers, and other persons.
              § 170.507
              Personal protective equipment.
              § 170.509
              Decontamination and eye flushing supplies for handlers.

              Subpart G—Exemptions, Exceptions and Equivalency
              § 170.601
              Exemptions.
              § 170.603
              Exceptions for entry by workers during restricted-entry intervals.
              § 170.605
              Agricultural employer responsibilities to protect workers entering treated areas during a restricted-entry interval.
              § 170.607
              Exceptions to personal protective equipment requirements specified on pesticide product labeling.
              § 170.609
              Equivalency requests.

            Authority:
            7 U.S.C. 136w.

            Source:
            57 FR 38151, Aug. 21, 1992, unless otherwise noted.

            Subpart A—General Provisions

              § 170.1
              Scope and purpose.
              This part contains a standard designed to reduce the risks of illness or injury resulting from workers' and handlers' occupational exposures to pesticides used in the production of agricultural plants on farms or in nurseries, greenhouses, and forests and also from the accidental exposure of workers and other persons to such pesticides. It requires workplace practices designed to reduce or eliminate exposure to pesticides and establishes procedures for responding to exposure-related emergencies.

              § 170.2
              Implementation and expiration dates.
              (a) Implementation date. Beginning January 2, 2017, the requirements of § 170.301 through § 170.609 of this part shall apply to any pesticide product that bears the statement “Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170”.
              (b) Expiration date. Sections 170.1 through 170.260 of this part shall expire on, and will no longer be effective after January 2, 2017.
              [80 FR 67556, Nov. 2, 2015]

              § 170.3
              Definitions.
              Terms used in this part have the same meanings they have in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, when used in this part, shall have the following meanings:

                Agricultural employer means any person who hires or contracts for the services of workers, for any type of compensation, to perform activities related to the production of agricultural plants, or any person who is an owner of or is responsible for the management or condition of an agricultural establishment that uses such workers.

                Agricultural establishment means any farm, forest, nursery, or greenhouse.

                Agricultural plant means any plant grown or maintained for commercial or research purposes and includes, but is not limited to, food, feed, and fiber plants; trees; turfgrass; flowers, shrubs; ornamentals; and seedlings.

                Chemigation means the application of pesticides through irrigation systems.

                Commercial pesticide handling establishment means any establishment, other than an agricultural establishment, that:
              (1) Employs any person, including a self-employed person, to apply on an agricultural establishment, pesticides used in the production of agricultural plants.
              (2) Employs any person, including a self-employed person, to perform on an agricultural establishment, tasks as a crop advisor.

                Crop advisor means any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural plants. The term does not include any person who is performing hand labor tasks.

                Early entry means entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired.

                Farm means any operation, other than a nursery or forest, engaged in the outdoor production of agricultural plants.

                Forest means any operation engaged in the outdoor production of any agricultural plant to produce wood fiber or timber products.

                Fumigant means any pesticide product that is a vapor or gas, or forms a vapor or gas on application, and whose method of pesticidal action is through the gaseous state.

                Greenhouse means any operation engaged in the production of agricultural plants inside any structure or space that is enclosed with nonporous covering and that is of sufficient size to permit worker entry. This term includes, but is not limited to, polyhouses, mushroom houses, rhubarb houses, and similar structures. It does not include such structures as malls, atriums, conservatories, arboretums, or office buildings where agricultural plants are present primarily for aesthetic or climatic modification.

                Hand labor means any agricultural activity performed by hand or with hand tools that causes a worker to have substantial contact with surfaces (such as plants, plant parts, or soil) that may contain pesticide residues. These activities include, but are not limited to, harvesting, detasseling, thinning, weeding, topping, planting, sucker removal, pruning, disbudding, roguing, and packing produce into containers in the field. Hand labor does not include operating, moving, or repairing irrigation or watering equipment or performing the tasks of crop advisors.

                Handler means any person, including a self-employed person:
              (1) Who is employed for any type of compensation by an agricultural establishment or commercial pesticide handling establishment to which subpart C of this part applies and who is:
              (i) Mixing, loading, transferring, or applying pesticides.
              (ii) Disposing of pesticides or pesticide containers.
              (iii) Handling opened containers of pesticides.
              (iv) Acting as a flagger.
              (v) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues.
              (vi) Assisting with the application of pesticides.
              (vii) Entering a greenhouse or other enclosed area after the application and before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (§ 170.110(c)(3)) or in the labeling has been met:
              (A) To operate ventilation equipment.
              (B) To adjust or remove coverings used in fumigation.
              (C) To monitor air levels.
              (viii) Entering a treated area outdoors after application of any soil fumigant to adjust or remove soil coverings such as tarpaulins.
              (ix) Performing tasks as a crop advisor:
              (A) During any pesticide application.
              (B) Before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (§ 170.110(c)(3)) or in the labeling has been met.
              (C) During any restricted-entry interval.
              (2) The term does not include any person who is only handling pesticide containers that have been emptied or cleaned according to pesticide product labeling instructions or, in the absence of such instructions, have been subjected to triple-rinsing or its equivalent.

                Handler employer means any person who is self-employed as a handler or who employs any handler, for any type of compensation.

                Immediate family includes only spouse, children, stepchildren, foster children, parents, stepparents, foster parents, brothers, and sisters.

                Nursery means any operation engaged in the outdoor production of any agricultural plant to produce cut flowers and ferns or plants that will be used in their entirety in another location. Such plants include, but are not limited to, flowering and foliage plants or trees; tree seedlings; live Christmas trees; vegetable, fruit, and ornamental transplants; and turfgrass produced for sod.

                Owner means any person who has a present possessory interest (fee, leasehold, rental, or other) in an agricultural establishment covered by this part. A person who has both leased such agricultural establishment to another person and granted that same person the right and full authority to manage and govern the use of such agricultural establishment is not an owner for purposes of this part.

                Restricted-entry interval means the time after the end of a pesticide application during which entry into the treated area is restricted.

                Treated area means any area to which a pesticide is being directed or has been directed.

                Worker means any person, including a self-employed person, who is employed for any type of compensation and who is performing activities relating to the production of agricultural plants on an agricultural establishment to which subpart B of this part applies. While persons employed by a commercial pesticide handling establishment are performing tasks as crop advisors, they are not workers covered by the requirements of subpart B of this part.

              § 170.7
              General duties and prohibited actions.
              (a) General duties. The agricultural employer or the handler employer, as appropriate, shall:
              (1) Assure that each worker subject to subpart B of this part or each handler subject to subpart C of this part receives the protections required by this part.
              (2) Assure that any pesticide to which subpart C of this part applies is used in a manner consistent with the labeling of the pesticide, including the requirements of this part.
              (3) Provide, to each person who supervises any worker or handler, information and directions sufficient to assure that each worker or handler receives the protections required by this part. Such information and directions shall specify which persons are responsible for actions required to comply with this part.
              (4) Require each person who supervises any worker or handler to assure compliance by the worker or handler with the provisions of this part and to assure that the worker or handler receives the protections required by this part.
              (b) Prohibited actions. The agricultural employer or the handler employer shall not take any retaliatory action for attempts to comply with this part or any action having the effect of preventing or discouraging any worker or handler from complying or attempting to comply with any requirement of this part.

              § 170.9
              Violations of this part.

              (a) Under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) (FIFRA) section 12(a)(2)(G) it is unlawful for any person “to use any registered pesticide in a manner inconsistent with its labeling.” When this part is referenced on a label, users must comply with all of its requirements except those that are inconsistent with product-specific instructions on the labeling. For the purposes of this part, EPA interprets the term “use” to include:
              (1) Preapplication activities, including, but not limited to:
              (i) Arranging for the application of the pesticide;
              (ii) Mixing and loading the pesticide; and
              (iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of handlers, decontamination, use and care of personal protective equipment, emergency information, and heat stress management.
              (2) Application of the pesticide.
              (3) Post-application activities necessary to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during the restricted-entry interval plus 30 days. These activities include, but are not limited to, responsibilities related to worker training, notification, and decontamination.

              (4) Other pesticide-related activities, including, but not limited to, providing emergency assistance, transporting or storing pesticides that have been opened, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.
              (b) A person who has a duty under this part, as referenced on the pesticide product label, and who fails to perform that duty, violates FIFRA section 12(a)(2)(G) and is subject to a civil penalty under section 14. A person who knowingly violates section 12(a)(2)(G) is subject to section 14 criminal sanctions.
              (c) FIFRA section 14(b)(4) provides that a person is liable for a penalty under FIFRA if another person employed by or acting for that person violates any provision of FIFRA. The term “acting for” includes both employment and contractual relationships.
              (d) The requirements of this part, including the decontamination requirements, shall not, for the purposes of section 653(b)(1) of title 29 of the U.S. Code, be deemed to be the exercise of statutory authority to prescribe or enforce standards or regulations affecting the general sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 1928.110, or other agricultural, nonpesticide hazards.

            Subpart B—Standard for Workers

              § 170.102
              Applicability of this subpart.
              Except as provided by §§ 170.103 and 170.104, this subpart applies when any pesticide product is used on an agricultural establishment in the production of agricultural plants.
              [60 FR 21952, May 3, 1995]

              § 170.103
              Exceptions.

                Exceptions. This subpart does not apply when any pesticide is applied on an agricultural establishment in the following circumstances:
              (a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities;
              (b) On livestock or other animals, or in or about animal premises;
              (c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses;
              (d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for aesthetic purposes or climatic modification;
              (e) By injection directly into agricultural plants. Direct injection does not include “hack and squirt,” “frill and spray,” chemigation, soil-incorporation, or soil-injection;
              (f) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use;
              (g) For control of vertebrate pests;
              (h) As attractants or repellents in traps;
              (i) On the harvested portions of agricultural plants or on harvested timber; and
              (j) For research uses of unregistered pesticides.
              [57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]

              § 170.104
              Exemptions.
              The workers listed in this section are exempt from the specified provisions of this subpart.
              (a) Owners of agricultural establishments. (1) The owner of an agricultural establishment is not required to provide to himself or members of his immediate family who are performing tasks related to the production of agricultural plants on their own agricultural establishment the protections of:
              (i) Section 170.112(c)(5) through (9).
              (ii) Section 170.112(c)(5) through (9) as referenced in §§ 170.112(d)(2)(iii) and 170.112(e).
              (iii) Section 170.120.
              (iv) Section 170.122.
              (v) Section 170.130.
              (vi) Section 170.135.
              (vii) Section 170.150.
              (viii) Section 170.160.
              (2) The owner of the agricultural establishment must provide the protections listed in paragraph (a)(1)(i) through (viii) of this section to other workers and other persons who are not members of his immediate family.
              (b) Crop advisors. (1) Provided that the conditions of paragraph (b)(2) of this section are met, a person who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, and persons performing crop advising tasks under such qualified crop advisor's direct supervision, are exempt from the provisions of:
              (i) Section 170.150.
              (ii) Section 170.160.
              A person is under the direct supervision of a crop advisor when the crop advisor exerts the supervisory controls set out in paragraphs (b)(2)(iii) and (iv) of this section. Direct supervision does not require that the crop advisor be physically present at all times, but the crop advisor must be readily accessible to the employees at all times.
              (2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4).
              (ii) Applies only when performing crop advising tasks in the treated area.
              (iii) The crop advisor must make specific determinations regarding the appropriate personal protective equipment, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.
              (iv) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide product and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor.
              [60 FR 21952, May 3, 1995, as amended at 73 FR 75598, Dec. 12, 2008]

              § 170.110
              Restrictions associated with pesticide applications.
              (a) Farms and forests. During the application of any pesticide on a farm or in a forest, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the treated area.
              (b) Nurseries. In a nursery, during any pesticide application described in column A of Table 1 of this paragraph, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the area specified in column B of Table 1 of this paragraph. After the application is completed, until the end of any restricted-entry interval, the entry-restricted area is the treated area.

                Table 1—Entry-Restricted Areas in Nurseries During Pesticide Applications

                  A. During Application of a Pesticide:
                  B. Workers are Prohibited in:

                  (1)(a) Applied:
                  Treated area plus 100 feet in all directions on the nursery

                  (i) Aerially, or

                  (ii) In an upward direction, or

                  (iii) Using a spray pressure greater than 150 psi, or

                  (b) Applied as a:

                  (i) Fumigant, or

                  (ii) Smoke, or

                  (iii) Mist, or

                  (iv) Fog, or

                  (v) Aerosol.

                  (2)(a) Applied downward using:
                  Treated are plus 25 feet in all directions on the nursery

                  (i) A height of greater than 12 inches from the planting medium, or

                  (ii) A fine spray, or

                  (iii) A spray pressure greater than 40 psi and less than 150 psi.

                  (b) Not as in 1 or 2(a) above but for which a respiratory protection device is required for application by the product labeling.

                  (3) Applied otherwise.
                  Treated area

              (c) Greenhouses. (1) When a pesticide application described in column A of Table 2 under paragraph (c)(4) of this section takes place in a greenhouse, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the area specified in column B of Table 2 until the time specified in column C of Table 2 has expired.
              (2) After the time specified in column C of Table 2 under paragraph (c)(4) of this section has expired, until the expiration of any restricted-entry interval, the agricultural employer shall not allow or direct any worker to enter or to remain in the treated area as specified in column D of Table 2 under paragraph (c)(4) of this section, except as provided in § 170.112.
              (3) When column C of Table 2 under paragraph (c)(4) of this section specifies that ventilation criteria must be met, ventilation shall continue until the air concentration is measured to be equal to or less than the inhalation exposure level the labeling requires to be achieved. If no inhalation exposure level is listed on the labeling, ventilation shall continue until after:
              (i) Ten air exchanges are completed; or
              (ii) Two hours of ventilation using fans or other mechanical ventilating systems; or
              (iii) Four hours of ventilation using vents, windows or other passive ventilation; or
              (iv) Eleven hours with no ventilation followed by 1 hour of mechanical ventilation; or
              (v) Eleven hours with no ventilation followed by 2 hours of passive ventilation; or
              (vi) Twenty-four hours with no ventilation.
              (4) The following Table 2 applies to paragraphs (c) (1), (2), and (3) of this section.

                Table 2—Greenhouse Entry Restrictions Associated With Pesticide Applications

                  A. When a Pesticide is Applied:
                  B. Workers are Prohibited in:
                  C. Until:
                  D. After the Expiration of Time in Column C Until the Restricted-Entry Interval Expires, the Entry-Restricted Area is:

                  (1) As a fumigant
                  Entire greenhouse plus any adjacent structure that cannot be sealed off from the treated area
                  The ventilation criteria of paragraph (c)(3) of this section are met
                  No entry restrictions after criteria in column C are met

                  (2) As a
                  Entire enclosed area
                  The ventilation criteria of paragraph (c)(3) of this section are met
                  Entire enclosed area is the treated area

                  (i) Smoke, or

                  (ii) Mist, or

                  (iii) Fog, or

                  (iv) Aerosol

                  (3) Not in 1 or 2 above, and for which a respiratory protection device is required for application by the product labeling
                  Entire enclosed area
                  The ventilation criteria of paragraph (c)(3) of this section are met
                  Treated area

                  (4) Not in 1, 2, or 3 above, and:
                  Treated area plus 25 feet in all directions in the enclosed area
                  Application is complete
                  Treated area

                  (i) From a height of greater than 12 in. from the planting medium, or

                  (ii) As a fine spray, or

                  (iii) Using a spray pressure greater than 40 psi

                  (5) Otherwise
                  Treated area
                  Application is complete
                  Treated area

              § 170.112
              Entry restrictions.
              (a) General restrictions. (1) After the application of any pesticide on an agricultural establishment, the agricultural employer shall not allow or direct any worker to enter or to remain in the treated area before the restricted-entry interval specified on the pesticide labeling has expired, except as provided in this section.
              (2) Entry-restricted areas in greenhouses are specified in column D in table 2 under § 170.110(c)(4).
              (3) When two or more pesticides are applied at the same time, the restricted-entry interval shall be the longest of the applicable intervals.
              (4) The agricultural employer shall assure that any worker who enters a treated area under a restricted-entry interval as permitted by paragraphs (c), (d), and (e) of this section uses the personal protective equipment specified in the product labeling for early-entry workers and follows any other requirements on the pesticide labeling regarding early entry.
              (b) Exception for activities with no contact. A worker may enter a treated area during a restricted-entry interval if the agricultural employer assures that both of the following are met:
              (1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants; and
              (2) No such entry is allowed until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
              (c) Exception for short-term activities. A worker may enter a treated area during a restricted-entry interval for short-term activities if the agricultural employer assures that the following requirements are met:
              (1) No hand labor activity is performed.
              (2) The time in treated areas under a restricted-entry interval for any worker does not exceed 1 hour in any 24-hour period.
              (3) No such entry is allowed for the first 4 hours following the end of the application, and no such entry is allowed thereafter until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
              (4) The personal protective equipment specified on the product labeling for early entry is provided to the worker. Such personal protective equipment shall conform to the following standards:
              (i) Personal protective equipment (PPE) means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.
              (ii) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.
              (iii) When “chemical-resistant” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.
              (iv) When “waterproof” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
              (v) When a “chemical-resistant suit” is specified by the product labeling, it shall be a loose-fitting, one- or two-piece, chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.

              (vi) When “coveralls” are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over a layer of clothing. If a chemical-resistant suit is substituted for coveralls, it need not be worn over a layer of clothing.

              (vii)(A) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials must not be worn for early-entry activities, unless gloves made of these materials are listed as acceptable for such use on the product labeling. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, leather gloves may be worn on top of chemical-resistant gloves. However, once leather gloves have been worn for this use, they shall not be worn thereafter for any other purpose, and they shall only be worn over chemical-resistant gloves.
              (B) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.
              (C) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
              (viii) When “chemical-resistant footwear” is specified by the product labeling, it shall be one of the following types of footwear: chemical-resistant shoes, chemical-resistant boots, or chemical-resistant shoe coverings worn over shoes or boots. If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable for workers, then leather boots may be worn in such terrain.
              (ix) When “protective eyewear” is specified by the product labeling, it shall be one of the following types of eyewear: goggles; face shield; safety glasses with front, brow, and temple protection; or a full-face respirator.
              (x) When “chemical-resistant headgear” is specified by the product labeling, it shall be either a chemical-resistant hood or a chemical-resistant hat with a wide brim.
              (5) The agricultural employer shall assure that the worker, before entering the treated area, either has read the product labeling or has been informed, in a manner that the worker can understand, of all labeling requirements related to human hazards or precautions, first aid, symptoms of poisoning, personal protective equipment specified for early entry, and any other labeling requirements related to safe use.
              (6) The agricultural employer shall assure that:
              (i) Workers wear the personal protective equipment correctly for its intended purpose and use personal protective equipment according to manufacturer's instructions.
              (ii) Before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
              (iii) Personal protective equipment that cannot be cleaned properly is disposed of in accordance with any applicable Federal, State, and local regulations.
              (iv) All personal protective equipment is cleaned according to manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it shall be washed thoroughly in detergent and hot water.
              (v) Before being stored, all clean personal protective equipment is dried thoroughly or is put in a well-ventilated place to dry.
              (vi) Personal protective equipment contaminated with pesticides is kept separately and washed separately from any other clothing or laundry.

              (vii) Any person who cleans or launders personal protective equipment is informed that such equipment may be contaminated with pesticides, of the potentially harmful effects of exposure to pesticides, and of the correct way(s) to handle and clean personal protective equipment and to protect themselves when handling equipment contaminated with pesticides.
              (viii) All clean personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
              (ix) Each worker is instructed how to put on, use, and remove the personal protective equipment and is informed about the importance of washing thoroughly after removing personal protective equipment.
              (x) Each worker is instructed in the prevention, recognition, and first aid treatment of heat-related illness.
              (xi) Workers have a clean place(s) away from pesticide-storage and pesticide-use areas for storing personal clothing not in use; putting on personal protective equipment at the start of any exposure period; and removing personal protective equipment at the end of any exposure period.
              (7) When personal protective equipment is required by the labeling of any pesticide for early entry, the agricultural employer shall assure that no worker is allowed or directed to perform the early-entry activity without implementing, when appropriate, measures to prevent heat-related illness.
              (8) During any early-entry activity, the agricultural employer shall provide a decontamination site in accordance with § 170.150.
              (9) The agricultural employer shall not allow or direct any worker to wear home or to take home personal protective equipment contaminated with pesticides.
              (d) Exception for an agricultural emergency. (1) An “agricultural emergency” means a sudden occurrence or set of circumstances which the agricultural employer could not have anticipated and over which the agricultural employer has no control, and which requires entry into a treated area during a restricted-entry interval, when no alternative practices would prevent or mitigate a substantial economic loss. A substantial economic loss means a loss in profitability greater than that which would be expected based on the experience and fluctuations of crop yields in previous years. Only losses caused by the agricultural emergency specific to the affected site and geographic area are considered. The contribution of mismanagement cannot be considered in determining the loss.
              (2) A worker may enter a treated area under a restricted-entry interval in an agricultural emergency to perform tasks, including hand labor tasks, necessary to mitigate the effects of the agricultural emergency, if the agricultural employer assures that all the following criteria are met:
              (i) A State, Tribal, or Federal Agency having jurisdiction declares the existence of circumstances that could cause an agricultural emergency on that agricultural establishment.
              (ii) The agricultural employer determines the agricultural establishment is subject to the circumstances declared under paragraph (d)(2)(i) of this section that result in an agricultural emergency meeting the criteria of paragraph (d)(1) of this section.
              (iii) The requirements of paragraphs (c) (3) through (9) of this section are met.
              (e) Exception requiring Agency approval. The Agency may, in accordance with paragraphs (e) (1) through (3) of this section, grant an exception from the requirements of this section. An exception may be withdrawn in accordance with paragraph (e)(6) of this section.
              (1) Exception requiring agency approval. A request for an exception must be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b) and must be accompanied by two copies of the following information:
              (i) The name, address, and telephone number of the submitter.
              (ii) The time period for which the exception is requested.

              (iii) A description of the crop(s) and specific crop production task(s) for which the exception is requested. Such a description must include an explanation as to the necessity of applying pesticides of a type and at a frequency such that the restricted-entry interval would interfere with necessary and time-sensitive hand labor tasks for the period for which the exception is sought.

              (iv) A description of the geographic area for which the exception is requested. If the exception request is for a limited geographic area, the explanation must include a description as to why the circumstances of exposure or economic impact resulting from the prohibition of routine hand labor tasks during the restricted-entry interval are unique to the geographic area named in the exception.
              (v) An explanation as to why, for each requested crop-task combination, alternative practices would not be technically or financially viable. Such alternative practices might include: rescheduling the pesticide application or hand labor activity; using a non-chemical pest control alternative; using an alternative to the hand labor tasks, such as machine cultivation; or substituting a pesticide with a shorter restricted-entry interval. This information should include estimates or data on per acre revenue and cost of production for the crop and area for which the exception is requested. These estimates or data should include: the situation prior to implementation of this final rule, the situation after implementation of this final rule if the exception is not granted, the situation after implementation of this final rule if the exception is granted, and specific information on individual factors which cause differences in revenues and costs among the three situations.
              (vi) A description or documentation of the safety and feasibility of such an exception, including, but not limited to, the feasibility of performing the necessary hand labor activity while wearing the personal protective equipment required for early entry for the pesticide(s) expected to be applied, the means of mitigating heat-related illness concerns, the period of time required daily per worker to perform the hand labor activity, any suggested methods of reducing the worker's exposure, and any other mitigating factors, such as the availability of running water for routine and emergency decontamination and mechanical devices that would reduce the workers' contact with the treated surfaces. The information should include the costs associated with early-entry, such as decontamination facilities, special information and training for the workers, heat stress avoidance procedures, and provision, inspection, cleaning, and maintenance of personal protective equipment. EPA will not grant exceptions where the costs of early entry equal or exceed the expected loss in value of crop yield or quality.
              (2) Notice of receipt. (i) When a request for an exception is submitted to the Agency along with all of the information required in paragraph (e)(1) of this section, the Agency shall issue a notice in the Federal Register stating that an exception is being considered, describing the nature of the exception, and allowing at least 30 days for interested parties to comment.
              (ii) If a request for an exception is submitted to the Agency without all of the information required in paragraph (e)(1) of this section, the Agency shall return the request to the submitter.
              (3) Exception decision. EPA will publish in the Federal Register its decision whether to grant the request for exception. EPA will base its decision on whether the benefits of the exception outweigh the costs, including the value of the health risks attributable to the exception. If the exception is granted, the notice will state the nature of and reasons for the exception.
              (4) Presumptive denial. (i) Except as provided in paragraph (e)(4)(ii) of this section, persons requesting an exception may assume that the exception has been denied if EPA has not issued its decision whether to grant the exception within 9 months from the comment-closure date specified in the Federal Register notice in which the Agency announced, in accordance with paragraph (e)(2) of this section, that it would consider the exception.

              (ii) Persons requesting an exception may not assume that the request has been denied as provided by paragraph (e)(4)(i) of this section if the Agency has taken action to extend its review period for a specified time interval due to the complexity of the exception request or to the number of exception requests concurrently under Agency review. EPA shall state the reason(s) for the delay in issuing a decision on the exception request. A notice of such an action may be published in the Federal Register or persons who requested the exception may be directly notified of the action.
              (5) Agricultural employer duties. When a worker enters a treated area during a restricted-entry interval under an exception granted under paragraph (e) of this section, the agricultural employer shall assure that the requirements of paragraphs (c) (3) through (9) of this section are met, unless the notice granting the exception specifically indicates otherwise.
              (6) Withdrawing an exception. An exception may be withdrawn by the Agency at any time if the Agency receives poisoning information or other data that indicate that the health risks imposed by this early-entry exception are unacceptable or if the Agency receives other information that indicates that the exception is no longer necessary or prudent. If the Agency determines that an exception should be withdrawn, it will publish a notice in the Federal Register, stating the basis for its determination. Affected parties would then have 30 days to request a hearing on the Agency's determination. The exception, however, would be discontinued as of the date specified by EPA in the notice, which may include any of the 30-day period and the time required for any subsequent hearing process. Thereafter the Agency will decide whether to withdraw the exception and will publish a notice in the Federal Register stating its decision.
              (7) List of exceptions granted by EPA. The following administrative exceptions from the requirements of this section have been granted by EPA. Each exception listed in paragraph (e)(7) of this section contains a reference to the Federal Register notice in which EPA has granted the exception and the effective dates of the exception. The terms and conditions of the exception appear in the referenced Federal Register notice.

              (i) Exception to perform irrigation tasks under specified conditions published in the Federal Register of May 3, 1995.

              (ii) Exceptions to perform limited contact tasks under specified conditions published in the Federal Register of May 3, 1995.
              [57 FR 38151, Aug. 21, 1992, as amended at 59 FR 30264, June 10, 1994; 60 FR 21954, May 3, 1995; 62 FR 52003, Oct. 3, 1997; 69 FR 53346, Sept. 1, 2004; 71 FR 35546, June 21, 2006; 73 FR 75598, Dec. 12, 2008]

              § 170.120
              Notice of applications.
              (a) Notification to workers of pesticide applications in greenhouses. The agricultural employer shall notify workers of any pesticide application in the greenhouse in accordance with this paragraph.
              (1) All pesticide applications shall be posted in accordance with paragraph (c) of this section.
              (2) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall also provide oral notification of the application to the worker in accordance with paragraph (d) of this section.
              (3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:
              (i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through the greenhouse; or
              (ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by paragraphs (d)(1) through (3) of this section.
              (b) Notification to workers on farms, in nurseries, or in forests of pesticide applications. The agricultural employer shall notify workers of any pesticide application on the farm or in the nursery or forest in accordance with this paragraph.

              (1) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall post signs in accordance with paragraph (c) of this section and shall provide oral notification of the application to the worker in accordance with paragraph (d) of this section.

              (2) For any pesticide other than those for which the labeling requires both posting and oral notification of applications, the agricultural employer shall give notice of the application to the worker either by the posting of warning signs in accordance with paragraph (c) of this section or orally in accordance with paragraph (d) of this section, and shall inform the workers as to which method of notification is in effect.
              (3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:
              (i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through on foot the treated area or any area within 1/4 mile of the treated area; or
              (ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by (d)(1) through (3) of this section.
              (c) Posted warning signs. The agricultural employer shall post warning signs in accordance with the following criteria:
              (1) The warning sign shall have a background color that contrasts with red. The words “DANGER” and “PELIGRO,” plus “PESTICIDES” and “PESTICIDAS,” shall be at the top of the sign, and the words “KEEP OUT” and “NO ENTRE” shall be at the bottom of the sign. Letters for all words must be clearly legible. A circle containing an upraised hand on the left and a stern face on the right must be near the center of the sign. The inside of the circle must be red, except that the hand and a large portion of the face must be in a shade that contrasts with red. The length of the hand must be at least twice the height of the smallest letters. The length of the face must be only slightly smaller than the hand. Additional information such as the name of the pesticide and the date of application may appear on the warning sign if it does not detract from the appearance of the sign or change the meaning of the required information. A black-and-white example of a warning sign meeting these requirements, other than the size requirements, follows:

                EC01MY92.111

              (2) The standard sign shall be at least 14 inches by 16 inches with letters at least 1 inch in height. Farms and forests shall use the standard size sign unless a smaller sign is necessary because the treated area is too small to accommodate a sign of this size. In nurseries and greenhouses, the agricultural employer may, at any time, use a sign smaller than the standard size sign. Whenever a small sign is used on any establishment, there are specific posting distances depending on the size of the lettering and symbol on the sign. If a sign is used with DANGER and PELIGRO in letters at least 7/8 inch in height and the remaining letters at least 1/2 inch in height and a red circle at least 3 inches in diameter containing an upraised hand and a stern face, the signs shall be no further than 50 feet apart. If a sign is used with DANGER and PELIGRO in letters at least 7/16 inch in height and the remaining letters at least 1/4 inch in height and a red circle at least 11/2 inches in diameter containing an upraised hand and a stern face, the signs shall be no further than 25 feet apart. A sign with DANGER and PELIGRO in letters less than 7/16 inch in height or with any words in letters less than 1/4 inch in height or a red circle smaller than 11/2 inches in diameter containing an upraised hand and a stern face will not satisfy the requirements of the rule. All signs must meet the requirements of paragraph (c)(1) of this section.
              (3) The employer may replace the Spanish portion of the warning sign with a non-English language read by the largest group of workers who do not read English. The replacement sign must be in the same format as the original sign and be visible and legible.
              (4) On farms and in forests and nurseries, the signs shall be visible from all usual points of worker entry to the treated area, including at least each access road, each border with any labor camp adjacent to the treated area, and each footpath and other walking route that enters the treated area. When there are no usual points of worker entry, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.
              (5) In greenhouses, the signs shall be posted so they are visible from all usual points of worker entry to the treated area including each aisle or other walking route that enters the treated area. When there are no usual points of worker entry to the treated area, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.
              (6) The signs shall:
              (i) Be posted no sooner than 24 hours before the scheduled application of the pesticide.
              (ii) Remain posted throughout the application and any restricted-entry interval.
              (iii) Be removed within 3 days after the end of the application and any restricted-entry interval and before agricultural-worker entry is permitted, other than entry permitted by § 170.112.
              (7) The signs shall remain visible and legible during the time they are posted.
              (8) When several contiguous areas are to be treated with pesticides on a rotating or sequential basis, the entire area may be posted. Worker entry, other than entry permitted by § 170.112, is prohibited for the entire area while the signs are posted.
              (d) Oral warnings. The agricultural employer shall provide oral warnings to workers in a manner that the worker can understand. If a worker will be on the premises during the application, the warning shall be given before the application takes place. Otherwise, the warning shall be given at the beginning of the worker's first work period during which the application is taking place or the restricted-entry interval for the pesticide is in effect. The warning shall consist of:
              (1) The location and description of the treated area.
              (2) The time during which entry is restricted.
              (3) Instructions not to enter the treated area until the restricted-entry interval has expired.
              [57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33207, June 26, 1996]

              § 170.122
              Providing specific information about applications.
              When workers are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the agricultural employer shall display, in accordance with this section, specific information about the pesticide.
              (a) Location, accessibility, and legibility. The information shall be displayed in the location specified for the pesticide safety poster in § 170.135(d) and shall be accessible and legible, as specified in § 170.135 (e) and (f).
              (b) Timing. (1) If warning signs are posted for the treated area before an application, the specific application information for that application shall be posted at the same time or earlier.

              (2) The information shall be posted before the application takes place, if workers will be on the establishment during application. Otherwise, the information shall be posted at the beginning of any worker's first work period.
              (3) The information shall continue to be displayed for at least 30 days after the end of the restricted-entry interval (or, if there is no restricted-entry interval, for at least 30 days after the end of the application) or at least until workers are no longer on the establishment, whichever is earlier.
              (c) Required information. The information shall include:
              (1) The location and description of the treated area.
              (2) The product name, EPA registration number, and active ingredient(s) of the pesticide.
              (3) The time and date the pesticide is to be applied.
              (4) The restricted-entry interval for the pesticide.

              § 170.124
              Notice of applications to handler employers.
              Whenever handlers who are employed by a commercial pesticide handling establishment will be performing pesticide handling tasks on an agricultural establishment, the agricultural employer shall provide to the handler employer, or assure that the handler employer is aware of, the following information concerning any areas on the agricultural establishment that the handler may be in (or may walk within 1/4 mile of) and that may be treated with a pesticide or that may be under a restricted-entry interval while the handler will be on the agricultural establishment:
              (a) Specific location and description of any such areas; and
              (b) Restrictions on entering those areas.

              § 170.130
              Pesticide safety training for workers.
              (a) General requirement—(1) Agricultural employer assurance. The agricultural employer shall assure that each worker, required by this section to be trained, has been trained according to this section during the last 5 years, counting from the end of the month in which the training was completed.
              (2) Requirement for workers performing early-entry activities. Before a worker enters a treated area on the agricultural establishment during a restricted-entry interval to perform early-entry activities permitted by § 170.112 and contacts anything that has been treated with the pesticide to which the restricted-entry interval applies, including but not limited to, soil, water, or surfaces of plants, the agricultural employer shall assure that the worker has been trained.
              (3) Requirements for other agricultural workers—(i) Information before entry. Except as provided in paragraph (a)(2) of this section, before a worker enters any areas on the agricultural establishment where, within the last 30 days a pesticide to which this subpart applies has been applied or the restricted-entry interval for such pesticide has been in effect, the agricultural employer shall assure that the worker has been provided the pesticide safety information specified in paragraph (c) of this section, in a manner that agricultural workers can understand, such as by providing written materials or oral communication or by other means. The agricultural employer must be able to verify compliance with this requirement.
              (ii) Training before the 6th day of entry. Except as provided in paragraph (a)(2) of this section, before the 6th day that a worker enters any areas on the agricultural establishment where, within the last 30 days a pesticide to which this subpart applies has been applied or a restricted-entry interval for such pesticide has been in effect, the agricultural employer shall assure that the worker has been trained.
              (b) Exceptions. The following persons need not be trained under this section:
              (1) A worker who is currently certified as an applicator of restricted-use pesticides under part 171 of this chapter.
              (2) A worker who satisfies the training requirements of part 171 of this chapter.
              (3) A worker who satisfies the handler training requirements of § 170.230(c).

              (4) A worker who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the information set out in § 170.230(c)(4).
              (c) Pesticide safety information. The pesticide safety information required by paragraph (a)(3)(i) shall be presented to workers in a manner that the workers can understand. At a minimum, the following information shall be provided:
              (1) Pesticides may be on or in plants, soil, irrigation water, or drifting from nearby applications.
              (2) Prevent pesticides from entering your body by:
              (i) Following directions and/or signs about keeping out of treated or restricted areas.
              (ii) Washing before eating, drinking, using chewing gum or tobacco, or using the toilet.
              (iii) Wearing work clothing that protects the body from pesticide residues.
              (iv) Washing/showering with soap and water, shampoo hair, and put on clean clothes after work.
              (v) Washing work clothes separately from other clothes before wearing them again.
              (vi) Washing immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
              (3) Further training will be provided within 5 days.
              (d) Training programs. (1) General pesticide safety information shall be presented to workers either orally from written materials or audiovisually. The information must be presented in a manner that the workers can understand (such as through a translator) using nontechnical terms. The presenter also shall respond to workers' questions.
              (2) The person who conducts the training shall meet at least one of the following criteria:
              (i) Be currently certified as an applicator of restricted-use pesticides under part 171 of this chapter; or
              (ii) Be currently designated as a trainer of certified applicators or pesticide handlers by a State, Federal, or Tribal agency having jurisdiction; or
              (iii) Have completed a pesticide safety train-the-trainer program approved by a State, Federal, or Tribal agency having jurisdiction; or
              (iv) Satisfy the training requirements in part 171 of this chapter or in § 170.230(c).
              (3) Any person who issues an EPA-approved Worker Protection Standard worker training certificate must assure that the worker who receives the training certificate has been trained in accordance with paragraph (d)(4) of this section.
              (4) The training materials shall convey, at a minimum, the following information:
              (i) Where and in what form pesticides may be encountered during work activities.
              (ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
              (iii) Routes through which pesticides can enter the body.
              (iv) Signs and symptoms of common types of pesticide poisoning.
              (v) Emergency first aid for pesticide injuries or poisonings.
              (vi) How to obtain emergency medical care.
              (vii) Routine and emergency decontamination procedures, including emergency eyeflushing techniques.
              (viii) Hazards from chemigation and drift.
              (ix) Hazards from pesticide residues on clothing.
              (x) Warnings about taking pesticides or pesticide containers home.
              (xi) Requirements of this subpart designed to reduce the risks of illness or injury resulting from workers' occupational exposure to pesticides, including application and entry restrictions, the design of the warning sign, posting of warning signs, oral warnings, the availability of specific information about applications, and the protection against retaliatory acts.
              (e) Verification of training. (1) Except as provided in paragraph (e)(2) of this section, if the agricultural employer assures that a worker possesses an EPA-approved Worker Protection Standard worker training certificate, then the requirements of paragraph (a) and (c) of this section will have been met.

              (2) If the agricultural employer is aware or has reason to know that an EPA-approved Worker Protection Standard worker training certificate has not been issued in accordance with this section, or has not been issued to the worker bearing the certificate, or the training was completed more than 5 years before the beginning of the current month, a worker's possession of that certificate does not meet the requirements of paragraph (a) of this section.
              [57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21947, 21952, May 3, 1995; 73 FR 75598, Dec. 12, 2008]

              § 170.135
              Posted pesticide safety information.
              (a) Requirement. When workers are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the agricultural employer shall display, in accordance with this section, pesticide safety information.
              (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the pesticide safety concepts listed in paragraphs (b)(1)(i) through (vii) and (b)(2) of this section. Displays conforming to § 170.311(a)(3) meet the requirements of this paragraph.
              (c) Emergency medical care information. (1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. Displays conforming to § 170.311(a)(3)(ix) meet the requirements of this paragraph.
              (2) The agricultural employer shall inform workers promptly of any change to the information on emergency medical care facilities.
              (d) Location. (1) The information shall be displayed in a central location on the farm or in the nursery or greenhouse where it can be readily seen and read by workers.
              (2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by workers and where workers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.
              (e) Accessibility. Workers shall be informed of the location of the information and shall be allowed access to it.
              (f) Legibility. The information shall remain legible during the time it is posted.
              [57 FR 38151, Aug. 21, 1992, as amended at 80 FR 67556, Nov. 2, 2015]

              § 170.150
              Decontamination.
              (a)(1) Requirement. The agricultural employer must provide decontamination supplies for workers in accordance with this section whenever:
              (i) Any worker on the agricultural establishment is performing an activity in the area where a pesticide was applied or a restricted-entry interval (REI) was in effect within the last 30 days, and;
              (ii) The worker contacts anything that has been treated with the pesticide, including, but not limited to soil, water, plants, plant surfaces, and plant parts.
              (2) Exception. The 30-day time period established in paragraph (a)(1)(i) of this section shall not apply if the only pesticides used in the treated area are products with an REI of 4 hours or less on the label (but not a product without an REI on the label). When workers are in such treated areas, the agricultural employer shall provide decontamination supplies for not less than 7 days following the expiration of any applicable REI.
              (b) General conditions. (1) The agricultural employer shall provide workers with enough water for routine washing and emergency eyeflushing. At all times when the water is available to workers, the employer shall assure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed.
              (2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eyeflushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.

              (3) The agricultural employer shall provide soap and single-use towels in quantities sufficient to meet worker's needs.
              (4) To provide for emergency eyeflushing, the agricultural employer shall assure that at least 1 pint of water is immediately available to each worker who is performing early-entry activities permitted by § 170.112 and for which the pesticide labeling requires protective eyewear. The eyeflush water shall be carried by the early-entry worker, or shall be on the vehicle the early-entry worker is using, or shall be otherwise immediately accessible.
              (c) Location. (1) The decontamination supplies shall be located together and be reasonably accessible to and not more than 1/4 mile from where workers are working.
              (2) For worker activities performed more than 1/4 mile from the nearest place of vehicular access:
              (i) The soap, single-use towels, and water may be at the nearest place of vehicular access.
              (ii) The agricultural employer may permit workers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.
              (3) The decontamination supplies shall not be maintained in an area being treated with pesticides.
              (4) The decontamination supplies shall not be maintained in an area that is under a restricted-entry interval, unless the workers for whom the supplies are provided are performing early-entry activities permitted by § 170.112 and involving contact with treated surfaces and the decontamination supplies would otherwise not be reasonably accessible to those workers.
              (d) Decontamination after early-entry activities. At the end of any exposure period for workers engaged in early-entry activities permitted by § 170.112 and involving contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants, the agricultural employer shall provide, at the site where the workers remove personal protective equipment, soap, clean towels, and a sufficient amount of water so that the workers may wash thoroughly.
              [57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33212, June 26, 1996]

              § 170.160
              Emergency assistance.
              If there is reason to believe that a person who is or has been employed on an agricultural establishment to perform tasks related to the production of agricultural plants has been poisoned or injured by exposure to pesticides used on the agricultural establishment, including, but not limited to, exposures from application, splash, spill, drift, or pesticide residues, the agricultural employer shall:
              (a) Make available to that person prompt transportation from the agricultural establishment, including any labor camp on the agricultural establishment, to an appropriate emergency medical facility.
              (b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on:
              (1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.
              (2) Antidote, first aid, and other medical information from the product labeling.
              (3) The circumstances of application or use of the pesticide on the agricultural establishment.
              (4) The circumstances of exposure of that person to the pesticide.

            Subpart C—Standard for Pesticide Handlers

              § 170.202
              Applicability of this subpart.
              Except as provided by §§ 170.203 and 170.204, this subpart applies when any pesticide is handled for use on an agricultural establishment.
              [60 FR 21952, May 3, 1995]

              § 170.203
              Exceptions.

                Exceptions. This subpart does not apply when any pesticide is handled for use on an agricultural establishment in the following circumstances:

              (a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities.
              (b) On livestock or other animals, or in or about animal premises.
              (c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses.
              (d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds and that are intended only for aesthetic purposes or climatic modification.
              (e) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use.
              (f) For control of vertebrate pests.
              (g) As attractants or repellents in traps.
              (h) On the harvested portions of agricultural plants or on harvested timber.
              (i) For research uses of unregistered pesticides.
              [57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]

              § 170.204
              Exemptions.
              The handlers listed in this section are exempt from the specified provisions of this subpart.
              (a) Owners of agricultural establishments. (1) The owner of an agricultural establishment is not required to provide to himself or members of his immediate family who are performing handling tasks on their own agricultural establishment the protections of:
              (i) Section 170.210(b) and (c).
              (ii) Section 170.222.
              (iii) Section 170.230.
              (iv) Section 170.232.
              (v) Section 170.234.
              (vi) Section 170.235.
              (vii) Section 170.240(e) through (g).
              (viii) Section 170.250.
              (ix) Section 170.260.
              (2) The owner of the agricultural establishment must provide the protections listed in paragraphs (a)(1) (i) through (ix) of this section to other handlers and other persons who are not members of his immediate family.
              (b) Crop advisors. (1) Provided that the conditions of paragraph (b)(2) of this section are met, a person who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, and persons performing crop advising tasks under such qualified crop advisor's direct supervision, are exempt from the provisions of:
              (i) Section 170.232.
              (ii) Section 170.240.
              (iii) Section 170.250.
              (iv) Section 170.260.
              A person is under the direct supervision of a crop advisor when the crop advisor exerts the supervisory controls set out in paragraphs (b)(2)(iv) and (v) of this section. Direct supervision does not require that the crop advisor be physically present at all times, but the crop advisor must be readily accessible to the employees at all times.
              (2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4).
              (ii) No entry into the treated area occurs until after application ends.
              (iii) Applies only when performing crop advising tasks in the treated area.
              (iv) The crop advisor must make specific determinations regarding the appropriate PPE, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.
              (v) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide products and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor.
              [60 FR 21953, May 3, 1995, as amended at 73 FR 75599, Dec. 12, 2008]

              § 170.210
              Restrictions during applications.
              (a) Contact with workers and other persons. The handler employer and the handler shall assure that no pesticide is applied so as to contact, either directly or through drift, any worker or other person, other than an appropriately trained and equipped handler.
              (b) Handlers handling highly toxic pesticides. The handler employer shall assure that any handler who is performing any handling activity with a product that has the skull and crossbones symbol on the front panel of the label is monitored visually or by voice communication at least every 2 hours.
              (c) Fumigant applications in greenhouses. The handler employer shall assure:
              (1) That any handler who handles a fumigant in a greenhouse, including a handler who enters the greenhouse before the acceptable inhalation exposure level or ventilation criteria have been met to monitor air levels or to initiate ventilation, maintains continuous visual or voice contact with another handler.
              (2) That the other handler has immediate access to the personal protective equipment required by the fumigant labeling for handlers in the event entry into the fumigated greenhouse becomes necessary for rescue.

              § 170.222
              Providing specific information about applications.
              When handlers (except those employed by a commercial pesticide handling establishment) are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the handler employer shall display, in accordance with this section, specific information about the pesticide.
              (a) Location, accessibility, and legibility. The information shall be displayed in the same location specified for the pesticide safety poster in § 170.235(d) of this part and shall be accessible and legible, as specified in § 170.235(e) and (f) of this part.
              (b) Timing. (1) If warning signs are posted for the treated area before an application, the specific application information for that application shall be posted at the same time or earlier.
              (2) The information shall be posted before the application takes place, if handlers (except those employed by a commercial pesticide handling establishment) will be on the establishment during application. Otherwise, the information shall be posted at the beginning of any such handler's first work period.
              (3) The information shall continue to be displayed for at least 30 days after the end of the restricted-entry interval (or, if there is no restricted-entry interval, for at least 30 days after the end of the application) or at least until the handlers are no longer on the establishment, whichever is earlier.
              (c) Required information. The information shall include:
              (1) The location and description of the treated area.
              (2) The product name, EPA registration number, and active ingredient(s) of the pesticide.
              (3) The time and date the pesticide is to be applied.
              (4) The restricted-entry interval for the pesticide.

              § 170.224
              Notice of applications to agricultural employers.
              Before the application of any pesticide on or in an agricultural establishment, the handler employer shall provide the following information to any agricultural employer for the establishment or shall assure that any agricultural employer is aware of:
              (a) Specific location and description of the treated area.
              (b) Time and date of application.
              (c) Product name, EPA registration number, and active ingredient(s).
              (d) Restricted-entry interval.
              (e) Whether posting and oral notification are required.
              (f) Any other product-specific requirements on the product labeling concerning protection of workers or other persons during or after application.

              § 170.230
              Pesticide safety training for handlers.
              (a) Requirement. Before any handler performs any handling task, the handler employer shall assure that the handler has been trained in accordance with this section during the last 5 years, counting from the end of the month in which the training was completed.
              (b) Exceptions. The following persons need not be trained under this section:
              (1) A handler who is currently certified as an applicator of restricted-use pesticides under part 171 of this chapter.
              (2) A handler who satisfies the training requirements of part 171 of this chapter.
              (3) A handler who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the information set out in § 170.230(c)(4).
              (c) Training programs. (1) General pesticide safety information shall be presented to handlers either orally from written materials or audiovisually. The information must be presented in a manner that the handlers can understand (such as through a translator). The presenter also shall respond to handlers' questions.
              (2) The person who conducts the training shall meet at least one of the following criteria:
              (i) Be currently certified as an applicator of restricted-use pesticides under part 171 of this chapter; or
              (ii) Be currently designated as a trainer of certified applicators or pesticide handlers by a State, Federal, or Tribal agency having jurisdiction; or
              (iii) Have completed a pesticide safety train-the-trainer program approved by a State, Federal, or Tribal agency having jurisdiction.
              (3) Any person who issues an EPA-approved Worker Protection Standard handler training certificate must assure that the handler who receives the training certificate has been trained in accordance with paragraph (c)(4) of this section.
              (4) The pesticide safety training materials must convey, at a minimum, the following information:
              (i) Format and meaning of information contained on pesticide labels and in labeling, including safety information such as precautionary statements about human health hazards.
              (ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
              (iii) Routes by which pesticides can enter the body.
              (iv) Signs and symptoms of common types of pesticide poisoning.
              (v) Emergency first aid for pesticide injuries or poisonings.
              (vi) How to obtain emergency medical care.
              (vii) Routine and emergency decontamination procedures.
              (viii) Need for and appropriate use of personal protective equipment.
              (ix) Prevention, recognition, and first aid treatment of heat-related illness.
              (x) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
              (xi) Environmental concerns such as drift, runoff, and wildlife hazards.
              (xii) Warnings about taking pesticides or pesticide containers home.
              (xiii) Requirements of this subpart that must be followed by handler employers for the protection of handlers and other persons, including the prohibition against applying pesticides in a manner that will cause contact with workers or other persons, the requirement to use personal protective equipment, the provisions for training and decontamination, and the protection against retaliatory acts.
              (d) Verification of training. (1) Except as provided in paragraph (d)(2) of this section, if the handler employer assures that a handler possesses an EPA-approved Worker Protection Standard handler training certificate, then the requirements of paragraph (a) of this section will have been met.

              (2) If the handler employer is aware or has reason to know that an EPA-approved Worker Protection Standard handler training certificate has not been issued in accordance with this section, or has not been issued to the handler bearing the certificate, or the handler training was completed more than 5 years before the beginning of the current month, a handler's possession of that certificate does not meet the requirements of paragraph (a) of this section.
              [57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21953, May 3, 1995]

              § 170.232
              Knowledge of labeling and site-specific information.
              (a) Knowledge of labeling information. (1) The handler employer shall assure that before the handler performs any handling activity, the handler either has read the product labeling or has been informed in a manner the handler can understand of all labeling requirements related to safe use of the pesticide, such as signal words, human hazard precautions, personal protective equipment requirements, first aid instructions, environmental precautions, and any additional precautions pertaining to the handling activity to be performed.
              (2) The handler employer shall assure that the handler has access to the product labeling information during handling activities.
              (b) Knowledge of site-specific information. Whenever a handler who is employed by a commercial pesticide handling establishment will be performing pesticide handling tasks on an agricultural establishment, the handler employer shall assure that the handler is aware of the following information concerning any areas on the agricultural establishment that the handler may be in (or may walk within 1/4 mile of) and that may be treated with a pesticide or that may be under a restricted-entry interval while the handler will be on the agricultural establishment:
              (1) Specific location and description of any such areas; and
              (2) Restrictions on entering those areas.

              § 170.234
              Safe operation of equipment.
              (a) The handler employer shall assure that before the handler uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment, including, when relevant, chemigation safety requirements and drift avoidance.
              (b) The handler employer shall assure that, before each day of use, equipment used for mixing, loading, transferring, or applying pesticides is inspected for leaks, clogging, and worn or damaged parts, and any damaged equipment is repaired or is replaced.
              (c) Before allowing any person to repair, clean, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the handler employer shall assure that pesticide residues have been removed from the equipment, unless the person doing the cleaning, repairing, or adjusting is a handler employed by the agricultural or commercial pesticide handling establishment. If pesticide residue removal is not feasible, the handler employer shall assure that the person who repairs, cleans, or adjusts such equipment is informed:
              (1) That such equipment may be contaminated with pesticides.
              (2) Of the potentially harmful effects of exposure to pesticides.
              (3) Of the correct way to handle such equipment.

              § 170.235
              Posted pesticide safety information.
              (a) Requirement. When handlers (except those employed by a commercial pesticide handling establishment) are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the handler employer shall display, in accordance with this section, pesticide safety information.
              (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the pesticide safety concepts listed in paragraphs (b)(1)(i) through (vii) and (b)(2) of this section. Displays conforming to § 170.311(a)(3) meet the requirements of this paragraph.
              (c) Emergency medical care information. (1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. Displays conforming to § 170.311(a)(3)(ix) meet the requirements of this paragraph.

              (2) The handler employer shall inform handlers promptly of any change to the information on emergency medical care facilities.

              (d) Location. (1) The information shall be displayed in a central location on the farm or in the nursery or greenhouse where it can be readily seen and read by handlers.
              (2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by handlers and where handlers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.
              (e) Accessibility. Handlers shall be informed of the location of the information and shall be allowed access to it.
              (f) Legibility. The information shall remain legible during the time it is posted.
              [57 FR 38151, Aug. 21, 1992, as amended at 80 FR 67556, Nov. 2, 2015]

              § 170.240
              Personal protective equipment.
              (a) Requirement. Any person who performs tasks as a pesticide handler shall use the clothing and personal protective equipment specified on the labeling for use of the product.
              (b) Definition. (1) Personal protective equipment (PPE) means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.
              (2) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.
              (c) Provision. When personal protective equipment is specified by the labeling of any pesticide for any handling activity, the handler employer shall provide the appropriate personal protective equipment in clean and operating condition to the handler.
              (1) When “chemical-resistant” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.
              (2) When “waterproof” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
              (3) When a “chemical-resistant suit” is specified by the product labeling, it shall be a loose-fitting, one- or two-piece chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.
              (4) When “coveralls” are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over another layer of clothing.
              (5)(i) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials may not be worn while mixing, loading, applying, or otherwise handling pesticides, unless gloves made of these materials are listed as acceptable for such use on the product labeling.
              (ii) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings, made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.

              (iii) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
              (6) When “chemical-resistant footwear” is specified by the product labeling, one of the following types of footwear must be worn:
              (i) Chemical-resistant shoes.
              (ii) Chemical-resistant boots.
              (iii) Chemical-resistant shoe coverings worn over shoes or boots.
              (7) When “protective eyewear” is specified by the product labeling, one of the following types of eyewear must be worn:
              (i) Goggles.
              (ii) Face shield.
              (iii) Safety glasses with front, brow, and temple protection.
              (iv) Full-face respirator.
              (8) When a “chemical-resistant apron” is specified by the product labeling, an apron that covers the front of the body from mid-chest to the knees shall be worn.
              (9) When a respirator is specified by the product labeling, it shall be appropriate for the pesticide product used and for the activity to be performed. The handler employer shall assure that the respirator fits correctly.
              (10) When “chemical-resistant headgear” is specified by the product labeling, it shall be either a chemical resistant hood or a chemical-resistant hat with a wide brim.
              (d) Exceptions to personal protective equipment specified on product labeling—(1) Body protection. (i) A chemical-resistant suit may be substituted for “coveralls,” and any requirement for an additional layer of clothing beneath is waived.
              (ii) A chemical-resistant suit may be substituted for “coveralls” and a chemical-resistant apron.
              (2) Boots. If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable, then leather boots may be worn in such terrain.
              (3) Gloves. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, then during handling activities with roses or other plants with sharp thorns, leather gloves may be worn over chemical-resistant glove liners. However, once leather gloves are worn for this use, thereafter they shall be worn only with chemical-resistant liners and they shall not be worn for any other use.
              (4) Closed systems. If handling tasks are performed using properly functioning systems that enclose the pesticide to prevent it from contacting handlers or other persons, and if such systems are used and are maintained in accordance with that manufacturer's written operating instructions, exceptions to labeling-specified personal protective equipment for the handling activity are permitted as provided in paragraphs (d)(4)(i) and (ii) of this section.
              (i) Persons using a closed system to mix or load pesticides with a signal word of DANGER or WARNING may substitute a long-sleeved shirt, long pants, shoes, socks, chemical-resistant apron, and any protective gloves specified on the labeling for handlers for the labeling-specified personal protective equipment.
              (ii) Persons using a closed system to mix or load pesticides other than those in paragraph (d)(4)(i) of this section or to perform other handling tasks may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment.
              (iii) Persons using a closed system that operates under pressure shall wear protective eyewear.
              (iv) Persons using a closed system shall have all labeling-specified personal protective equipment immediately available for use in an emergency.
              (5) Enclosed cabs. If handling tasks are performed from inside a cab that has a nonporous barrier which totally surrounds the occupants of the cab and prevents contact with pesticides outside of the cab, exceptions to personal protective equipment specified on the product labeling for that handling activity are permitted as provided in paragraphs (d)(5) (i) through (iv) of this section.

              (i) Persons occupying an enclosed cab may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device is specified on the pesticide product labeling for the handling activity, it must be worn.
              (ii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than a dust/mist filtering respirator may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device other than a dust/mist-filtering respirator is specified on the pesticide product labeling, it must be worn.
              (iii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than the vapor- or gas-removing respirator specified on pesticide product labeling may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If an air-supplying respirator or a self-contained breathing apparatus (SCBA) is specified on the pesticide product labeling, it must be worn.
              (iv) Persons occupying an enclosed cab shall have all labeling-specified personal protective equipment immediately available and stored in a chemical-resistant container, such as a plastic bag. They shall wear such personal protective equipment if it is necessary to exit the cab and contact pesticide-treated surfaces in the treated area. Once personal protective equipment is worn in the treated area, it must be removed before reentering the cab.
              (6) Aerial application—(i) Use of gloves. The wearing of chemical-resistant gloves when entering or leaving an aircraft used to apply pesticides is optional, unless such gloves are required on the pesticide product labeling. If gloves are brought into the cockpit of an aircraft that has been used to apply pesticides, the gloves shall be kept in an enclosed container to prevent contamination of the inside of the cockpit.
              (ii) Open cockpit. Persons occupying an open cockpit shall use the personal protective equipment specified in the product labeling for use during application, except that chemical-resistant footwear need not be worn. A helmet may be substituted for chemical-resistant headgear. A visor may be substituted for protective eyewear.
              (iii) Enclosed cockpit. Persons occupying an enclosed cockpit may substitute a long-sleeved shirt, long pants, shoes, and socks for labeling-specified personal protective equipment.
              (7) Crop advisors. Crop advisors entering treated areas while a restricted-entry interval is in effect may wear the personal protective equipment specified on the pesticide labeling for early-entry activities instead of the personal protective equipment specified on the pesticide labeling for handling activities, provided:
              (i) Application has been completed for at least 4 hours.
              (ii) Any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
              (e) Use of personal protective equipment. (1) The handler employer shall assure that personal protective equipment is used correctly for its intended purpose and is used according to the manufacturer's instructions.
              (2) The handler employer shall assure that, before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
              (f) Cleaning and maintenance. (1) The handler employer shall assure that all personal protective equipment is cleaned according to the manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it shall be washed thoroughly in detergent and hot water.

              (2) If any personal protective equipment cannot be cleaned properly, the handler employer shall dispose of the personal protective equipment in accordance with any applicable Federal, State, and local regulations. Coveralls or other absorbent materials that have been drenched or heavily contaminated with an undiluted pesticide that has the signal word DANGER or WARNING on the label shall be not be reused.
              (3) The handler employer shall assure that contaminated personal protective equipment is kept separately and washed separately from any other clothing or laundry.
              (4) The handler employer shall assure that all clean personal protective equipment shall be either dried thoroughly before being stored or shall be put in a well ventilated place to dry.
              (5) The handler employer shall assure that all personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
              (6) The handler employer shall assure that when dust/mist filtering respirators are used, the filters shall be replaced:
              (i) When breathing resistance becomes excessive.
              (ii) When the filter element has physical damage or tears.
              (iii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
              (iv) In the absence of any other instructions or indications of service life, at the end of each day's work period.
              (7) The handler employer shall assure that when gas- or vapor-removing respirators are used, the gas- or vapor-removing canisters or cartridges shall be replaced:
              (i) At the first indication of odor, taste, or irritation.
              (ii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
              (iii) In the absence of any other instructions or indications of service life, at the end of each day's work period.
              (8) The handler employer shall inform any person who cleans or launders personal protective equipment:
              (i) That such equipment may be contaminated with pesticides.
              (ii) Of the potentially harmful effects of exposure to pesticides.
              (iii) Of the correct way(s) to clean personal protective equipment and to protect themselves when handling such equipment.
              (9) The handler employer shall assure that handlers have a clean place(s) away from pesticide storage and pesticide use areas where they may:
              (i) Store personal clothing not in use.
              (ii) Put on personal protective equipment at the start of any exposure period.
              (iii) Remove personal protective equipment at the end of any exposure period.
              (10) The handler employer shall not allow or direct any handler to wear home or to take home personal protective equipment contaminated with pesticides.
              (g) Heat-related illness. When the use of personal protective equipment is specified by the labeling of any pesticide for the handling activity, the handler employer shall assure that no handler is allowed or directed to perform the handling activity unless appropriate measures are taken, if necessary, to prevent heat-related illness.
              [57 FR 38151, Aug. 21, 1992, as amended at 69 FR 53346, Sept. 1, 2004]

              § 170.250
              Decontamination.
              (a) Requirement. During any handling activity, the handler employer shall provide for handlers, in accordance with this section, decontamination supplies for washing off pesticides and pesticide residues.
              (b) General conditions. (1) The handler employer shall provide handlers with enough water for routine washing, for emergency eyeflushing, and for washing the entire body in case of an emergency. At all times when the water is available to handlers, the handler employer shall assure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed.
              (2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eye flushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.

              (3) The handler employer shall provide soap and single-use towels in quantities sufficient to meet handlers' needs.

              (4) The handler employer shall provide one clean change of clothing, such as coveralls, for use in an emergency.
              (c) Location. The decontamination supplies shall be located together and be reasonably accessible to and not more than 1/4 mile from each handler during the handling activity.
              (1) Exception for mixing sites. For mixing activities, decontamination supplies shall be at the mixing site.
              (2) Exception for pilots. Decontamination supplies for a pilot who is applying pesticides aerially shall be in the airplaine or at the aircraft loading site.
              (3) Exception for handling pesticides in remote areas. When handling activities are performed more than 1/4 mile from the nearest place of vehicular access:
              (i) The soap, single-use towels, clean change of clothing, and water may be at the nearest place of vehicular access.
              (ii) The handler employer may permit handlers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.
              (4) Decontamination supplies in treated areas. The decontamination supplies shall not be in an area being treated with pesticides or in an area under a restricted-entry interval, unless:
              (i) The decontamination supplies are in the area where the handler is performing handling activities;
              (ii) The soap, single-use towels, and clean change of clothing are in enclosed containers; and
              (iii) The water is running tap water or is enclosed in a container.
              (d) Emergency eyeflushing. To provide for emergency eyeflushing, the handler employer shall assure that at least 1 pint of water is immediately available to each handler who is performing tasks for which the pesticide labeling requires protective eyewear. The eyeflush water shall be carried by the handler, or shall be on the vehicle or aircraft the handler is using, or shall be otherwise immediately accessible.
              (e) Decontamination after handling activities. At the end of any exposure period, the handler employer shall provide at the site where handlers remove personal protective equipment, soap, clean towels, and a sufficient amount of water so that the handlers may wash thoroughly.
              [57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33213, June 26, 1996]

              § 170.260
              Emergency assistance.
              If there is reason to believe that a person who is or has been employed by an agricultural establishment or commercial pesticide handling establishment to perform pesticide handling tasks has been poisoned or injured by exposure to pesticides as a result of that employment, including, but not limited to, exposures from handling tasks or from application, splash, spill, drift, or pesticide residues, the handler employer shall:
              (a) Make available to that person prompt transportation from the place of employment or the handling site to an appropriate emergency medical facility.
              (b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on:
              (1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.
              (2) Antidote, first aid, and other medical information from the product labeling.
              (3) The circumstances of handling of the pesticide.
              (4) The circumstances of exposure of that person to the pesticide.

            Subpart D—General Provisions

              Source:
              80 FR 67557, Nov. 2, 2015, unless otherwise noted.

              § 170.301
              Scope and purpose.

              This regulation is primarily intended to reduce the risks of illness or injury to workers and handlers resulting from occupational exposures to pesticides used in the production of agricultural plants on agricultural establishments. It requires agricultural employers and commercial pesticide handler employers to provide specific information and protections to workers, handlers and other persons when pesticides are used on agricultural establishments in the production of agricultural plants. It also requires handlers to wear the labeling-specified clothing and personal protective equipment when performing handler activities, and to take measures to protect workers and other persons during pesticide applications.

              § 170.303
              Applicability of this part.
              (a) This regulation applies whenever a pesticide product bearing a label requiring compliance with this part is used in the production of agricultural plants on an agricultural establishment, except as provided in paragraphs (b) and (c) of this section.
              (b) This regulation does not apply when a pesticide product bearing a label requiring compliance with this part is used on an agricultural establishment in any of the following circumstances:
              (1) As part of government-sponsored public pest control programs over which the owner, agricultural employer and handler employer have no control, such as mosquito abatement and Mediterranean fruit fly eradication programs.
              (2) On plants other than agricultural plants, which may include plants in home fruit and vegetable gardens and home greenhouses, and permanent plantings for ornamental purposes, such as plants that are in ornamental gardens, parks, public or private landscaping, lawns or other grounds that are intended only for aesthetic purposes or climatic modification.
              (3) For control of vertebrate pests, unless directly related to the production of an agricultural plant.
              (4) As attractants or repellents in traps.
              (5) On the harvested portions of agricultural plants or on harvested timber.
              (6) For research uses of unregistered pesticides.
              (7) On pasture and rangeland where the forage will not be harvested for hay.
              (8) In a manner not directly related to the production of agricultural plants, including, but not limited to structural pest control and control of vegetation in non-crop areas.
              (c) Where a pesticide product's labeling-specific directions for use or other labeling requirements are inconsistent with requirements of this part, users must comply with the pesticide product labeling, except as provided for in §§ 170.601, 170.603 and 170.607.

              § 170.305
              Definitions.
              Terms used in this part have the same meanings they have in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, when used in this part, shall have the following meanings:

                Agricultural employer means any person who is an owner of, or is responsible for the management or condition of, an agricultural establishment, and who employs any worker or handler.

                Agricultural establishment means any farm, forest operation, or nursery engaged in the outdoor or enclosed space production of agricultural plants. An establishment that is not primarily agricultural is an agricultural establishment if it produces agricultural plants for transplant or use (in part or their entirety) in another location instead of purchasing the agricultural plants.

                Agricultural plant means any plant, or part thereof, grown, maintained, or otherwise produced for commercial purposes, including growing, maintaining or otherwise producing plants for sale or trade, for research or experimental purposes, or for use in part or their entirety in another location. Agricultural plant includes, but is not limited to, grains, fruits and vegetables; wood fiber or timber products; flowering and foliage plants and trees; seedlings and transplants; and turf grass produced for sod. Agricultural plant does not include pasture or rangeland used for grazing.

                Application exclusion zone means the area surrounding the application equipment that must be free of all persons other than appropriately trained and equipped handlers during pesticide applications.

                Chemigation means the application of pesticides through irrigation systems.

                Closed system means an engineering control used to protect handlers from pesticide exposure hazards when mixing and loading pesticides.

                Commercial pesticide handler employer means any person, other than an agricultural employer, who employs any handler to perform handler activities on an agricultural establishment. A labor contractor who does not provide pesticide application services or supervise the performance of handler activities, but merely employs laborers who perform handler activities at the direction of an agricultural or handler employer, is not a commercial pesticide handler employer.

                Commercial pesticide handling establishment means any enterprise, other than an agricultural establishment, that provides pesticide handler or crop advising services to agricultural establishments.

                Crop advisor means any person who is assessing pest numbers, damage, pesticide distribution, or the status or requirements of agricultural plants.

                Designated representative means any persons designated in writing by a worker or handler to exercise a right of access on behalf of the worker or handler to request and obtain a copy of the pesticide application and hazard information required by § 170.309(h) in accordance with § 170.311(b) of this part.

                Early entry means entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired.

                Employ means to obtain, directly or through a labor contractor, the services of a person in exchange for a salary or wages, including piece-rate wages, without regard to who may pay or who may receive the salary or wages. It includes obtaining the services of a self-employed person, an independent contractor, or a person compensated by a third party, except that it does not include an agricultural employer obtaining the services of a handler through a commercial pesticide handler employer or a commercial pesticide handling establishment.

                Enclosed cab means a cab with a nonporous barrier that totally surrounds the occupant(s) of the cab and prevents dermal contact with pesticides that are being applied outside of the cab.

                Enclosed space production means production of an agricultural plant indoors or in a structure or space that is covered in whole or in part by any nonporous covering and that is large enough to permit a person to enter.

                Fumigant means any pesticide product that is a vapor or gas, or forms a vapor or gas upon application, and whose pesticidal action is achieved through the gaseous or vapor state.

                Hand labor means any agricultural activity performed by hand or with hand tools that causes a worker to have substantial contact with plants, plant parts, or soil and other surfaces that may contain pesticide residues, except that hand labor does not include operating, moving, or repairing irrigation or watering equipment or performing crop advisor tasks.

                Handler means any person, including a self-employed person, who is employed by an agricultural employer or commercial pesticide handler employer and performs any of the following activities:
              (1) Mixing, loading, or applying pesticides.
              (2) Disposing of pesticides.
              (3) Handling opened containers of pesticides, emptying, triple-rinsing, or cleaning pesticide containers according to pesticide product labeling instructions, or disposing of pesticide containers that have not been cleaned. The term does not include any person who is only handling unopened pesticide containers or pesticide containers that have been emptied or cleaned according to pesticide product labeling instructions.
              (4) Acting as a flagger.
              (5) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues.
              (6) Assisting with the application of pesticides.
              (7) Entering an enclosed space after the application of a pesticide and before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by § 170.405(b)(3) or the labeling has been met to operate ventilation equipment, monitor air levels, or adjust or remove coverings used in fumigation.

              (8) Entering a treated area outdoors after application of any soil fumigant during the labeling-specified entry-restricted period to adjust or remove coverings used in fumigation.
              (9) Performing tasks as a crop advisor during any pesticide application or restricted-entry interval, or before the inhalation exposure level listed in the pesticide product labeling has been reached or one of the ventilation criteria established by § 170.405(b)(3) or the pesticide product labeling has been met.

                Handler employer means any person who is self-employed as a handler or who employs any handler.

                Immediate family is limited to the spouse, parents, stepparents, foster parents, father-in-law, mother-in-law, children, stepchildren, foster children, sons-in-law, daughters-in-law, grandparents, grandchildren, brothers, sisters, brothers-in-law, sisters-in-law, aunts, uncles, nieces, nephews, and first cousins. “First cousin” means the child of a parent's sibling, i.e., the child of an aunt or uncle.

                Labor contractor means a person, other than a commercial pesticide handler employer, who employs workers or handlers to perform tasks on an agricultural establishment for an agricultural employer or a commercial pesticide handler employer.

                Outdoor production means production of an agricultural plant in an outside area that is not enclosed or covered in any way that would obstruct the natural air flow.

                Owner means any person who has a present possessory interest (e.g., fee, leasehold, rental, or other) in an agricultural establishment. A person who has both leased such agricultural establishment to another person and granted that same person the right and full authority to manage and govern the use of such agricultural establishment is not an owner for purposes of this part.

                Personal protective equipment means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respirators, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.

                Restricted-entry interval means the time after the end of a pesticide application during which entry into the treated area is restricted.

                Safety data sheet has the same meaning as the definition at 29 CFR 1900.1200(c).

                Treated area means any area to which a pesticide is being directed or has been directed.

                Use, as in “to use a pesticide” means any of the following:
              (1) Pre-application activities, including, but not limited to:
              (i) Arranging for the application of the pesticide.
              (ii) Mixing and loading the pesticide.
              (iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of workers or handlers, providing decontamination supplies, providing pesticide safety information and pesticide application and hazard information, use and care of personal protective equipment, providing emergency assistance, and heat stress management.
              (2) Application of the pesticide.
              (3) Post-application activities intended to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during and after the restricted-entry interval, including responsibilities related to worker notification, training of workers or early-entry workers, providing decontamination supplies, providing pesticide safety information and pesticide application and hazard information, use and care of personal protective equipment, providing emergency assistance, and heat stress management.
              (4) Other pesticide-related activities, including, but not limited to, transporting or storing pesticides that have been opened, cleaning equipment, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.

                Worker means any person, including a self-employed person, who is employed and performs activities directly relating to the production of agricultural plants on an agricultural establishment.

                Worker housing area means any place or area of land on or near an agricultural establishment where housing or space for housing is provided for workers or handlers by an agricultural employer, owner, labor contractor, or any other person responsible for the recruitment or employment of agricultural workers.

              § 170.309
              Agricultural employer duties.
              Agricultural employers must:
              (a) Ensure that any pesticide is used in a manner consistent with the pesticide product labeling, including the requirements of this part, when applied on the agricultural establishment.
              (b) Ensure that each worker and handler subject to this part receives the protections required by this part.
              (c) Ensure that any handler and any early entry worker is at least 18 years old.
              (d) Provide to each person, including labor contractors, who supervises any workers or handlers information and directions sufficient to ensure that each worker and handler receives the protections required by this part. Such information and directions must specify the tasks for which the supervisor is responsible in order to comply with the provisions of this part.
              (e) Require each person, including labor contractors, who supervises any workers or handlers to provide sufficient information and directions to each worker and handler to ensure that they can comply with the provisions of this part.
              (f) Provide emergency assistance in accordance with this paragraph. If there is reason to believe that a worker or handler has experienced a potential pesticide exposure during his or her employment on the agricultural establishment or shows symptoms similar to those associated with acute exposure to pesticides during or within 72 hours after his or her employment on the agricultural establishment, and needs emergency medical treatment, the agricultural employer must do all of the following promptly after learning of the possible poisoning or injury:
              (1) Make available to that person transportation from the agricultural establishment, including any worker housing area on the establishment, to an operating medical care facility capable of providing emergency medical treatment to a person exposed to pesticides.
              (2) Provide all of the following information to the treating medical personnel:
              (i) Copies of the applicable safety data sheet(s) and the product name(s), EPA registration number(s) and active ingredient(s) for each pesticide product to which the person may have been exposed.
              (ii) The circumstances of application or use of the pesticide on the agricultural establishment.
              (iii) The circumstances that could have resulted in exposure to the pesticide.
              (g) Ensure that workers or other persons employed by the agricultural establishment do not clean, repair, or adjust pesticide application equipment, unless trained as a handler under § 170.501. Before allowing any person not directly employed by the agricultural establishment to clean, repair, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the agricultural employer must provide all of the following information to such person:
              (1) Pesticide application equipment may be contaminated with pesticides.
              (2) The potentially harmful effects of exposure to pesticides.
              (3) Procedures for handling pesticide application equipment and for limiting exposure to pesticide residues.
              (4) Personal hygiene practices and decontamination procedures for preventing pesticide exposures and removing pesticide residues.
              (h) Display, maintain, and provide access to pesticide safety information and pesticide application and hazard information in accordance with § 170.311 if workers or handlers are on the establishment and within the last 30 days a pesticide product has been used or a restricted-entry interval for such pesticide has been in effect on the establishment.

              (i) Ensure that before a handler uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment.

              (j) Ensure that before each day of use, equipment used for mixing, loading, transferring, or applying pesticides is inspected for leaks, clogging, and worn or damaged parts, and any damaged equipment is repaired or replaced.
              (k) Ensure that whenever handlers employed by a commercial pesticide handling establishment will be on an agricultural establishment, the handler employer is provided information about, or is aware of, the specific location and description of any treated areas on the agricultural establishment where a restricted-entry interval is in effect that the handler may be in (or may walk within 1/4 mile of), and any restrictions on entering those areas.
              (l) Ensure that workers do not enter any area on the agricultural establishment where a pesticide has been applied until the applicable pesticide application and hazard information for each pesticide product applied to that area is displayed in accordance with § 170.311(b), and until after the restricted-entry interval has expired and all treated area warning signs have been removed or covered, except for entry permitted by § 170.603 of this part.
              (m) Provide any records or other information required by this part for inspection and copying upon request by an employee of EPA or any duly authorized representative of a Federal, State or Tribal government agency responsible for pesticide enforcement.

              § 170.311
              Display requirements for pesticide safety information and pesticide application and hazard information.
              (a) Display of Pesticide Safety Information. Whenever pesticide safety information and pesticide application and hazard information are required to be provided under § 170.309(h), pesticide safety information must be displayed in accordance with this paragraph.
              (1) General. The pesticide safety information must be conveyed in a manner that workers and handlers can understand.
              (2) Content prior to January 1, 2018. Prior to January 1, 2018, the safety information must include all of the following points:
              (i) Help keep pesticides from entering your body. Avoid getting on your skin or into your body any pesticides that may be on plants and soil, in irrigation water, or drifting from nearby applications.
              (ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
              (iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
              (iv) Wash or shower with soap and water, shampoo hair, and put on clean clothes after work.
              (v) Wash work clothes separately from other clothes before wearing them again.
              (vi) Wash immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
              (vii) Follow directions about keeping out of treated or restricted areas.
              (viii) The name, address, and telephone number of a nearby operating medical care facility capable of providing emergency medical treatment. This information must be clearly identified as emergency medical contact information on the display.
              (ix) There are Federal rules to protect workers and handlers, including a requirement for safety training.
              (3) Content after January 1, 2018. After January 1, 2018, the pesticide safety information must include all of the points in § 170.311(a)(3)(i)-(x) instead of the points listed in § 170.311(a)(2)(i)-(ix).
              (i) Avoid getting on the skin or into the body any pesticides that may be on or in plants, soil, irrigation water, tractors, and other equipment, on used personal protective equipment, or drifting from nearby applications.
              (ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
              (iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).

              (iv) Wash or shower with soap and water, shampoo hair, and put on clean clothes after work.

              (v) Wash work clothes separately from other clothes before wearing them again.
              (vi) If pesticides are spilled or sprayed on the body use decontamination supplies to wash immediately, or rinse off in the nearest clean water, including springs, streams, lakes or other sources if more readily available than decontamination supplies, and as soon as possible, wash or shower with soap and water, shampoo hair, and change into clean clothes.
              (vii) Follow directions about keeping out of treated areas and application exclusion zones.
              (viii) Instructions to employees to seek medical attention as soon as possible if they believe they have been poisoned, injured or made ill by pesticides.
              (ix) The name, address, and telephone number of a nearby operating medical care facility capable of providing emergency medical treatment. This information must be clearly identified as emergency medical contact information on the display.
              (x) The name, address and telephone number of the State or Tribal pesticide regulatory agency.
              (4) Changes to pesticide safety information. The agricultural employer must update the pesticide safety information display within 24 hours of notice of any changes to the information required in §§ 170.311(a)(2)(viii) or 170.311(a)(3)(ix).
              (5) Location. The pesticide safety information must be displayed at each of the following sites on the agricultural establishment:
              (i) The site selected pursuant to § 170.311(b)(2) for display of pesticide application and hazard information.
              (ii) Anywhere that decontamination supplies must be provided on the agricultural establishment pursuant to §§ 170.411, 170.509 or 170.605, but only when the decontamination supplies are located at permanent sites or being provided at locations and in quantities to meet the requirements for 11 or more workers or handlers.
              (6) Accessibility. When pesticide safety information is required to be displayed, workers and handlers must be allowed access to the pesticide safety information at all times during normal work hours.
              (7) Legibility. The pesticide safety information must remain legible at all times when the information is required to be displayed.
              (b) Keeping and displaying pesticide application and hazard information. Whenever pesticide safety information and pesticide application and hazard information is required to be provided under § 170.309(h), pesticide application and hazard information for any pesticides that are used on the agricultural establishment must be displayed, retained, and made accessible in accordance with this paragraph.
              (1) Content. The pesticide application and hazard information must include all of the following information for each pesticide product applied:
              (i) A copy of the safety data sheet.
              (ii) The name, EPA registration number, and active ingredient(s) of the pesticide product.
              (iii) The crop or site treated and the location and description of the treated area.
              (iv) The date(s) and times the application started and ended.
              (v) The duration of the applicable labeling-specified restricted-entry interval for that application.
              (2) Location. The pesticide application and hazard information must be displayed at a place on the agricultural establishment where workers and handlers are likely to pass by or congregate and where it can be readily seen and read.
              (3) Accessibility. When the pesticide application and hazard information is required to be displayed, workers and handlers must be allowed access to the location of the information at all times during normal work hours.
              (4) Legibility. The pesticide application and hazard information must remain legible at all times when the information is required to be displayed.
              (5) Timing. The pesticide application and hazard information for each pesticide product applied must be displayed no later than 24 hours after the end of the application of the pesticide. The pesticide application and hazard information must be displayed continuously from the beginning of the display period until at least 30 days after the end of the last applicable restricted-entry interval, or until workers or handlers are no longer on the establishment, whichever is earlier.
              (6) Record retention. Whenever pesticide safety information and pesticide application and hazard information is required to be displayed in accordance with this paragraph (b), the agricultural employer must retain the pesticide application and hazard information described in § 170.311(b)(1) on the agricultural establishment for two years after the date of expiration of the restricted-entry interval applicable to the pesticide application conducted.
              (7) Access to pesticide application and hazard information by a worker or handler.

              (i) If a person is or was employed as a worker or handler by an establishment during the period that particular pesticide application and hazard information was required to be displayed and retained for two years in accordance with §§ 170.311(b)(5) and 170.311(b)(6), and the person requests a copy of such application and/or hazard information, or requests access to such application and/or hazard information after it is no longer required to be displayed, the agricultural employer must provide the worker or handler with a copy of or access to all of the requested information within 15 days of the receipt of any such request. The worker or handler may make the request orally or in writing.

              (ii) Whenever a record has been previously provided without cost to a worker or handler or their designated representative, the agricultural employer may charge reasonable, non-discriminatory administrative costs (i.e., search and copying expenses but not including overhead expenses) for a request by the worker or handler for additional copies of the record.

                (8) Access to pesticide application and hazard information by treating medical personnel. Any treating medical personnel, or any person acting under the supervision of treating medical personnel, may request, orally or in writing, access to or a copy of any information required to be retained for two years by § 170.311(b)(6) in order to inform diagnosis or treatment of a worker or handler who was employed on the establishment during the period that the information was required to be displayed. The agricultural employer must promptly provide a copy of or access to all of the requested information applicable to the worker's or handler's time of employment on the establishment after receipt of the request.
              (9) Access to pesticide application and hazard information by a designated representative.

              (i) Any worker's or handler's designated representative may request access to or a copy of any information required to be retained for two years by § 170.311(b)(6) on behalf of a worker or handler employed on the establishment during the period that the information was required to be displayed. The agricultural employer must provide access to or a copy of the requested information applicable to the worker's or handler's time of employment on the establishment within 15 days after receiving any such request, provided the request meets the requirements specified in § 170.311(b)(9)(ii).
              (ii) A request by a designated representative for access to or a copy of any pesticide application and/or hazard information must be in writing and must contain all of the following:
              (A) The name of the worker or handler being represented.
              (B) A description of the specific information being requested. The description should include the dates of employment of the worker or handler, the date or dates for which the records are requested, type of work conducted by the worker or handler (e.g., planting, harvesting, applying pesticides, mixing or loading pesticides) during the period for which the records are requested, and the specific application and/or hazard information requested.
              (C) A written statement clearly designating the representative to request pesticide application and hazard information on the worker's or handler's behalf, bearing the worker's or handler's printed name and signature, the date of the designation, and the printed name and contact information for the designated representative.

              (D) If the worker or handler requests that the pesticide application and/or the hazard information be sent, direction for where to send the information (e.g., mailing address or email address).

              (iii) If the written request from a designated representative contains all of the necessary information specified in § 170.313(b)(9)(ii), the employer must provide a copy of or access to all of the requested information applicable to the worker's or handler's time of employment on the establishment to the designated representative within 15 days of receiving the request.

              (iv) Whenever a record has been previously provided without cost to a worker or handler or their designated representative, the agricultural employer may charge reasonable, non-discriminatory administrative costs (i.e., search and copying expenses but not including overhead expenses) for a request by the designated representative for additional copies of the record.

              § 170.313
              Commercial pesticide handler employer duties.
              Commercial pesticide handler employers must:
              (a) Ensure that any pesticide is used in a manner consistent with the pesticide product labeling, including the requirements of this part, when applied on an agricultural establishment by a handler employed by the commercial pesticide handling establishment.
              (b) Ensure each handler employed by the commercial pesticide handling establishment and subject to this part receives the protections required by this part.
              (c) Ensure that any handler employed by the commercial pesticide handling establishment is at least 18 years old.
              (d) Provide to each person, including labor contractors, who supervises any handlers employed by the commercial pesticide handling establishment, information and directions sufficient to ensure that each handler receives the protections required by this part. Such information and directions must specify the tasks for which the supervisor is responsible in order to comply with the provisions of this part.
              (e) Require each person, including labor contractors, who supervises any handlers employed by the commercial pesticide handling establishment, to provide sufficient information and directions to each handler to ensure that the handler can comply with the provisions of this part.
              (f) Ensure that before any handler employed by the commercial pesticide handling establishment uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment.
              (g) Ensure that, before each day of use, equipment used by their employees for mixing, loading, transferring, or applying pesticides is inspected for leaks, obstructions, and worn or damaged parts, and any damaged equipment is repaired or is replaced.
              (h) Ensure that whenever a handler who is employed by a commercial pesticide handling establishment will be on an agricultural establishment, the handler is provided information about, or is aware of, the specific location and description of any treated areas where a restricted-entry interval is in effect, and the restrictions on entering those areas.
              (i) Provide the agricultural employer all of the following information before the application of any pesticide on an agricultural establishment:
              (1) Specific location(s) and description of the area(s) to be treated.
              (2) The date(s) and start and estimated end times of application.
              (3) Product name, EPA registration number, and active ingredient(s).
              (4) The labeling-specified restricted-entry interval applicable for the application.
              (5) Whether posting, oral notification or both are required under § 170.409.
              (6) Any restrictions or use directions on the pesticide product labeling that must be followed for protection of workers, handlers, or other persons during or after application.

              (j) If there are any changes to the information provided in § 170.313(i)(1), § 170.313(i)(4), § 170.313(i)(5), § 170.313(i)(6) or if the start time for the application will be earlier than originally forecasted or scheduled, ensure that the agricultural employer is provided updated information prior to the application. If there are any changes to any other information provided pursuant to § 170.313(i), the commercial pesticide handler employer must provide updated information to the agricultural employer within two hours after completing the application. Changes to the estimated application end time of less than one hour need not be reported to the agricultural employer.
              (k) Provide emergency assistance in accordance with this paragraph. If there is reason to believe that a handler employed by the commercial pesticide handling establishment has experienced a potential pesticide exposure during his or her employment by the commercial pesticide handling establishment or shows symptoms similar to those associated with acute exposure to pesticides during or within 72 hours after his or her employment by the commercial pesticide handling establishment, and needs emergency medical treatment, the commercial pesticide handler employer must do all of the following promptly after learning of the possible poisoning or injury:
              (1) Make available to that person transportation from the commercial pesticide handling establishment, or any agricultural establishment on which that handler may be working on behalf of the commercial pesticide handling establishment, to an operating medical care facility capable of providing emergency medical treatment to a person exposed to pesticides.
              (2) Provide all of the following information to the treating medical personnel:
              (i) Copies of the applicable safety data sheet(s) and the product name(s), EPA registration number(s) and active ingredient(s) for each pesticide product to which the person may have been exposed.
              (ii) The circumstances of application or use of the pesticide.
              (iii) The circumstances that could have resulted in exposure to the pesticide.
              (l) Ensure that persons directly employed by the commercial pesticide handling establishment do not clean, repair, or adjust pesticide application equipment, unless trained as a handler under § 170.501. Before allowing any person not directly employed by the commercial pesticide handling establishment to clean, repair, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the commercial pesticide handler employer must provide all of the following information to such persons:
              (1) Notice that the pesticide application equipment may be contaminated with pesticides.
              (2) The potentially harmful effects of exposure to pesticides.
              (3) Procedures for handling pesticide application equipment and for limiting exposure to pesticide residues.
              (4) Personal hygiene practices and decontamination procedures for preventing pesticide exposures and removing pesticide residues.
              (m) Provide any records or other information required by this part for inspection and copying upon request by an employee of EPA or any duly authorized representative of a Federal, State or Tribal government agency responsible for pesticide enforcement.

              § 170.315
              Prohibited actions.
              No agricultural employer, commercial pesticide handler employer, or other person involved in the use of a pesticide to which this part applies, shall intimidate, threaten, coerce, or discriminate against any worker or handler for complying with or attempting to comply with this part, or because the worker or handler provided, caused to be provided or is about to provide information to the employer or the EPA or any duly authorized representative of a Federal, State or Tribal government regarding conduct that the worker or handler reasonably believes violates this part, has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing concerning compliance with this part, or has objected to, or refused to participate in, any activity, policy, practice, or assigned task that the worker or handler reasonably believed to be in violation of this part. Any such intimidation, threat, coercion, or discrimination violates FIFRA section 12(a)(2)(G), 7 U.S.C. 136j(a)(2)(G).

              § 170.317
              Violations of this part.

              (a) Under FIFRA section 12(a)(2)(G), it is unlawful for any person “to use any registered pesticide in a manner inconsistent with its labeling.” When this part is referenced on a label, users must comply with all of its requirements, except those that are inconsistent with product-specific instructions on the pesticide product labeling, except as provided for in §§ 170.601, 170.603 and 170.607.
              (b) A person who has a duty under this part, as referenced on the pesticide product labeling, and who fails to perform that duty, violates FIFRA section 12(a)(2)(G) and is subject to a civil penalty under section 14. A person who knowingly violates section 12(a)(2)(G) is subject to section 14 criminal sanctions.
              (c) FIFRA section 14(b)(4) provides that a person is liable for a penalty under FIFRA if another person employed by or acting for that person violates any provision of FIFRA. The term “acting for” includes both employment and contractual relationships, including, but not limited to, labor contractors.
              (d) The requirements of this part, including the decontamination requirements, must not, for the purposes of section 653(b)(1) of Title 29 of the U.S. Code, be deemed to be the exercise of statutory authority to prescribe or enforce standards or regulations affecting the general sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 1928.110, or other agricultural non-pesticide hazards.

            Subpart E—Requirements for Protection of Agricultural Workers

              Source:
              80 FR 67562, Nov. 2, 2015, unless otherwise noted.

              § 170.401
              Training requirements for workers.
              (a) General requirement. Before any worker performs any task in a treated area on an agricultural establishment where within the last 30 days a pesticide product has been used or a restricted-entry interval for such pesticide has been in effect, the agricultural employer must ensure that each worker has been trained in accordance with this section within the last 12 months, except as provided in paragraph (b) of this section.
              (b) Exceptions. The following workers need not be trained under this section:
              (1) A worker who is currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
              (2) A worker who has satisfied the handler training requirements in § 170.501.
              (3) A worker who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or the State or Tribal agency responsible for pesticide enforcement, provided that such certification or licensing requires pesticide safety training that includes all the topics in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
              (c) Training programs. (1) Pesticide safety training must be presented to workers either orally from written materials or audio-visually, at a location that is reasonably free from distraction and conducive to training. All training materials must be EPA-approved. The training must be presented in a manner that the workers can understand, such as through a translator. The training must be conducted by a person who meets the worker trainer requirements of paragraph (c)(4) of this section, and who must be present during the entire training program and must respond to workers' questions.
              (2) The training must include, at a minimum, all of the following topics:
              (i) Where and in what form pesticides may be encountered during work activities.
              (ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
              (iii) Routes through which pesticides can enter the body.
              (iv) Signs and symptoms of common types of pesticide poisoning.
              (v) Emergency first aid for pesticide injuries or poisonings.
              (vi) How to obtain emergency medical care.
              (vii) Routine and emergency decontamination procedures, including emergency eye flushing techniques.
              (viii) Hazards from chemigation and drift.
              (ix) Hazards from pesticide residues on clothing.

              (x) Warnings about taking pesticides or pesticide containers home.

              (xi) Requirements of this subpart designed to reduce the risks of illness or injury resulting from workers' occupational exposure to pesticides, including application and entry restrictions, the design of the warning sign, posting of warning signs, oral warnings, the availability of specific information about applications, and the protection against retaliatory acts.

              (3) EPA intends to make available to the public training materials that may be used to conduct training conforming to the requirements of this section. Within 180 days after a notice of availability of such training materials appears in the Federal Register, but no earlier than January 1, 2018, training programs required under this section must include, at a minimum, all of the topics listed in § 170.401(c)(3)(i)-(xxiii) instead of the topics listed in § 170.401(c)(2)(i)-(xi).
              (i) The responsibility of agricultural employers to provide workers and handlers with information and protections designed to reduce work-related pesticide exposures and illnesses. This includes ensuring workers and handlers have been trained on pesticide safety, providing pesticide safety and application and hazard information, decontamination supplies and emergency medical assistance, and notifying workers of restrictions during applications and on entering pesticide treated areas. A worker or handler may designate in writing a representative to request access to pesticide application and hazard information.
              (ii) How to recognize and understand the meaning of the posted warning signs used for notifying workers of restrictions on entering pesticide treated areas on the establishment.
              (iii) How to follow directions and/or signs about keeping out of pesticide treated areas subject to a restricted-entry interval and application exclusion zones.
              (iv) Where and in what forms pesticides may be encountered during work activities, and potential sources of pesticide exposure on the agricultural establishment. This includes exposure to pesticide residues that may be on or in plants, soil, tractors, application and chemigation equipment, or used personal protective equipment, and that pesticides may drift through the air from nearby applications or be in irrigation water.
              (v) Potential hazards from toxicity and exposure that pesticides present to workers and their families, including acute and chronic effects, delayed effects, and sensitization.
              (vi) Routes through which pesticides can enter the body.
              (vii) Signs and symptoms of common types of pesticide poisoning.
              (viii) Emergency first aid for pesticide injuries or poisonings.
              (ix) Routine and emergency decontamination procedures, including emergency eye flushing techniques, and if pesticides are spilled or sprayed on the body to use decontamination supplies to wash immediately or rinse off in the nearest clean water, including springs, streams, lakes or other sources if more readily available than decontamination supplies, and as soon as possible, wash or shower with soap and water, shampoo hair, and change into clean clothes.
              (x) How and when to obtain emergency medical care.
              (xi) When working in pesticide treated areas, wear work clothing that protects the body from pesticide residues and wash hands before eating, drinking, using chewing gum or tobacco, or using the toilet.
              (xii) Wash or shower with soap and water, shampoo hair, and change into clean clothes as soon as possible after working in pesticide treated areas.
              (xiii) Potential hazards from pesticide residues on clothing.
              (xiv) Wash work clothes before wearing them again and wash them separately from other clothes.
              (xv) Do not take pesticides or pesticide containers used at work to your home.
              (xvi) Safety data sheets provide hazard, emergency medical treatment and other information about the pesticides used on the establishment they may come in contact with. The responsibility of agricultural employers to do all of the following:
              (A) Display safety data sheets for all pesticides used on the establishment.

              (B) Provide workers and handlers information about the location of the safety data sheets on the establishment.
              (C) Provide workers and handlers unimpeded access to safety data sheets during normal work hours.
              (xvii) The rule prohibits agricultural employers from allowing or directing any worker to mix, load or apply pesticides or assist in the application of pesticides unless the worker has been trained as a handler.
              (xviii) The responsibility of agricultural employers to provide specific information to workers before directing them to perform early-entry activities. Workers must be 18 years old to perform early-entry activities.
              (xix) Potential hazards to children and pregnant women from pesticide exposure.
              (xx) Keep children and nonworking family members away from pesticide treated areas.
              (xxi) After working in pesticide treated areas, remove work boots or shoes before entering your home, and remove work clothes and wash or shower before physical contact with children or family members.
              (xxii) How to report suspected pesticide use violations to the State or Tribal agency responsible for pesticide enforcement.
              (xxiii) The rule prohibits agricultural employers from intimidating, threatening, coercing, or discriminating against any worker or handler for complying with or attempting to comply with the requirements of this rule, or because the worker or handler provided, caused to be provided or is about to provide information to the employer or the EPA or its agents regarding conduct that the employee reasonably believes violates this part, and/or made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing concerning compliance with this rule.
              (4) The person who conducts the training must meet one of the following criteria:
              (i) Be designated as a trainer of certified applicators, handlers or workers by EPA or the State or Tribal agency responsible for pesticide enforcement.
              (ii) Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of workers.
              (iii) Be currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
              (d) Recordkeeping. (1) For each worker required to be trained under paragraph (a), the agricultural employer must maintain on the agricultural establishment, for two years from the date of the training, a record documenting each worker's training including all of the following:
              (i) The trained worker's printed name and signature.
              (ii) The date of the training.
              (iii) Information identifying which EPA-approved training materials were used.
              (iv) The trainer's name and documentation showing that the trainer met the requirements of § 170.401(c)(4) at the time of training.
              (v) The agricultural employer's name.
              (2) An agricultural employer who provides, directly or indirectly, training required under paragraph (a) must provide to the worker upon request a copy of the record of the training that contains the information required under § 170.401(d)(1).

              § 170.403
              Establishment-specific information for workers.
              Before any worker performs any activity in a treated area on an agricultural establishment where within the last 30 days a pesticide product has been used, or a restricted-entry interval for such pesticide has been in effect, the agricultural employer must ensure that the worker has been informed of, in a manner the worker can understand, all of the following establishment-specific information:
              (a) The location of pesticide safety information required by § 170.311(a).
              (b) The location of pesticide application and hazard information required by § 170.311(b).
              (c) The location of decontamination supplies required by § 170.411.

              § 170.405
              Entry restrictions associated with pesticide applications.
              (a) Outdoor production pesticide applications. (1) The application exclusion zone is defined as follows:

              (i) The application exclusion zone is the area that extends 100 feet horizontally from the application equipment in all directions during application when the pesticide is applied by any of the following methods:
              (A) Aerially.
              (B) Air blast application.
              (C) As a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns).
              (D) As a fumigant, smoke, mist, or fog.
              (ii) The application exclusion zone is the area that extends 25 feet horizontally from the application equipment in all directions during application when the pesticide is applied not as in § 170.405(a)(1)(i)(A)-(D) and is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater).
              (iii) There is no application exclusion zone when the pesticide is applied in a manner other than those covered in paragraphs (a)(1)(i) and (a)(1)(ii) of this section.
              (2) During any outdoor production pesticide application, the agricultural employer must not allow or direct any worker or other person, other than an appropriately trained and equipped handler involved in the application, to enter or to remain in the treated area or an application exclusion zone that is within the boundaries of the establishment until the application is complete.
              (3) After the application is complete, the area subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407 is the treated area.
              (b) Enclosed space production pesticide applications. (1) During any enclosed space production pesticide application described in column A of the Table under paragraph (b)(4) of this section, the agricultural employer must not allow or direct any worker or other person, other than an appropriately trained and equipped handler involved in the application, to enter or to remain in the area specified in column B of the Table under paragraph (b)(4) of this section during the application and until the time specified in column C of the Table under paragraph (b)(4) of this section has expired.
              (2) After the time specified in column C of the Table under paragraph (b)(4) of this section has expired, the area subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407 is the area specified in column D of the Table under paragraph (b)(4) of this section.
              (3) When column C of the Table under paragraph (b)(4) of this section specifies that ventilation criteria must be met, ventilation must continue until the air concentration is measured to be equal to or less than the inhalation exposure level required by the labeling. If no inhalation exposure level is listed on the labeling, ventilation must continue until after one of the following conditions is met:
              (i) Ten air exchanges are completed.
              (ii) Two hours of ventilation using fans or other mechanical ventilating systems.
              (iii) Four hours of ventilation using vents, windows, or other passive ventilation.
              (iv) Eleven hours with no ventilation followed by one hour of mechanical ventilation.
              (v) Eleven hours with no ventilation followed by two hours of passive ventilation.
              (vi) Twenty-four hours with no ventilation.

              (4) The following Table applies to paragraphs (b)(1), (2), and (3) of this section.

                Table—Entry Restrictions During Enclosed Space Production Pesticide Applications

                  A. When a pesticide is applied:
                  B. Workers and other persons, other than appropriately trained and equipped handlers, areprohibited in:

                  C. Until:
                  D. After the expiration of time specified in column C, the area subject to the restricted-entryinterval is:

                  (1) As a fumigant
                  Entire enclosed space plus any adjacent structure or area that cannot be sealed off from the treated area
                  The ventilation criteria of paragraph (b)(3) of this section are met
                  No post-application entry restrictions required by § 170.407 after criteria in column C are met.

                  (2) As a(i) Smoke, or
                    (ii) Mist, or
                    (iii) Fog, or
                    (iv) As a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns)

                  Entire enclosed space
                  The ventilation criteria of paragraph (b)(3) of this section are met
                  Entire enclosed space.

                  (3) Not as in (1) or (2), and for which a respiratory protection device is required for application by the pesticide product labeling
                  Entire enclosed space
                  The ventilation criteria of paragraph (b)(3) of this section are met
                  Treated area.

                  (4) Not as in (1), (2) or (3), and:(i) From a height of greater than 12 inches from the planting medium, or
                    (ii) As a spray using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater)

                  Treated area plus 25 feet in all directions of the treated area, but not outside the enclosed space
                  Application is complete
                  Treated area.

                  (5) Otherwise
                  Treated area
                  Application is complete
                  Treated area.

              § 170.407
              Worker entry restrictions after pesticide applications.
              (a) After the application of any pesticide to an area of outdoor production, the agricultural employer must not allow or direct any worker to enter or to remain in the treated area before the restricted-entry interval specified on the pesticide product labeling has expired and all treated area warning signs have been removed or covered, except for early-entry activities permitted by § 170.603.
              (b) After the application of any pesticide to an area of enclosed space production, the agricultural employer must not allow or direct any worker to enter or to remain in the areas specified in column D of the Table in § 170.405(b)(4), before the restricted-entry interval specified on the pesticide product labeling has expired and all treated area warning signs have been removed or covered, except for early-entry activities permitted by § 170.603.
              (c) When two or more pesticides are applied to a treated area at the same time, the applicable restricted-entry interval is the longest of all applicable restricted-entry intervals.

              § 170.409
              Oral and posted notification of worker entry restrictions.
              (a) General Requirement. The agricultural employer must notify workers of all entry restrictions required by §§ 170.405 and 170.407 in accordance with this section.
              (1) Type of notification required—(i) Double notification. If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer must post signs in accordance with paragraph (b) of this section and must also provide oral notification of the application to workers in accordance with paragraph (c) of this section.
              (ii) Outdoor production areas subject to restricted-entry intervals greater than 48 hours. If a pesticide with product labeling that requires a restricted-entry interval greater than 48 hours is applied to an outdoor production area, the agricultural employer must notify workers of the application by posting warning signs in accordance with paragraph (b) of this section.
              (iii) Outdoor production areas subject to restricted-entry intervals equal to or less than 48 hours. If a pesticide with product labeling that requires a restricted-entry interval equal to or less than 48 hours is applied to an outdoor production area, the agricultural employer must notify workers of the application either by posting warning signs in accordance with paragraph (b) of this section or by providing workers with an oral warning in accordance with paragraph (c) of this section.
              (iv) Enclosed space production areas subject to restricted-entry intervals greater than four hours. If a pesticide with product labeling that requires a restricted-entry interval greater than four hours is applied to an enclosed space production area, the agricultural employer must notify workers of the application by posting warning signs in accordance with paragraph (b) of this section.
              (v) Enclosed space production areas subject to restricted-entry intervals equal to or less than four hours. If a pesticide with product labeling that requires a restricted-entry interval equal to or less than four hours is applied to an enclosed space production area, the agricultural employer must notify workers of the application either by posting warning signs in accordance with paragraph (b) of this section or by providing workers with an oral warning in accordance with paragraph (c) of this section.
              (2) Exceptions. Notification does not need to be given to a worker if the agricultural employer can ensure that one of the following is met:
              (i) From the start of the application in an enclosed space production area until the end of any restricted-entry interval, the worker will not enter any part of the entire enclosed structure or space.
              (ii) From the start of the application to an outdoor production area until the end of any restricted-entry interval, the worker will not enter, work in, remain in, or pass on foot through the treated area or any area within 1/4 mile of the treated area on the agricultural establishment.
              (iii) The worker was involved in the application of the pesticide as a handler, and is aware of all information required by paragraph (c)(1) of this section.
              (b) Requirements for posted warning signs. If notification by posted warning signs is required pursuant to paragraph (a) of this section, the agricultural employer must, unless otherwise prescribed by the label, ensure that all warning signs meet the requirements of this paragraph. When several contiguous areas are to be treated with pesticides on a rotating or sequential basis, the entire area may be posted. Worker entry is prohibited for the entire area while the signs are posted, except for entry permitted by § 170.603 of this part.
              (1) General. The warning signs must meet all of the following requirements:
              (i) Be one of the three sizes specified in paragraph (b)(3) of this section and comply with the posting placement and spacing requirements applicable to that sign size.
              (ii) Be posted prior to but no earlier than 24 hours before the scheduled application of the pesticide.
              (iii) Remain posted throughout the application and any restricted-entry interval.
              (iv) Be removed or covered within three days after the end of the application or any restricted-entry interval, whichever is later, except that signs may remain posted after the restricted-entry interval has expired as long as all of the following conditions are met:
              (A) The agricultural employer instructs any workers on the establishment that may come within 1/4 mile of the treated area not to enter that treated area while the signs are posted.
              (B) The agricultural employer ensures that workers do not enter the treated area while the signs remain posted, other than entry permitted by § 170.603 of this part.
              (v) Remain visible and legible during the time they are required to be posted.
              (2) Content. (i) The warning sign must have a white background. The words “DANGER” and “PELIGRO,” plus “PESTICIDES” and “PESTICIDAS,” must be at the top of the sign, and the words “KEEP OUT” and “NO ENTRE” must be at the bottom of the sign. Letters for all words must be clearly legible. A circle containing an upraised hand on the left and a stern face on the right must be near the center of the sign. The inside of the circle must be red, except that the hand and a large portion of the face must be in white. The length of the hand must be at least twice the height of the smallest letters. The length of the face must be only slightly smaller than the hand. Additional information such as the name of the pesticide and the date of application may appear on the warning sign if it does not detract from the size and appearance of the sign or change the meaning of the required information. An example of a warning sign meeting these requirements, other than the size and color requirements, follows:

                ER02NO15.000

              (ii) The agricultural employer may replace the Spanish language portion of the warning sign with equivalent terms in an alternative non-English language if that alternative language is the language read by the largest group of workers at that agricultural establishment who do not read English. The alternative language sign must be in the same format as the original sign and conform to all other requirements of paragraph (b)(2)(i) of this section.
              (3) Size and posting. (i) The standard sign must be at least 14 inches by 16 inches with letters at least one inch in height.

              (ii) When posting an outdoor production area using the standard sign, the signs must be visible from all reasonably expected points of worker entry to the treated area, including at least each access road, each border with any worker housing area within 100 feet of the treated area and each footpath and other walking route that enters the treated area. Where there are no reasonably expected points of worker entry, signs must be posted in the corners of the treated area or in any other location affording maximum visibility.
              (iii) When posting an enclosed space production area using the standard sign and the entire structure or space is subject to the labeling-specified restricted-entry interval and the post-application entry restrictions specified in § 170.407, the signs must be posted so they are visible from all reasonably expected points of worker entry to the structure or space. When posting treated areas in enclosed space production using the standard sign and the treated area only comprises a subsection of the structure or space, the signs must be posted so they are visible from all reasonably expected points of worker entry to the treated area including each aisle or other walking route that enters the treated area. Where there are no reasonably expected points of worker entry to the treated area, signs must be posted in the corners of the treated area or in any other location affording maximum visibility.
              (iv) If a smaller warning sign is used with “DANGER” and “PELIGRO” in letters at least 7/8 inch in height and the remaining letters at least 1/2 inch in height and a red circle at least three inches in diameter containing an upraised hand and a stern face, the signs must be posted no farther than 50 feet apart around the perimeter of the treated area in addition to the locations specified in paragraphs (b)(3)(ii) or (b)(3)(iii) of this section.
              (v) If a smaller sign is used with “DANGER” and “PELIGRO” in letters at least 7/16 inch in height and the remaining letters at least 1/4 inch in height and a red circle at least one and a half inches in diameter containing an upraised hand and a stern face, the signs must be posted no farther than 25 feet apart around the perimeter of the treated area in addition to the locations specified in paragraphs (b)(3)(ii) or (b)(3)(iii) of this section.
              (vi) A sign with “DANGER” and “PELIGRO” in letters less than 7/16 inch in height or with any words in letters less than 1/4 inch in height or a red circle smaller than one and a half inches in diameter containing an upraised hand and a stern face will not satisfy the requirements of the rule.
              (c) Oral warnings—Requirement. If oral notification is required pursuant to paragraph (a) of this section, the agricultural employer must provide oral warnings to workers in a manner that the workers can understand. If a worker will be on the establishment when an application begins, the warning must be given before the application begins. If a worker arrives on the establishment while an application is taking place or a restricted-entry interval for a pesticide application is in effect, the warning must be given at the beginning of the worker's work period. The warning must include all of the following:
              (1) The location(s) and description of any treated area(s) subject to the entry restrictions during and after application specified in §§ 170.405 and 170.407.
              (2) The dates and times during which entry is restricted in any treated area(s) subject to the entry restrictions during and after application specified in §§ 170.405 and 170.407.
              (3) Instructions not to enter the treated area or an application exclusion zone during application, and that entry to the treated area is not allowed until the restricted-entry interval has expired and all treated area warning signs have been removed or covered, except for entry permitted by § 170.603 of this part.

              § 170.411
              Decontamination supplies for workers.
              (a) Requirement. The agricultural employer must provide decontamination supplies for routine washing and emergency decontamination in accordance with this section for any worker on an agricultural establishment who is performing an activity in an area where a pesticide was applied and who contacts anything that has been treated with the pesticide, including, but not limited to, soil, water, and plants.
              (b) Materials and quantities. The decontamination supplies required in paragraph (a) of this section must include at least 1 gallon of water per worker at the beginning of each worker's work period for routine washing and emergency decontamination, soap, and single-use towels. The supplies must meet all of the following requirements:

              (1) Water. At all times when this part requires agricultural employers to make water available to workers, the agricultural employer must ensure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed. If a water source is used for mixing pesticides, it must not be used for decontamination, unless equipped with properly functioning valves or other mechanisms that prevent contamination of the water with pesticides, such as anti-backflow siphons, one-way or check valves, or an air gap sufficient to prevent contamination.
              (2) Soap and single-use towels. The agricultural employer must provide soap and single-use towels for drying in quantities sufficient to meet the workers' reasonable needs. Hand sanitizing gels and liquids or wet towelettes do not meet the requirement for soap. Wet towelettes do not meet the requirement for single-use towels.
              (c) Timing. (1) If any pesticide with a restricted-entry interval greater than four hours was applied, the decontamination supplies must be provided from the time workers first enter the treated area until at least 30 days after the restricted-entry interval expires.
              (2) If the only pesticides applied in the treated area are products with restricted-entry intervals of four hours or less, the decontamination supplies must be provided from the time workers first enter the treated area until at least seven days after the restricted-entry interval expires.
              (d) Location. The decontamination supplies must be located together outside any treated area or area subject to a restricted-entry interval, and must be reasonably accessible to the workers. The decontamination supplies must not be more than 1/4 mile from where workers are working, except that where workers are working more than 1/4 mile from the nearest place of vehicular access or more than 1/4 mile from any non-treated area, the decontamination supplies may be at the nearest place of vehicular access outside any treated area or area subject to a restricted-entry interval.

            Subpart F—Requirements for Protection of Agricultural Pesticide Handlers

              Source:
              80 FR 67567, Nov. 2, 2015, unless otherwise noted.

              § 170.501
              Training requirements for handlers.
              (a) General requirement. Before any handler performs any handler activity involving a pesticide product, the handler employer must ensure that the handler has been trained in accordance with this section within the last 12 months, except as provided in paragraph (b) of this section.
              (b) Exceptions. The following handlers need not be trained under this section:
              (1) A handler who is currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
              (2) A handler who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or the State or Tribal agency responsible for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the topics set out in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
              (c) Training programs. (1) Pesticide safety training must be presented to handlers either orally from written materials or audio-visually, at a location that is reasonably free from distraction and conducive to training. All training materials must be EPA-approved. The training must be presented in a manner that the handlers can understand, such as through a translator. The training must be conducted by a person who meets the handler trainer requirements of paragraph (c)(4) of this section, and who must be present during the entire training program and must respond to handlers' questions.
              (2) The pesticide safety training materials must include, at a minimum, all of the following topics:

              (i) Format and meaning of information contained on pesticide labels and in labeling, including safety information such as precautionary statements about human health hazards.

              (ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
              (iii) Routes by which pesticides can enter the body.
              (iv) Signs and symptoms of common types of pesticide poisoning.
              (v) Emergency first aid for pesticide injuries or poisonings.
              (vi) How to obtain emergency medical care.
              (vii) Routine and emergency decontamination procedures.
              (viii) Need for and appropriate use of personal protective equipment.
              (ix) Prevention, recognition, and first aid treatment of heat-related illness.
              (x) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
              (xi) Environmental concerns such as drift, runoff, and wildlife hazards.
              (xii) Warnings about taking pesticides or pesticide containers home.
              (xiii) Requirements of this subpart that must be followed by handler employers for the protection of handlers and other persons, including the prohibition against applying pesticides in a manner that will cause contact with workers or other persons, the requirement to use personal protective equipment, the provisions for training and decontamination, and the protection against retaliatory acts.

              (3) EPA intends to make available to the public training materials that may be used to conduct training conforming to the requirements of this section. Within 180 days after a notice of availability of such training materials appears in the Federal Register, but no earlier than January 1, 2018, training programs required under this section must include, at a minimum, all of the topics listed in § 170.501(c)(3)(i)-(xiv) instead of the points listed in § 170.501(c)(2)(i)-(xiii).
              (i) All the topics required by § 170.401(c)(3).
              (ii) Information on proper application and use of pesticides.
              (iii) Handlers must follow the portions of the labeling applicable to the safe use of the pesticide.
              (iv) Format and meaning of information contained on pesticide labels and in labeling applicable to the safe use of the pesticide.
              (v) Need for and appropriate use and removal of all personal protective equipment.
              (vi) How to recognize, prevent, and provide first aid treatment for heat-related illness.
              (vii) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
              (viii) Environmental concerns, such as drift, runoff, and wildlife hazards.
              (ix) Handlers must not apply pesticides in a manner that results in contact with workers or other persons.
              (x) The responsibility of handler employers to provide handlers with information and protections designed to reduce work-related pesticide exposures and illnesses. This includes providing, cleaning, maintaining, storing, and ensuring proper use of all required personal protective equipment; providing decontamination supplies; and providing specific information about pesticide use and labeling information.
              (xi) Handlers must suspend a pesticide application if workers or other persons are in the application exclusion zone.
              (xii) Handlers must be at least 18 years old.
              (xiii) The responsibility of handler employers to ensure handlers have received respirator fit-testing, training and medical evaluation if they are required to wear a respirator by the product labeling.
              (xiv) The responsibility of agricultural employers to post treated areas as required by this rule.
              (4) The person who conducts the training must have one of the following qualifications:
              (i) Be designated as a trainer of certified applicators or pesticide handlers by EPA or the State or Tribal agency responsible for pesticide enforcement.
              (ii) Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of handlers.
              (iii) Be currently certified as an applicator of restricted use pesticides under part 171 of this chapter.
              (d) Recordkeeping. (1) Handler employers must maintain records of training for handlers employed by their establishment for two years after the date of the training. The records must be maintained on the establishment and must include all of the following information:
              (i) The trained handler's printed name and signature.
              (ii) The date of the training.
              (iii) Information identifying which EPA-approved training materials were used.
              (iv) The trainer's name and documentation showing that the trainer met the requirements of § 170.501(c)(4) at the time of training.
              (v) The handler employer's name.
              (2) The handler employer must, upon request by a handler trained on the establishment, provide to the handler a copy of the record of the training that contains the information required under § 170.501(d)(1).

              § 170.503
              Knowledge of labeling, application-specific, and establishment-specific information for handlers.
              (a) Knowledge of labeling and application-specific information. (1) The handler employer must ensure that before any handler performs any handler activity involving a pesticide product, the handler either has read the portions of the labeling applicable to the safe use of the pesticide or has been informed in a manner the handler can understand of all labeling requirements and use directions applicable to the safe use of the pesticide.
              (2) The handler employer must ensure that the handler has access to the applicable product labeling at all times during handler activities.
              (3) The handler employer must ensure that the handler is aware of requirements for any entry restrictions, application exclusion zones and restricted-entry intervals as described in §§ 170.405 and 170.407 that may apply based on the handler's activity.
              (b) Knowledge of establishment-specific information. Before any handler performs any handler activity on an agricultural establishment where within the last 30 days a pesticide product has been used, or a restricted-entry interval for such pesticide has been in effect, the handler employer must ensure that the handler has been informed, in a manner the handler can understand, all of the following establishment-specific information:
              (1) The location of pesticide safety information required by § 170.311(a).
              (2) The location of pesticide application and hazard information required by § 170.311(b).
              (3) The location of decontamination supplies required by § 170.509.

              § 170.505
              Requirements during applications to protect handlers, workers, and other persons.
              (a) Prohibition from contacting workers and other persons with pesticides during application. The handler employer and the handler must ensure that no pesticide is applied so as to contact, directly or through drift, any worker or other person, other than an appropriately trained and equipped handler involved in the application.
              (b) Suspending applications. After January 1, 2018, the handler performing the application must immediately suspend a pesticide application if any worker or other person, other than an appropriately trained and equipped handler involved in the application, is in the application exclusion zone described in § 170.405(a)(1) or the area specified in column B of the Table in § 170.405(b)(4).
              (c) Handlers using highly toxic pesticides. The handler employer must ensure that any handler who is performing any handler activity with a pesticide product that has the skull-and-crossbones symbol on the front panel of the pesticide product label is monitored visually or by voice communication at least every two hours.
              (d) Fumigant applications in enclosed space production. The handler employer must ensure all of the following:
              (1) Any handler in an enclosed space production area during a fumigant application maintains continuous visual or voice contact with another handler stationed immediately outside of the enclosed space.
              (2) The handler stationed outside the enclosed space has immediate access to and uses the personal protective equipment required by the fumigant labeling for applicators in the event that entry becomes necessary for rescue.

              § 170.507
              Personal protective equipment.
              (a) Handler responsibilities. Any person who performs handler activities involving a pesticide product must use the clothing and personal protective equipment specified on the pesticide product labeling for use of the product, except as provided in § 170.607 of this part.
              (b) Employer responsibilities for providing personal protective equipment. The handler employer must provide to the handler the personal protective equipment required by the pesticide product labeling in accordance with this section. The handler employer must ensure that the personal protective equipment is clean and in proper operating condition. For the purposes of this section, long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, and socks are not considered personal protective equipment, although such work clothing must be worn if required by the pesticide product labeling.
              (1) If the pesticide product labeling requires that “chemical-resistant” personal protective equipment be worn, it must be made of material that allows no measurable movement of the pesticide being used through the material during use.
              (2) If the pesticide product labeling requires that “waterproof” personal protective equipment be worn, it must be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
              (3) If the pesticide product labeling requires that a “chemical-resistant suit” be worn, it must be a loose-fitting, one- or two-piece chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.
              (4) If the pesticide product labeling requires that “coveralls” be worn, they must be loose-fitting, one- or two-piece garments that cover, at a minimum, the entire body except head, hands, and feet.
              (5) Gloves must be the type specified on the pesticide product labeling.
              (i) Gloves made of leather, cotton, or other absorbent materials may not be worn while performing handler activities unless gloves made of these materials are listed as acceptable for such use on the pesticide product labeling.
              (ii) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings, made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.
              (iii) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners must not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
              (6) If the pesticide product labeling requires that “chemical-resistant footwear” be worn, one of the following types of footwear must be worn:
              (i) Chemical-resistant shoes.
              (ii) Chemical-resistant boots.
              (iii) Chemical-resistant shoe coverings worn over shoes or boots.
              (7) If the pesticide product labeling requires that “protective eyewear” be worn, one of the following types of eyewear must be worn:
              (i) Goggles.
              (ii) Face shield.
              (iii) Safety glasses with front, brow, and temple protection.
              (iv) Full-face respirator.
              (8) If the pesticide product labeling requires that a “chemical-resistant apron” be worn, a chemical-resistant apron that covers the front of the body from mid-chest to the knees must be worn.

              (9) If the pesticide product labeling requires that “chemical-resistant headgear” be worn, it must be either a chemical-resistant hood or a chemical-resistant hat with a wide brim.

              (10) The respirator specified by the pesticide product labeling must be used. Whenever a respirator is required by the pesticide product labeling, the handler employer must ensure that the requirements of paragraphs (b)(10)(i) through (iii) of this section are met before the handler performs any handler activity where the respirator is required to be worn. The handler employer must maintain for two years, on the establishment, records documenting the completion of the requirements of paragraphs (b)(10)(i) through (iii) of this section.
              (i) Handler employers must provide handlers with fit testing using the respirator specified on the pesticide product labeling in a manner that conforms to the provisions of 29 CFR 1910.134.
              (ii) Handler employers must provide handlers with training in the use of the respirator specified on the pesticide product labeling in a manner that conforms to the provisions of 29 CFR 1910.134(k)(1)(i) through(vi).
              (iii) Handler employers must provide handlers with a medical evaluation by a physician or other licensed health care professional that conforms to the provisions of 29 CFR 1910.134 to ensure the handler's physical ability to safely wear the respirator specified on the pesticide product labeling.
              (c) Use of personal protective equipment. (1) The handler employer must ensure that personal protective equipment is used correctly for its intended purpose and is used according to the manufacturer's instructions.
              (2) The handler employer must ensure that, before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
              (d) Cleaning and maintenance. (1) The handler employer must ensure that all personal protective equipment is cleaned according to the manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it must be washed thoroughly in detergent and hot water.
              (2) If any personal protective equipment cannot or will not be cleaned properly, the handler employer must ensure the contaminated personal protective equipment is made unusable as apparel or is made unavailable for further use by employees or third parties. The contaminated personal protective equipment must be disposed of in accordance with any applicable laws or regulations. Coveralls or other absorbent materials that have been drenched or heavily contaminated with a pesticide that has the signal word “DANGER” or “WARNING” on the label must not be reused and must be disposed of as specified in this paragraph. Handler employers must ensure that any person who handles contaminated personal protective equipment described in this paragraph wears the gloves specified on the pesticide product labeling for mixing and loading the product(s) comprising the contaminant(s) on the equipment. If two or more pesticides are included in the contaminants, the gloves worn must meet the requirements for mixing and loading all of the pesticide products.
              (3) The handler employer must ensure that contaminated personal protective equipment is kept separate from non-contaminated personal protective equipment, other clothing or laundry and washed separately from any other clothing or laundry.
              (4) The handler employer must ensure that all washed personal protective equipment is dried thoroughly before being stored or reused.
              (5) The handler employer must ensure that all clean personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
              (6) The handler employer must ensure that when filtering facepiece respirators are used, they are replaced when one of the following conditions is met:
              (i) When breathing resistance becomes excessive.
              (ii) When the filter element has physical damage or tears.
              (iii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
              (iv) In the absence of any other instructions or indications of service life, at the end of eight hours of cumulative use.

              (7) The handler employer must ensure that when gas- or vapor-removing respirators are used, the gas- or vapor-removing canisters or cartridges are replaced before further respirator use when one of the following conditions is met:
              (i) At the first indication of odor, taste, or irritation.
              (ii) When the maximum use time is reached as determined by a change schedule conforming to the provisions of 29 CFR 1910.134(d)(3)(iii)(B)(2).
              (iii) When breathing resistance becomes excessive.
              (iv) When required according to manufacturer's recommendations or pesticide product labeling instructions, whichever is more frequent.
              (v) In the absence of any other instructions or indications of service life, at the end of eight hours of cumulative use.
              (8) The handler employer must inform any person who cleans or launders personal protective equipment of all the following:
              (i) That such equipment may be contaminated with pesticides and there are potentially harmful effects from exposure to pesticides.
              (ii) The correct way(s) to clean personal protective equipment and how to protect themselves when handling such equipment.
              (iii) Proper decontamination procedures that should be followed after handling contaminated personal protective equipment.
              (9) The handler employer must ensure that handlers have a place(s) away from pesticide storage and pesticide use areas where they may do all of the following:
              (i) Store personal clothing not worn during handling activities.
              (ii) Put on personal protective equipment at the start of any exposure period.
              (iii) Remove personal protective equipment at the end of any exposure period.
              (10) The handler employer must not allow or direct any handler to wear home or to take home employer-provided personal protective equipment contaminated with pesticides.
              (e) Heat-related illness. Where a pesticide's labeling requires the use of personal protective equipment for a handler activity, the handler employer must take appropriate measures to prevent heat-related illness.

              § 170.509
              Decontamination and eye flushing supplies for handlers.
              (a) Requirement. The handler employer must provide decontamination and eye flushing supplies in accordance with this section for any handler that is performing any handler activity or removing personal protective equipment at the place for changing required by § 170.507(d)(9).
              (b) General conditions. The decontamination supplies required in paragraph (a) of this section must include: at least three gallons of water per handler at the beginning of each handler's work period for routine washing and potential emergency decontamination; soap; single-use towels; and clean clothing for use in an emergency. The decontamination and eye flushing supplies required in paragraph (a) of this section must meet all of the following requirements:
              (1) Water. At all times when this section requires handler employers to make water available to handlers for routine washing, emergency decontamination or eye flushing, the handler employer must ensure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed. If a water source is used for mixing pesticides, it must not be used for decontamination or eye flushing supplies, unless equipped with properly functioning valves or other mechanisms that prevent contamination of the water with pesticides, such as anti-backflow siphons, one-way or check valves, or an air gap sufficient to prevent contamination.
              (2) Soap and single-use towels. The handler employer must provide soap and single-use towels for drying in quantities sufficient to meet the handlers' needs. Hand sanitizing gels and liquids or wet towelettes do not meet the requirement for soap. Wet towelettes do not meet the requirement for single-use towels.
              (3) Clean change of clothing. The handler employer must provide one clean change of clothing, such as coveralls, for use in an emergency.

              (c) Location. The decontamination supplies must be located together outside any treated area or area subject to a restricted-entry interval, and must be reasonably accessible to each handler during the handler activity. The decontamination supplies must not be more than 1/4 mile from the handler, except that where the handler activity is more than 1/4 mile from the nearest place of vehicular access or more than 1/4 mile from any non-treated area, the decontamination supplies may be at the nearest place of vehicular access outside any treated area or area subject to a restricted-entry interval.
              (1) Mixing sites. Decontamination supplies must be provided at any mixing site.
              (2) Exception for pilots. Decontamination supplies for a pilot who is applying pesticides aerially must be in the aircraft or at the aircraft loading site.
              (3) Exception for treated areas. The decontamination supplies must be outside any treated area or area subject to a restricted-entry interval, unless the soap, single-use towels, water and clean change of clothing are protected from pesticide contamination in closed containers.
              (d) Emergency eye-flushing. (1) Whenever a handler is mixing or loading a pesticide product whose labeling requires protective eyewear for handlers, or is mixing or loading any pesticide using a closed system operating under pressure, the handler employer must provide at each mixing/loading site immediately available to the handler, at least one system that is capable of delivering gently running water at a rate of least 0.4 gallons per minute for at least 15 minutes, or at least six gallons of water in containers suitable for providing a gentle eye-flush for about 15 minutes.
              (2) Whenever a handler is applying a pesticide product whose labeling requires protective eyewear for handlers, the handler employer must provide at least one pint of water per handler in portable containers that are immediately available to each handler.

            Subpart G—Exemptions, Exceptions and Equivalency

              Source:
              80 FR 67570, Nov. 2, 2015, unless otherwise noted.

              § 170.601
              Exemptions.
              (a) Exemption for owners of agricultural establishments and their immediate families. (1) On any agricultural establishment where a majority of the establishment is owned by one or more members of the same immediate family, the owner(s) of the establishment are not required to provide the protections of the following provisions to themselves or members of their immediate family when they are performing handling activities or tasks related to the production of agricultural plants that would otherwise be covered by this part on their own agricultural establishment.
              (i) Section 170.309(c).
              (ii) Section 170.309(f) through (j).
              (iii) Section 170.311.
              (iv) Section 170.401.
              (v) Section 170.403.
              (vi) Section 170.409.
              (vii) Sections 170.411 and 170.509.
              (viii) Section 170.501.
              (ix) Section 170.503.
              (x) Section 170.505(c) and (d).
              (xi) Section 170.507(c) through (e).
              (xii) Section 170.605(a) through (c) and (e) through (j).
              (2) The owners of agricultural establishments must provide all of the applicable protections required by this part for any employees or other persons on the establishment that are not members of their immediate family.

                (b) Exemption for certified crop advisors. Certified crop advisors may make their own determination for the appropriate personal protective equipment for entry into a treated area during a restricted-entry interval and substitute their self-determined set of personal protective equipment for the labeling-required personal protective equipment, and the requirements of §§ 170.309(e), 170.309(f), 170.313(k), 170.503(a), 170.507 and 170.509 of this part do not apply to certified crop advisors provided the application is complete and all of the following conditions are met:

              (1) The crop advisor is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal agency responsible for pesticide enforcement.
              (2) The certification or licensing program requires pesticide safety training that includes all the information in § 170.501(c)(2) or § 170.501(c)(3) as applicable depending on the date of training.
              (3) The crop advisor who enters a treated area during a restricted-entry interval only performs crop advising tasks while in the treated area.

              § 170.603
              Exceptions for entry by workers during restricted-entry intervals.
              An agricultural employer may direct workers to enter treated areas where a restricted-entry interval is in effect to perform certain activities as provided in this section, provided that the agricultural employer ensures all of the applicable conditions of this section and § 170.605 of this part are met.
              (a) Exception for activities with no contact. A worker may enter a treated area during a restricted-entry interval if the agricultural employer ensures that all of the following conditions are met:
              (1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants. This exception does not allow workers to perform any activities that involve contact with treated surfaces even if workers are wearing personal protective equipment.
              (2) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
              (b) Exception for short-term activities. A worker may enter a treated area during a restricted-entry interval for short-term activities, if the agricultural employer ensures that all of the following requirements are met:
              (1) No hand labor activity is performed.
              (2) The time in treated areas where a restricted-entry interval is in effect does not exceed one hour in any 24-hour period for any worker.
              (3) No such entry is allowed during the first 4 hours after the application ends.
              (4) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
              (c) Exception for an agricultural emergency. (1) An agricultural emergency means a sudden occurrence or set of circumstances that the agricultural employer could not have anticipated and over which the agricultural employer has no control, that requires entry into a treated area during a restricted-entry interval, and when no alternative practices would prevent or mitigate a substantial economic loss. A substantial economic loss means a loss in profitability greater than that which would be expected based on the experience and fluctuations of crop yields in previous years. Only losses caused by the agricultural emergency specific to the affected site and geographic area are considered. Losses resulting from mismanagement cannot be included when determining whether a loss is substantial.
              (2) A worker may enter a treated area where a restricted-entry interval is in effect in an agricultural emergency to perform tasks necessary to mitigate the effects of the agricultural emergency, including hand labor tasks, if the agricultural employer ensures that all the following criteria are met:
              (i) The State department of agriculture, or the State or Tribal agency responsible for pesticide enforcement declares an agricultural emergency that applies to the treated area, or agricultural employer has determined that the circumstances within the treated area are the same as circumstances the State department of agriculture, or the State or Tribal agency responsible for pesticide enforcement has previously determined would constitute an agricultural emergency.

              (ii) The agricultural employer determines that the agricultural establishment is subject to the circumstances that result in an agricultural emergency meeting the criteria of paragraph (c)(1) of this section.
              (iii) If the labeling of any pesticide product applied to the treated area requires workers to be notified of the location of treated areas by both posting and oral notification, then the agricultural employer must ensure that no individual worker spends more than four hours out of any 24-hour period in treated areas where such a restricted-entry interval is in effect.
              (iv) No such entry is allowed during the first 4 hours after the application ends.
              (v) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
              (d) Exceptions for limited contact and irrigation activities. A worker may enter a treated area during a restricted-entry interval for limited contact or irrigation activities, if the agricultural employer ensures that all of the following requirements are met:
              (1) No hand labor activity is performed.
              (2) No worker is allowed in the treated area for more than eight hours in a 24-hour period.
              (3) No such entry is allowed during the first 4 hours after the application ends.
              (4) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
              (5) The task is one that, if not performed before the restricted-entry interval expires, would cause substantial economic loss, and there are no alternative tasks that would prevent substantial loss.
              (6) With the exception of irrigation tasks, the need for the task could not have been foreseen.
              (7) The worker has no contact with pesticide-treated surfaces other than minimal contact with feet, lower legs, hands, and forearms.
              (8) The labeling of the pesticide product that was applied does not require that workers be notified of the location of treated areas by both posting and oral notification.

              § 170.605
              Agricultural employer responsibilities to protect workers entering treated areas during a restricted-entry interval.
              If an agricultural employer directs a worker to perform activities in a treated area where a restricted-entry interval is in effect, all of the following requirements must be met:
              (a) The agricultural employer must ensure that the worker is at least 18 years old.
              (b) Prior to early entry, the agricultural employer must provide to each early-entry worker the information described in paragraphs (b)(1) through (8) of this section. The information must be provided orally in a manner that the worker can understand.
              (1) Location of early-entry area where work activities are to be performed.
              (2) Pesticide(s) applied.
              (3) Dates and times that the restricted-entry interval begins and ends.
              (4) Which exception in § 170.603 is the basis for the early entry, and a description of tasks that may be performed under the exception.
              (5) Whether contact with treated surfaces is permitted under the exception.
              (6) Amount of time the worker is allowed to remain in the treated area.
              (7) Personal protective equipment required by the pesticide product labeling for early entry.
              (8) Location of the pesticide safety information required by § 170.311(a) and the location of the decontamination supplies required by § 170.605(h).
              (c) Prior to early entry, the agricultural employer must ensure that each worker either has read the applicable pesticide product labeling or has been informed, in a manner that the worker can understand, of all labeling requirements and statements related to human hazards or precautions, first aid, and user safety.

              (d) The agricultural employer must ensure that each worker who enters a treated area during a restricted-entry interval is provided the personal protective equipment specified in the pesticide product labeling for early entry. The agricultural employer must ensure that the worker uses the personal protective equipment as intended according to manufacturer's instructions and follows any other applicable requirements on the pesticide product labeling. Personal protective equipment must conform to the standards in § 170.507(b)(1) through (9).
              (e) The agricultural employer must maintain the personal protective equipment in accordance with § 170.507(c) and (d).
              (f) The agricultural employer must ensure that no worker is allowed or directed to wear personal protective equipment without implementing measures sufficient to prevent heat-related illness and that each worker is instructed in the prevention, recognition, and first aid treatment of heat-related illness.
              (g) The agricultural employer must instruct each worker on the proper use and removal of the personal protective equipment, and as appropriate, on its cleaning, maintenance and disposal. The agricultural employer must not allow or direct any worker to wear home or to take home employer-provided personal protective equipment contaminated with pesticides.
              (h) During any early-entry activity, the agricultural employer must provide decontamination supplies in accordance with § 170.509, except the decontamination supplies must be outside any area being treated with pesticides or subject to a restricted-entry interval, unless the decontamination supplies would otherwise not be reasonably accessible to workers performing early-entry tasks.
              (i) If the pesticide product labeling of the product applied requires protective eyewear, the agricultural employer must provide at least one pint of water per worker in portable containers for eyeflushing that is immediately available to each worker who is performing early-entry activities.
              (j) At the end of any early-entry activities the agricultural employer must provide, at the site where the workers remove personal protective equipment, soap, single-use towels and at least three gallons of water per worker so that the workers may wash thoroughly.

              § 170.607
              Exceptions to personal protective equipment requirements specified on pesticide product labeling.
              (a) Body protection. (1) A chemical-resistant suit may be substituted for coveralls. If a chemical-resistant suit is substituted for coveralls, any labeling requirement for an additional layer of clothing beneath the coveralls is waived.
              (2) A chemical-resistant suit may be substituted for coveralls and a chemical-resistant apron.
              (b) Boots. If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable, then leather boots may be worn in such terrain.
              (c) Gloves. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, then during activities with plants with sharp thorns, leather gloves may be worn over chemical-resistant glove liners. However, once leather gloves are worn for this use, thereafter they must be worn only with chemical-resistant liners and they must not be worn for any other use.
              (d) Closed systems.(1) When pesticides are being mixed or loaded using a closed system that meets all of the requirements in paragraph (d)(2) of this section, and the handler employer meets the requirements of paragraph (d)(3) of this section, the following exceptions to labeling-specified personal protective equipment are permitted:
              (i) Handlers using a closed system to mix or load pesticides with a signal word of “DANGER” or “WARNING” may substitute a long-sleeved shirt, long pants, shoes and socks, chemical-resistant apron, protective eyewear, and any protective gloves specified on the labeling for handlers for the labeling-specified personal protective equipment.

              (ii) Handlers using a closed system to mix or load pesticides other than those specified in paragraph (d)(1)(i) of this section may substitute protective eyewear, long-sleeved shirt, long pants, and shoes and socks for the labeling-specified personal protective equipment.

              (2) The exceptions of paragraph (d)(1) of this section apply only in the following situations:
              (i) Where the closed system removes the pesticide from its original container and transfers the pesticide product through connecting hoses, pipes and couplings that are sufficiently tight to prevent exposure of handlers to the pesticide product, except for the negligible escape associated with normal operation of the system.
              (ii) When loading intact, sealed, water soluble packaging into a mixing tank or system. If the integrity of a water soluble packaging is compromised (for example, if the packaging is dissolved, broken, punctured, torn, or in any way allows its contents to escape), it is no longer a closed system and the labeling-specified personal protective equipment must be worn.
              (3) The exceptions of paragraph (d)(1) of this section apply only where the handler employer has satisfied the requirements of § 170.313 and all of the following conditions:
              (i) Each closed system must have written operating instructions that are clearly legible and include: Operating procedures for use, including the safe removal of a probe; maintenance, cleaning and repair; known restrictions or limitations relating to the system, such as incompatible pesticides, sizes (or types) of containers or closures that cannot be handled by the system; any limits on the ability to measure a pesticide; and special procedures or limitations regarding partially-filled containers.
              (ii) The written operating instructions for the closed system must be available at the mixing or loading site and must be made available to any handlers who use the system.
              (iii) Any handler operating the closed system must be trained in its use and operate the closed system in accordance with its written operating instructions.
              (iv) The closed system must be cleaned and maintained as specified in the written operating instructions and as needed to make sure the system functions properly.
              (v) All personal protective equipment specified in the pesticide product labeling is immediately available to the handler for use in an emergency.
              (vi) Protective eyewear must be worn when using closed systems operating under pressure.
              (e) Enclosed cabs. (1) If a handler applies a pesticide from inside a vehicle's enclosed cab, and if the conditions listed in paragraph (e)(2) of this section are met, exceptions to the personal protective equipment requirements specified on the product labeling for applicators are permitted as provided in paragraph (e)(3) of this section.
              (2) All of the personal protective equipment required by the pesticide product labeling for applicators must be immediately available and stored in a sealed container to prevent contamination. Handlers must wear the applicator personal protective equipment required by the pesticide product labeling if they exit the cab within a treated area during application or when a restricted-entry interval is in effect. Once personal protective equipment is worn in a treated area, it must be removed before reentering the cab to prevent contamination of the cab.
              (3) Handlers may substitute a long-sleeved shirt, long pants, shoes and socks for the labeling-specified personal protective equipment for skin and eye protection. If a filtering facepiece respirator (NIOSH approval number prefix TC-84A) or dust/mist filtering respirator is required by the pesticide product labeling for applicators, then that respirator need not be worn inside the enclosed cab if the enclosed cab has a properly functioning air ventilation system which is used and maintained in accordance with the manufacture's written operating instructions. If any other type of respirator is required by the pesticide labeling for applicators, then that respirator must be worn.
              (f) Aerial applications—(1) Use of gloves. The wearing of chemical-resistant gloves when entering or leaving an aircraft used to apply pesticides is optional, unless such gloves are required on the pesticide product labeling. If gloves are brought into the cockpit of an aircraft that has been used to apply pesticides, the gloves shall be kept in an enclosed container to prevent contamination of the inside of the cockpit.

              (2) Open cockpit. Handlers applying pesticides from an open cockpit aircraft must use the personal protective equipment specified in the pesticide product labeling for use during application, except that chemical-resistant footwear need not be worn. A helmet may be substituted for chemical-resistant headgear. A helmet with a face shield lowered to cover the face may be substituted for protective eyewear.
              (3) Enclosed cockpit. Persons occupying an enclosed cockpit may substitute a long-sleeved shirt, long pants, shoes, and socks for labeling-specified personal protective equipment.
              (g) Crop advisors. (1) Provided the conditions of paragraphs (g)(2) through (g)(4) of this section are met, crop advisors and their employees entering treated areas to perform crop advising tasks while a restricted-entry interval is in effect may substitute either of the following sets of personal protective equipment for the personal protective equipment specified on the pesticide labeling for handler activities:
              (i) The personal protective equipment specified on the pesticide product labeling for early entry.
              (ii) Coveralls, shoes plus socks and chemical-resistant gloves made of any waterproof material, and eye protection if the pesticide product labeling applied requires protective eyewear for handlers.
              (2) The application has been complete for at least four hours.
              (3) No such entry is allowed until any inhalation exposure level listed in the pesticide product labeling has been reached or any ventilation criteria required by § 170.405(b)(3) or the pesticide product labeling have been met.
              (4) The crop advisor or crop advisor employee who enters a treated area during a restricted-entry interval only performs crop advising tasks while in the treated area.

              § 170.609
              Equivalency requests.
              (a) States and Tribes that have promulgated worker protection regulations to protect agricultural workers and pesticide handlers from occupational pesticide exposure effective prior to January 1, 2016, have the option of requesting authority to continue implementing any provision(s) of the State's or Tribe's existing regulations that provides equivalent or greater protection in lieu of implementing any similar provision(s) in this part.

              (b) States or Tribes must submit requests for the authority to continue implementing State or Tribal regulation provision(s) in lieu of any similar provision(s) in this part by June 29, 2016. The request must be in the form of a letter from the State or Tribe to EPA that includes all of the following:
              (1) Identification of the provision(s) of this part for which the State or Tribe is requesting regulatory equivalency.
              (2) Appropriate documentation establishing that the pertinent State or Tribal worker protection provision(s) provides environmental and human health protection that meets or exceeds the protections provided by the identified provision(s) in this part.
              (3) Identification of any additional modifications to existing State or Tribal regulations that would be necessary in order to provide environmental and human health protection that meets or exceeds the similar provisions of this part, and an estimated timetable for the State or Tribe to effect these changes.
              (4) The expected economic impact of requiring compliance with the requirement(s) of this part in comparison with compliance with the State or Tribal requirement(s), and an explanation of why it is important that employers subject to the State or Tribal authority comply with the State or Tribal requirement(s) in lieu of similar provision(s) in this part.
              (5) The signature of the designated representative of the State or Tribal agency responsible for pesticide enforcement.
              (c) EPA's Office of Pesticide Programs will review the State's or Tribe's letter and supporting materials and determine whether the State or Tribal provision(s) provide environmental and human health protection that meets or exceeds the comparable provision(s) of this part.

              (d) EPA's Office of Pesticide Programs will inform the State or Tribe of its determination through a letter. The letter will either:

              (1) Authorize the State or Tribe to continue implementing its worker protection regulatory provision(s) in lieu of the comparable provision(s) of this part; or
              (2) Deny the State or Tribe authorization to continue implementing its worker protection regulatory provision(s) in lieu of the comparable provision(s) of this part and detail any reasons for declining authorization.
              (e) Subsequent revisions. Any State or Tribe that has received authorization from EPA through the process outlined in this section to continue implementing its State or Tribal worker protection regulatory provision(s) must inform EPA by letter within six months of any revision to the State or Tribal worker protection laws or regulations. The letter must contain the same information outlined in paragraph (b) of this section. The State or Tribe may continue implementing provisions of its worker protection regulations identified under paragraph (b) of this section unless and until EPA informs the State or Tribe through a letter that EPA has determined that the State's or Tribe's worker protection regulations no longer provide environmental and human health protection that meets or exceeds the comparable provision(s) of this part based on the revisions.

          Pt. 171
          PART 171—CERTIFICATION OF PESTICIDE APPLICATORS

              Subpart A—General Provisions
              Sec.
              171.1
              Scope.
              171.3
              Definitions.
              171.5
              Effective date.

              Subpart B—Certification Requirements for Applicators of Restricted Use Pesticides
              171.101
              Commercial applicator certification categories.
              171.103
              Standards for certification of commercial applicators.
              171.105
              Standards for certification of private applicators.
              171.107
              Standards for recertification of certified applicators.

              Subpart C—Supervision of Noncertified Applicators
              171.201
              Requirements for direct supervision of noncertified applicators by certified applicators.

              Subpart D—Certification Plans
              171.301
              General.
              171.303
              Requirements for State certification plans.
              171.305
              Requirements for Federal agency certification plans.
              171.307
              Certification of applicators in Indian country.
              171.309
              Modification and withdrawal of approval of certification plans.
              171.311
              EPA-administered applicator certification programs.

            Authority:
            7 U.S.C. 136i and 136w.

            Source:
            39 FR 36449, Oct. 9, 1974, unless otherwise noted.

            Subpart A—General Provisions

              § 171.1
              Scope.
              (a) This part establishes Federal standards for the certification and recertification of applicators of restricted use pesticides, and requirements for pesticide applicator certification plans administered by State, Tribal, and Federal agencies. The standards address the requirements for certification and recertification of applicators using restricted use pesticides, requirements for certified applicators supervising the use of restricted use pesticides by noncertified applicators, and requirements for noncertified persons using restricted use pesticides under the direct supervision of a certified applicator.

              (b) A person is a certified applicator for purposes of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., only if the person holds a certification issued pursuant to a plan approved in accordance with this part and currently valid in the pertinent jurisdiction. As provided in FIFRA section 12(a)(2)(F), it is unlawful for any person to make available for use or to use any pesticide classified for restricted use other than in accordance with the requirements of this part.
              [82 FR 1028, Jan. 4, 2017]

              § 171.3
              Definitions.

              Terms used in this part have the same meanings they have in FIFRA and 40 CFR part 152. In addition, the following terms have the meaning specified in this section when used in this part:

                Agricultural commodity means any plant, fungus, or algae, or part thereof, or any animal or animal product, produced by a person (including, but not limited to, farmers, ranchers, vineyardists, plant propagators, Christmas tree growers, aquaculturists, floriculturists, orchardists, foresters, or other comparable persons) primarily for sale, consumption, propagation, or other use by man or animals.

                Agency means the U.S. Environmental Protection Agency (EPA), unless otherwise specified.

                Application and applying means the dispersal of a pesticide on, in, at, or directed toward a target site.

                Applicator means any individual using a restricted use pesticide. An applicator may be certified as a commercial or private applicator as defined in FIFRA or may be a noncertified applicator as defined in this part.

                Calibration means measurement of dispersal or output of application equipment and adjustment of such equipment to establish a specific rate of dispersal and, if applicable, droplet or particle size of a pesticide, and/or equalized dispersal pattern.

                Certification means a certifying authority's issuance, pursuant to this part, of authorization to a person to use or supervise the use of restricted use pesticides.

                Certifying authority means the Agency, or a State, Tribal, or Federal agency that issues restricted use pesticide applicator certifications pursuant to a certification plan approved by the Agency under this part.

                Compatibility means the extent to which a pesticide can be combined with other chemicals without causing undesirable results.

                Competency means having the practical knowledge, skills, experience, and judgment necessary to perform functions associated with restricted use pesticide application without causing unreasonable adverse effects, where the nature and degree of competency required relate directly to the nature of the activity and the degree of independent responsibility.

                Dealership means any establishment owned or operated by a restricted use pesticide retail dealer where restricted use pesticides are distributed or sold.

                Fumigant means a restricted use pesticide that bears labeling designating it as a fumigant.

                Fumigation means the use of a fumigant.

                Immediate family means familial relationships limited to the spouse, parents, stepparents, foster parents, father-in-law, mother-in-law, children, stepchildren, foster children, sons-in-law, daughters-in-law, grandparents, grandchildren, brothers, sisters, brothers-in-law, sisters-in-law, aunts, uncles, nieces, nephews, and first cousins. “First cousin” means the child of a parent's sibling, i.e., the child of an aunt or uncle.

                Indian country means:
              (1) All land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and, including rights-of-way running through the reservation.
              (2) All dependent Indian communities within the borders of the United States whether within the original or subsequently acquired territory thereof, and whether within or without the limits of a State.
              (3) All Indian allotments, the Indian titles to which have not been extinguished, including rights-of-way running through the same.

                Indian Tribe or Tribe means any Indian or Alaska Native Tribe, band, nation, pueblo, village, or community included in the list of Tribes published by the Secretary of the Interior pursuant to the Federally Recognized Indian Tribe List Act.

                Mishap means an event that adversely affects man or the environment and that is related to the use or presence of a pesticide, whether the event was unexpected or intentional.

                Nontarget organism means any plant, animal or other organism other than the target pests that a pesticide is intended to affect.

                Noncertified applicator means any person who is not certified in accordance with this part to use or supervise the use of restricted use pesticides in the category appropriate to the type of application being conducted in the pertinent jurisdiction, but who is using restricted use pesticides under the direct supervision of a person certified as a commercial or private applicator in accordance with this part.

                Ornamental means trees, shrubs, flowers, and other plantings intended primarily for aesthetic purposes in and around habitations, buildings and surrounding grounds, including residences, parks, streets, and commercial, industrial, and institutional buildings.

                Personal protective equipment means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respirators, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.

                Practical knowledge means the possession of pertinent facts and comprehension sufficient to properly perform functions associated with use of restricted use pesticides, including properly responding to reasonably foreseeable problems and situations.

                Principal place of business means the principal location, either residence or office, where a person conducts a business that involves the use of restricted use pesticides. A person who applies restricted use pesticides in more than one State or area of Indian country may designate a location within a State or area of Indian country as its principal place of business for that State or area of Indian country.

                Regulated pest means a particular species of pest specifically subject to Tribal, State or Federal regulatory restrictions, regulations, or control procedures intended to protect the hosts, man and/or the environment.

                Restricted use pesticide means a pesticide that is classified for restricted use under the provisions of section 3(d) of FIFRA and 40 CFR part 152, subpart I.

                Restricted use pesticide retail dealer means any person who distributes or sells restricted use pesticides to any person, excluding transactions solely between persons who are pesticide producers, registrants, wholesalers, or retail sellers, acting only in those capacities.

                Toxicity means the property of a pesticide that refers to the degree to which the pesticide, and its degradates and metabolites, are able to cause an adverse physiological effect on an organism.

                Use, as in “to use a pesticide” means any of the following:
              (1) Pre-application activities involving mixing and loading the pesticide.
              (2) Applying the pesticide, including, but not limited to, supervising the use of a pesticide by a noncertified applicator.
              (3) Other pesticide-related activities, including, but not limited to, transporting or storing pesticide containers that have been opened, cleaning equipment, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.

                Use-specific instructions means the information and requirements specific to a particular pesticide product or work site that an applicator needs in order to use the pesticide in accordance with applicable requirements and without causing unreasonable adverse effects.
              [82 FR 1028, Jan. 4, 2017]

              § 171.5
              Effective date.
              (a) This part is effective March 6, 2017. Certification plans approved by EPA before the effective date remain approved except as provided in §§ 171.5(b)-(d) and 171.309.
              (b) Status of certification plans approved before effective date. A certification plan approved by EPA before March 6, 2017 remains approved until March 4, 2020, except as provided in paragraph (c) of this section and § 171.309.
              (c) Extension of an existing plan during EPA review of proposed revisions. If by March 4, 2020, a certifying authority has submitted to EPA a proposed modification of its certification plan pursuant to subpart D of this part, its certification plan approved by EPA before March 6, 2017 will remain in effect until EPA has approved or rejected the modified plan pursuant to § 171.309(a)(4) or March 4, 2022, whichever is earlier, except as provided in paragraph (d) of this section and § 171.309(b).
              (d) Extension of an existing plan after EPA has approved a revised plan. Where EPA has approved a certifying authority's modified certification plan pursuant to § 171.309(a)(4), the certification plan approved by EPA before March 6, 2017 shall remain in effect as specified in EPA's approval of the modified certification plan.
              (e) States, Tribes, or Federal agencies that do not have an EPA-approved certification plan in effect may submit to EPA for review and approval a certification plan that meets or exceeds all of the applicable requirements of this part any time.
              [82 FR 1029, Jan. 4, 2017]

            Subpart B—Certification Requirements for Applicators of Restricted Use Pesticides

              Source:
              82 FR 1029, Jan. 4, 2017, unless otherwise noted.

              § 171.101
              Commercial applicator certification categories.

                Certification categories. Categories of commercial applicators using or supervising the use of restricted use pesticides are identified below.
              (a) Agricultural pest control—(1) Crop pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides in production of agricultural commodities, including but not limited to grains, vegetables, small fruits, tree fruits, peanuts, tree nuts, tobacco, cotton, feed and forage crops including grasslands, and non-crop agricultural lands.
              (2) Livestock pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides on animals or to places on or in which animals are confined. Certification in this category alone is not sufficient to authorize the purchase, use, or supervision of use of products for predator control listed in paragraphs (k) and (l) of this section.
              (b) Forest pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides in forests, forest nurseries and forest seed production.
              (c) Ornamental and turf pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides to control pests in the maintenance and production of ornamental plants and turf.
              (d) Seed treatment. This category applies to commercial applicators using or supervising the use of restricted use pesticides on seeds in seed treatment facilities.
              (e) Aquatic pest control. This category applies to commercial applicators who use or supervise the use of any restricted use pesticide purposefully applied to standing or running water, excluding applicators engaged in public health related activities included in as specified in paragraph (h) of this section.
              (f) Right-of-way pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides in the maintenance of roadsides, powerlines, pipelines, and railway rights-of-way, and similar areas.
              (g) Industrial, institutional, and structural pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides in, on, or around the following: Food handling establishments, packing houses, and food-processing facilities; human dwellings; institutions, such as schools, hospitals and prisons; and industrial establishments, including manufacturing facilities, warehouses, grain elevators, and any other structures and adjacent areas, public or private, for the protection of stored, processed, or manufactured products.
              (h) Public health pest control. This category applies to State, Tribal, Federal or other governmental employees and contractors who use or supervise the use of restricted use pesticides in government-sponsored public health programs for the management and control of pests having medical and public health importance.
              (i) Regulatory pest control. This category applies to State, Tribal, Federal, or other local governmental employees and contractors who use or supervise the use of restricted use pesticides in government-sponsored programs for the control of regulated pests. Certification in this category does not authorize the purchase, use, or supervision of use of products for predator control listed in paragraphs (k) and (l) of this section.
              (j) Demonstration and research. This category applies to individuals who demonstrate to the public the proper use and techniques of application of restricted use pesticides or supervise such demonstration and to persons conducting field research with restricted use pesticides, and in doing so, use or supervise the use of restricted use pesticides. This includes such individuals as extension specialists and county agents, commercial representatives demonstrating restricted use pesticide products, individuals demonstrating application or pest control methods used in public or private programs, and State, Federal, commercial, and other persons conducting field research on or involving restricted use pesticides.
              (k) Sodium cyanide predator control. This pest control category applies to commercial applicators who use or supervise the use of sodium cyanide in a mechanical ejection device to control regulated predators.
              (l) Sodium fluoroacetate predator control. This pest control category applies to commercial applicators who use or supervise the use of sodium fluoroacetate in a protective collar to control regulated predators.
              (m) Soil fumigation. This category applies to commercial applicators who use or supervise the use of a restricted use pesticide to fumigate soil.
              (n) Non-soil fumigation. This category applies to commercial applicators who use or supervise the use of a restricted use pesticide to fumigate anything other than soil.
              (o) Aerial pest control. This category applies to commercial applicators who use or supervise the use of restricted use pesticides applied by fixed or rotary wing aircraft.

              § 171.103
              Standards for certification of commercial applicators.
              (a) Determination of competency. To be determined to have the necessary competency in the use and handling of restricted use pesticides by a State, Tribe, or Federal agency, a commercial applicator must receive a passing score on a written examination that meets the standards specified in paragraph (a)(2) of this section and any related performance testing that is required by the State, Tribe, or Federal agency. Examinations and any alternate methods employed by the certifying authority to determine applicator competency must include the core standards applicable to all categories (paragraph (c) of this section) and the standards applicable to each category in which an applicator seeks certification (paragraph (d) of this section). Certification processes must meet all of the following criteria:
              (1) Commercial applicator minimum age. A commercial applicator must be at least 18 years old.
              (2) Examination standards. The certifying authority must ensure that examinations conform to all of the following standards:
              (i) The examination must be presented and answered in writing.
              (ii) The examination must be proctored by an individual designated by the certifying authority and who is not seeking certification at any examination session that he or she is proctoring.
              (iii) Each person seeking certification must present at the time of examination valid, government-issued photo identification or other form of similarly reliable identification authorized by the certifying authority as proof of identity and age to be eligible for certification.
              (iv) Candidates must be monitored throughout the examination period.
              (v) Candidates must be instructed in examination procedures before beginning the examination.
              (vi) Examinations must be kept secure before, during, and after the examination period so that only the candidates have access to the examination, and candidates have access only in the presence of the proctor.
              (vii) Candidates must not have verbal or non-verbal communication with anyone other than the proctor during the examination period.

              (viii) No portion of the examination or any associated reference materials described in paragraph (a)(2)(ix) of this section may be copied or retained by any person other than a person authorized by the certifying authority to copy or retain the examination or any associated reference materials described in paragraph (a)(2)(ix) of this section.
              (ix) The only reference materials used during the examination are those that are approved by the certifying authority and provided and collected by the proctor.
              (x) Reference materials provided to examinees are reviewed after the examination is complete to ensure that no portion of the reference material has been removed, altered, or destroyed.
              (xi) The proctor reports to the certifying authority any examination administration inconsistencies or irregularities, including but not limited to cheating, use of unauthorized materials, and attempts to copy or retain the examination.
              (xii) The examination must be conducted in accordance with any other requirements of the certifying authority related to examination administration.
              (xiii) The certifying authority must notify each candidate of the results of his or her examination.
              (b) Additional methods of determining competency. In addition to written examination requirements for determining competency, a certifying authority may employ additional methods for determining applicator competency, such as performance testing. Any such additional methods must be specified in the certifying authority's Agency-approved certification plan and must comply with the applicable standards in paragraph (a) of this section.
              (c) Core standards for all categories of certified commercial applicators. Persons seeking certification as commercial applicators must demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticides by passing a written examination. Written examinations for all commercial applicators must address all of the following areas of competency:
              (1) Label and labeling comprehension. Familiarity with pesticide labels and labeling and their functions, including all of the following:
              (i) The general format and terminology of pesticide labels and labeling.
              (ii) Understanding instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels and labeling.
              (iii) Understanding that it is a violation of Federal law to use any registered pesticide in a manner inconsistent with its labeling.
              (iv) Understanding labeling requirements that a certified applicator must be physically present at the site of the application.
              (v) Understanding labeling requirements for supervising noncertified applicators working under the direct supervision of a certified applicator.
              (vi) Understanding that applicators must comply with all use restrictions and directions for use contained in pesticide labels and labeling, including being certified in the certification category appropriate to the type and site of the application.
              (vii) Understanding the meaning of product classification as either general or restricted use and that a product may be unclassified.
              (viii) Understanding and complying with product-specific notification requirements.
              (ix) Recognizing and understanding the difference between mandatory and advisory labeling language.
              (2) Safety. Measures to avoid or minimize adverse health effects, including all of the following:
              (i) Understanding the different natures of the risks of acute toxicity and chronic toxicity, as well as the long-term effects of pesticides.
              (ii) Understanding that a pesticide's risk is a function of exposure and the pesticide's toxicity.
              (iii) Recognition of likely ways in which dermal, inhalation, and oral exposure may occur.
              (iv) Common types and causes of pesticide mishaps.
              (v) Precautions to prevent injury to applicators and other individuals in or near treated areas.

              (vi) Need for, and proper use of, protective clothing and personal protective equipment.

              (vii) Symptoms of pesticide poisoning.
              (viii) First aid and other procedures to be followed in case of a pesticide mishap.
              (ix) Proper identification, storage, transport, handling, mixing procedures, and disposal methods for pesticides and used pesticide containers, including precautions to be taken to prevent children from having access to pesticides and pesticide containers.
              (3) Environment. The potential environmental consequences of the use and misuse of pesticides, including the influence of all of the following:
              (i) Weather and other indoor and outdoor climatic conditions.
              (ii) Types of terrain, soil, or other substrate.
              (iii) Presence of fish, wildlife, and other non-target organisms.
              (iv) Drainage patterns.
              (4) Pests. The proper identification and effective control of pests, including all of the following:
              (i) The importance of correctly identifying target pests and selecting the proper pesticide product(s) for effective pest control.
              (ii) Verifying that the labeling does not prohibit the use of the product to control the target pest(s).
              (5) Pesticides. Characteristics of pesticides, including all of the following:
              (i) Types of pesticides.
              (ii) Types of formulations.
              (iii) Compatibility, synergism, persistence, and animal and plant toxicity of the formulations.
              (iv) Hazards and residues associated with use.
              (v) Factors that influence effectiveness or lead to problems such as pesticide resistance.
              (vi) Dilution procedures.
              (6) Equipment. Application equipment, including all of the following:
              (i) Types of equipment and advantages and limitations of each type.
              (ii) Use, maintenance, and calibration procedures.
              (7) Application methods. Selecting appropriate application methods, including all of the following:
              (i) Methods used to apply various forms and formulations of pesticides.
              (ii) Knowledge of which application method to use in a given situation and that use of a fumigant, aerial application, sodium cyanide, or sodium fluoroacetate requires additional certification.
              (iii) How selection of application method and use of a pesticide may result in proper use, unnecessary or ineffective use, and misuse.
              (iv) Prevention of drift and pesticide loss into the environment.
              (8) Laws and regulations. Knowledge of all applicable State, Tribal, and Federal laws and regulations.
              (9) Responsibilities of supervisors of noncertified applicators. Knowledge of the responsibilities of certified applicators supervising noncertified applicators, including all of the following:
              (i) Understanding and complying with requirements in § 171.201 of this part for certified commercial applicators who supervise noncertified applicators using restricted use pesticides.
              (ii) The recordkeeping requirements of pesticide safety training for noncertified applicators who use restricted use pesticides under the direct supervision of a certified applicator.
              (iii) Providing use-specific instructions to noncertified applicators using restricted use pesticides under the direct supervision of a certified applicator.
              (iv) Explaining pertinent State, Tribal, and Federal laws and regulations to noncertified applicators who use restricted use pesticides under the direct supervision of a certified applicator.
              (10) Professionalism. Understanding the importance of all of the following:
              (i) Maintaining chemical security for restricted use pesticides.
              (ii) How to communicate information about pesticide exposures and risks with customers and the public.
              (iii) Appropriate product stewardship for certified applicators.
              (d) Specific standards of competency for each category of commercial applicators. In addition to satisfying the requirements of paragraph (c) of this section, to be certified as commercial applicators, persons must demonstrate through written examinations practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticides for each category for which they intend to apply restricted use pesticides, except as provided at §§ 171.303(a)(4) and 171.305(a)(5). The minimum competency standards for each category are listed in paragraphs (d)(1) through (15) of this section. Examinations for each category of certification listed in § 171.101 must be based on the standards of competency specified in paragraphs (d)(1) through (15) of this section and examples of problems and situations appropriate to the particular category in which the applicator is seeking certification.
              (1) Agricultural pest control.

              (i) Crop pest control. Applicators must demonstrate practical knowledge of crops, grasslands, and non-crop agricultural lands and the specific pests of those areas on which they may be using restricted use pesticides. The importance of such competency is amplified by the extensive areas involved, the quantities of pesticides needed, and the ultimate use of many commodities as food and feed. The required knowledge includes pre-harvest intervals, restricted entry intervals, phytotoxicity, potential for environmental contamination such as soil and water problems, non-target injury, and other problems resulting from the use of restricted use pesticides in agricultural areas. The required knowledge also includes the potential for phytotoxicity due to a wide variety of plants to be protected, for drift, for persistence beyond the intended period of pest control, and for non-target exposures.
              (ii) Livestock pest control. Applicators must demonstrate practical knowledge of such animals and their associated pests. The required knowledge includes specific pesticide toxicity and residue potential, and the hazards associated with such factors as formulation, application techniques, age of animals, stress, and extent of treatment.
              (2) Forest pest control. Applicators must demonstrate practical knowledge of types of forests, forest nurseries, and seed production within the jurisdiction of the certifying authority and the pests involved. The required knowledge includes the cyclic occurrence of certain pests and specific population dynamics as a basis for programming pesticide applications, the relevant organisms causing harm and their vulnerability to the pesticides to be applied, how to determine when pesticide use is proper, selection of application method and proper use of application equipment to minimize non-target exposures, and appropriate responses to meteorological factors and adjacent land use. The required knowledge also includes the potential for phytotoxicity due to a wide variety of plants to be protected, for drift, for persistence beyond the intended period of pest control, and for non-target exposures.
              (3) Ornamental and turf pest control. Applicators must demonstrate practical knowledge of pesticide problems associated with the production and maintenance of ornamental plants and turf. The required knowledge includes the potential for phytotoxicity due to a wide variety of plants to be protected, for drift, for persistence beyond the intended period of pest control, and for non-target exposures. Because of the frequent proximity of human habitations to application activities, applicators in this category must demonstrate practical knowledge of application methods that will minimize or prevent hazards to humans, pets, and other domestic animals.
              (4) Seed treatment. Applicators must demonstrate practical knowledge including recognizing types of seeds to be treated, the effects of carriers and surface active agents on pesticide binding and germination, the hazards associated with handling, sorting and mixing, and misuse of treated seed, the importance of proper application techniques to avoid harm to non-target organisms, and the proper disposal of unused treated seeds.
              (5) Aquatic pest control. Applicators must demonstrate practical knowledge of the characteristics of various aquatic use situations, the potential for adverse effects on non-target plants, fish, birds, beneficial insects and other organisms in the immediate aquatic environment and downstream, and the principles of limited area application.
              (6) Right-of-way pest control. Applicators must demonstrate practical knowledge of the types of environments (terrestrial and aquatic) traversed by rights-of-way, recognition of target pests, and techniques to minimize non-target exposure, runoff, drift, and excessive foliage destruction. The required knowledge also includes the potential for phytotoxicity due to a wide variety of plants and pests to be controlled, and for persistence beyond the intended period of pest control.
              (7) Industrial, institutional, and structural pest control. Applicators must demonstrate a practical knowledge of industrial, institutional, and structural pests, including recognizing those pests and signs of their presence, their habitats, their life cycles, biology, and behavior as it may be relevant to problem identification and control. Applicators must demonstrate practical knowledge of types of formulations appropriate for control of industrial, institutional and structural pests, and methods of application that avoid contamination of food, minimize damage to and contamination of areas treated, minimize acute and chronic exposure of people and pets, and minimize environmental impacts of outdoor applications.
              (8) Public health pest control. Applicators must demonstrate practical knowledge of pests that are important vectors of disease, including recognizing the pests and signs of their presence, their habitats, their life cycles, biology and behavior as it may be relevant to problem identification and control. The required knowledge also includes how to minimize damage to and contamination of areas treated, acute and chronic exposure of people and pets, and non-target exposures.
              (9) Regulatory pest control. Applicators must demonstrate practical knowledge of regulated pests, applicable laws relating to quarantine and other regulation of regulated pests, and the potential impact on the environment of restricted use pesticides used in suppression and eradication programs. They must demonstrate knowledge of factors influencing introduction, spread, and population dynamics of regulated pests.
              (10) Demonstration and research. Applicators must demonstrate practical knowledge of the potential problems, pests, and population levels reasonably expected to occur in a demonstration situation and the effects of restricted use pesticides on target and non-target organisms. In addition, they must demonstrate competency in each pest control category applicable to their demonstrations.
              (11) Sodium cyanide predator control. Applicators must demonstrate practical knowledge of mammalian predator pests, including recognizing those pests and signs of their presence, their habitats, their life cycles, biology, and behavior as it may be relevant to pest identification and control. Applicators must demonstrate comprehension of all laws and regulations applicable to the use of mechanical ejection devices for sodium cyanide, including the restrictions on the use of sodium cyanide products ordered by the EPA Administrator. . Applicators must also demonstrate practical knowledge and understanding of all of the specific use restrictions for sodium cyanide devices, including safe handling and proper placement of the capsules and device, proper use of the antidote kit, notification to medical personnel before use of the device, conditions of and restrictions on when and where devices can be used, requirements to consult U.S. Fish and Wildlife Service maps before use to avoid affecting endangered species, maximum density of devices, provisions for supervising and monitoring applicators, required information exchange in locations where more than one agency is authorized to place devices, and specific requirements for recordkeeping, monitoring, field posting, proper storage, and disposal of damaged or used sodium cyanide capsules.
              (12) Sodium fluoroacetate predator control. Applicators must demonstrate practical knowledge of mammalian predator pests, including recognizing those pests and signs of their presence, their habitats, their life cycles, biology, and behavior as it may be relevant to pest identification and control. Applicators must demonstrate comprehension of all laws and regulations applicable to the use of sodium fluoroacetate products, including the restrictions on the use of sodium fluoroacetate products ordered by the EPA Administrator. Applicators must also demonstrate practical knowledge and understanding of the specific use restrictions for sodium fluoroacetate in the livestock protection collar, including where and when sodium fluoroacetate products can be used, safe handling and placement of collars, and practical treatment of sodium fluoroacetate poisoning in humans and domestic animals. Applicators must also demonstrate practical knowledge and understanding of specific requirements for field posting, monitoring, recordkeeping, proper storage of collars, disposal of punctured or leaking collars, disposal of contaminated animal remains, vegetation, soil, and clothing, and reporting of suspected and actual poisoning, mishap, or injury to threatened or endangered species, humans, domestic animals, or non-target wild animals.
              (13) Soil fumigation. Applicators must demonstrate practical knowledge of the pest problems and pest control practices associated with performing soil fumigation applications, including all the following:
              (i) Label and labeling comprehension. Familiarity with the pesticide labels and labeling for products used to perform soil fumigation, including all of the following:
              (A) Labeling requirements specific to soil fumigants.
              (B) Requirements for certified applicators of fumigants, fumigant handlers and permitted fumigant handler activities, and the safety information that certified applicators must provide to noncertified applicators using fumigants under their direct supervision.
              (C) Entry-restricted periods for tarped and untarped field application scenarios.
              (D) Recordkeeping requirements.
              (E) Labeling provisions unique to fumigant products containing certain active ingredients.
              (ii) Safety. Measures to minimize adverse health effects, including all of the following:
              (A) Understanding how certified applicators, noncertified applicators using fumigants under direct supervision of certified applicators, field workers, and bystanders can become exposed to fumigants.
              (B) Common problems and mistakes that can result in direct exposure to fumigants.
              (C) Signs and symptoms of human exposure to fumigants.
              (D) Air concentrations of a fumigant that require that applicators wear respirators or exit the work area entirely.
              (E) Steps to take if a fumigant applicator experiences sensory irritation.
              (F) Understanding air monitoring, when it is required, and where and when to take samples.
              (G) Buffer zones, including procedures for buffer zone monitoring and who is permitted to be in a buffer zone.
              (H) First aid measures to take in the event of exposure to a soil fumigant.
              (I) Labeling requirements for transportation, storage, spill clean up, and emergency response for soil fumigants, including safe disposal of containers and contaminated soil, and management of empty containers.
              (iii) Soil fumigant chemical characteristics. Characteristics of soil fumigants, including all of the following:
              (A) Chemical characteristics of soil fumigants.
              (B) Specific human exposure concerns for soil fumigants.
              (C) How soil fumigants change from a liquid or solid to a gas.
              (D) How soil fumigants disperse in the application zone.
              (E) Compatibility concerns for tanks, hoses, tubing, and other equipment.
              (iv) Application. Selecting appropriate application methods and timing, including all of the following:
              (A) Application methods, including but not limited to water-run and non-water- run applications, and equipment commonly used for each soil fumigant.
              (B) Site characteristics that influence fumigant exposure.
              (C) Understanding temperature inversions and their impact on soil fumigant application.
              (D) Weather conditions that could impact timing of soil fumigant application, such as air stability, air temperature, humidity, and wind currents, and labeling statements limiting applications during specific weather conditions.
              (E) Conducting pre-application inspection of application equipment.

              (F) Understanding the purpose and methods of soil sealing, including the factors that determine which soil sealing method to use.

              (G) Understanding the use of tarps, including the range of tarps available, how to seal tarps, and labeling requirements for tarp removal, perforation, and repair.
              (H) Calculating the amount of product required for a specific treatment area.
              (I) Understanding the basic techniques for calibrating soil fumigant application equipment.
              (v) Soil and pest factors. Soil and pest factors that influence fumigant activity, including all of the following:
              (A) Influence of soil factors on fumigant volatility and movement within the soil profile.
              (B) Factors that influence gaseous movement through the soil profile and into the air.
              (C) Soil characteristics, including how soil characteristics affect the success of a soil fumigant application, assessing soil moisture, and correcting for soil characteristics that could hinder a successful soil fumigant application.
              (D) Identifying pests causing the damage and verifying they can be controlled with soil fumigation.
              (E) Understanding the relationship between pest density and application rate.
              (F) The importance of proper application depth and timing.
              (vi) Personal protective equipment. Understanding what personal protective equipment is necessary and how to use it properly, including all of the following:
              (A) Following labeling directions for required personal protective equipment.
              (B) Selecting, inspecting, using, caring for, replacing, and disposing of personal protective equipment.
              (C) Understanding the types of respirators required when using specific soil fumigants and how to use them properly, including medical evaluation, fit testing, and required replacement of cartridges and canisters.
              (D) Labeling requirements and other laws applicable to medical evaluation for respirator use, fit tests, training, and recordkeeping.
              (vii) Fumigant management plans and post-application summaries. Information about fumigant management plans, including all of the following:
              (A) When a fumigant management plan must be in effect, how long it must be kept on file, where it must be kept during the application, and who must have access to it.
              (B) The elements of a fumigant management plan and resources available to assist the applicator in preparing a fumigant management plan.
              (C) The person responsible for verifying that a fumigant management plan is accurate.
              (D) The elements, purpose and content of a post-application summary, who must prepare it, and when it must be completed.
              (viii) Buffer zones and posting requirements. Understanding buffer zones and posting requirements, including all of the following:
              (A) Buffer zones and the buffer zone period.
              (B) Identifying who is allowed in a buffer zone during the buffer zone period and who is prohibited from being in a buffer zone during the buffer zone period.
              (C) Using the buffer zone table from the labeling to determine the size of the buffer zone.
              (D) Factors that determine the buffer zone credits for application scenarios and calculating buffer zones using credits.
              (E) Distinguishing buffer zone posting and treated area posting, including the pre-application and post-application posting timeframes for each.
              (F) Proper choice and placement of warning signs.
              (14) Non-soil fumigation. Applicators must demonstrate practical knowledge of the pest problems and pest control practices associated with performing fumigation applications of restricted use pesticides to sites other than soil, including all the following:
              (i) Label & labeling comprehension. Familiarity with the pesticide labels and labeling for products used to perform non-soil fumigation, including labeling requirements specific to non-soil fumigants.
              (ii) Safety. Measures to minimize adverse health effects, including all of the following:

              (A) Understanding how certified applicators, noncertified applicators using fumigants under direct supervision of certified applicators, and bystanders can become exposed to fumigants.
              (B) Common problems and mistakes that can result in direct exposure to fumigants.
              (C) Signs and symptoms of human exposure to fumigants.
              (D) Air concentrations of a fumigant that require applicators to wear respirators or to exit the work area entirely.
              (E) Steps to take if a fumigant applicator experiences sensory irritation.
              (F) Understanding air monitoring, when it is required, and where and when to take samples.
              (G) Buffer zones, including procedures for buffer zone monitoring and who is permitted to be in a buffer zone.
              (H) First aid measures to take in the event of exposure to a fumigant.
              (I) Labeling requirements for transportation, storage, spill clean up, and emergency response for non-soil fumigants, including safe disposal of containers and contaminated materials, and management of empty containers.
              (iii) Non-soil fumigant chemical characteristics. Characteristics of non-soil fumigants, including all of the following:
              (A) Chemical characteristics of non-soil fumigants.
              (B) Specific human exposure concerns for non-soil fumigants.
              (C) How fumigants change from a liquid or solid to a gas.
              (D) How fumigants disperse in the application zone.
              (E) Compatibility concerns for tanks, hoses, tubing, and other equipment.
              (iv) Application. Selecting appropriate application methods and timing, including all of the following:
              (A) Application methods and equipment commonly used for non-soil fumigation.
              (B) Site characteristics that influence fumigant exposure.
              (C) Conditions that could impact timing of non-soil fumigant application, such as air stability, air temperature, humidity, and wind currents, and labeling statements limiting applications under specific conditions.
              (D) Conducting pre-application inspection of application equipment and the site to be fumigated.
              (E) Understanding the purpose and methods of sealing the area to be fumigated, including the factors that determine which sealing method to use.
              (F) Calculating the amount of product required for a specific treatment area.
              (G) Understanding the basic techniques for calibrating non-soil fumigant application equipment.
              (H) Understanding when and how to conduct air monitoring and when it is required.
              (v) Pest factors. Pest factors that influence fumigant activity, including all of the following:
              (A) Influence of pest factors on fumigant volatility.
              (B) Factors that influence gaseous movement through the area being fumigated and into the air.
              (C) Identifying pests causing the damage and verifying they can be controlled with fumigation.
              (D) Understanding the relationship between pest density and application rate.
              (E) The importance of proper application rate and timing.
              (vi) Personal protective equipment. Understanding what personal protective equipment is necessary and how to use it properly, including all of the following:
              (A) Following labeling directions for required personal protective equipment.
              (B) Selecting, inspecting, using, caring for, replacing, and disposing of personal protective equipment.
              (C) Understanding the types of respirators required when using specific non-soil fumigants and how to use them properly, including medical evaluation, fit testing, and required replacement of cartridges and canisters.
              (D) Labeling requirements and other laws applicable to medical evaluation for respirator use, fit tests, training, and recordkeeping.
              (vii) Fumigant management plans and post-application summaries. Information about fumigant management plans and when they are required, including all of the following:

              (A) When a fumigant management plan must be in effect, how long it must be kept on file, where it must be kept during the application, and who must have access to it.
              (B) The elements of a fumigant management plan and resources available to assist the applicator in preparing a fumigant management plan.
              (C) The person responsible for verifying that a fumigant management plan is accurate.
              (D) The elements, purpose and content of a post-application summary, who must prepare it, and when it must be completed.
              (viii) Posting requirements. Understanding posting requirements, including all of the following:
              (A) Understanding who is allowed in an area being fumigated or after fumigation and who is prohibited from being in such areas.
              (B) Distinguishing fumigant labeling-required posting and treated area posting, including the pre-application and post-application posting timeframes for each.
              (C) Proper choice and placement of warning signs.
              (15) Aerial pest control. Applicators must demonstrate practical knowledge of the pest problems and pest control practices associated with performing aerial application of restricted use pesticides, including all the following:
              (i) Labeling. Labeling requirements and restrictions specific to aerial application of pesticides including:
              (A) Spray volumes.
              (B) Buffers and no-spray zones.
              (C) Weather conditions specific to wind and inversions.
              (ii) Application equipment. Understand how to choose and maintain aerial application equipment, including all of the following:
              (A) The importance of inspecting application equipment to ensure it is in proper operating condition prior to beginning an application.
              (B) Selecting proper nozzles to ensure appropriate pesticide dispersal and to minimize drift.
              (C) Knowledge of the components of an aerial pesticide application system, including pesticide hoppers, tanks, pumps, and types of nozzles.
              (D) Interpreting a nozzle flow rate chart.
              (E) Determining the number of nozzles for intended pesticide output using nozzle flow rate chart, aircraft speed, and swath width.
              (F) How to ensure nozzles are placed to compensate for uneven dispersal due to uneven airflow from wingtip vortices, helicopter rotor turbulence, and aircraft propeller turbulence.
              (G) Where to place nozzles to produce the appropriate droplet size.
              (H) How to maintain the application system in good repair, including pressure gauge accuracy, filter cleaning according to schedule, and checking nozzles for excessive wear.
              (I) How to calculate required and actual flow rates.
              (J) How to verify flow rate using fixed timing, open timing, known distance, or a flow meter.
              (K) When to adjust and calibrate application equipment.
              (iii) Application considerations. The applicator must demonstrate knowledge of factors to consider before and during application, including all of the following:
              (A) Weather conditions that could impact application by affecting aircraft engine power, take-off distance, and climb rate, or by promoting spray droplet evaporation.
              (B) How to determine wind velocity, direction, and air density at the application site.
              (C) The potential impact of thermals and temperature inversions on aerial pesticide application.
              (iv) Minimizing drift. The applicator must demonstrate knowledge of methods to minimize off-target pesticide movement, including all of the following:
              (A) How to determine drift potential of a product using a smoke generator.
              (B) How to evaluate vertical and horizontal smoke plumes to assess wind direction, speed, and concentration.
              (C) Selecting techniques that minimize pesticide movement out of the area to be treated.

              (D) Documenting special equipment configurations or flight patterns used to reduce off-target pesticide drift.

              (v) Performing aerial application. The applicator must demonstrate competency in performing an aerial pesticide application, including all of the following:
              (A) Selecting a flight altitude that minimizes streaking and off-target pesticide drift.
              (B) Choosing a flight pattern that ensures applicator and bystander safety and proper application.
              (C) The importance of engaging and disengaging spray precisely when entering and exiting a predetermined swath pattern.
              (D) Tools available to mark swaths, such as global positioning systems and flags.
              (E) Recordkeeping requirements for aerial pesticide applications including application conditions if applicable.
              (e) Exceptions. The requirements in § 171.103(a)-(d) of this part do not apply to the following persons:
              (1) Persons conducting laboratory research involving restricted use pesticides.
              (2) Doctors of Medicine and Doctors of Veterinary Medicine applying restricted use pesticides to patients during the course of the ordinary practice of those professions.

              § 171.105
              Standards for certification of private applicators.
              (a) General private applicator certification. Before using or supervising the use of a restricted use pesticide as a private applicator, a person must be certified by an appropriate certifying authority as having the necessary competency to use restricted use pesticides for pest control in the production of agricultural commodities, which includes the ability to read and understand pesticide labeling. Certification in this general private applicator certification category alone is not sufficient to authorize the purchase, use, or supervision of use of the restricted use pesticide products in the categories listed in paragraphs (b) through (f) of this section. Persons seeking certification as private applicators must demonstrate practical knowledge of the principles and practices of pest control associated with the production of agricultural commodities and effective use of restricted use pesticides, including all of the following:
              (1) Label and labeling comprehension. Familiarity with pesticide labels and labeling and their functions, including all of the following:
              (i) The general format and terminology of pesticide labels and labeling.
              (ii) Understanding instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels and labeling.
              (iii) Understanding that it is a violation of Federal law to use any registered pesticide in a manner inconsistent with its labeling.
              (iv) Understanding when a certified applicator must be physically present at the site of the application based on labeling requirements.
              (v) Understanding labeling requirements for supervising noncertified applicators working under the direct supervision of a certified applicator.
              (vi) Understanding that applicators must comply with all use restrictions and directions for use contained in pesticide labels and labeling, including being certified in the appropriate category to use restricted use pesticides for fumigation or aerial application, or predator control devices containing sodium cyanide or sodium fluoroacetate, if applicable.
              (vii) Understanding the meaning of product classification as either general or restricted use, and that a product may be unclassified.
              (viii) Understanding and complying with product-specific notification requirements.
              (ix) Recognizing and understanding the difference between mandatory and advisory labeling language.
              (2) Safety. Measures to avoid or minimize adverse health effects, including all of the following:
              (i) Understanding the different natures of the risks of acute toxicity and chronic toxicity, as well as the long-term effects of pesticides.
              (ii) Understanding that a pesticide's risk is a function of exposure and the pesticide's toxicity.
              (iii) Recognition of likely ways in which dermal, inhalation, and oral exposure may occur.

              (iv) Common types and causes of pesticide mishaps.

              (v) Precautions to prevent injury to applicators and other individuals in or near treated areas.
              (vi) Need for, and proper use of, protective clothing and personal protective equipment.
              (vii) Symptoms of pesticide poisoning.
              (viii) First aid and other procedures to be followed in case of a pesticide mishap.
              (ix) Proper identification, storage, transport, handling, mixing procedures, and disposal methods for pesticides and used pesticide containers, including precautions to be taken to prevent children from having access to pesticides and pesticide containers.
              (3) Environment. The potential environmental consequences of the use and misuse of pesticides, including the influence of the following:
              (i) Weather and other climatic conditions.
              (ii) Types of terrain, soil, or other substrate.
              (iii) Presence of fish, wildlife, and other non-target organisms.
              (iv) Drainage patterns.
              (4) Pests. The proper identification and effective control of pests, including all of the following:
              (i) The importance of correctly identifying target pests and selecting the proper pesticide product(s).
              (ii) Verifying that the labeling does not prohibit the use of the product to control the target pest(s).
              (5) Pesticides. Characteristics of pesticides, including all of the following:
              (i) Types of pesticides.
              (ii) Types of formulations.
              (iii) Compatibility, synergism, persistence, and animal and plant toxicity of the formulations.
              (iv) Hazards and residues associated with use.
              (v) Factors that influence effectiveness or lead to problems such as pesticide resistance.
              (vi) Dilution procedures.
              (6) Equipment. Application equipment, including all of the following:
              (i) Types of equipment and advantages and limitations of each type.
              (ii) Uses, maintenance, and calibration procedures.
              (7) Application methods. Selecting appropriate application methods, including all of the following:
              (i) Methods used to apply various forms and formulations of pesticides.
              (ii) Knowledge of which application method to use in a given situation and that use of a fumigant, aerial application, or predator control device containing sodium cyanide or sodium fluoroacetate requires additional certification.
              (iii) How selection of application method and use of a pesticide may result in proper use, unnecessary or ineffective use, and misuse.
              (iv) Prevention of drift and pesticide loss into the environment.
              (8) Laws and regulations. Knowledge of all applicable State, Tribal, and Federal laws and regulations, including understanding the Worker Protection Standard in 40 CFR part 170 and the circumstances where compliance is required.
              (9) Responsibilities for supervisors of noncertified applicators. Certified applicator responsibilities related to supervision of noncertified applicators, including all of the following:
              (i) Understanding and complying with requirements in § 171.201 of this part for private applicators who supervise noncertified applicators using restricted use pesticides.
              (ii) Providing use-specific instructions to noncertified applicators using restricted use pesticides under the direct supervision of a certified applicator.
              (iii) Explaining appropriate State, Tribal, and Federal laws and regulations to noncertified applicators working under the direct supervision of a certified applicator.
              (10) Stewardship. Understanding the importance of all of the following:
              (i) Maintaining chemical security for restricted use pesticides.
              (ii) How to communicate information about pesticide exposures and risks with agricultural workers and handlers and other persons.
              (11) Agricultural pest control. Practical knowledge of pest control applications to agricultural commodities including all of the following:

              (i) Specific pests of relevant agricultural commodities.

              (ii) How to avoid contamination of ground and surface waters.
              (iii) Understanding pre-harvest and restricted entry intervals and entry-restricted periods and areas.
              (iv) Understanding specific pesticide toxicity and residue potential when pesticides are applied to animal or animal product agricultural commodities.
              (v) Relative hazards associated with using pesticides on animals or places in which animals are confined based on formulation, application technique, age of animal, stress, and extent of treatment.
              (b) Sodium cyanide predator control. In addition to satisfying the requirements in paragraph (a) of this section, in order to use sodium cyanide in a mechanical ejection device, private applicators must demonstrate comprehension of all laws and regulations applicable to the use of mechanical ejection devices for sodium cyanide, including the restrictions on the use of sodium cyanide products ordered by the EPA Administrator. Applicators must also demonstrate practical knowledge and understanding of all of the specific use restrictions for sodium cyanide devices, including safe handling and proper placement of the capsules and device, proper use of the antidote kit, notification to medical personnel before use of the device, conditions of and restrictions on where devices can be used, requirements to consult U.S. Fish and Wildlife Service maps before use to avoid affecting endangered species, maximum density of devices, provisions for supervising and monitoring applicators, required information exchange in locations where more than one agency is authorized to place devices, and specific requirements for recordkeeping, monitoring, field posting, proper storage, and disposal of damaged or used sodium cyanide capsules.
              (c) Sodium fluoroacetate predator control. In addition to satisfying the requirements in paragraph (a) of this section, in order to use sodium fluoroacetate, private applicators must demonstrate comprehension of all laws and regulations applicable to the use of sodium fluoroacetate products, including the restrictions on the use of sodium fluoroacetate products ordered by the EPA Administrator. Applicators must also demonstrate practical knowledge and understanding of the specific use restrictions for sodium fluoroacetate in the livestock protection collar, including where and when sodium fluoroacetate products can be used, safe handling and placement of collars, and practical treatment of sodium fluoroacetate poisoning in humans and domestic animals. Applicators must also demonstrate practical knowledge and understanding of specific requirements for field posting, monitoring, recordkeeping, proper storage of collars, disposal of punctured or leaking collars, disposal of contaminated animal remains, vegetation, soil, and clothing, and reporting of suspected and actual poisoning, mishap, or injury to threatened or endangered species, humans, domestic animals, or non-target wild animals.
              (d) Soil fumigation. In addition to satisfying the requirements in paragraph (a) of this section, private applicators that use or supervise the use of a restricted use pesticide to fumigate soil must demonstrate practical knowledge of the pest problems and pest control practices associated with performing soil fumigant applications, including all the following:
              (1) Label and labeling comprehension. Familiarity with the pesticide labels and labeling for products used to perform soil fumigation, including all of the following:
              (i) Labeling requirements specific to soil fumigants.
              (ii) Requirements for certified applicators of fumigants, fumigant handlers and permitted fumigant handler activities, and the safety information that certified applicators must provide to noncertified applicators using fumigants under the direct supervision of certified applicators.
              (iii) Entry-restricted period for different tarped and untarped field application scenarios.
              (iv) Recordkeeping requirements imposed by product labels and labeling.
              (v) Labeling provisions unique to products containing certain active ingredients.

              (vi) Labeling requirements for fumigant management plans, such as when a fumigant management plan must be in effect, how long it must be kept on file, where it must be kept during the application, and who must have access to it; the elements of a fumigant management plan and resources available to assist the applicator in preparing a fumigant management plan; the person responsible for verifying that a fumigant management plan is accurate; and the elements, purpose and content of a post-application summary, who must prepare it, and when it must be completed.
              (2) Safety. Measures to minimize adverse health effects, including all of the following:
              (i) Understanding how certified applicators, noncertified applicators using fumigants under the direct supervision of certified applicators, field workers, and bystanders can become exposed to fumigants.
              (ii) Common problems and mistakes that can result in direct exposure to fumigants.
              (iii) Signs and symptoms of human exposure to fumigants.
              (iv) Air concentrations of a fumigant that require applicators to wear respirators or to exit the work area entirely.
              (v) Steps to take if a fumigant applicator experiences sensory irritation.
              (vi) Understanding air monitoring, when it is required, and where and when to take samples.
              (vii) Buffer zones, including procedures for buffer zone monitoring and who is permitted to be in a buffer zone.
              (viii) First aid measures to take in the event of exposure to a soil fumigant.
              (ix) Labeling requirements for transportation, storage, spill cleanup, and emergency response for soil fumigants, including safe disposal of containers and contaminated soil, and management of empty containers.
              (3) Soil fumigant chemical characteristics. Characteristics of soil fumigants, including all of the following:
              (i) Chemical characteristics of soil fumigants.
              (ii) Specific human exposure concerns for soil fumigants.
              (iii) How soil fumigants change from a liquid or solid to a gas.
              (iv) How soil fumigants disperse in the application zone.
              (v) Compatibility concerns for tanks, hoses, tubing, and other equipment.
              (4) Application. Selecting appropriate application methods and timing, including all of the following:
              (i) Application methods, including but not limited to water-run and non-water-run applications, and equipment commonly used for each soil fumigant.
              (ii) Site characteristics that influence fumigant exposure.
              (iii) Understanding temperature inversions and their impact on soil fumigant application.
              (iv) Weather conditions that could impact timing of soil fumigant application, such as air stability, air temperature, humidity, and wind currents, and labeling statements limiting applications during specific weather conditions.
              (v) Conducting pre-application inspection of application equipment.
              (vi) Understanding the purpose and methods of soil sealing, including the factors that determine which soil sealing method to use.
              (vii) Understanding the use of tarps, including the range of tarps available, how to seal tarps, and labeling requirements for tarp removal, perforation, and repair.
              (viii) Calculating the amount of product required for a specific treatment area.
              (ix) Understanding the basic techniques for calibrating soil fumigant application equipment.
              (5) Soil and pest factors. Soil and pest factors that influence fumigant activity, including all of the following:
              (i) Influence of soil factors on fumigant volatility and movement within the soil profile.
              (ii) Factors that influence gaseous movement through the soil profile and into the air.
              (iii) Soil characteristics, including how soil characteristics affect the success of a soil fumigant application, assessing soil moisture, and correcting for soil characteristics that could hinder a successful soil fumigant application.

              (iv) Identifying pests causing the damage and verifying they can be controlled with soil fumigation.

              (v) Understanding the relationship between pest density and application rate.
              (vi) The importance of proper application depth and timing.
              (6) Personal protective equipment. Understanding what personal protective equipment is necessary and how to use it properly, including all of the following:
              (i) Following labeling directions for required personal protective equipment.
              (ii) Selecting, inspecting, using, caring for, replacing, and disposing of personal protective equipment.
              (iii) Understanding the types of respirators required when using specific soil fumigants and how to use them properly, including medical evaluation, fit testing, and required replacement of cartridges and canisters.
              (iv) Labeling requirements and other laws applicable to medical evaluation for respirator use, fit tests, training, and recordkeeping.
              (7) Fumigant management plans and post-application summaries. Information about fumigant management plans, including all of the following:
              (i) When a fumigant management plan must be in effect, how long it must be kept on file, where it must be kept during the application, and who must have access to it.
              (ii) The elements of a fumigant management plan and resources available to assist the applicator in preparing a fumigant management plan.
              (iii) The person responsible for verifying that a fumigant management plan is accurate.
              (iv) The elements, purpose and content of a post-application summary, who must prepare it, and when it must be completed.
              (8) Buffer zones and posting requirements. Understanding buffer zones and posting requirements, including all of the following:
              (i) Buffer zones and the buffer zone period.
              (ii) Identifying who may be in a buffer zone during the buffer zone period and who is prohibited from being in a buffer zone during the buffer zone period.
              (iii) Using the buffer zone table from the labeling to determine the size of the buffer zone.
              (iv) Factors that determine the buffer zone credits for application scenarios and calculating buffer zones using credits.
              (v) Distinguishing buffer zone posting and treated area posting, including the pre-application and post-application posting timeframes for each.
              (vi) Proper choice and placement of warning signs.
              (e) Non-soil fumigation. In addition to satisfying the requirements in paragraph (a) of this section, private applicators that use or supervise the use of a restricted use pesticide to fumigate anything other than soil must demonstrate practical knowledge of the pest problems and pest control practices associated with performing fumigation applications to sites other than soil, including all the following:
              (1) Label and labeling comprehension. Familiarity with the pesticide labels and labeling for products used to perform non-soil fumigation, including labeling requirements specific to non-soil fumigants.
              (2) Safety. Measures to minimize adverse health effects, including all of the following:
              (i) Understanding how certified applicators, handlers, and bystanders can become exposed to fumigants.
              (ii) Common problems and mistakes that can result in direct exposure to fumigants.
              (iii) Signs and symptoms of human exposure to fumigants.
              (iv) When air concentrations of a fumigant triggers handlers to wear respirators or to exit the work area entirely.
              (v) Steps to take if a person using a fumigant experiences sensory irritation.
              (vi) Understanding air monitoring, when it is required, and where and when to take samples.
              (vii) Buffer zones, including procedures for buffer zone monitoring and who is permitted to be in a buffer zone.
              (viii) First aid measures to take in the event of exposure to a fumigant.

              (ix) Labeling requirements for transportation, storage, spill clean up, and emergency response for non-soil fumigants, including safe disposal of containers and contaminated materials, and management of empty containers.
              (3) Non-soil fumigant chemical characteristics. Characteristics of non-soil fumigants, including all of the following:
              (i) Chemical characteristics of non-soil fumigants.
              (ii) Specific human exposure concerns for non-soil fumigants.
              (iii) How fumigants change from a liquid or solid to a gas.
              (iv) How fumigants disperse in the application zone.
              (v) Compatibility concerns for tanks, hoses, tubing, and other equipment.
              (4) Application. Selecting appropriate application methods and timing, including all of the following:
              (i) Application methods and equipment commonly used for non-soil fumigation.
              (ii) Site characteristics that influence fumigant exposure.
              (iii) Conditions that could impact timing of non-soil fumigant application, such as air stability, air temperature, humidity, and wind currents, and labeling statements limiting applications when specific conditions are present.
              (iv) Conducting pre-application inspection of application equipment and the site to be fumigated.
              (v) Understanding the purpose and methods of sealing the area to be fumigated, including the factors that determine which sealing method to use.
              (vi) Calculating the amount of product required for a specific treatment area.
              (vii) Understanding the basic techniques for calibrating non-soil fumigant application equipment.
              (viii) Understanding when and how to conduct air monitoring and when it is required.
              (5) Pest factors. Pest factors that influence fumigant activity, including all of the following:
              (i) Influence of pest factors on fumigant volatility.
              (ii) Factors that influence gaseous movement through the area being fumigated and into the air.
              (iii) Identifying pests causing the damage and verifying they can be controlled with fumigation.
              (iv) Understanding the relationship between pest density and application rate.
              (v) The importance of proper application rate and timing.
              (6) Personal protective equipment. Understanding what personal protective equipment is necessary and how to use it properly, including all of the following:
              (i) Following labeling directions for required personal protective equipment.
              (ii) Selecting, inspecting, using, caring for, replacing, and disposing of personal protective equipment.
              (iii) Understanding the types of respirators required when using specific soil fumigants and how to use them properly, including medical evaluation, fit testing, and required replacement of cartridges and canisters.
              (iv) Labeling requirements and other laws applicable to medical evaluation for respirator use, fit tests, training, and recordkeeping.
              (7) Fumigant management plans and post-application summaries. Information about fumigant management plans and when they are required, including all of the following:
              (i) When a fumigant management plan must be in effect, how long it must be kept on file, where it must be kept during the application, and who must have access to it.
              (ii) The elements of a fumigant management plan and resources available to assist the applicator in preparing a fumigant management plan.
              (iii) The person responsible for verifying that a fumigant management plan is accurate.
              (iv) The elements, purpose and content of a post-application summary, who must prepare it, and when it must be completed.
              (8) Posting requirements. Understanding posting requirements, including all of the following:
              (i) Understanding who is allowed in an area being fumigated or after fumigation and who is prohibited from being in such areas.

              (ii) Distinguishing fumigant labeling-required posting and treated area posting, including the pre-application and post-application posting timeframes for each.

              (iii) Proper choice and placement of warning signs.
              (f) Aerial pest control. In addition to satisfying the requirements in paragraph (a) of this section, private applicators that use or supervise the use of restricted use pesticides applied by fixed or rotary wing aircraft must demonstrate practical knowledge of the pest problems and pest control practices associated with performing aerial application, including all the following:
              (1) Labeling. Labeling requirements and restrictions specific to aerial application of pesticides including:
              (i) Spray volumes.
              (ii) Buffers and no-spray zones.
              (iii) Weather conditions specific to wind and inversions.
              (iv) Labeling-mandated recordkeeping requirements for aerial pesticide applications including application conditions if applicable.
              (2) Application equipment. Understand how to choose and maintain aerial application equipment, including all of the following:
              (i) The importance of inspecting application equipment to ensure it is in proper operating condition prior to beginning an application.
              (ii) Selecting proper nozzles to ensure appropriate pesticide dispersal and to minimize drift.
              (iii) Knowledge of the components of an aerial pesticide application system, including pesticide hoppers, tanks, pumps, and types of nozzles.
              (iv) Interpreting a nozzle flow rate chart.
              (v) Determining the number of nozzles for intended pesticide output using nozzle flow rate chart, aircraft speed, and swath width.
              (vi) How to ensure nozzles are placed to compensate for uneven dispersal due to uneven airflow from wingtip vortices, helicopter rotor turbulence, and aircraft propeller turbulence.
              (vii) Where to place nozzles to produce the appropriate droplet size.
              (viii) How to maintain the application system in good repair, including pressure gauge accuracy, filter cleaning according to schedule, and checking nozzles for excessive wear.
              (ix) How to calculate required and actual flow rates.
              (x) How to verify flow rate using fixed timing, open timing, known distance, or a flow meter.
              (xi) When to adjust and calibrate application equipment.
              (3) Application considerations. The applicator must demonstrate knowledge of factors to consider before and during application, including all of the following:
              (i) Weather conditions that could impact application by affecting aircraft engine power, take-off distance, and climb rate, or by promoting spray droplet evaporation.
              (ii) How to determine wind velocity, direction, and air density at the application site.
              (iii) The potential impact of thermals and temperature inversions on aerial pesticide application.
              (4) Minimizing drift. The applicator must demonstrate knowledge of methods to minimize off-target pesticide movement, including all of the following:
              (i) How to determine drift potential of a product using a smoke generator.
              (ii) How to evaluate vertical and horizontal smoke plumes to assess wind direction, speed, and concentration.
              (iii) Selecting techniques that minimize pesticide movement out of the area to be treated.
              (iv) Documenting special equipment configurations or flight patterns used to reduce off-target pesticide drift.
              (5) Performing aerial application. The applicator must demonstrate competency in performing an aerial pesticide application, including all of the following:
              (i) Selecting a flight altitude that minimizes streaking and off-target pesticide drift.
              (ii) Choosing a flight pattern that ensures applicator and bystander safety and proper application.
              (iii) The importance of engaging and disengaging spray precisely when entering and exiting a predetermined swath pattern.
              (iv) Tools available to mark swaths, such as global positioning systems and flags.
              (g) Private applicator minimum age. A private applicator must be at least 18 years old.

              (h) Private applicator competency. The competency of each candidate for private applicator certification must be established by the certifying authority based upon the certification standards set forth in paragraphs (a) through (g) of this section in order to assure that private applicators have the competency to use and supervise the use of restricted use pesticides in accordance with applicable State, Tribal, and Federal laws and regulations. The certifying authority must use either a written examination process as described in paragraph (h)(1) of this section or a non-examination training process as described in paragraph (h)(2) of this section to assure the competency of private applicators in regard to the general certification standards applicable to all private applicators outlined in paragraph (a) of this section, and, if applicable, the specific standards for the each of the categories outlined in paragraphs (b) through (f) of this section in which a private applicator is to be certified.
              (1) Determination of competency by examination. If the certifying authority uses an examination process to determine the competency of private applicators, the examination process must meet all of the requirements of § 171.103(a)(2).
              (2) Training for competency without examination. Any candidate for certification as a private applicator may complete a training program approved by the certifying authority to establish competency. A training program to establish private applicator competency must conform to all of the following criteria:
              (i) Identification. Each person seeking certification must present a valid, government-issued photo identification, or other form of similarly reliable identification authorized by the certifying authority, to the certifying authority or designated representative as proof of identity and age at the time of the training program to be eligible for certification.
              (ii) Training programs for private applicator general certification and category certification.

              (A) The training program for general private applicator certification must cover the competency standards outlined in paragraph (a) of this section in sufficient detail to allow the private applicator to demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticides.
              (B) The training program for each relevant category for private applicator certification must cover the competency standards outlined in paragraphs (b) through (f) of this section in sufficient detail to allow the private applicator to demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticides for each category in which he or she intends to apply restricted use pesticides, and must be in addition to the training program required for general private applicator certification.
              (i) Exceptions. The requirements in § 171.105(a)-(h) of this part do not apply to the following persons:
              (1) Persons conducting laboratory research involving restricted use pesticides.
              (2) Doctors of Medicine and Doctors of Veterinary Medicine applying restricted use pesticides to patients during the course of the ordinary practice of those professions.

              § 171.107
              Standards for recertification of certified applicators.
              (a) Maintenance of continued competency. Each commercial and private applicator certification shall expire five years after issuance, unless the applicator is recertified in accordance with this section. A certifying authority may establish a shorter certification period. In order for a certified applicator's certification to continue without interruption, the certified applicator must be recertified under this section before the expiration of his or her current certification.
              (b) Process for recertification. Minimum standards for recertification by written examination, or through continuing education programs, are as follows:
              (1) Written examination. A certified applicator may be found eligible for recertification upon passing a written examination approved by the certifying authority and that is designed to evaluate whether the certified applicator demonstrates the level of competency required by § 171.103 for commercial applicators or § 171.105 for private applicators. The examination shall conform to the applicable standards for examinations set forth in § 171.103(a)(2) of this part.
              (2) Continuing education programs. A certified applicator may be found eligible for recertification upon successfully completing a continuing education program pursuant to the certifying authority's EPA-approved certification plan.
              (i) The quantity, content, and quality of a continuing education program to maintain applicator certification must be sufficient to ensure the applicator continues to demonstrate the level of competency required by § 171.103 for commercial applicators or § 171.105 for private applicators.
              (ii) Any continuing education course or event relied upon for applicator recertification must be approved by the certifying authority as being suitable for its purpose in the certifying authority's recertification process.
              (iii) A certifying authority must ensure that any continuing education course or event, including an online or other distance education course or event, relied upon for applicator recertification includes a process to verify the applicator's successful completion of the course or event.

            Subpart C—Supervision of Noncertified Applicators

              Source:
              82 FR 1040, Jan. 4, 2018, unless otherwise noted.

              § 171.201
              Requirements for direct supervision of noncertified applicators by certified applicators.
              (a) Applicability. This section applies to any certified applicator who allows or relies on a noncertified applicator to use a restricted use pesticide under the certified applicator's direct supervision.
              (b) General requirements. (1) Requirements for the certified applicator.
              (i) The certified applicator must have a practical knowledge of applicable Federal, State and Tribal supervisory requirements, including any requirements on the product label and labeling, regarding the use of restricted use pesticides by noncertified applicators.
              (ii) The certified applicator must be certified in each category as set forth in §§ 171.101 and 171.105(a) through (f) applicable to the supervised pesticide use.
              (2) Requirements for the noncertified applicator. The certified applicator must ensure that each noncertified applicator using a restricted use pesticide under his or her direct supervision meets all of the following requirements before using a restricted use pesticide:
              (i) The noncertified applicator has satisfied the qualification requirements under paragraph (c) of this section.
              (ii) The noncertified applicator has been instructed within the last 12 months in the safe operation of any equipment he or she will use for mixing, loading, transferring, or applying pesticides.
              (iii) The noncertified applicator has met the minimum age required to use restricted use pesticides under the supervision of a certified applicator. A noncertified applicator must be at least 18 years old, except that a noncertified applicator must be at least 16 years old if all of the following requirements are met:
              (A) The noncertified applicator is using the restricted use pesticide under the direct supervision of a private applicator who is an immediate family member.
              (B) The restricted use pesticide is not a fumigant, sodium cyanide, or sodium fluoroacetate.
              (C) The noncertified applicator is not applying the restricted use pesticide aerially.
              (3) Use-specific conditions that must be met in order for a noncertified applicator to use a restricted use pesticide. The certified applicator must ensure that all of the following requirements are met before allowing a noncertified applicator to use a restricted use pesticide under his or her direct supervision:

              (i) The certified applicator must ensure that the noncertified applicator has access to the applicable product labeling at all times during its use.

              (ii) Where the labeling of a pesticide product requires that personal protective equipment be worn for mixing, loading, application, or any other use activities, the certified applicator must ensure that any noncertified applicator has clean, labeling-required personal protective equipment in proper operating condition and that the personal protective equipment is worn and used correctly for its intended purpose.
              (iii) The certified applicator must provide to each noncertified applicator before use of a restricted use pesticide instructions specific to the site and pesticide used. These instructions must include labeling directions, precautions, and requirements applicable to the specific use and site, and how the characteristics of the use site (e.g., surface and ground water, endangered species, local population) and the conditions of application (e.g., equipment, method of application, formulation) might increase or decrease the risk of adverse effects. The certified applicator must provide this information in a manner that the noncertified applicator can understand.
              (iv) The certified applicator must ensure that before each day of use equipment used for mixing, loading, transferring, or applying pesticides is in proper operating condition as intended by the manufacturer, and can be used without risk of reasonably foreseeable adverse effects to the noncertified applicator, other persons, or the environment.
              (v) The certified applicator must ensure that a means to immediately communicate with the certified applicator is available to each noncertified applicator using restricted use pesticides under his or her direct supervision.
              (vi) The certified applicator must be physically present at the site of the use being supervised when required by the product labeling.
              (vii) If the certified applicator is a commercial applicator, the certified applicator must create or verify the existence of the records required by paragraph (e) of this section.
              (c) Noncertified applicator qualifications. Before any noncertified applicator uses a restricted use pesticide under the direct supervision of the certified applicator, the supervising certified applicator must ensure that the noncertified applicator has met at least one of the following qualifications:
              (1) The noncertified applicator has been trained in accordance with paragraph (d) of this section within the last 12 months.
              (2) The noncertified applicator has met the training requirements for an agricultural handler under 40 CFR 170.501 of this title within the last 12 months.
              (3) The noncertified applicator has met the requirements established by a certifying authority that meet or exceed the standards in § 171.201(c)(1).
              (4) The noncertified applicator is currently a certified applicator but is not certified to perform the type of application being conducted or is not certified in the jurisdiction where the use will take place.
              (d) Noncertified applicator training program. (1) General noncertified applicator training must be presented to noncertified applicators either orally from written materials or audiovisually. The information must be presented in a manner that the noncertified applicators can understand, such as through a translator. The person conducting the training must be present during the entire training program and must respond to the noncertified applicators' questions.
              (2) The person who conducts the training must meet one of the following criteria:
              (i) Be currently certified as an applicator of restricted use pesticides under this part.
              (ii) Be currently designated as a trainer of certified applicators or pesticide handlers by EPA, the certifying authority, or a State, Tribal, or Federal agency having jurisdiction.
              (iii) Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of handlers under 40 CFR part 170.

              (3) The noncertified applicator training materials must include the information that noncertified applicators need in order to protect themselves, other people, and the environment before, during, and after making a restricted use pesticide application. The noncertified applicator training materials must include, at a minimum, the following:
              (i) Potential hazards from toxicity and exposure that pesticides present to noncertified applicators and their families, including acute and chronic effects, delayed effects, and sensitization.
              (ii) Routes through which pesticides can enter the body.
              (iii) Signs and symptoms of common types of pesticide poisoning.
              (iv) Emergency first aid for pesticide injuries or poisonings.
              (v) Routine and emergency decontamination procedures, including emergency eye flushing techniques. Noncertified applicators must be instructed that if pesticides are spilled or sprayed on the body, to immediately wash or to rinse off in the nearest clean water. Noncertified applicators must also be instructed to wash or shower with soap and water, shampoo hair, and change into clean clothes as soon as possible.
              (vi) How and when to obtain emergency medical care.
              (vii) After working with pesticides, wash hands before eating, drinking, using chewing gum or tobacco, or using the toilet.
              (viii) Wash or shower with soap and water, shampoo hair and change into clean clothes as soon as possible after working with pesticides.
              (ix) Potential hazards from pesticide residues on clothing.
              (x) Wash work clothes before wearing them again and wash them separately from other clothes.
              (xi) Do not take pesticides or pesticide containers used at work to your home.
              (xii) Potential hazards to children and pregnant women from pesticide exposure.
              (xiii) After working with pesticides, remove work boots or shoes before entering your home, and remove work clothes and wash or shower before physical contact with children or family members.
              (xiv) How to report suspected pesticide use violations to the appropriate State or Tribal agency responsible for pesticide enforcement.
              (xv) Format and meaning of information contained on pesticide labels and in labeling applicable to the safe use of the pesticide, including the location and meaning of the restricted use product statement, how to identify when the labeling requires the certified applicator to be physically present during the use of the pesticide, and information on personal protective equipment.
              (xvi) Need for, and appropriate use and removal of, personal protective equipment.
              (xvii) How to recognize, prevent, and provide first aid treatment for heat-related illness.
              (xviii) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
              (xix) Environmental concerns such as drift, runoff, and wildlife hazards.
              (xx) Restricted use pesticides may be used only by a certified applicator or by a noncertified applicator working under the direct supervision of a certified applicator.
              (xxi) The certified applicator's responsibility to provide to each noncertified applicator instructions specific to the site and pesticide used. These instructions must include labeling directions, precautions, and requirements applicable to the specific use and site, and how the characteristics of the use site (e.g., surface and ground water, endangered species, local population, and risks) and the conditions of application (e.g., equipment, method of application, formulation, and risks) might increase or decrease the risk of adverse effects. The certified applicator must provide these instructions in a manner the noncertified applicator can understand.
              (xxii) The certified applicator's responsibility to ensure that each noncertified applicator has access to the applicable product labeling at all times during its use.

              (xxiii) The certified applicator's responsibility to ensure that where the labeling of a pesticide product requires that personal protective equipment be worn for mixing, loading, application, or any other use activities, each noncertified applicator has clean, labeling-required personal protective equipment in proper operating condition and that the personal protective equipment is worn and use correctly for its intended purpose.
              (xxiv) The certified applicator's responsibility to ensure that before each day of use equipment used for mixing, loading, transferring, or applying pesticides is in proper operating condition as intended by the manufacturer, and can be used without risk of reasonably foreseeable adverse effects to the noncertified applicator, other persons, or the environment.
              (xxv) The certified applicator's responsibility to ensure that a means to immediately communicate with the certified applicator is available to each noncertified applicator using restricted use pesticides under his or her direct supervision.
              (e) Recordkeeping. (1) Commercial applicators must create or verify the existence of records documenting that each noncertified applicator has the qualifications required in paragraph (c) of this section. For each noncertified applicator, the records must contain the information appropriate to the method of qualification as provided in paragraphs (e)(1)(i) through (e)(1)(iv).
              (i) If the noncertified applicator was trained in accordance with paragraph (c)(1) of this section, the record must contain all of the following information:
              (A) The noncertified applicator's printed name and signature.
              (B) The date the training requirement in paragraph (c) of this section was met.
              (C) The name of the person who provided the training.
              (D) The title or a description of the training provided.
              (ii) If the noncertified applicator was trained as an agricultural handler under 40 CFR 170.501 in accordance with paragraph (c)(2) of this section, the record must contain all of the information required at 40 CFR 170.501(d)(1).
              (iii) If the noncertified applicator qualified by satisfying the requirements established by the certifying authority, as described in paragraph (c)(3) of this section, the record must contain the information required by the certifying authority.
              (iv) If the noncertified applicator is a certified applicator who is not certified to perform the type of application being conducted or not certified in the jurisdiction where the use will take place, as described in paragraph (c)(4) of this section, the record must include all of the following information:
              (A) The noncertified applicator's name.
              (B) The noncertified applicator's certification number.
              (C) The expiration date of the noncertified applicator's certification.
              (D) The certifying authority that issued the certification.
              (2) The commercial applicator must create or verify the existence of the record containing the information in paragraph (e)(1) of this section before allowing the noncertified applicator to use restricted use pesticides under his or her direct supervision.
              (3) The commercial applicator supervising any noncertified applicator must have access to records documenting the information required in paragraph (e)(1) of this section at the commercial applicator's principal place of business for two years from the date the noncertified applicator used the restricted use pesticide.
              (f) Exceptions. The requirements in § 171.201(a) through (e) of this part do not apply to the following persons:
              (1) Persons conducting laboratory research involving restricted use pesticides.
              (2) Doctors of Medicine and Doctors of Veterinary Medicine applying restricted use pesticides to patients during the course of the ordinary practice of those professions.

            Subpart D—Certification Plans

              Source:
              82 FR 1042, Jan. 4, 2017, unless otherwise noted.

              § 171.301
              General.
              (a) Jurisdiction. A certification issued under a particular certifying authority's certification plan is only valid within the geographical area specified in the certification plan approved by the Agency.

              § 171.303
              Requirements for State certification plans.
              (a) Conformance with Federal standards for certification of applicators of restricted use pesticides. A State may certify applicators of restricted use pesticides only in accordance with a State certification plan approved by the Agency. The State certification plan must meet all of the following requirements:
              (1) The State certification plan must include a full description of the proposed process the State will use to assess applicator competency to use or supervise the use of restricted use pesticides in the State.
              (2) The State certification plan must specify which of the certification categories listed in § 171.101 will be included in the plan.
              (i) A State certification plan may omit any unneeded certification categories.
              (ii) A State certification plan may designate subcategories within the categories described in §§ 171.101 and 171.105(b) through (f) as it deems necessary.
              (iii) A State certification plan may include additional certification categories not covered by the existing Federal categories described in §§ 171.101 and 171.105(b)-(f).
              (iv) A State certification plan may combine the categories described in § 171.101(m) through (n) into a single general fumigation category for commercial applicators.
              (v) A State certification plan may combine the categories described in § 171.105(d) through (e) into a single general fumigation category for private applicators.
              (3) For each of the categories adopted pursuant to paragraph (b)(1) of this section, the State certification plan must include standards for the certification of applicators of restricted use pesticides that meet or exceed those standards prescribed by the Agency under §§ 171.101 through 171.105, except as provided in paragraph (a)(4) of this section.
              (4) A State may adopt a limited use category for commercial applicators. A limited use category covers a small number of commercial applicators engaged in a use that does not clearly fit within any of the commercial applicator categories specified pursuant to paragraph (b)(2) of this section, and allows only the use of a limited set of restricted use pesticides by specific application methods. A State adopting a limited use category must include all of the following in its certification plan:
              (i) A definition of the limited use category, specifying the restricted use pesticide(s), use sites, and specific application methods permitted.
              (ii) An explanation of why it is not practical to include the limited use within any of the commercial applicator categories specified pursuant to paragraph (b)(2) of this section.
              (iii) A requirement that candidates for certification in a limited use category pass the written examination covering the core standards at § 171.103(c) and demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticide(s) covered by the limited use category.
              (iv) Specific competency standards for the limited use category.
              (v) The process by which applicators must demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of the restricted use pesticides authorized under the limited use category based on the competency standards identified in paragraph (a)(4)(iv) of this section. This does not have to be accomplished by a written examination.
              (vi) A description of the recertification standards for the limited use category and how those standards meet or exceed the standards prescribed by the Agency under § 171.107.
              (vii) A description of the limited use certification credential. The credential must clearly state that the applicator is only authorized to purchase and use the specific restricted use pesticide(s) identified in that credential.

              (5) The State certification plan must include standards for certification examinations that meet or exceed the standards prescribed by the Agency under § 171.103(a)(2), including a description of any alternative identification that a State will authorize in addition to a valid, government-issued photo identification.

              (6) The State certification plan must include standards for the recertification of applicators of restricted use pesticides that meet or exceed those standards prescribed by the Agency under § 171.107.
              (7) The State certification plan must include standards for the direct supervision of noncertified applicators by certified private and commercial applicators of restricted use pesticides that meet or exceed those standards prescribed by the Agency under § 171.201, or must state that use by noncertified applicators is not permitted.
              (8) The State certification plan must describe the credentials or documents the State certifying authority will issue to each certified applicator verifying certification.
              (9) A State may waive any or all of the procedures specified in § 171.103, § 171.105, and § 171.107 of this part when certifying applicators in reliance on valid current certifications issued by another State, Tribal, or Federal agency under an EPA-approved certification plan. The State certification plan must explain whether, and if so, under what circumstances, the State will certify applicators based in whole or in part on their holding a valid current certification issued by another State, Tribe or Federal agency. Such certifications are subject to all of the following conditions:
              (i) A State may rely only on valid current certifications that are issued under an approved State, Tribal or Federal agency certification plan.
              (ii) The State has examined the standards of competency used by the State, Tribe, or Federal agency that originally certified the applicator and has determined that, for each category of certification that will be accepted, they are comparable to its own standards.
              (iii) Any State that chooses to certify applicators based, in whole or in part, on the applicator having been certified by another State, Tribe, or Federal agency, must include in its plan a mechanism that allows the State to terminate an applicator's certification upon notification that the applicator's original certification terminates because the certificate holder has been convicted under section 14(b) of FIFRA or has been subject to a final order imposing a civil penalty under section 14(a) of FIFRA.
              (iv) The State issuing a certification based in whole or in part on the applicator holding a valid current certification issued by another State, Tribe or Federal agency must issue an appropriate State credential or document to the applicator.
              (b) Contents of an application for EPA approval of a State plan for certification of applicators of restricted use pesticides.

              (1) The application for Agency approval of a State certification plan must list and describe the categories of certification.
              (2) The application for Agency approval of a State certification plan must contain satisfactory documentation that the State standards for the certification of commercial applicators meet or exceed those standards prescribed by the Agency under §§ 171.101 and 171.103. Such documentation must include one of the following:
              (i) A statement that the State has adopted the same standards for certification of commercial applicators prescribed by the Agency under §§ 171.101 and 171.103 and a citation of the specific State laws and/or regulations demonstrating that the State has adopted such standards.
              (ii) A statement that the State has adopted its own standards that meet or exceed the standards for certification of commercial applicators prescribed by the Agency under §§ 171.101 and 171.103. If the State selects this option, the application for Agency approval of a State certification plan must include all of the following:
              (A) A list and detailed description of all the categories and subcategories to be used for certification of commercial applicators in the State and a citation to the specific State laws and/or regulations demonstrating that the State has adopted such categories and subcategories.

              (B) A list and detailed description of all of the standards for certification of commercial applicators adopted by the State and a citation to the specific State laws and/or regulations demonstrating that the State has adopted such standards. Any additional categories or subcategories established by a State must be included in the application for Agency approval of a State plan and must clearly describe the standards the State will use to determine if the applicator has the necessary competency.
              (C) A description of the State's commercial applicator certification examination standards and an explanation of how they meet or exceed the standards prescribed by the Agency under § 171.103(a)(2).
              (3) The application for Agency approval of a State certification plan must contain satisfactory documentation that the State standards for the certification of private applicators meet or exceed those standards prescribed by the Agency under § 171.105. Such documentation must include a statement that the State has adopted its own standards that meet or exceed the standards for certification of private applicators of restricted use pesticides prescribed by the Agency under § 171.105. The application for Agency approval of a State certification plan must include all of the following:
              (i) A list and detailed description of all the categories and subcategories to be used for certification of private applicators in the State and a citation to the specific State laws and/or regulations demonstrating that the State has adopted such categories and subcategories.
              (ii) A list and detailed description of all of the standards for certification of private applicators adopted by the State and a citation to the specific State laws and/or regulations demonstrating that the State has adopted such standards. Any additional categories or subcategories established by a State must be identified in the application for Agency approval of a State plan and the application must clearly describe the standards the State will use to determine if the applicator has the necessary competency.
              (iii) If private applicator certification is based upon written examination, a description of the State's private applicator certification examination standards and an explanation of how those meet or exceed the standards prescribed by the Agency under § 171.103(a)(2).
              (iv) If private applicator certification is based upon training, an explanation of how the quantity, content, and quality of the State's training program ensure that a private applicator demonstrates the level of competency required § 171.105 for private applicators, addressing, at the minimum, all of the following factors:
              (A) The quantity of training required to become certified as a private applicator.
              (B) The content that is covered by the training and how the State ensures that required content is covered.
              (C) The process the State uses to approve training programs for private applicator certification.
              (D) How the State ensures the ongoing quality of the training program for private applicator certification.
              (4) The application for Agency approval of a State certification plan must contain satisfactory documentation that the State standards for the recertification of applicators of restricted use pesticides meet or exceed those standards prescribed by the Agency under § 171.107. Such documentation must include a statement that the State has adopted its own standards that meet or exceed the standards for recertification prescribed by the Agency under § 171.107. The application for Agency approval of a State certification plan must include all of the following:
              (i) A list and detailed description of all of the State standards for recertification of private and commercial applicators, including the elements described in § 171.303(b)(4)(ii) through (iv), and a citation of the specific State laws and/or regulations demonstrating that the State has adopted such standards.
              (ii) The certification period, which may not exceed five years.

              (iii) If recertification is based upon written examination, a description of the State's process for reviewing, and updating as necessary, the written examination(s) to ensure that the written examination(s) evaluates whether a certified applicator demonstrates the level of competency required by § 171.103 for commercial applicators or § 171.105 for private applicators.

              (iv) If recertification is based upon continuing education, an explanation of how the quantity, content, and quality of the State's continuing education program ensures that a certified applicator continues to demonstrate the level of competency required by § 171.103 for commercial applicators or § 171.105 for private applicators, including but not limited to:
              (A) The quantity of continuing education required to maintain certification.
              (B) The content that is covered by the continuing education program and how the State ensures the required content is covered.
              (C) The process the State uses to approve continuing education courses or events, including information about how the State ensures that any continuing education courses or events verify the applicator's successful completion of the course or event.
              (D) How the State ensures the ongoing quality of the continuing education program.
              (5) The application for Agency approval of a State certification plan must contain satisfactory documentation that the State standards for the direct supervision of noncertified applicators by certified private and commercial applicators of restricted use pesticides meet or exceed those standards prescribed by the Agency under § 171.201. Such documentation may include one or more of the following as applicable:
              (i) A statement that the State has adopted the standards for direct supervision of noncertified applicators by certified private and/or commercial applicators prescribed by the Agency under § 171.201 and a citation of the specific State laws and/or regulations demonstrating that the State has adopted such standards.
              (ii) A statement that the State prohibits noncertified applicators from using restricted use pesticides under the direct supervision of certified private and/or commercial applicators, and a citation of the specific State laws and/or regulations demonstrating that the State has adopted such a prohibition.
              (iii) A statement that the State has adopted standards for direct supervision of noncertified applicators by certified private and/or commercial applicators that meet or exceed the standards prescribed by the Agency under § 171.201, a citation of the specific State laws and/or regulations demonstrating that the State has adopted such standards, and an explanation of how the State standards meet or exceed the standards prescribed by the Agency under § 171.201.
              (6) The application for Agency approval of a State certification plan must include all of the following:
              (i) A written statement by the Governor of the State designating a lead agency responsible for administering the State certification plan. The lead agency will serve as the central contact point for the Agency. The State certification plan must identify the primary point of contact at the lead agency responsible for administering the State certification plan and serving as the central contact for the Agency on any issues related to the State certification plan. In the event that more than one agency or organization will be responsible for performing functions under the State certification plan, the application for Agency approval of a State plan must identify all such agencies and organizations and list the functions to be performed by each, including compliance monitoring and enforcement responsibilities. The application for Agency approval of a State plan must indicate how these functions will be coordinated by the lead agency to ensure consistency of the administration of the State certification plan.
              (ii) A written opinion from the State attorney general or from the legal counsel of the State lead agency that states that the lead agency and other cooperating agencies have the legal authority necessary to carry out the State certification plan.
              (iii) A listing of the qualified personnel that the lead agency and any cooperating agencies or organizations have to carry out the State certification plan. The list must include the number of staff, job titles, and job functions of such personnel of the lead agency and any cooperating organizations.

              (iv) A commitment by the State that the lead agency and any cooperators will ensure sufficient resources are available to carry out the applicator certification program as detailed in the State certification plan.
              (v) A document outlining the State's proposed approach and anticipated timeframe for implementing the State certification plan after EPA approves the State certification plan.
              (7) The application for Agency approval of a State certification plan must include a complete copy of all State laws and regulations relevant to the State certification plan. In addition, the application for Agency approval of a State plan must include citations to the specific State laws and regulations that demonstrate specific legal authority for each of the following:
              (i) Provisions for and listing of the acts which would constitute grounds for denying, suspending, and revoking certification of applicators. Such grounds must include, at a minimum, misuse of a pesticide, falsification of any records required to be maintained by the certified applicator, a criminal conviction under section 14(b) of FIFRA, a final order imposing civil penalty under section 14(a) of FIFRA, and conclusion of a State enforcement action for violations of State laws or regulations relevant to the State certification plan.
              (ii) Provisions for reviewing, and where appropriate, suspending or revoking an applicator's certification based on any of the grounds listed in the plan pursuant to paragraph (b)(7)(i) of this section, or a criminal conviction under section 14(b) of FIFRA, a final order imposing civil penalty under section 14(a) of FIFRA, or conclusion of a State enforcement action for violations of State laws or regulations relevant to the State certification plan.
              (iii) Provisions for assessing criminal and civil penalties for violations of State laws or regulations relevant to the State certification plan.
              (iv) Provisions for right of entry by consent or warrant by State officials at reasonable times for sampling, inspection, and observation purposes.
              (v) Provisions making it unlawful for persons other than certified applicators or noncertified applicators working under a certified applicator's direct supervision to use restricted use pesticides.
              (vi) Provisions requiring certified commercial applicators to record and maintain for the period of at least two years routine operational records containing information on types, amounts, uses, dates, and places of application of restricted use pesticides and for ensuring that such records will be available to appropriate State officials. Such provisions must require commercial applicators to record and maintain, at a minimum, all of the following:
              (A) The name and address of the person for whom the restricted use pesticide was applied.
              (B) The location of the restricted use pesticide application.
              (C) The size of the area treated.
              (D) The crop, commodity, stored product, or site to which the restricted use pesticide was applied.
              (E) The time and date of the restricted use pesticide application.
              (F) The brand or product name of the restricted use pesticide applied.
              (G) The EPA registration number of the restricted use pesticide applied.
              (H) The total amount of the restricted use pesticide applied per location per application.
              (I) The name and certification number of the certified applicator that made or supervised the application, and, if applicable, the name of any noncertified applicator(s) that made the application under the direct supervision of the certified applicator.
              (J) Records required under § 171.201(e).
              (vii) Provisions requiring restricted use pesticide retail dealers to record and maintain at each individual dealership, for the period of at least two years, records of each transaction where a restricted use pesticide is distributed or sold to any person, excluding transactions solely between persons who are pesticide producers, registrants, wholesalers, or retail sellers, acting only in those capacities. Records of each such transaction must include all of the following information:

              (A) Name and address of the residence or principal place of business of each certified applicator to whom the restricted use pesticide was distributed or sold, or if applicable, the name and address of the residence or principal place of business of each noncertified person to whom the restricted use pesticide was distributed or sold for application by a certified applicator.
              (B) The certification number on the certification document presented to the seller evidencing the valid certification of the certified applicator authorized to purchase the restricted use pesticide, the State, Tribe or Federal agency that issued the certification document, the expiration date of the certified applicator's certification, and the category(ies) in which the applicator is certified relevant to the pesticide(s) sold.
              (C) The product name and EPA registration number of the restricted use pesticide(s) distributed or sold in the transaction, including any applicable emergency exemption or State special local need registration number.
              (D) The quantity of the restricted use pesticide(s) distributed or sold in the transaction.
              (E) The date of the transaction.
              (c) Requirement to submit reports to the Agency. The State must agree to submit the following reports to the Agency in a manner and containing the information that the Agency requires:
              (1) An annual report to be submitted by the State lead agency to the Agency by the date established by the Agency that includes all of the following information:
              (i) The number of new general private applicator certifications and recertifications issued during the last 12 month reporting period, and total number of applicators holding a valid general private applicator certification at the end of the last 12 month reporting period.
              (ii) For each private applicator category specified in the certification plan, the numbers of new certifications and recertifications issued during the last 12 month reporting period, and the total number holding valid certifications in each category at the end of the last 12 month reporting period.
              (iii) The numbers of new commercial applicator certifications and recertifications issued during the last 12 month reporting period, and the total number of applicators certified in at least one commercial applicator certification category at the end of the last 12 month reporting period.
              (iv) For each commercial applicator certification category or subcategory specified in the certification plan, the numbers of new certifications and recertifications issued during the last 12 month reporting period, and the total number of commercial applicators holding a valid certification in each category or subcategory at the end of the last 12 month reporting period.
              (v) A description of any modifications made to the approved certification plan during the last 12 month reporting period that have not been previously evaluated by the Agency under § 171.309(a)(3).
              (vi) A description of any proposed changes to the certification plan that the State anticipates making during the next reporting period that may affect the certification program.
              (vii) A summary of enforcement activities related to the use of restricted use pesticides during the last 12 month reporting period.
              (2) Any other reports reasonably required by the Agency in its oversight of restricted use pesticides.

              § 171.305
              Requirements for Federal agency certification plans.
              (a) A Federal agency may certify applicators of restricted use pesticides only in accordance with a Federal agency certification plan approved by the Agency. Certification must be limited to the employees of the Federal agency covered by the certification plan and will be valid only for those uses of restricted use pesticides conducted in the performance of the employees' official duties.
              (1) The Federal agency certification plan must include a full description of the proposed process the Federal agency will use to assess applicator competency to use or supervise the use of restricted use pesticides.
              (2) Employees certified by the Federal agency must meet the standards for commercial applicators.

              (3) The Federal agency certification plan must list and describe the categories of certification from the certification categories listed in § 171.101 that will be included in the plan except that:
              (i) A Federal agency certification plan may omit any unneeded certification categories.
              (ii) A Federal agency certification plan may designate subcategories within the categories described in § 171.101 as it deems necessary.
              (iii) A Federal agency certification plan may include additional certification categories not covered by the existing Federal categories described in § 171.101.
              (iv) A Federal agency certification plan may combine the categories described in § 171.101(m) through (n) into a single general fumigation category for commercial applicators.
              (4) For each of the categories adopted pursuant to paragraph (b)(1) of this section, the Federal agency plan must include standards for the certification of applicators of restricted use pesticides that meet or exceed those standards prescribed by the Agency under §§ 171.101 through 171.103, except as provided at paragraph (a)(5) of this section.
              (5) A Federal agency may adopt a limited use category for commercial applicators. A limited use category covers a small number of applicators engaged in a use that does not clearly fit within any of the categories in § 171.101, and allows only the use of a limited set of restricted use pesticides by specific application methods. A Federal agency adopting a limited use category must include all of the following in its certification plan:
              (i) A definition of the limited use category, specifying the restricted use pesticide(s), use sites, and specific application methods permitted.
              (ii) An explanation of why it is not practical to include the limited use category in any of the categories in § 171.101.
              (iii) A requirement that candidates for certification in a limited use category pass the written examination covering the core standards at § 171.103(c) and demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticide(s) covered by the limited use category.
              (iv) Specific competency standards for the limited use category.
              (v) The process by which applicators must demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of restricted use pesticides covered by the limited use category based on the competency standards identified in paragraph (a)(5)(iv) of this section. This does not have to be accomplished by a written examination.
              (vi) A description of the recertification standards for the limited use category and how those standards meet or exceed the standards prescribed by the Agency under § 171.107.
              (vii) A description of the limited use certification credential. The credential must clearly state that the applicator is only authorized to purchase and use the specific restricted use pesticide(s) identified in that credential.
              (6) The Federal agency standards for certification examinations must meet or exceed the standards prescribed by the Agency under § 171.103(a)(2), including a description of any alternative identification that the Federal agency will authorize in addition to a valid, government-issued photo identification.
              (7) The Federal agency standards for the recertification of applicators of restricted use pesticides must meet or exceed those standards prescribed by the Agency under § 171.107.
              (8) The Federal agency standards for the direct supervision of noncertified applicators by certified private and commercial applicators of restricted use pesticides must meet or exceed those standards prescribed by the Agency under § 171.201.
              (9) The Federal agency certification plan must describe the credentials or documents the Federal agency will issue to each certified applicator verifying certification of applicators.

              (10) A Federal agency may waive any or all of the procedures specified in § 171.103, § 171.105, and § 171.107 of this part when certifying applicators in reliance on valid current certifications issued by another State, Tribal, or Federal agency under an EPA-approved certification plan. The Federal agency certification plan must explain whether, and if so, under what circumstances, the Federal agency will certify applicators based in whole or in part on their holding a valid current certification issued by another State, Tribe or Federal agency. Such certifications are subject to all of the conditions listed at § 171.303(a)(9).
              (b) Contents of an application for EPA approval of a Federal agency plan for certification of applicators of restricted use pesticides.

              (1) The application for Agency approval of a Federal agency certification plan must list and describe the categories of certification.
              (2) The application for Agency approval of a Federal agency certification plan must contain satisfactory documentation that the Federal agency standards for certification of commercial applicators meet or exceed those standards prescribed by the Agency under §§ 171.101 and 171.103. Such a statement must include one of the following:
              (i) A statement that the Federal agency has adopted the same standards for certification prescribed by the Agency under §§ 171.101 through 171.103.
              (ii) A statement that the Federal agency has adopted its own standards that meet or exceed the standards for certification prescribed by the Agency under §§ 171.101 through 171.103. If the Federal agency selects this option, the application for Agency approval of a Federal agency certification plan must include all of the following:
              (A) A list and detailed description of all the categories and subcategories to be used for certification of commercial applicators.
              (B) A list and detailed description of all of the standards for certification of commercial applicators adopted by the Federal agency. Any additional categories or subcategories established by a Federal agency must be included in the application for Agency approval of a Federal agency plan and must clearly describe the standards the Federal agency will use to determine if the applicator has the necessary competency.
              (C) A description of the Federal agency's certification examination standards and an explanation of how those meet or exceed the standards prescribed by the Agency under § 171.103(a)(2).
              (3) The application for Agency approval of a Federal agency plan must contain satisfactory documentation that the Federal agency standards for recertification of commercial applicators of restricted use pesticides meet or exceed the standards for recertification prescribed by the Agency under § 171.107. Such documentation must include a statement that the Federal agency has adopted its own standards that meet or exceed the standards for recertification prescribed by the Agency under § 171.107. The application for Agency approval of a Federal agency certification plan must include all of the following:
              (i) A list and detailed description of all the standards for recertification adopted by the Federal agency.
              (ii) The certification period, which may not exceed five years.
              (iii) If recertification is based upon written examination, a description of the Federal agency's process for reviewing, and updating as necessary, the written examination(s) and to ensure that the written examination(s) evaluate whether a commercial applicator demonstrates the level of competency required by § 171.103.
              (iv) If recertification is based upon continuing education, an explanation of how the quantity, content and quality of the Federal agency's continuing education program ensure that a commercial applicator continues to demonstrate the level of competency required by § 171.103 for commercial applicators, including but not limited to, all of the following:
              (A) The quantity of continuing education required to maintain certification.
              (B) The content that is covered by the continuing education program and how the Federal agency ensures the relevant content is covered.

              (C) The process the Federal agency uses to approve continuing education training courses or events, including information about how the Federal agency ensures that any continuing education courses or events verify the commercial applicator's successful completion of the course or event.

              (D) How the Federal agency ensures the ongoing quality of the continuing education program.
              (4) The application for Agency approval of a Federal agency certification plan must contain satisfactory documentation that the Federal agency standards for direct supervision of noncertified applicators by commercial applicators meet or exceed those standards prescribed by the Agency under § 171.201. Such documentation may include one or more of the following as applicable:
              (i) A statement that the Federal agency has adopted the standards for direct supervision of noncertified applicators by commercial applicators prescribed by the Agency under § 171.201.
              (ii) A statement that the Federal agency prohibits noncertified applicators from using restricted use pesticides under the direct supervision of commercial applicators.
              (iii) A statement that the Federal agency has adopted standards for direct supervision of noncertified applicators by commercial applicators that meet or exceed the standards prescribed by the Agency under § 171.201 and an explanation of how the Federal agency standards meet or exceed the standards prescribed by the Agency under § 171.201.
              (5) The application for Agency approval of a Federal agency certification plan must meet or exceed all of the applicable requirements in § 171.303. However, in place of the legal authorities required in § 171.303(b)(7), the Federal agency may use administrative controls inherent in the employer-employee relationship to accomplish the objectives of § 171.303(b)(7). The application for Agency approval of a Federal agency certification plan must include a detailed description of how the Federal agency will exercise its administrative authority, where appropriate to deny, suspend or revoke certificates of employees who misuse pesticides, falsify records, or violate relevant provisions of FIFRA. Similarly, the application for Agency approval of a Federal agency certification plan must include a commitment that the Federal agency will record and maintain for the period of at least two years routine operational records containing information on types, amounts, uses, dates, and places of application of restricted use pesticides and that such records will be available to State and Federal officials. Such recordkeeping requirements must require Federal agency employees certified as commercial applicators to record and maintain, at a minimum, all of the records specified in § 171.303(b)(7)(vi).
              (c) The application for Agency approval of a Federal agency certification plan must include a commitment by the Federal agency to submit an annual report to the Agency in a manner that the Agency requires that includes all of the following information:
              (1) The numbers of new, recertified, and total commercial applicators certified in at least one certification category at the end of the last 12 month reporting period.
              (2) For each commercial applicator certification category specified in § 171.101 or subcategory specified in the Federal agency certification plan, the numbers of new, recertified and total commercial applicators holding a valid certification in each of those categories at the end of the last 12 month reporting period.
              (3) A description of any modifications made to the approved certification plan during the last 12 month reporting period that have not been previously evaluated under § 171.309(a)(3).
              (4) A description of any proposed changes to the certification plan that may affect the certification program that the Federal agency anticipates making during the next reporting period.
              (5) A summary of enforcement activities related to use of restricted use pesticides by applicators certified by the Federal agency during the last 12 month reporting period.
              (d) The application for Agency approval of a Federal agency certification plan must include a commitment by the Federal agency to submit any other reports reasonably required by the Agency in its oversight of the use of restricted use pesticides.

              (e) If applicators certified under the Federal agency plan will make any applications of restricted use pesticides in areas that are not subject to exclusive federal jurisdiction, the application for Agency approval of a Federal agency certification plan must meet all of the following additional requirements:
              (1) The Federal agency plan must have a provision that affirms Federal agency certified applicators will comply with all applicable State and Tribal pesticide laws and regulations of the jurisdiction in which the restricted pesticide is being used when using restricted use pesticides areas that are not subject to exclusive federal jurisdiction, including any substantive State or Tribal standards in regard to qualifications for commercial applicator certification that exceed the Federal agency's standards.
              (2) The Federal agency plan must have a provision for the Federal agency to notify the appropriate EPA Regional office and State or Tribal pesticide authority in the event of misuse or suspected misuse of a restricted use pesticide by a Federal agency employee and any pesticide exposure incident involving human or environmental harm that may have been caused by an application of a restricted use pesticide made by a Federal agency employee in an area not subject to exclusive federal jurisdiction.
              (3) The Federal agency plan must have a provision for the Federal agency to cooperate with the Agency and the State or Tribal pesticide authority in any investigation or enforcement action undertaken in connection with an application of a restricted use pesticide made by a Federal agency employee in an area not subject to exclusive federal jurisdiction.

              § 171.307
              Certification of applicators in Indian country.
              All applicators of restricted use pesticides in Indian country must hold a certification valid in that area of Indian country, or be working under the direct supervision of a certified applicator whose certification is valid in that area of Indian country. An Indian Tribe may certify applicators of restricted use pesticides in Indian country only pursuant to a certification plan approved by the Agency that meets the requirements of paragraph (a) or (b) of this section. The Agency may implement a Federal certification plan, pursuant to paragraph (c) of this section and § 171.311, for an area of Indian country not covered by an approved plan.
              (a) An Indian Tribe may choose to allow persons holding currently valid certifications issued under one or more specified State, Tribal, or Federal agency certification plans to use restricted use pesticides within the Tribe's Indian country.
              (1) A certification plan under paragraph (a) of this section must consist of a written agreement between the Tribe and the relevant EPA Region(s) that contains all of the following information:
              (i) A detailed map or legal description of the area(s) of Indian country covered by the plan.
              (ii) A listing of the State(s), Tribe(s) or Federal agency(ies) upon whose certifications the Tribe will rely.
              (iii) A description of any Tribal law, regulation, or code relating to application of restricted use pesticides in the covered area of Indian country, including a citation to each applicable Tribal law, regulation, or code.
              (iv) A description of the procedures and relevant authorities for carrying out compliance monitoring under and enforcement of the plan, including all of the following:
              (A) A description of the Agency and Tribal roles and procedures for conducting inspections.
              (B) A description of the Agency and Tribal roles and procedures for handling case development and enforcement actions and actions on certifications, including procedures for exchange of information.
              (C) A description of the Agency and Tribal roles and procedures for handling complaint referrals.

              (v) A description and copy of any separate agreements relevant to administering the certification plan and carrying out related compliance monitoring and enforcement activities. The description shall include a listing of all parties involved in each separate agreement and the respective roles, responsibilities, and relevant authorities of those parties.

              (2) To the extent that an Indian Tribe is precluded from exercising criminal enforcement authority, the Federal government will exercise primary criminal enforcement authority in regard to a certification plan under paragraph (a) of this section. The Tribe and the relevant EPA Region(s) shall develop a procedure whereby the Tribe will provide potential investigative leads to EPA and/or other appropriate Federal agencies in an appropriate and timely manner. This procedure shall encompass, at a minimum, all circumstances in which the Tribe is precluded from exercising relevant criminal enforcement authority. This procedure shall be included as part of the agreement between the Tribe and relevant EPA Region(s) described in paragraph (a)(1) of this section.
              (3) A plan for the certification of applicators under paragraph (a) of this section shall not be effective until the agreement between the Tribe and the relevant EPA Region(s) has been signed by the Tribe and the appropriate EPA Regional Administrator(s).
              (b) An Indian Tribe may choose to develop its own certification plan for certifying private and commercial applicators to use or supervise the use of restricted use pesticides.
              (1) A certification plan under paragraph (b) of this section shall consist of a written plan submitted by the Tribe to the Agency for approval that includes all of the following information:
              (i) A detailed map or legal description of the area(s) of Indian country covered by the plan.
              (ii) A demonstration that the plan meets all requirements of § 171.303 applicable to State plans, except that the Tribe's plan will not be required to meet the requirements of § 171.303(b)(6)(iii) with respect to provisions for criminal penalties, or any other requirement for assessing criminal penalties.
              (2) To the extent that an Indian Tribe is precluded from exercising criminal enforcement authority, the Federal government will exercise primary criminal enforcement authority in regard to a certification plan under paragraph (b) of this section. The Tribe and the relevant EPA Region(s) shall develop a procedure whereby the Tribe will provide potential investigative leads to EPA and/or other appropriate Federal agencies in an appropriate and timely manner. This procedure shall encompass, at a minimum, all circumstances in which the Tribe is precluded from exercising relevant criminal enforcement authority and shall be described in a memorandum of agreement signed by the Tribe and the relevant EPA Regional Administrator(s).
              (3) A plan for the certification of applicators under paragraph (b) of this section shall not be effective until the memorandum of agreement required under paragraph (b)(2) of this section has been signed by the Tribe and the relevant EPA Region(s) and the plan has been approved by the Agency.
              (c) In any area of Indian country not covered by an approved certification plan, the Agency may, in consultation with the Tribe(s) affected, implement an EPA-administered certification plan under § 171.311 for certifying private and commercial applicators to use or supervise the use of restricted use pesticides.

              (1) Prior to publishing a notice of a proposed EPA-administered certification plan for an area of Indian country in the Federal Register for review and comment under § 171.311(d)(3), the Agency shall notify the relevant Indian Tribe(s) of EPA's intent to propose the plan.
              (2) The Agency will not implement an EPA-administered certification plan for any area of Indian country where, prior to the expiration of the notice and comment period provided under § 171.311(d)(3), the chairperson or equivalent elected leader of the relevant Tribe provides the Agency with a written statement of the Tribe's position that the plan should not be implemented.

              § 171.309
              Modification and withdrawal of approval of certification plans.
              (a) Modifications to approved certification plans. A State, Tribe, or Federal agency may make modifications to its approved certification plan, provided that all of the following conditions are met:

              (1) Determination of plan compliance. Before modifying an approved certification plan, the State, Tribe, or Federal agency must determine that the proposed modifications will not impair the certification plan's compliance with the requirements of this part or any other Federal laws or regulations.
              (2) Requirement for Agency notification. The State, Tribe, or Federal agency must notify the Agency of any plan modifications within 90 days after the final State, Tribal, or Federal agency plan modifications become effective or when it submits its required annual report to the Agency, whichever occurs first.
              (3) Additional requirements for substantial modifications to approved certification plans. Before making any substantial modifications to an approved certification plan, the State, Tribe or Federal agency must consult with the Agency and obtain Agency approval of the proposed modifications. Substantial modifications include the following:
              (i) Addition or deletion of a mechanism for certification and/or recertification.
              (ii) Establishment of a new private applicator category, private applicator subcategory, commercial applicator category, or commercial applicator subcategory.
              (iii) Any other changes that the Agency has notified the State, Tribal or Federal agency that the Agency considers to be substantial modifications.
              (4) Agency decision. The Agency shall make a written determination regarding the modified certification plan's compliance with the requirements of this part. The Agency shall give the certifying authority submitting a certification plan notice and opportunity for an informal hearing before rejecting the plan. The Agency's approval may be subject to reasonable terms and conditions. If the Agency approves modifications to a certification plan, that approval shall specify a schedule for implementation of the modified certification plan.
              (b) Withdrawal of approval. If at any time the Agency determines that a State, Tribal, or Federal agency certification plan does not comply with the requirements of this part or any other Federal laws or regulations, or that a State, Tribal, or Federal agency is not administering the certification plan as approved under this part, or that a State is not carrying out a program adequate to ensure compliance with FIFRA section 19(f), the Agency may withdraw approval of the certification plan. Before withdrawing approval of a certification plan, the Agency will notify the State, Tribal, or Federal agency and provide the opportunity for an informal hearing. If appropriate, the Agency may allow the State, Tribe, or Federal agency a reasonable time, not to exceed 90 days, to take corrective action.

              § 171.311
              EPA-administered applicator certification programs.
              (a) Applicability. This section applies in any State or area of Indian country where there is no approved State or Tribal certification plan in effect.
              (b) Certification requirement. In any State or area of Indian country where EPA administers a certification plan, any person who uses or supervises the use of any restricted use pesticide must meet one of the following criteria:
              (1) A commercial applicator must be certified in each category and subcategory, if any, as described in the EPA-administered plan, for which the applicator is applying or supervising the application of restricted use pesticides.
              (2) A private applicator must be certified in each category and subcategory, if any, as described in the EPA-administered plan, for which the applicator is applying or supervising the application of restricted use pesticides.
              (3) A noncertified applicator may only use a restricted use pesticide under the direct supervision of an applicator certified under the EPA-administered plan, in accordance with the requirements in § 171.201, and only for uses in categories authorized by that certified applicator's certification.
              (c) Implementation of EPA-administered plans in States.

              (1) In any State where this section is applicable, the Agency, in consultation with the Governor, may implement an EPA-administered plan for the certification of applicators of restricted use pesticides.

              (2) Such a plan will meet the applicable requirements of § 171.303. Prior to the implementation of the plan, the Agency will publish in the Federal Register for review and comment a summary of the proposed EPA-administered plan for the certification of applicators and will generally make available copies of the proposed plan within the State. The summary will include all of the following:
              (i) An outline of the proposed procedures and requirements for private and commercial applicator certification and recertification.
              (ii) A description of the proposed categories and subcategories for certification.
              (iii) A description of any proposed conditions for the recognition of State, Tribal, or Federal agency certifications.
              (iv) An outline of the proposed arrangements for coordination and communication between the Agency and the State regarding applicator certifications and pesticide compliance monitoring and enforcement.
              (d) Implementation of EPA-administered plans in Indian country.

              (1) In any area of Indian country where this section is applicable and consistent with the provisions of § 171.307(c), the Agency, in consultation with the appropriate Indian Tribe(s), may implement a plan for the certification of applicators of restricted use pesticides.
              (2) An EPA-administered plan may be implemented in the Indian country of an individual Tribe or multiple Tribes located within a specified geographic area.

              (3) Such a plan will meet the applicable requirements of § 171.303 and § 171.307(c). Prior to the implementation of the plan, the Agency will publish in the Federal Register for review and comment a summary of the proposed EPA-administered plan for the certification of applicators and will generally make available copies of the proposed plan within the area(s) of Indian country to be covered by the proposed plan. The summary will include all of the following:
              (i) A description of the area(s) of Indian country to be covered by the proposed plan.
              (ii) An outline of the proposed procedures and requirements for private and commercial applicator certification and recertification.
              (iii) A description of the proposed categories and subcategories for certification.
              (iv) A description of any proposed conditions for the recognition of State, Tribal, or Federal agency certifications.
              (v) An outline of the proposed arrangements for coordination and communication between the Agency and the relevant Tribe(s) regarding applicator certifications and pesticide compliance monitoring and enforcement.
              (e) Denial, suspension, modification, or revocation of a certification.

              (1) The Agency may suspend all or part of a certified applicator's certification issued under an EPA-administered plan or, after opportunity for a hearing, may deny issuance of, or revoke or modify, an applicator's certification issued under an EPA-administered plan, if the Agency finds that the applicator has been convicted under FIFRA section 14(b), has been subject to a final order imposing a civil penalty under FIFRA section 14(a), or has committed any of the following acts:
              (i) Used any registered pesticide in a manner inconsistent with its labeling.
              (ii) Made available for use, or used, any registered pesticide classified for restricted use other than in accordance with FIFRA section 3(d) and any regulations promulgated thereunder.
              (iii) Refused to keep and maintain any records required pursuant to this section.
              (iv) Made false or fraudulent records, invoices or reports.
              (v) Failed to comply with any limitations or restrictions on a valid current certificate.
              (vi) Violated any other provision of FIFRA and the regulations promulgated thereunder.

              (vii) Allowed a noncertified applicator to use a restricted use pesticide in a manner inconsistent with the requirements in § 171.201.

              (viii) Violated any provision of a State, Tribal or Federal agency certification plan or its associated laws or regulations.
              (2) If the Agency intends to deny, revoke, or modify an applicator's certification, the Agency will:
              (i) Notify the applicator of all of the following:
              (A) The legal and factual ground(s) upon which the denial, revocation, or modification is based.
              (B) The time period during which the denial, revocation or modification is effective, whether permanent or otherwise.
              (C) The conditions, if any, under which the applicator may become certified or recertified.
              (D) Any additional conditions the Agency may impose.
              (ii) Provide the applicator an opportunity to request an informal hearing prior to final Agency action to deny, revoke or modify the certification, and the opportunity to offer written statements of facts, explanations, comments, and arguments relevant to the proposed action.
              (3) If a hearing is requested by an applicator pursuant to paragraph (e)(2)(ii) of this section, the Agency will appoint an attorney in the Agency as Presiding Officer to conduct an informal hearing. No person shall serve as Presiding Officer if he or she has had any prior connection with the specific case.
              (4) The Presiding Officer appointed pursuant to paragraph (e)(3) of this section shall do all of the following:
              (i) Conduct a fair, orderly and impartial hearing, without unnecessary delay.
              (ii) Provide such procedural opportunities as the Presiding Officer may deem necessary to a fair and impartial hearing.
              (iii) Consider all relevant evidence, explanation, comment and argument properly submitted.
              (iii) Promptly notify the parties of the final decision and order. Such an order is a final Agency action subject to judicial review in accordance with FIFRA section 16.
              (5) If the Agency determines that the public health, interest or welfare warrants immediate action to suspend the certified applicator's certification during the course of the procedures specified in paragraphs (e)(2) through (e)(4) of this section, the Agency will do all of the following:
              (i) Notify the certified applicator of the ground(s) upon which the suspension action is based.
              (ii) Notify the certified applicator of the time period during which the suspension is effective.
              (iii) Notify the certified applicator of the Agency's intent to revoke or modify the certification, as appropriate, in accord with paragraph (e)(2) of this section. If such revocation or modification notice has not previously been issued, it must be issued at the same time the suspension notice is issued.
              (6) In cases where the act constituting grounds for suspension of a certification is neither willful nor contrary to the public interest, health, or safety, the certified applicator may have additional procedural rights under 5 U.S.C. 558(c).
              (7) Any notice, decision or order issued by the Agency under paragraph (e) of this section, and any documents and information considered by the Presiding Officer in issuing an order under paragraph (e)(4)(iv) of this section, shall be available to the public except as otherwise provided by FIFRA section 10 or by 40 CFR part 2. Any hearing at which oral testimony is presented shall be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information that may be entitled to confidentiality under FIFRA section 10 or under 40 CFR part 2.
              (f) Restricted use pesticide retail dealer reporting and recordkeeping requirements, availability of records, and failure to comply.

              (1) Reporting requirements. Each restricted use pesticide retail dealer in a State or area of Indian country where the Agency implements an EPA-administered plan must do both of the following:

              (i) Report to the Agency the business name by which the restricted use pesticide retail dealer operates and the name and business address of each of his or her dealerships. This report must be submitted to the appropriate EPA Regional office no later than 60 days after the EPA-administered plan becomes effective or 60 days after the date the person becomes a restricted use pesticide retail dealer in an area where an EPA-administered plan is in effect, whichever occurs later.
              (ii) Submit revisions to the initial report to the appropriate EPA Regional office reflecting any name changes, additions or deletions of dealerships. Revisions must be submitted to the appropriate EPA Regional office within 10 days of the occurrence of such change, addition or deletion.
              (2) Recordkeeping requirement. A restricted use pesticide retail dealer is required to create and maintain records of each sale of restricted use pesticides to any person, excluding transactions solely between persons who are pesticide producers, registrants, wholesalers, or retail sellers, acting only in those capacities. Each restricted use pesticide retail dealer must maintain at each individual dealership records of each transaction where a restricted use pesticide is distributed or sold by that dealership to any person. Records of each such transaction must be maintained for a period of two years after the date of the transaction and must include all of the following information:
              (i) Name and address of the residence or principal place of business of each certified applicator to whom the restricted use pesticide was distributed or sold, or if applicable, the name and address of the residence or principal place of business of each noncertified person to whom the restricted use pesticide was distributed or sold, for application by a certified applicator.
              (ii) The certification number on the certification document presented to the seller evidencing the valid certification of the certified applicator authorized to purchase the restricted use pesticide, the State, Tribe or Federal agency that issued the certification document, the expiration date of the certified applicator's certification, and the category(ies) in which the certified applicator is certified relevant to the pesticide(s) sold.
              (iii) The product name and EPA registration number of the restricted use pesticide(s) distributed or sold in the transaction, including any emergency exemption or State special local need registration number, if applicable.
              (iv) The quantity of the restricted use pesticide(s) distributed or sold in the transaction.
              (v) The date of the transaction.
              (3) Availability of required records. Each restricted use pesticide retail dealer must, upon request of any authorized officer or employee of the Agency, or other authorized agent or person duly designated by the Agency, furnish or permit such person at all reasonable times to have access to and copy all records required to be maintained under this section.
              (4) Failure to comply. Any person who fails to comply with the provisions of this section may be subject to civil or criminal sanctions, under FIFRA section 14, or 18 U.S.C. 1001.

          Pt. 172
          PART 172—EXPERIMENTAL USE PERMITS

              Subpart A—Federal Issuance of Experimental Use Permits
              Sec.
              172.1
              Definitions.
              172.2
              General.
              172.3
              Scope of requirement.
              172.4
              Applications.
              172.5
              The permit.
              172.6
              Labeling.
              172.7
              Importation of technical material.
              172.8
              Program surveillance and reporting of data.
              172.9
              Renewals.
              172.10
              Refusals to issue and revocation.
              172.11
              Publication.

              Subpart B—State Issuance of Experimental Use Permits
              172.20
              Scope.
              172.21
              Definitions.
              172.22
              General.
              172.23
              State plans.
              172.24
              State issuance of permits.
              172.25
              Administration of State programs.
              172.26
              EPA review of permits.

              Subpart C—Notification for Certain Genetically Modified Microbial Pesticides
              172.43
              Definitions.
              172.45
              Requirement for a notification.
              172.46
              Submission of a notification.
              172.48
              Data requirements for a notification.
              172.50
              Response to a notification.
              172.52
              Notification exemption process.
              172.57

              Submission of information regarding potential unreasonable adverse effects.

              172.59
              Enforcement.

            Authority:
            7 U.S.C. 136c, 136w. Section 172.4 is also issued under 31 U.S.C. 9701.

            Source:
            40 FR 18782, Apr. 30, 1975, unless otherwise noted.

            Subpart A—Federal Issuance of Experimental Use Permits

              § 172.1
              Definitions.
              Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:

                Act means the Federal Insecticide, Fungicide and Rodenticide Act, as amended.

                Applicant means any person who applies for an experimental use permit pursuant to section 5 of the Act.

                Cooperator means any person who grants permission to a permittee or a permittee's designated participant for the use of an experimental use pesticide at an application site owned or controlled by the cooperator.

                Experimental animals means individual animals or groups of animals, regardless of species, intended for use and used solely for research purposes. The term does not include animals intended to be used for any food purposes

                Participant means any person acting as a representative of the permittee and responsible for making available for use, or supervising the use or evaluation of, an experimental use pesticide to be applied at a specific application site.

                Permittee means any applicant to whom an experimental use permit has been granted.

                Value for pesticide purposes means that characteristic of a substance or mixture of substances which produces an efficacious action on a pest.
              [73 FR 75599, Dec. 12, 2008]

              § 172.2
              General.
              (a) Pursuant to section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 983), and except as herein provided by § 172.3, any person wishing to accumulate information necessary to register under section 3 of the Act and the regulations thereunder (1) a pesticide not registered with this Agency or (2) a registered pesticide for a use not previously approved in the registration of the pesticide may apply to the Administrator at any time for an experimental use permit.
              (b) Pesticides under experimental use permits may not be sold or distributed other than through participants and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit.

              § 172.3
              Scope of requirement.
              (a) An experimental use permit (EUP) is generally required for testing of any unregistered pesticide or any registered pesticide being tested for an unregistered use. However, as described in paragraph (b) of this section, certain of such tests are presumed not to involve unreasonable adverse effects and, therefore, do not require an EUP.
              (b) Except as provided in subpart C of this part or as specifically determined by the Environmental Protection Agency (EPA), it may be presumed that EUPs are not required when:
              (1) The experimental use of the pesticide is limited to:
              (i) Laboratory or greenhouse tests,
              (ii) Limited replicated field trials as described in paragraph (c) of this section to confirm such tests, or
              (iii) Other tests as described in paragraph (c) of this section whose purpose is only to assess the pesticide's potential efficacy, toxicity, or other properties.
              (2) The producer, applicator, or any other person conducting the test does not expect to receive any benefit in pest control from the pesticide's use.
              (c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this section, the following types of experimental tests are presumed not to need an EUP:
              (1) A small-scale test involving use of a particular pesticide that is conducted on a cumulative total of no more than 10 acres of land per pest, except that:
              (i) When testing for more than one target pest occurs at the same time and in the same locality, the 10 acre limitation shall encompass all of the target pests.

              (ii) Any food or feed crops involved in, or affected by, such tests (including, but not limited to, crops subsequently grown on such land which may reasonably be expected to contain residues of the tested pesticides) shall be destroyed or consumed only by experimental animals unless an appropriate tolerance or exemption from a tolerance has been established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for residues of the pesticide.
              (2) A small-scale test involving the use of a particular pesticide that is conducted on a cumulative total of no more than 1 surface acre of water per pest, except that:
              (i) When the testing for more than one target pest occurs at the same time and in the same locality, the 1 acre limitation shall encompass all of the target pests.
              (ii) Waters which are involved in or affected by such tests are not used for irrigation purposes, drinking water supplies, or body contact recreational activities.
              (iii) Testing shall not be conducted in any waters which contain or affect fish, shellfish, plants, or animals taken for recreational or commercial purposes and used for food or feed, unless an appropriate tolerance or exemption from a tolerance has been established under the FFDCA for residues of the pesticide.
              (3) Animal treatment tests involving the use of a particular pesticide that are conducted only on experimental animals which will not be used for food or feed, unless an appropriate tolerance or an exemption from a tolerance has been established for animal products and byproducts under the FFDCA for residues of the pesticide.
              (d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section are not all-inclusive and do not preclude testing in larger areas or larger numbers of units if the intended use meets the criteria of paragraph (a) of this section. However, tests which do not come within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section, absent a specific determination by EPA to the contrary, require an EUP. Persons intending to conduct tests who are uncertain whether the testing may be conducted without a permit may submit a request for determination to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). Such a request shall include the information listed in § 172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an unregistered product, the information in § 172.4(b)(3)(i).
              (e) Notwithstanding paragraphs (b) through (d) of this section, EPA may, on a case-by-case basis, require that certain testing of a particular pesticide or class of pesticides be carried out under an EUP, if it is determined that such EPA oversight is warranted. If EPA determines that an EUP is required, it will notify the developer of the pesticide of the need for an EUP and provide opportunity for comment or objections before imposing the requirement.

              (f) No EUP is required for a substance or mixture of substances being put through tests for the sole purpose of gathering data required for approval of such substance or mixture under the FFDCA (21 U.S.C. 301 et seq.) as:
              (1) A “new drug” (21 U.S.C. sec. 321(p) and sec. 355).
              (2) A “new animal drug” (21 U.S.C. sec. 321(w) and sec. 360(b)), or
              (3) An “animal feed” (21 U.S.C. sec. 321 (x)) containing a “new animal drug” (21 U.S.C. sec. 360(b)).
              (g) Paragraph (f) of this section shall not apply when a purpose of such test is to accumulate information necessary to register a pesticide under section 3 of the Act.
              [59 FR 45611, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006; 73 FR 75599, Dec. 12, 2008]

              § 172.4
              Applications.
              (a) Time for submission. An application or request for amendment to an existing permit shall be submitted as far as possible in advance of the intended date of shipment or use to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              (b) Contents of applications—(1) General requirements. (i) The name and address of the applicant;

              (ii) The registration number of the product, if registered;

              (iii) The purpose or objectives of the proposed testing; a description in detail of the proposed testing program including test parameters; a designation of the pest organism(s) involved; the amount of pesticide product proposed for use; the crops, fauna, flora, sites, modes, dosage rates, and situation of application on or in which the pesticide is to be used; the States in which the proposed program will be conducted; the number of acres, number of structural sites, or number of animals by State to be treated or included in the area of experimental use; the proposed dates or period(s) during which the testing program is to be conducted; and the manner in which supervision of the program will be accomplished;
              (iv) The name, street address, telephone number, and qualifications of all participants in the program (whether or not in the employ of the applicant). A permit must be amended to add or change participants;
              (v) The name and street address of all cooperators, if available at the time an application is submitted or as soon thereafter as available;
              (vi) A description and the specific results of any appropriate prior testing of the product conducted by the applicant to determine toxicity and effects in or on target organisms at the site of application; and to determine phytotoxicity and other forms of toxicity or effects on nontarget plants, animals, and insects at or near the site of application; and to determine adverse effects on the environment;
              (vii) The proposed method of storage and disposition of any unused experimental use pesticide and its containers; and
              (viii) Such other additional pertinent information as the Administrator may require.
              (2) Requirement for tolerance. If the experimental use pesticide is to be used in such a manner that any residue can reasonably be expected to result in or on food or feed, the applicant must:
              (i) Submit evidence that a tolerance or exemption from the requirement of a tolerance has been established for residues of the pesticide in or on such food or feed under section 408 of the Federal Food, Drug, and Cosmetic Act; or
              (ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act; or
              (iii) Certify that the food or feed derived from the experimental program will be destroyed or fed only to experimental animals for testing purposes, or otherwise disposed of in a manner which will not endanger man or the environment. The method of such destruction or disposition shall be provided in the application for the permit.
              (3) Additional requirements for unregistered pesticide products. (i) A complete confidential statement of composition for the formulation to be tested giving the name and percentage by weight of each ingredient, active and inert;
              (ii) Chemical and physical properties of each active ingredient of the formulation to be tested, including, but not limited to, the manufacturing or laboratory processes and analytical methods suitable for determining the active ingredients in the formulation;
              (iii) Appropriate date, if available, on the rate of decline of residues on the treated crop or environmental site or other information for determination regarding entry of persons into treated areas; and
              (iv) Results of toxicity tests and other data relevant to the product's potential for causing injury to the users or other persons who may be exposed, including any available epidemiological information as to man.
              (c) Fees. The payment of fees for experimental use permits shall apply as specified in subpart U of part 152 of the chapter.
              [40 FR 18782, Apr. 30, 1975, as amended at 53 FR 19115, May 26, 1988; 71 FR 35546, June 21, 2006; 73 FR 75599, Dec. 12, 2008]

              § 172.5
              The permit.
              (a) Issuance. The Experimental Use Permit shall be issued when the Administrator determines that the conditions of section 5 of the Act, and the regulations thereunder, have been met subject to such terms and conditions as the Administrator determines are warranted.
              (b) Duration. Permits will be effective for a specified period of time, normally one year, depending upon the crop or site to be tested and the requirements of the testing program submitted. The applicant should propose a suitable duration of the permit commensurate with the program submitted. Permits and associated temporary tolerances may be renewed, extended, or amended upon request if circumstances warrant.
              (c) Limitations. The quantity of a pesticide allowed by a permit may be less than requested if it is determined that the available information on efficacy, toxicity or other hazards, the need for data, or the adequacy of program supervision does not justify the quantity of the pesticide requested. Other limitations may also be placed in the permit if necessary for the protection of the public health and the environment.
              (d) Additions. With respect to an experimental use pesticide containing any chemical or combination of chemicals not included in any previously registered pesticides, the Administrator may require that additional studies be conducted during the permit period to gather data to support the establishment of tolerances and/or registration. To the extent practicable, the applicant will be notified of any such requirements before or at the time an experimental use permit is issued.
              (e) Maintenance of records. All producers of pesticides produced pursuant to an experimental use permit shall maintain records in accordance with part 169.

              § 172.6
              Labeling.
              (a) Contents. Except as provided by paragraph (b) of this section, all pesticides shipped or used under an experimental use permit shall be labeled with directions and conditions for use which shall include the following:
              (1) The prominent statement, “For Experimental Use Only”;
              (2) The Experimental Use Permit number;
              (3) The statement, “Not for sale to any person other than a participant or cooperator of the EPA-approved Experimental Use Program”;
              (4) The name, brand, or trademark;
              (5) The name and address of the permittee, producer, or registrant;
              (6) The net contents;
              (7) An ingredient statement;
              (8) Warning or caution statements;
              (9) Any appropriate limitations on entry of persons into treated areas;
              (10) The establishment registration number, except in those cases where application of the pesticide is made solely by the producer; and
              (11) The directions for use, except that the Administrator may approve the use of the experimental program as labeling provided that such program is to be distributed with the product.
              (b) Supplemental labeling. In the case of a registered pesticide, the Administrator may, at his discretion, permit a pesticide to be used under an experimental use permit with supplemental labeling as approved by him.

              § 172.7
              Importation of technical material.
              Technical materials may be imported without registration in sufficient quantities to formulate a pesticide for which an Experimental Use Permit has been requested if the application for such permit states that such importation will occur.

              § 172.8
              Program surveillance and reporting of data.
              (a) The permittee shall supervise the test program and evaluate the results of testing at each site of application. It will further be the responsibility of the permittee to report immediately to the Administrator, or to any person designated by him, any adverse effects from use of, or exposure to, the pesticide.
              (b) The permittee shall submit the following reports to the Registration Division during the experimental program.
              (1) [Reserved]
              (2) A final report shall be submitted within 180 days after the expiration of the permit, unless a request for extension of time is approved, and shall include:
              (i) All data gathered during the testing program; field notes need not be submitted but must be maintained and submitted upon request;

              (ii) A description of the disposition of any pesticide containers and any unused pesticides including amounts disposed of and the method and site of disposition; and

              (iii) The method of disposition of affected food and/or feed.
              The data under paragraph (b)(2)(i) of this section above may be submitted as part of an application for registration submitted within 180 days after the expiration of the permit, provided that the final report shall include a statement that such application has been made, and the date of such application.
              (c) In addition to the reporting requirements provided for elsewhere in this part, in the case of any meat-producing animals or birds that receive a direct treatment or application of any experimental use pesticide, the name and location of the packing plant where the animals will be processed shall be sent to the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Washington, DC 20250, at least 10 days before the animals are to be shipped for slaughter. This requirement may be waived, on request, by the USDA. These provisions do not exempt treated food-producing animals and their products from compliance with other applicable inspection requirements.
              (d) Failure to submit required reports may constitute grounds for revocation of the permit.
              (e) For the purpose of supervising the use of experimental use pesticides, the Agency may require the permittee or any participant to give reasonable advance notification of the intended dates, times, and sites on which such experimental use pesticide will be applied.
              (f) The permittee or participants in the experimental use program will permit any authorized representative of the Agency, upon presentation of official identification, entry, at any reasonable time, to any premises involved in the testing program to inspect and to determine whether there has been compliance with the terms and conditions of the permit.
              [40 FR 18782, Apr. 30, 1975, as amended at 60 FR 32097, June 19, 1995]

              § 172.9
              Renewals.
              Applications for renewal of experimental use permits and temporary tolerances, to provide for additional testing, shall be submitted prior to expiration of the permit. Requirements for renewals are the same as for applications under § 172.4, except that information previously submitted may be incorporated by reference.

              § 172.10
              Refusals to issue and revocation.
              (a) Refusal. At any time that the Administrator determines that an experimental use permit is not justified, or that the issuance of such a permit would cause unreasonable adverse effects on the environment, or that for any other reason provided for under the law a permit shall not be issued, he shall notify the applicant in writing.
              (b) Revocation. The Administrator may revoke an experimental use permit if he finds that its terms or conditions are being violated or that its terms or conditions are inadequate to avoid unreasonable adverse effects on the environment, or if new evidence is obtained which demonstrates that the tolerance will be inadequate to protect the public health, or for failure to meet any other provision of this part 172. The Administrator will notify the permittee in writing of such revocation. The permittee shall notify all participants of such revocation as soon as possible after he receives notice of revocation. The revocation of a permit shall not preclude the Administrator from initiating civil or criminal sanctions for the violations of the permit conditions or otherwise as authorized by law.
              (c) Hearing. In the event that an applicant for an experimental use permit wishes to contest the refusal to issue an experimental use permit, or an experimental use permittee wishes to contest the revocation of any such permit, he shall, within twenty days after receipt of notice of such refusal or revocation, file with the Administrator a written request for an opportunity to confer with the Administrator or his designee. Within twenty days after such conference, the applicant or permittee will be notified of the Administrator's final decision.

              § 172.11
              Publication.
              (a) Notice of receipt of an experimental use permit application. The Administrator shall publish notice in the Federal Register of receipt of an application for an experimental use permit upon finding that issuance of the experimental use permit may be of regional or national significance. This notice shall include:
              (1) The active ingredients,
              (2) Use pattern(s),
              (3) Quantity of pesticide,
              (4) Total acreage,
              (5) Location of area of application,
              (6) A statement soliciting comments from any interested persons regarding the application.
              (b) Public hearing. The Administrator may hold a public hearing, and publish notice in the Federal Register of the date and location of the hearing, when he determines that there is sufficient interest in the application to warrant a hearing, based upon the comments received in response to the Notice of Receipt of an Application, or that a hearing would otherwise be in the public interest.
              (c) Issuance of experimental use permit. The Administrator shall give prompt notice in the Federal Register of the issuance of an experimental use permit. The notice shall include:
              (1) The active ingredients,
              (2) Use pattern(s),
              (3) Quantity of pesticide,
              (4) Total acreage,
              (5) Location of area of application,
              (6) A statement indicating where the experimental use permit is available for public inspection.

            Subpart B—State Issuance of Experimental Use Permits

              Source:
              44 FR 41787, July 18, 1979, unless otherwise noted.

              § 172.20
              Scope.
              This subpart sets forth regulations governing State issuance of experimental use permits pursuant to section 5(f) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). It also sets forth regulations governing authorization by the Administrator of State experimental use permit programs.

              § 172.21
              Definitions.
              Terms used in this subpart shall have the meaning set forth in FIFRA and in § 172.1.

                Designated State agency means the State agency designated by State law or other authority to be responsible for registering pesticides to meet special local needs.

                Public or private agricultural research agency or educational institution means any organization engaged in research pertaining to the agricultural use of pesticides, or any educational institution engaged in pesticide research. Any research agency or educational institution whose principal function is to promote, or whose principal source of income is directly derived from, the sale or distribution of pesticides (or their active ingredients) does not come within the meaning of this term.
              [73 FR 75599, Dec. 12, 2008]

              § 172.22
              General.
              (a) Experimental use permits are not required under this rule in those situations described in § 172.3 of subpart A pertaining to Federal experimental use permits.
              (b) Subpart B is not applicable to experimental use permits issued by a State, as required by State law, to a permittee who already holds a valid Federal experimental use permit issued under subpart A for the same purpose, or who is not required to obtain a permit under this rule.
              (c) Pesticide products used under experimental use permits may not be sold or distributed other than through participants, and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit.
              (d) Establishments in which pesticide products under State experimental use permits are produced shall be registered as required by 40 CFR 167.2(a) and producers of such products shall maintain books and records as required by 40 CFR 169.2.

              (e) Pesticide products and their containers used under this rule must also be packaged, stored, transported, used, and disposed of in accordance with all applicable Federal laws and regulations, including the Resource Conservation and Recovery Act of 1976 as amended (Pub. L. 94-580; 90 Stat. 2795; 42 U.S.C. 6901 et seq.) (RCRA), and rules thereunder.

              § 172.23
              State plans.
              (a) Submission. (1) A State may, by submitting a State plan, request the Administrator to authorize the designated State agency to issue experimental use permits under section 5(f) of FIFRA.
              (2) A State shall request authorization to issue experimental use permits by having the Governor or Chief Executive Officer or his designated agent submit a State plan in writing to the Administrator.
              (b) Contents. A State plan shall include—
              (1) A designation of the State agency responsible for the administration of the State experimental use permit program.
              (2) An opinion of the State attorney general or the legal counsel of the designated State agency that the State has the requisite legal authorities as set forth in paragraph (c)(1)(i) of this section, accompanied by copies of the applicable State laws and regulations.
              (3) A description of procedures that the designated State agency will follow:
              (i) To review experimental use permit applications, to ensure that experimental use permits will be issued in accordance with the terms and conditions of the authorization, FIFRA, and this subpart; and
              (ii) To supervise use pursuant to the permits, and to ensure that permits are used in accordance with their terms and conditions, FIFRA, and this subpart.
              (c) Criteria for EPA acceptance of State plan. (1) The Administrator shall grant authorization to issue experimental use permits if the State plan establishes that the designated State agency—
              (i) Has adequate legal authority under State law to implement the plan, including authority:
              (A) To issue experimental use permits, subject to limitations necessary for the protection of public health and the environment;
              (B) To supervise the use of a pesticide pursuant to an experimental use permit, as provided in § 172.25(c);
              (C) To deny an experimental use permit if it determines that a permit is not justified, or that the issuance of the permit would cause unreasonable adverse effects on the environment;
              (D) To amend or revoke an experimental use permit, if the designated State agency finds that:
              (1) The terms and conditions of the permit are being violated, or are inadequate to avoid unreasonable adverse effects on the environment;
              (2) Any required tolerance under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) has been revoked by EPA, or any exemption from the requirement for tolerance has been withdrawn by EPA; or
              (3) A failure by the permittee or any cooperator to meet any other provision of FIFRA or this subpart has occurred;
              (E) To enter, by consent or by warrant or by other legal means, in connection with an experimental use permit, a permittee's or cooperator's premises at reasonable times in order to sample or inspect any pesticides used or property treated, to inspect any equipment or records kept, or to observe any activities conducted, as necessary to enforce compliance with State law, the terms of the permit, and this subpart;
              (F) To comply in all other respects with the requirements of this subpart, including labeling requirements; and
              (ii) Utilizes procedures for the review of each permit which are adequate to ensure that the State program will be administered in accordance with the purposes of FIFRA and this subpart.

              (2) After receiving a State plan, EPA shall publish a Federal Register notice announcing the fact and inviting interested parties to comment thereon.
              (d) Approval, rejection, and revocation. (1) EPA shall approve or reject the State plan within 90 days after receipt of all information necessary for final review of the plan, including copies of effective statutes and regulations which satisfy the requirements of this subpart.
              (2) The Administrator may at any time revoke the authorization of a State to issue experimental use permits if he determines that the designated State agency has not complied with the requirements of this subpart or with the terms and conditions of such authorization. State experimental use permits issued prior to the revocation of authority shall remain valid until they expire or until three years from the date of revocation of the State's authority, whichever comes first, unless sooner revoked by EPA under § 172.26(c) of this subpart.

              (3) Notices of approval, rejection, and revocation shall be published in the Federal Register, as well as the basis for such approval, rejection, or revocation.
              (4) Prior to rejecting or revoking authorization, the Administrator shall notify the State in writing of his intention to take such action, along with the basis for such action, and shall afford the State the opportunity for a hearing, and time to take corrective action.

              § 172.24
              State issuance of permits.
              (a) General. Upon approval of a State plan by the Administrator under § 172.23, the designated State agency is authorized to issue, amend, renew, deny or revoke experimental use permits subject to the terms of the authorization and these regulations.
              (b) Authority. A designated State agency may issue an experimental use permit—
              (1) To any person for the purpose of gathering the data necessary to support the State registration of a pesticide to meet special local needs under section 24(c), FIFRA.
              (2) To any agricultural research agency or educational institution conducting work within the State for the purpose of experimentation:
              (i) Which is done within the State; and
              (ii) Which is not directly intended to result in the registration of a specific pesticide product.
              (3) For use of a restricted use pesticide only if the pesticide is to be used by, or under the direct supervision of, an applicator certified in accordance with section 11 of FIFRA.
              (c) Limitations. (1) In the case of applicants who need to gather data required to register a pesticide product to meet a special local need under section 24(c) of FIFRA, a State may only issue experimental use permits for the types of pesticide products and uses which it has authority to register under section 24(c).
              (2) A State may not issue an experimental use permit under § 172.24(b)(1) or § 172.24(b)(2) for any of the following:
              (i) A product containing an active or inert ingredient not contained in any EPA-registered product;
              (ii) A product containing an active or inert ingredient which is currently subject to an EPA cancellation or suspension of registration order, or which is currently subject to an EPA notice of intent to suspend or cancel registration because of human health, environmental or efficacy considerations; except that the State may issue a permit for such a product for a purpose or in a formulation—
              (A) Which was not specifically considered in, or which is not subject to, such suspension or cancellation proceedings, after consultation with appropriate EPA officials; or
              (B) Which was specifically considered during such proceedings but not suspended, cancelled, or subjected to a notice of intent to suspend or cancel;

              (iii) A use of a product which has been the subject of a notice of denial of registration published in the Federal Register pursuant to section 3(c)(6) of FIFRA and part 154 of this chapter; or

              (iv) A use of a product which may involve use in or on food or feed other than as authorized under § 172.24(d), Requirement of tolerance.

              (3) A State may not issue an experimental use permit for use of a pesticide product in an area or in an amount in excess of that necessary to accomplish the purposes for which the permit was issued under paragraph (b) of this section.
              (d) Requirement of tolerance. If the experimental use pesticide is to be used in or on food or feed, the applicant must—
              (1) Submit evidence that:

              (i) A tolerance or exemption from the requirement of a tolerance has been established for residues of the pesticide in or on such food or feed under section 408 of the Federal Food, Drug and Cosmetic Act; and
              (ii) The proposed program would not reasonably be expected to result in residues of the pesticide in or on such food or feed in excess of that authorized under section 408 of the Federal Food, Drug and Cosmetic Act; and
              (iii) All inert ingredients in the pesticide are exempted from the requirement of a tolerance under the appropriate section of 40 CFR part 180, subpart D; or
              (2) Certify that the food or feed derived from the experimental program will be destroyed or fed only to experimental animals for testing purposes, or otherwise disposed of in a manner which will not endanger man or the environment. The method of destruction or disposal shall be described in the application for the permit.
              [44 FR 41787, July 18, 1979, as amended at 50 FR 49020, Nov. 27, 1985; 73 FR 75599, Dec. 12, 2008]

              § 172.25
              Administration of State programs.
              (a) General. State experimental use permit programs shall be consistent with the Federal experimental use permit program, as set forth in subpart A of 40 CFR part 172.
              (b) Procedures leading to issuance. An application for an experimental use permit shall be made in writing, and shall contain sufficient information, including a confidential statement of formula for any new product, to enable the State to determine whether use pursuant to the permit would be in accordance with the purposes of FIFRA and this subpart.
              (c) Labeling. (1) New products shall bear labeling satisfying the requirements of § 172.6(a), except that the prominent statement “For Distribution and Experimental Use Only Within (State)” shall be used in place of “For Experimental Use Only”. The designated State agency may approve, as directions for use on labeling, the experimental program, provided such program is to be distributed with the product.
              (2) The designated State agency may permit an EPA or State registered pesticide to be used under an experimental use permit with supplemental labeling as approved by the State agency. In exercising this discretion, the designated State agency shall ensure that the supplemental labeling and the registered label together satisfy the requirements of § 172.6(a).
              (d) Duration. State experimental use permits shall be issued for a specified period of time, not to exceed three years, depending upon the nature of the pest problem and the requirements of the testing program submitted. The designated State agency may renew, extend or amend the stated duration of a permit, if circumstances warrant.
              (e) Limitations. The designated State agency shall impose such limitations in the permit as are necessary to protect health and the environment, including limitations on quantity, sites, area, disposal, and other aspects of pesticide use.
              (f) Program surveillance and reporting of data. (1) The permittee shall supervise the test program and evaluate the results of testing at each site of application. The designated State agency shall require the permittee to report to it immediately any adverse effects resulting from use of, or exposure to, the pesticide.
              (2) During the course of the program, the designated State agency shall require the permittee to submit such reports (both special and periodic) as are necessary to supervise effectively the progress of the program to prevent unreasonable adverse effects on man or the environment. The designated State agency shall also require the permittee to submit a final report at the conclusion of the program. Where applicable, such reports shall also be made available to the U.S. Department of Agriculture, Food Service and Quality Service (FSQS), as required by § 172.8(c).
              (g) Disposal. All pesticides and pesticide containers, whether disposed of during the course of a State permit or remaining at the termination of a permit, must either be:

              (1) Disposed of in accordance with a disposal plan approved as part of the experimental program; or

              (2) Returned to the permittee for storage or disposal in accordance with the requirements of RCRA and rules there under; or
              (3) If the product is currently registered, used in accordance with the registered label.
              [44 FR 41787, July 18, 1979, as amended at 60 FR 32097, June 19, 1995]

              § 172.26
              EPA review of permits.
              (a) Notification of State action. (1) Within 10 days after the issuance of an experimental use permit, the designated State agency shall notifiy EPA of the action by forwarding to the appropriate EPA Regional Office a copy of the permit, a description of the experimental program to be conducted under the terms of the permit, a copy of the approved labeling, and a copy of the confidential statement of formula for any new product.
              (2) Within 10 days after amendment or revocation of an experimental use permit by a State, the designated State agency shall notify the appropriate EPA Regional Office in writing of the amendment or revocation. The notice shall include a brief explanation of the reason for the amendment or revocation. If amendments to permits include changes in the approved labeling, the designated State agency shall also forward a copy of the amended labeling.
              (3) EPA shall give notice in the Federal Register of State issuance of experimental use permits.
              (b) Reports. The designated State agency shall submit the following reports to EPA:
              (1) An annual report covering the number of permits issued, the names and addresses of permittees, the names of the products covered by permits, and the State permit numbers issued;
              (2) Reports, as requested by EPA, containing any information that EPA may determine necessary to ensure that a State has acted in compliance with provisions of FIFRA and this subpart; and
              (3) Reports of any serious adverse effect(s), as soon thereafter as possible, from use of, or exposure to, a pesticide used pursuant to an experimental use permit.
              (c) Revocation by EPA. (1) The Administrator may revoke an experimental use permit issued under this subpart if he finds:
              (i) That its terms and conditions are being violated;
              (ii) That its terms and conditions are inadequate to avoid unreasonable adverse effects on the environment;
              (iii) That new evidence demonstrates that any tolerance upon which the permit is based will be inadequate to protect the public health, or that any exemption from the requirement for a tolerance is no longer appropriate; or
              (iv) That a failure by the permittee to meet any other provisions of FIFRA or this subpart has occurred.
              (2) The Administrator shall, prior to revoking a State experimental use permit, consult with the State agency which issued the permit, except in cases where continued use of the pesticide under the permit would create an imminent hazard to man or the environment.
              (3) The Administrator shall notify the designated State agency, in writing, of the revocation, and the State agency shall notify the permittee, also in writing, of the revocation.
              (4) The permittee shall notify all participants of the revocation within 10 days after he receives notice of revocation.
              (5) The revocation of a permit shall not preclude the Administrator from initiating civil or criminal sanctions for violations of the permit conditions or other violations, as authorized by law.
              (6) If a permittee wishes to contest the revocation of a State experimental use permit, he shall, within 30 days after receipt of notice of such revocation, file with the Administrator a written request for an opportunity to confer with the Administrator or his designee. The revocation of the permit shall remain effective pending the outcome of any conference requested under this paragraph.
              (7) If a permittee requests a conference under paragraph (c)(6) of this section, the Administrator shall provide the permittee:

              (i) With information as to the time, place and nature of the conference, and of the matters of fact and law asserted by the Agency as grounds for the revocation action;

              (ii) An opportunity to offer a written statement of facts, explanations, and arguments relevant to the revocation action;
              (iii) All other procedural opportunities to which the permittee may be entitled by law.
              (8) The Administrator shall notify the affected permittee and State Agency, in writing, of his final decision on the revocation matter as expeditiously as possible and shall attempt to do so within 30 days after the conclusion of a conference conducted under paragraph (c)(7). The Administrator shall also provide the permittee and the State agency with a written statement of the reasons for his decision, which shall take into account the evidence presented pursuant to paragraph (c)(7)(ii) of this section.
              (9) A decision to revoke a permit under paragraph (c)(8) of this section is a final Agency action subject to judicial review as provided by law.
              [44 FR 41787, July 18, 1979, as amended at 73 FR 75599, Dec. 12, 2008]

            Subpart C—Notification for Certain Genetically Modified Microbial Pesticides

              Source:
              59 FR 45612, Sept. 1, 1994, unless otherwise noted.

              § 172.43
              Definitions.
              Terms used in this subpart shall, with the exception of those defined below, have the meaning set forth in the Act and in § 172.1.

                Containment and inactivation controls means any combination of mechanical, procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a facility.

                Deliberately modified means the directed addition, rearrangement, or removal of nucleotide sequences to or from genetic material.

                Introduction of genetic material means the movement of nucleotide sequences into a microorganism, regardless of the technique used.

                Inversions of genetic material means the replacement of an internal section of a chromosome in the reverse orientation.

                Microbial pesticide means a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:
              (1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
              (2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
              (3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.

                Microbial pesticides resulting from rearrangements means a microbial pesticide resulting from translocations or inversions of genetic material.

                Microorganism means a bacterium, fungus, alga, virus, or protozoan.

                Nonindigenous microbial pesticide means a microbial pesticide brought into one of the following geographic areas from outside that area:

              (1) The continental United States, including Alaska, and the immediately adjoining countries (i.e., Canada and Mexico).
              (2) The Hawaiian Islands.
              (3) The Caribbean Islands including Puerto Rico and the U.S. Virgin Islands.

                Pesticidal property means a characteristic exhibited by a microorganism that contributes to the intentional use of the microorganism to prevent, destroy, repel, or mitigate a pest or to act as a plant regulator, defoliant, or desiccant.

                Single genome means the sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under axenic culture conditions from that isolate.

                Small-scale test means the experimental use of a microbial pesticide in a facility such as a laboratory or greenhouse, or use in limited replicated field trials or other tests as described in § 172.3(c).

                Test or testing means any use of a microbial pesticide consistent with section 5 of the Act, including limited replicated field trials and associated activities.

                Translocations of genetic material means a chromosomal configuration in which part of a chromosome becomes attached to a different chromosome, or inserts in a different location on the same chromosome.
              [59 FR 45612, Sept. 1, 1994, as amended at 72 FR 61029, Oct. 26, 2007]

              § 172.45
              Requirement for a notification.
              (a) Who must submit a Notification. Notwithstanding § 172.3, any person who plans to conduct small-scale testing of a type of microbial pesticide identified in paragraph (c) of this section must submit a Notification to EPA and obtain prior approval for either of the following tests:
              (1) Small-scale tests that involve an intentional environmental introduction of that microbial pesticide.
              (2) Small-scale tests performed in a facility without adequate containment and inactivation controls as provided in paragraph (e) of this section.
              (b) Alternative to Notification. In lieu of a Notification, any person required to submit a Notification under paragraph (a) of this section may submit an application for an experimental use permit (EUP) to EPA for approval.
              (c) Small-scale testing that requires a Notification. As provided in paragraph (a) of this section, and notwithstanding any other approval by any governmental entity, EPA review and approval are required prior to the initiation of any small-scale test involving either of the following microbial pesticides:
              (1) Microbial pesticides whose pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified.

              (2) Nonindigenous microbial pesticides that have not been acted upon by the U.S. Department of Agriculture (i.e., either by issuing or denying a permit or determining that a permit is unnecessary; or a permit is not pending with the USDA).
              (d) Small-scale testing that does not require a Notification. (1) Testing conducted with microbial pesticides identified in paragraph (c) of this section, but made exempt pursuant to § 172.52, does not require a Notification. The following microbial pesticides (or classes of pesticides) are exempt from the notification requirement in paragraph (a) of this section:
              (i) Microbial pesticides resulting from deletions or rearrangements within a single genome that are brought about by the introduction of genetic material that has been deliberately modified.
              (ii) [Reserved]
              (2) Testing conducted in a facility with adequate containment and inactivation controls, as provided in paragraph (e) of this section, does not require a Notification.
              (e) Selection and use of containment and inactivation controls. (1) Selection and use of containment and inactivation controls for a particular microbial pesticide shall take into account the following:
              (i) Factors relevant to the microbial pesticide's ability to survive in the environment.
              (ii) Potential routes of release in air, solids, and liquids; in or on waste materials and equipment; in or on people (including maintenance and custodial personnel); and in or on other organisms such as insects and rodents.
              (iii) Procedures for transfer of materials between facilities.
              (iv) Plans for routine or emergency clean-up and test termination.
              (2) For purposes of paragraph (e)(1) of this section, EPA will presume that compliance with the containment provisions of the National Institutes of Health (NIH) “Guidelines for Research Involving Recombinant DNA Molecules” (51 FR 16958, May 7, 1986) constitutes selection and use of adequate containment and inactivation controls.
              (3) The selection of containment and inactivation controls shall be approved by an authorized official of the organization that is conducting the test prior to commencement of the test.
              (4) Records shall be developed and maintained describing the selection and use of the containment and inactivation controls, including contingency plans for emergency clean-up and test termination, that will be used during the test. These records shall be available for inspection at the test facility. In addition, these records shall be submitted to EPA at EPA's request and within the time frame specified in EPA's request.

              (5) Subsequent to any EPA review of the containment/inactivation controls selected under paragraph (e)(1) of this section, changes to the controls necessary to prevent unreasonable adverse effects must be made upon EPA request. Failure to comply with EPA's request shall result in automatic revocation of the exemption from the requirement to submit a Notification.

              § 172.46
              Submission of a notification.
              (a) When to submit a Notification. A Notification shall be submitted for approval at least 90 days prior to the initiation of the proposed test.
              (b) Where to submit a notification. A notification shall be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Biotechnology Notification Review.
              (c) How to format a Notification. A Notification submitted under this section must comply with the following procedures, but is not required to comply with the format and other provisions governing submission of data in §§ 158.32 and 158.33 or §§ 161.32 and 161.33 of this chapter. However, because data submitted with the Notification may subsequently be used to support other regulatory actions (e.g., used in EUP or registration applications), it is recommended that such data comply with EPA requirements in §§ 158.32 and 158.33 of this chapter.
              (1) Each Notification must be accompanied by a transmittal document that clearly identifies the EPA action supported as a Biotechnology Notification Review.
              (2) Five copies of each Notification must be submitted to EPA.
              (3) Any claims of confidentiality for information submitted in the Notification must be made as described in paragraph (d) of this section.
              (d) How to make confidential business information (CBI) claims in a Notification. Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as CBI, a submitter may assert a claim of confidentiality for all or part of the information submitted to EPA in a Notification (See part 2, subpart B of this chapter). To assert such a claim, the submitter must comply with the following procedures:
              (1) Any claim of confidentiality must accompany the information at the time the information is submitted to EPA. Failure to assert a claim at that time will be considered a waiver of confidentiality for the information submitted, and the information may be made available to the public, subject to section 10(g) of the Act, with no further notice to the submitter.
              (2) Of the five copies of the Notification required by paragraph (c) of this section, four copies must be complete with the information that is claimed confidential clearly marked in the manner described in § 2.203(b) of this chapter. All information claimed as confidential must be deleted from the fifth copy, but it must be otherwise complete. The first page of the fifth copy must be marked “Contains no information claimed as confidential.” EPA may include the fifth copy in a public file without further notice. EPA will consider incomplete a Notification containing information claimed as CBI that is not submitted in accordance with this paragraph and will suspend the review period on the Notification until such procedures are followed.
              (3) Any claim of confidentiality must be accompanied, at the time the claim is made, by comments substantiating the claim and explaining why the submitter believes that the information should not be disclosed. The submitter should refer to § 2.204(e)(4) of this chapter for points to address in the substantiation. If such comments are themselves claimed confidential and are marked confidential when submitted to EPA, they will be treated as such in accordance with § 2.205(c) of this chapter. EPA will consider incomplete all Notifications containing information claimed as CBI that are not accompanied by substantiation, and will suspend the review period on such Notifications until the required substantiation is provided.

              (4) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent and by means of the procedures set forth in section 10 of the Act, in this subpart, and in part 2 of this chapter.
              [59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006; 72 FR 61029, Oct. 26, 2007; 73 FR 75600, Dec. 12, 2008]

              § 172.48
              Data requirements for a notification.
              This section identifies the data and information to be included in each Notification. When specific information is not submitted, an explanation of why it is not practical or necessary to provide the information is to be provided.
              (a) The identity of the microorganism which constitutes the microbial pesticide including:
              (1) Summary of data supporting the taxonomic designation and its interpretation.
              (2) Means and limit of detection using sensitive and specific methods (e.g., note the use of any markers that are used to distinguish the introduced population from native microorganisms). Introduction into the microbial pesticide of a unique genetic marker is encouraged.
              (b) Description of the natural habitat of the parental strain of the microbial pesticide including information on:
              (1) Physical and chemical features important to growth and survival of the parental strain.
              (2) Biological features of the parental strain that would have an impact on the microbial pesticide (e.g., presence of phages that infect the microorganism).
              (3) Competitors.
              (c) Information on the host range of the microbial pesticide, if any, with an assessment of infectivity and pathogenicity to nontarget organisms.
              (d) Information on survival and the ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment into which the microbial pesticide will be introduced, and in substantially different environments that may be in the immediate vicinity). These data may be derived from the scientific literature or from tests conducted in a laboratory or other containment facility.
              (e) The identity of possible transmission vectors (e.g., insects).
              (f) Data on relative environmental competitiveness compared to the parental strain of the microbial pesticide.
              (g) Description of the methods used to genetically modify the microbial pesticide.
              (h) The identity and location of the gene segments that have been rearranged or inserted/deleted (host source, nature, and, for example, base sequence data, or restriction enzyme map of the genes).
              (i) Information on the control region of the genes, and a description of the new traits or characteristics that are expressed.
              (j) Data on potential for genetic transfer and exchange with other organisms and on genetic stability of any inserted sequences in the microbial pesticide.
              (k) A description of the proposed testing program including:
              (1) The purpose or objectives of the proposed testing.
              (2) Designation of the pest organisms involved (common and scientific names).
              (3) The States in which the proposed program will be conducted.
              (4) The exact location of the test sites (including proximity to residences and human activities, surface water, etc.).
              (5) The crops, fauna, flora, geographical description of sites, modes, dosage rates, frequency, and situation of application on or in which the pesticide is to be used.
              (6) The total amount of pesticide product proposed for use in the testing.
              (7) The method of application.
              (8) A comparison of the natural habitat of the microbial pesticide with the proposed test site.
              (9) The number of acres, structural sites, or animals/plants by State, to be treated or included in the area of experimental use.
              (10) Procedures to be used to protect the test area from intrusion by unauthorized individuals.
              (11) The proposed dates or periods during which the testing program is to be conducted, and the manner in which supervision of the program will be accomplished.

              (12) Description of procedures for monitoring the microbial pesticide within and adjacent to the test site during the test.
              (13) The method of sanitation or disposal of plants, animals, soils, farm tools, machinery etc., that will be exposed to the microbial pesticide during or after the test.
              (14) Means of evaluating potential adverse effects and methods of controlling the microbial pesticide if detected beyond the test area.
              (l) A statement of composition for the formulation to be tested, giving:
              (1) The name and percentage by weight (or other suitable units) of each ingredient, active and inert.
              (2) Production methods.
              (3) Extraneous microorganisms present as contaminants.
              (4) Amount and potency of any toxin present.
              (5) Where applicable, the number of viable microorganisms per unit weight or volume of the product or other appropriate system for designating the quantity of active ingredient.
              (m) Any additional factual information regarding the potential for unreasonable adverse effects on the environment.

              § 172.50
              Response to a notification.
              (a) EPA will review and evaluate each Notification as expeditiously as possible and will make a determination no later than 90 days after receipt of the complete Notification; however, under no circumstances shall the proposed test proceed until the submitter has received notice from EPA of its approval of such test.
              (b) For each Notification, EPA may make the following determinations:
              (1) Require additional information from the submitter to assess the proposed test adequately.
              (2) Approve the proposed test.
              (3) Approve the proposed test provided that the submitter makes certain modifications to the test proposal.
              (4) Require an EUP for the test.
              (5) Disapprove the proposed test because of the potential for unreasonable adverse effects. Such disapproval by EPA shall be considered the equivalent of denial of an EUP and the remedies for such denial provided by § 172.10 are available to the submitter.
              (c) If the proposed test is approved by EPA, then the submitter shall perform the test in the same manner described in the Notification, subject to any requirements imposed under paragraph (b)(3) of this section.

              § 172.52
              Notification exemption process.
              (a) Initiation of the exemption process. Pesticides may be added to the list of exemptions in § 172.45(d) by rule at EPA's initiative or in response to a petition submitted in accordance with paragraph (b) of this section.
              (b) Petitions for exemption from the requirement for a Notification—(1) Who may submit a petition. Any person may submit a petition requesting an exemption from the notification requirements of this subpart for a specific microbial pesticide or class of microbial pesticides.
              (2) Where to submit a petition. All petitions shall be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              (3) Content of petition. Each petition shall contain the following:
              (i) Name and address of petitioner and name, address, and telephone number of a person who may be contacted for further information.
              (ii) Description of the exemption requested, including the specific microbial pesticide or class of microbial pesticides to be tested under the petition for exemption.
              (iii) Basis for the petitioner's contention that the specific microbial pesticide or class of microbial pesticides meet the criteria of § 172.3 for small-scale tests of pesticides that do not require an EUP.
              (iv) Discussion of the extent to which the microbial pesticide or class of microbial pesticides covered by the petition differ from microbial pesticides that are already registered or subject to an EUP under the Act.
              (4) Administrative action on a petition. EPA will review and evaluate petitions as expeditiously as possible and may request further information from the petitioner to assess the proposed exemption adequately. No later than 180 days after the submission of a petition, or 90 days after the last submission of additional information by the petitioner, whichever is later, EPA will take one of the following actions with respect to the petition:

              (i) Grant the petition and publish a notice of proposed rulemaking in the Federal Register for a 45-day comment period proposing the exemption requested by the petitioner.

              (ii) Grant the petition and publish a notice of proposed rulemaking in the Federal Register for a 45-day comment period proposing an exemption under such terms and conditions as EPA deems appropriate.
              (iii) Deny the petition and provide the petitioner with a written explanation of EPA's decision.
              (5) Confidential business information (CBI) claims. To assert a claim of confidentiality, the petitioner must comply with the applicable procedures in § 172.46(d).
              (6) Supplements, amendments, and withdrawals. The petitioner may supplement, amend, or withdraw his or her petition in writing without EPA approval at any time prior to the granting or denial of the petition under paragraph (b)(4) of this section. The withdrawal of a petition shall be without prejudice to the resubmission of the petition at a later date.
              [59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006]

              § 172.57
              Submission of information regarding potential unreasonable adverse effects.
              Any person using a microbial pesticide in small-scale testing covered by this subpart who obtains information regarding potential unreasonable adverse effects on health or the environment must within 30 days of receipt of such information submit the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of such information. The requirement to submit information applies both to those microbial pesticides subject to the notification requirements under § 172.45(c) and those that are exempt under § 172.45(d).

              § 172.59
              Enforcement.
              (a) Imminent threat of substantial harm to health or the environment. The use of a microbial pesticide in small-scale testing covered by this subpart (whether subject to the notification requirements of § 172.45(c) or exempt under § 172.45(d)) in a manner that creates an imminent threat of substantial harm to health or the environment is prohibited, and is considered a violation of section 12(a)(2)(S) of the Act.
              (b) EPA response to violations. Under section 14 of the Act, EPA may seek civil or criminal penalties for violations of the Act. Failure to comply with the regulations in this part could result in civil or criminal penalties. Moreover, under sections 14 and 16(c) of the Act, EPA may at any time take appropriate action against violators to prevent or otherwise restrain use of a microbial pesticide in small-scale testing if it is determined that:
              (1) Such use would create an imminent threat of substantial harm to health or the environment that is prohibited under paragraph (a) of this section; or
              (2) The terms or conditions on which approval of the testing was granted under this subpart C are violated.

          Pt. 173
          PART 173—PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS

            Sec.
            173.1
            Applicability.
            173.2
            Definitions.
            173.3
            Initiation of rescission proceedings.
            173.4
            Informal conference and settlement.
            173.5
            Request for hearing.
            173.6
            Publication of the notice; scheduling the hearing.
            173.7
            Hearing and recommended decision.
            173.8
            Final order.
            173.9
            Judicial review.

            Authority:
            7 U.S.C. 136w and 136w-2.

            Source:
            46 FR 26059, May 11, 1981, unless otherwise noted.

            § 173.1
            Applicability.

            These procedures govern any proceeding to rescind a State's primary enforcement responsibility for pesticide use violations conducted under section 27(b) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA), 7 U.S.C. 136 et seq.

            § 173.2
            Definitions.
            For purposes of this part:
            (a) Administrator means the Administrator of the United States Environmental Protection Agency or his delegate.
            (b) Notice of intent to rescind means a notice to a State issued under § 173.3 which initiates a proceeding to rescind the State's primary enforcement responsibility for pesticide use violations.
            (c) State means the agency or agencies primarily responsible for enforcing pesticide use laws or regulations within the State or jurisdiction undergoing rescission proceedings.
            (d) Party to the proceeding shall mean the State or the Agency's Office of Enforcement.
            (e) Presiding Officer means an attorney appointed by the Administrator to conduct the rescission proceeding. The Presiding Officer shall be an employee or representative of the Agency and shall not have had prior direct connection with the specific proceeding except in circumstances where subsequent hearings are in order.

            § 173.3
            Initiation of rescission proceedings.
            (a) Whenever the Administrator determines that a State having primary enforcement responsibility for pesticide use violations is not carrying out such responsibility, or cannot carry out such responsibility due to the lack of adequate legal authority, the Administrator shall notify the State in writing of his intent to rescind its primary enforcement responsibility, in whole or in part, by serving upon the State a notice of intent to rescind.
            (b) The notice of intent to rescind shall:
            (1) Specify those aspects of the State's pesticide use enforcement program determined to be inadequate;
            (2) Specify the facts which underlie the findings contained in the rescission notice;
            (3) Have attached thereto copies of any relevant documents discoverable under the Federal Rules of Civil Procedure and the Freedom of Information Act which contain data relied upon by the Administrator in making his decision to issue the notice;
            (4) Have attached thereto a copy of this part; and
            (5) Be sent to the State by certified mail, return receipt requested.
            (c) The State may respond in writing to the findings specified in the notice of intent to rescind.

            § 173.4
            Informal conference and settlement.
            (a) After receipt of a notice of intent to rescind, the State may request that an informal conference be held between appropriate State and EPA officials to discuss the findings made in the notice of intent to rescind. The informal conference shall then be held in the State. If the Administrator finds, on the basis of information submitted by the State at the conference, that the deficiencies specified in the notice did not exist or were corrected by the State, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding.
            (b) At any time after receipt of a notice of intent to rescind and before the issuance of a final order, the State and EPA may resolve the issues raised in the notice by agreement. Any settlement agreement shall be in writing and signed by the parties and shall:
            (1) Detail the deficiencies found in the State program;
            (2) Specify the steps the State has taken or will take to remedy the deficiencies; and
            (3) Set forth a precise schedule for each remedial action yet to be initiated.
            (c) If a written agreement is signed by the parties, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding. If the State does not comply with the terms of the settlement agreement, the Administrator may reissue the notice of intent to rescind.

            § 173.5
            Request for hearing.
            A State may request a hearing before a Presiding Officer not later than sixty (60) days after receipt of a notice of intent to rescind.

            § 173.6
            Publication of the notice; scheduling the hearing.

            (a) If the Administrator has not issued an order terminating the rescission proceeding within sixty (60) days after service of the notice of intent to rescind upon the State, the Administrator shall publish the notice of intent to rescind in the Federal Register. The Administrator may modify the original notice of intent to rescind before its publication by deleting those deficiencies listed in the original notice which have been corrected or which were shown not to have existed. The public may submit comments upon the matters specified in the published notice of intent to rescind within the time specified therein.

            (b) Concurrently with the publication of the notice of intent to rescind, the Administrator shall schedule a hearing in the State if one has been requested by the State. The date, time, and location of the hearing shall be published in the Federal Register along with the notice of intent to rescind.
            (c) If a hearing is requested and the Administrator has not issued an order terminating the rescission proceeding, the Administrator shall provide for a hearing as scheduled. Representatives of the State, EPA, and the public may present evidence at the hearing. The Administrator shall appoint a Presiding Officer who shall preside over the hearing and make a recommended decision regarding the adequacy of the State's pesticide use enforcement program. The Administrator, after consultation with the State, may prescribe additional procedures governing the conduct of the hearing.

            (d) If a termination order is issued or the hearing is rescheduled after the notice of intent to rescind is published in the Federal Register, such order or notice rescheduling the hearing shall also be published in the Federal Register.

            § 173.7
            Hearing and recommended decision.
            (a) The Presiding Officer shall:
            (1) Conduct a fair and impartial hearing, without unnecessary delay;
            (2) Ensure that the facts are fully elicited; and
            (3) Consider all evidence, comment, and argument which is submitted by persons who will be affected by the outcome of the proceeding and which is not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of little probative value. The Presiding Officer may require any prospective witness to make available, in advance of the hearing, a brief summary of his or her testimony.
            (b) If, following the close of the hearing, the Presiding Officer finds that the State has corrected, or has agreed in writing to correct, the deficiencies specified in the notice of intent to rescind or has shown that such deficiencies do not exist, the Presiding Officer shall issue a decision recommending that the notice of intent to rescind be withdrawn and that the rescission proceeding be terminated.
            (c) If, following the close of the hearing, the Presiding Officer finds that the State has not corrected the deficiencies in its program, the Presiding Officer shall issue a decision recommending that the State's primary enforcement responsibility for pesticide use violations be rescinded in whole or in part.
            (d) The recommended decision of the Presiding Officer shall become final Agency action forty-five (45) days after its service upon the parties and without further proceedings unless (1) an appeal to the Administrator is taken from it by a party to the proceeding, or (2) the Administrator elects, sua sponte, to review the recommended decision.

            § 173.8
            Final order.

            (a) If the State does not request a hearing within the sixty-day time period and the Administrator has not issued an order withdrawing the notice of intent to rescind, the Administrator shall issue a final order as soon as practicable after the time for public comment on the notice of intent to rescind has elapsed. The final order shall either withdraw the notice of intent to rescind and terminate the proceeding or rescind, in whole or in part, the State's primary enforcement responsibility for pesticide use violations.

            (b) If a hearing has been held and the Presiding Officer has made a recommended decision, then either the Office of Enforcement or the State may appeal the recommended decision to the Administrator or the Administrator may elect to review the recommended decision on his own initiative.
            (c) After an appeal or sua sponte review the Administrator shall issue a final order terminating the rescission proceeding or rescinding, in whole or in part, the State's primary enforcement responsibility for pesticide use violations.
            (d) In no event may the Administrator issue his final decision sooner than ninety (90) days after service of the notice of intent to rescind on a State.

            (e) Any final order, or a recommended decision which becomes a final order under § 173.7(c), shall be published in the Federal Register.

            § 173.9
            Judicial review.
            The State may appeal an order rescinding, in whole or in part, its primary enforcement responsibility for pesticide use violations to the appropriate federal court pursuant to section 16 of FIFRA.

          Pt. 174
          PART 174—PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS

              Subpart A—General Provisions
              Sec.
              174.1
              Scope and purpose.
              174.3
              Definitions.
              174.9
              Confidential business information claims for plant-incorporated protectant submissions.

              Subpart B—Exemptions
              174.21
              General qualifications for exemptions.
              174.25
              Plant-incorporated protectant from sexually compatible plant.

              Subpart C—Registration Procedures and Requirements [Reserved]

              Subpart D—Monitoring and Recordkeeping
              174.71
              Submission of information regarding adverse effects.

              Subparts E-F [Reserved]

              Subpart G—Labeling Requirements [Reserved]

              Subpart H—Data Requirements [Reserved]

              Subpart I [Reserved]

              Subpart J—Good Laboratory Practices [Reserved]

              Subpart K—Export Requirements [Reserved]

              Subparts L-T [Reserved]

              Subpart U—Experimental Use Permits [Reserved]

              Subpart V [Reserved]

              Subpart W—Tolerances and Tolerance Exemptions
              174.500
              Scope and purpose.
              174.501

                Bacillus thuringiensis Vip3Aa protein in corn and cotton; exemption from the requirement of a tolerance.
              174.502

                Bacillus thuringiensis Cry1A.105 protein; exemption from the requirement of a tolerance.
              174.504

                Bacillus thuringiensis Cry1F protein; exemption from the requirement of a tolerance.
              174.505

                Bacillus thuringiensis modified Cry3A protein (mCry3A) in corn; exemption from the requirement of a tolerance.
              174.506

                Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in corn; exemption from the requirement of a tolerance.
              174.507
              Nucleic acids that are part of a plant-incorporated protectant; exemption from the requirement of a tolerance.
              174.508
              Pesticidal substance from sexually compatible plant; exemption from the requirement of a tolerance.
              174.509

                Bacillus thuringiensis Cry3A protein; exemption from the requirement of a tolerance.
              174.510

                Bacillus thuringiensis Cry1Ac protein in all plants; exemption from the requirement of a tolerance.
              174.511

                Bacillus thuringiensis Cry1Ab protein in all plants; exemption from the requirement of a tolerance.
              174.512
              Coat Protein of Potato Virus Y; exemption from the requirement of a tolerance.
              174.513
              Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene); exemption from the requirement of a tolerance.
              174.514

              Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus; exemption from the requirement for a tolerance.
              174.515
              Coat Protein of Papaya Ringspot Virus; exemption from the requirement of a tolerance.
              174.516
              Coat protein of cucumber mosaic virus; exemption from the requirement of a tolerance.
              174.517

                Bacillus thuringiensis Cry9C protein in corn; exemption from the requirement of a tolerance.
              174.518

                Bacillus thuringiensis Cry3Bb1 protein in corn; exemption from the requirement of a tolerance.
              174.519

                Bacillus thuringiensis Cry2Ab2 protein; exemption from the requirement of a tolerance.
              174.521
              Neomycin phosphotransferase II; exemption from the requirement of a tolerance.
              174.522
              Phosphinothricin Acetyltransferase (PAT); exemption from the requirement of a tolerance.
              174.523
              CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all plants; exemption from the requirement of a tolerance.
              174.524
              Glyphosate Oxidoreductase GOX or GOXv247 in all plants; exemption from the requirement of a tolerance.
              174.525
              E. coli B-D-glucuronidase enzyme as a plant-incorporated protectant inert ingredient; exemption from the requirement of a tolerance.
              174.526
              Hygromycin B phosphotransferase (APH4) marker protein in all plants; exemption from the requirement of a tolerance.
              174.527
              Phosphomannose isomerase in all plants; exemption from the requirement of a tolerance.
              174.529

                Bacillus thuringiensis modified Cry1Ab protein as identified under OECD Unique Identifier SYN-IR67B-1 in cotton; exemption from the requirement of a tolerance.
              174.530

                Bacillus thuringiensis Cry2Ae protein in cotton; exemption from the requirement of a tolerance.
              174.531
              Coat protein of plum pox virus; exemption from the requirement of a tolerance.
              174.532

                Bacillus thuringiensis eCry3.1Ab protein in corn; exemption from the requirement of a tolerance.
              174.533

                Glycine max Herbicide-Resistant Acetolactate Synthase (GM-HRA) inert ingredient; exemption from the requirement of a tolerance.
              174.534
              VNT1 protein; exemption from the requirement of a tolerance.
              174.535
              Spinach Defensin proteins; temporary exemption from the requirement of a tolerance.
              174.536

                Bacillus thuringiensis mCry51Aa2 protein in cotton; temporary exemption from the requirement of a tolerance.
              174.537
              HPPD-4 protein; exemption from the requirement of a tolerance.
              174.539
              Cry51Aa2.834_16 protein; exemption from the requirement of a tolerance.
              174.540
              Bacillus thuringiensis Cry14Ab-1 protein; exemption from the requirement of a tolerance.

              Subpart X—List of Approved Inert Ingredients
              174.700
              Scope and purpose.
              174.705
              Inert ingredients from sexually compatible plant.

              Subparts Y-Z [Reserved]

            Authority:
            7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

            Source:
            66 FR 37814, July 19, 2001, unless otherwise noted.

            Subpart A—General Provisions

              § 174.1
              Scope and purpose.
              The characteristics of plant-incorporated protectants such as their production and use in plants, their biological properties, and their ability to spread and increase in quantity in the environment distinguish them from traditional chemical pesticides. Therefore, plant-incorporated protectants are subject to some different regulatory requirements and procedures than traditional chemical pesticides. This part sets forth regulatory requirements, criteria, and procedures applicable to plant-incorporated protectants under FIFRA and FFDCA. When applied to plant-incorporated protectants, the definitions and regulations in this part supersede the regulations found in parts 150 through 180 of this chapter to the extent that the regulations conflict. Unless otherwise superseded by this part, the regulations in parts 150 through 180 of this chapter apply to plant-incorporated protectants.

              § 174.3
              Definitions.
              Terms used in this part have the same meaning as in FIFRA. In addition, the following terms have the meaning set forth in this section.

                Active ingredient means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for the production of such a pesticidal substance.

                Administrator means the Administrator of the United States Environmental Protection Agency or his/her delegate.

                Bridging crosses between plants means the utilization of an intermediate plant in a cross to produce a viable zygote between the intermediate plant and a first plant, in order to cross the plant resulting from that zygote with a third plant that would not otherwise be able to produce viable zygotes from the fusion of its gametes with those of the first plant. The result of the bridging cross is the mixing of genetic material of the first and third plant through the formation of an intermediate zygote.

                Cell fusion means the fusion in vitro of two or more cells or protoplasts.

                Conventional breeding of plants means the creation of progeny through either: The union of gametes, i.e., syngamy, brought together through processes such as pollination, including bridging crosses between plants and wide crosses, or vegetative reproduction. It does not include use of any of the following technologies: Recombinant DNA; other techniques wherein the genetic material is extracted from an organism and introduced into the genome of the recipient plant through, for example, micro-injection, macro-injection, micro-encapsulation; or cell fusion.

                EPA means the United States Environmental Protection Agency.

                Exudate means a substance gradually discharged or secreted across intact cellular membranes or cell walls and present in the intercellular spaces or on the exterior surfaces of the plant.

                FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).

                FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 et seq.).

                Food includes articles used for food or drink by humans or other animals.

                Food plant means a plant which either in part or in toto, is used as food.

                Genetic material necessary for the production means both: Genetic material that encodes a substance or leads to the production of a substance; and regulatory regions. It does not include noncoding, nonexpressed nucleotide sequences.

                Genome means the sum of the heritable genetic material in the plant, including genetic material in the nucleus and organelles.

                In a living plant means inside the living plant, on the surface of the living plant, or as an exudate from the living plant.

                Inert ingredient, means any substance, such as a selectable marker, other than the active ingredient, where the substance is used to confirm or ensure the presence of the active ingredient, and includes the genetic material necessary for the production of the substance, provided that genetic material is intentionally introduced into a living plant in addition to the active ingredient.

                Living plant means a plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.

                Noncoding, nonexpressed nucleotide sequences means the nucleotide sequences are not transcribed and are not involved in gene expression. Examples of noncoding, nonexpressed nucleotide sequences include, but are not limited to, linkers, adapters, homopolymers, and sequences of restriction enzyme recognition sites.

                Nucleic acids means ribosides or deoxyribosides of adenine, thymine, guanine, cytosine, and uracil; polymers of the deoxyribose-5′-monophosphates of thymine, cytosine, guanine, and adenine linked by successive 3′-5′ phosphodiester bonds (also known as deoxyribonucleic acid); and polymers of the ribose-5′-monophosphates of uracil, cytosine, guanine, and adenine linked by successive 3′-5′ phosphodiester bonds (also known as ribonucleic acid). The term does not apply to nucleic acid analogues (e.g., dideoxycytidine), or polymers containing nucleic acid analogues.

                Pesticidal substance, means a substance that is intended to be produced and used in a living plant, or in the produce thereof, for a pesticidal purpose, during any part of a plant's life cyle (e.g., in the embryo, seed, seedling, mature plant).

                Plant, for plant-incorporated protectants, means an organism classified using the 5-kingdom classification system of Whittaker in the kingdom Plantae. This includes, but is not limited to, bryophytes such as mosses, pteridophytes such as ferns, gymnosperms such as conifers, and angiosperms such as most major crop plants.

                Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.

                Produce thereof, when used with respect to plants containing plant- incorporated protectants only, means a product of a living plant containing a plant-incorporated protectant, where the pesticidal substance is intended to serve a pesticidal purpose after the product has been separated from the living plant. Examples of such products include, but are not limited to, agricultural produce, grains, and lumber. Products such as raw agricultural commodities bearing pesticide chemical residues are not “produce thereof” when the residues are not intended to serve a pesticidal purpose in the produce.

                Recipient plant means the living plant in which the plant-incorporated protectant is intended to be produced and used.

                Recombinant DNA means the genetic material has been manipulated in vitro through the use of restriction endonucleases and/or other enzymes that aid in modifying genetic material, and subsequently introduced into the genome of the plant.

                Regulatory region means genetic material that controls the expression of the genetic material that encodes a pesticidal substance or leads to the production of a pesticidal substance. Examples of regulatory regions include, but are not limited to, promoters, enhancers, and terminators.

                Sexually compatible, when referring to plants, means a viable zygote is formed only through the union of two gametes through conventional breeding.

                Source means the donor of the genetic material that encodes a pesticidal substance or leads to the production of a pesticidal substance.

                Vegetative reproduction means either:
              (1) In seed plants, reproduction by apomixis, or
              (2) In other plants, reproduction by fragmentation, or division of the somatic body.

                Wide crosses means to facilitate the formation of viable zygotes through the use of surgical alteration of the plant pistil, bud pollination, mentor pollen, immunosuppressants, in vitro fertilization, pre-pollination and post-pollination hormone treatments, manipulation of chromosome numbers, embryo culture, or ovary and ovule cultures.

              § 174.9
              Confidential business information claims for plant-incorporated protectant submissions.
              Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as Confidential Business Information (CBI), a submitter may assert a claim of confidentiality for all or part of the information submitted to EPA in a submission for a plant-incorporated protectant. (See part 2, subpart B of this chapter.) To assert such a claim, the submitter must comply with all of the following procedures:
              (a) Any claim of confidentiality must accompany the information at the time the information is submitted to EPA. Failure to assert a claim at that time constitutes a waiver of confidentiality for the information submitted, and the information may be made available to the public, subject to section 10(g) of FIFRA, with no further notice to the submitter.

              (b) Any claim of confidentiality must be accompanied, at the time the claim is made, by comments substantiating the claim and explaining why the submitter believes that the information should not be disclosed. The submitter must address each of the points listed in § 2.204(e)(4) of this chapter in the substantiation. EPA will consider incomplete all plant-incorporated protectant submissions containing information claimed as CBI that are not accompanied by substantiation, and will suspend any applicable review of such submissions until the required substantiation is provided.

            Subpart B—Exemptions

              § 174.21
              General qualifications for exemptions.
              A plant-incorporated protectant is exempt from the requirements of FIFRA, other than the requirements of § 174.71, if it meets all of the following criteria:
              (a) The plant-incorporated protectant meets the criteria listed in at least one of the sections in §§ 174.25 through 174.50.

              (b) When the plant-incorporated protectant is intended to be produced and used in a crop used as food, the residues of the plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA (as amended, 21 U.S.C. 321 et seq.) as codified at §§ 174.507 through 174.508, or no tolerance would otherwise be required for the plant-incorporated protectant.
              (c) Any inert ingredient that is part of the plant-incorporated protectant is on the list codified at § 174.705. Plant-incorporated protectants that are not exempt from the requirements of FIFRA under this subpart are subject to all the requirements of FIFRA.
              [66 FR 37814, July 19, 2001, as amended at 72 FR 20434, Apr. 25, 2007]

              § 174.25
              Plant-incorporated protectant from sexually compatible plant.
              A plant-incorporated protectant is exempt if all of the following conditions are met:
              (a) The genetic material that encodes the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient plant.
              (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient plant.

            Subpart C—Registration Procedures and Requirements [Reserved]

            Subpart D—Monitoring and Recordkeeping

              § 174.71
              Submission of information regarding adverse effects.
              (a) Any person who produces, for sale or distribution, a plant-incorporated protectant exempt under subpart B of this part, who obtains any information regarding adverse effects on human health or the environment alleged to have been caused by the plant-incorporated protectant must submit such information to EPA. This requirement does not apply to any person who does not produce a plant-incorporated protectant exempt under subpart B of this part. This may include, for example, researchers performing field experiments, breeders making crosses among plant varieties with the goal of developing new plant varieties, or a person who only sells propagative materials (e.g., seed) to farmers without producing the propagative materials themselves. EPA must receive the report within 30 calendar days of the date the producer first possesses or knows of the information.
              (b) Adverse effects on human health or the environment for purposes of plant-incorporated protectant means at a minimum information about incidents affecting humans or other nontarget organisms where both:
              (1) The producer is aware, or has been informed, that a person or nontarget organism allegedly suffered a toxic or adverse effect due to exposure to (e.g., ingestion of) a plant-incorporated protectant.
              (2) The producer has or could reasonably obtain information concerning where the incident occurred.
              (c) All of the following information, if available, must be included in a report.
              (1) Name of reporter, address, and telephone number.
              (2) Name, address, and telephone of contact person (if different than reporter).
              (3) Description of incident.
              (4) Date producer became aware of incident.
              (5) Date of incident.
              (6) Location of incident.

              (d) Reports and questions should be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
              [66 FR 37814, July 19, 2001, as amended at 71 FR 35546, June 21, 2006]

            Subparts E-F [Reserved]

            Subpart G—Labeling [Reserved]

            Subpart H—Data Requirements [Reserved]

            Subpart I [Reserved]

            Subpart J—Good Laboratory Practices [Reserved]

            Subpart K—Export Requirements [Reserved]

            Subparts L-T [Reserved]

            Subpart U—Experimental Use Permits [Reserved]

            Subpart V [Reserved]

            Subpart W—Tolerances and Tolerance Exemptions

              § 174.500
              Scope and purpose.
              This subpart lists the tolerances and exemptions from the requirement of a tolerance for residues of plant-incorporated protectants in or on food commodities.
              [72 FR 20434, Apr. 25, 2007]

              § 174.501

                Bacillus thuringiensis Vip3Aa protein in corn and cotton; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Vip3Aa proteins in or on corn or cotton are exempt from the requirement of a tolerance when used as plant-incorporated protectants in or on the food and feed commodities of corn; corn, field; corn, sweet; corn, pop; and cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.
              [73 FR 45624, Aug. 6, 2008]

              § 174.502

                Bacillus thuringiensis Cry1A.105 protein; exemption from the requirement of a tolerance.
              (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on the food and feed commodities of corn; corn, field, flour; corn, field, forage; corn, field, grain; corn, field, grits; corn, field, meal; corn, field, refined oil; corn, field, stover; corn, sweet, forage; corn, sweet, kernel plus cob with husk removed; corn, sweet, stover; and corn, pop, grain and corn, pop, stover are exempt from the requirement of a tolerance when the Bacillus thuringiensis Cry1A.105 protein is used as a plant-incorporated protectant in these food and feed corn commodities.
              (b) Residues of Bacillus thuringiensis Cry1A.105 protein in or on soybean are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities of soybean.
              [74 FR 39543, Aug. 7, 2009, as amended at 80 FR 25950, May 6, 2015]

              § 174.504

                Bacillus thuringiensis Cry1F protein; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry1F protein in the food and feed commodities of corn, field; corn, sweet; corn, pop; cotton; and soybean are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in corn, field; corn, sweet; corn, pop; cotton, and soybean.
              [79 FR 8295, Feb. 12, 2014]

              § 174.505

                Bacillus thuringiensis modified Cry3A protein (mCry3A) in corn; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis modified Cry3A protein (mCry3A) in corn are exempt from the requirement of a tolerance when used as plant-incorporated protectant in the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop.
              [72 FR 20434, Apr. 25, 2007]

              § 174.506

                Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in corn; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in corn are exempted from the requirement of a tolerance when used as plant-incorporated protectants in the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop.
              [72 FR 20434, Apr. 25, 2007]

              § 174.507
              Nucleic acids that are part of a plant-incorporated protectant; exemption from the requirement of a tolerance.
              Residues of nucleic acids that are part of a plant-incorporated protectant are exempt from the requirement of a tolerance.
              [66 FR 37830, July 19, 2001. Redesignated at 72 FR 20434, April 25, 2007]

              § 174.508
              Pesticidal substance from sexually compatible plant; exemption from the requirement of a tolerance.
              Residues of a pesticidal substance that is part of a plant-incorporated protectant from a sexually compatible plant are exempt from the requirement of a tolerance if all the following conditions are met:
              (a) The genetic material that encodes for the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient food plant.
              (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient food plant.
              (c) The residues of the pesticidal substance are not present in food from the plant at levels that are injurious or deleterious to human health.
              [66 FR 37854, July 19, 2001. Redesignated at 72 FR 20434, April 25, 2007]

              § 174.509

                Bacillus thuringiensis Cry3A protein; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry3A protein are exempted from the requirement of a tolerance when used as a plant-incorporated protectant in potatoes.
              [72 FR 20435, Apr. 25, 2007]

              § 174.510

                Bacillus thuringiensis Cry1Ac protein in all plants; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry1Ac protein in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectants in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.511

                Bacillus thuringiensis Cry1Ab protein in all plants; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry1Ab protein in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectants in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.512
              Coat Protein of Potato Virus Y; exemption from the requirement of a tolerance.
              Residues of Coat Protein of Potato Virus Y are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.513
              Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene); exemption from the requirement of a tolerance.
              An exemption from the requirement of a tolerance is established for residues of the plant-incorporated protectant Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene) in or on all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.514
              Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus; exemption from the requirement for a tolerance.

              Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.515
              Coat Protein of Papaya Ringspot Virus; exemption from the requirement of a tolerance.
              Residues of Coat Protein of Papaya Ringspot Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.516
              Coat protein of cucumber mosaic virus; exemption from the requirement of a tolerance.
              Residues of Coat Protein of Cucumber Mosaic Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.517

                Bacillus thuringiensis Cry9C protein in corn; exemption from the requirement of a tolerance.
              The plant-incorporated protectant Bacillus thuringiensis Cry9C protein in corn is exempted from the requirement of a tolerance for residues, only in corn used for feed; as well as in meat, poultry, milk, or eggs resulting from animals fed such feed.
              [72 FR 20435, Apr. 25, 2007]

              § 174.518

                Bacillus thuringiensis Cry3Bb1 protein in corn; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry3Bb1 protein in corn are exempt from the requirement of a tolerance when used as plant-incorporated protectants in the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop.
              [72 FR 20435, Apr. 25, 2007]

              § 174.519

                Bacillus thuringiensis Cry2Ab2 protein; exemption from the requirement of a tolerance.
              (a) Residues of Bacillus thuringiensis Cry2Ab2 protein in or on corn or cotton are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities of corn; corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts.
              (b) Residues of Bacillus thuringiensis Cry2Ab2 protein in or on soybean are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities of soybean.
              [80 FR 25604, May 5, 2015]

              § 174.521
              Neomycin phosphotransferase II; exemption from the requirement of a tolerance.
              Residues of the neomycin phosphotransferase II (NPTII) enzyme are exempted from the requirement of a tolerance in all food commodities when used as a plant-incorporated protectant inert ingredient.
              [72 FR 20435, Apr. 25, 2007]

              § 174.522
              Phosphinothricin Acetyltransferase (PAT); exemption from the requirement of a tolerance.
              Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.523
              CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all plants; exemption from the requirement of a tolerance.
              Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase enzyme in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.524
              Glyphosate Oxidoreductase GOX or GOXv247 in all plants; exemption from the requirement of a tolerance.

              Residues of the Glyphosate Oxidoreductase GOX or GOXv247 enzyme in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.525
              E. coli B-D-glucuronidase enzyme as a plant-incorporated protectant inert ingredient; exemption from the requirement of a tolerance.
              Residues of E. coli B-D-glucuronidase enzyme are exempt from the requirement of a tolerance when used as a plant-incorporated protectant inert ingredient in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.526
              Hygromycin B phosphotransferase (APH4) marker protein in all plants; exemption from the requirement of a tolerance.
              Residues of the Hygromycin B phosphotransferase (APH4) enzyme in all plants are exempt from the requirement of a tolerance when used as a plant-incorporated protectant inert ingredient in cotton.
              [72 FR 20435, Apr. 25, 2007]

              § 174.527
              Phosphomannose isomerase in all plants; exemption from the requirement of a tolerance.
              Residues of the phosphomannose isomerase (PMI) enzyme in plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities.
              [72 FR 20435, Apr. 25, 2007]

              § 174.529

                Bacillus thuringiensis modified Cry1Ab protein as identified under OECD Unique Identifier SYN-IR67B-1 in cotton; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis modified Cry1Ab protein as identified under OECD Unique Identifier SYN-IR67B-1 are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.
              [73 FR 40764, July 16, 2008]

              § 174.530

                Bacillus thuringiensis Cry2Ae protein in cotton; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry2Ae protein in or on the food and feed commodities of cotton; cotton, undelinted seed; cotton, gin byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; and cotton, refined oil, are exempt from the requirement of a tolerance when Bacillus thuringiensis Cry2Ae protein is used as a plant-incorporated protectant in cotton.
              [77 FR 6475, Feb. 8, 2012]

              § 174.531
              Coat protein of plum pox virus; exemption from the requirement of a tolerance.
              Residues of the coat protein of plum pox virus in or on the food commodities of fruit, stone, Group 12; and almond, are exempt from the requirement of a tolerance in these food commodities when expressed by the plant-incorporated protectant, coat protein gene of plum pox virus, and used in accordance with good agricultural practices.
              [75 FR 29435, May 26, 2010]

              § 174.532

                Bacillus thuringiensis eCry3.1Ab protein in corn; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop are exempt from the requirement of a tolerance when Bacillus thuringiensis eCry3.1Ab protein in corn is used as a plant-incorporated protectant.
              [77 FR 47291, Aug. 8, 2012]

              § 174.533

                Glycine max Herbicide-Resistant Acetolactate Synthase (GM-HRA) inert ingredient; exemption from the requirement of a tolerance.
              Residues of Glycine max herbicide-resistant acetolactate synthase (GM-HRA) enzyme in or on the food and feed commodities of soybean are exempt from the requirement of a tolerance when used as a plant-incorporated protectant inert ingredient.
              [78 FR 9321, Feb. 8, 2013]

              § 174.534
              VNT1 protein; exemption from the requirement of a tolerance.

              Residues of VNT1 protein in potato are exempt from the requirement of a tolerance when the Rpi-vnt1 gene that express the VNT1 protein is used as a plant-incorporated protectant in potato.
              [82 FR 11515, Feb. 24, 2017]

              § 174.535
              Spinach Defensin proteins; temporary exemption from the requirement of a tolerance.

              Residues of the defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach (Spinacia oleracea L.) in or on citrus food commodities are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in citrus plants in accordance with the terms of Experimental Use Permit No. 88232-EUP-1. This temporary exemption from the requirement of a tolerance expires on May 31, 2021.
              [83 FR 24944, May 31, 2018]

              § 174.536

                Bacillus thuringiensis mCry51Aa2 protein in cotton; temporary exemption from the requirement of a tolerance.
              Residues of the protein mCry51Aa2 in or on the food and feed commodities of cotton: Cotton, undelinted seed; cotton, gin byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; and cotton, refined oil are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in cotton plants in accordance with the terms of Experimental Use Permit No. 524-EUP-108. This temporary exemption from the requirement of a tolerance expires on February 28, 2019.
              [82 FR 18230, Apr. 18, 2017]

              § 174.537
              HPPD-4 protein; exemption from the requirement of a tolerance.

              Residues of the HPPD-4 protein, which is a modified protein derived from the 4-hydroxyphenylpyruvate dioxygenase enzyme of Pseudomonas fluorescens, in or on all food commodities are exempt from the requirement of a tolerance, when the HPPD-4 protein is used as a plant-incorporated protectant inert ingredient.
              [82 FR 57140, Dec. 4, 2017]

              § 174.539
              Cry51Aa2.834_16 protein; exemption from the requirement of a tolerance.

              Residues of the Cry51Aa2.834_16 protein, which is a modified protein derived from the Cry51Aa2 protein of Bacillus thuringiensis, in or on cotton are exempt from the requirement of a tolerance, when the Cry51Aa2.834_16 protein is used as a plant-incorporated protectant.
              [83 FR 3603, Jan. 26, 2018]

              § 174.540
              Bacillus thuringiensis Cry14Ab-1 protein; exemption from the requirement of a tolerance.
              Residues of Bacillus thuringiensis Cry14Ab-1 protein in or on soybean food and feed commodities are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in soybean.
              [85 FR 35008, June 8, 2020]

            Subpart X—List of Approved Inert Ingredients

              § 174.700
              Scope and purpose.
              This subpart lists the inert ingredients that have been exempted from FIFRA and FFDCA section 408 requirements and may be used in a plant-incorporated protectant listed in subpart B of this part.
              [66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007]

              § 174.705
              Inert ingredients from sexually compatible plant.
              An inert ingredient, and residues of the inert ingredient, are exempt if all of the following conditions are met:
              (a) The genetic material that encodes the inert ingredient or leads to the production of the inert ingredient is derived from a plant sexually compatible with the recipient food plant.

              (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient food plant.
              (c) The residues of the inert ingredient are not present in food from the plant at levels that are injurious or deleterious to human health.
              [66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007]

            Subparts Y-Z [Reserved]

          Pt. 176
          PART 176—TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS

            Sec.
            176.1
            Scope and applicability.
            176.3
            Definitions.
            176.5
            Establishment of a time-limited tolerance or exemption.
            176.7
            Information needed to establish a tolerance.
            176.9
            Publication of a tolerance.
            176.11
            Duration of a tolerance.
            176.13
            Modification of a time-limited tolerance.
            176.15
            Effect of a tolerance.

            Authority:
            21 U.S.C. 346a and 371.

            Source:
            65 FR 64131, Oct. 25, 2000, unless otherwise noted.

            § 176.1
            Scope and applicability.
            This part describes the procedures and criteria under which EPA will establish time-limited tolerances and exemptions from the requirement of a tolerance for pesticide chemical residues associated with use of pesticides under emergency or crisis exemptions under FIFRA section 18. This part applies only to tolerances issued on the initiative of EPA as the result of the issuance of an emergency exemption or the declaration of a crisis exemption. This part does not cover time-limited tolerances in any other circumstances.

            § 176.3
            Definitions.
            The terms have the same meaning as in the Federal Insecticide, Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug, and Cosmetic Act section 201 and § 166.3 of this chapter. In addition, the following terms are defined for the purposes of this part.

              Agency means the U.S. Environmental Protection Agency.

              Applicant means any entity authorized under section 18 of FIFRA to request an emergency exemption that requests such an exemption under § 166.20 of this chapter, or issues a crisis exemption under § 166.40 of this chapter.

              Crisis exemption means an exemption authorized under FIFRA section 18, in accordance with §§ 166.40 through 166.53 of this chapter.

              Emergency exemption means a specific, quarantine, or public health exemption authorized under FIFRA section 18 and the regulations at §§ 166.20 through 166.35 of this chapter.

              EPA means the U.S. Environmental Protection Agency.

              FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).

              FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C 136 et seq.).

              Tolerance means the maximum amount of a pesticide chemical residue that may lawfully be present in or on a raw agricultural commodity, or processed food, or animal feed, expressed as parts per million by weight of the pesticide chemical residue in the food or feed.

              Tolerance exemption means a formal determination by the Agency pursuant to FFDCA section 408(c), 21 U.S.C 346a(c), that no tolerance is needed for a given pesticide chemical residue in or on a particular food commodity. For purposes of this part, the term “tolerance” shall include an exemption from the requirement of a tolerance.

            § 176.5
            Establishment of a time-limited tolerance or exemption.
            EPA will establish a time-limited tolerance for pesticide chemical residues in or on raw or processed food or feed resulting from the use of a pesticide chemical, if EPA authorizes an emergency exemption or a crisis exemption. EPA will consider establishing such a tolerance only if an applicant acting under authority of FIFRA section 18 either has requested an emergency exemption, has stated its intention to issue a crisis exemption, or has issued a crisis exemption for a use that may result, directly or indirectly, in pesticide chemical residues in food or feed.

            § 176.7
            Information needed to establish a tolerance.
            (a) EPA will establish a time-limited tolerance only if EPA can determine that the tolerance is safe, that is, there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. EPA will base its determination upon data submitted by the applicant and other readily available data. If, taking into account the limited duration and emergency nature of a section 18 application, and based on the available data the Agency cannot conclude that there is a reasonable certainty that no harm will result from the use proposed by the applicant or granted pursuant to a crisis exemption, EPA will not establish a tolerance.
            (b) Data and other relevant information to support the establishment of a time-limited tolerance may be submitted by the applicant, or by any other person, in support of the time-limited tolerance. The applicant may also cite relevant data previously submitted to the Agency.

            § 176.9
            Publication of a tolerance.

            (a) If EPA issues an emergency exemption or crisis exemption under FIFRA section 18, and EPA concludes that the tolerance for residues resulting from use of the pesticide under the exemption will be safe, then EPA will establish the tolerance by publishing an amendment to 40 CFR part 180 in the Federal Register.

            (b) A tolerance under this part may be established without prior publication of a proposed tolerance or comment period.

            § 176.11
            Duration of a tolerance.

            (a) Tolerances issued under this part will become effective upon publication in the Federal Register, unless otherwise specified by the Administrator.

            (b) Unless extended, tolerances will automatically expire and be revoked, without further action by EPA, at the time set out in the final rule published in Federal Register.

            (c) The Administrator may revoke a tolerance at any time if the Administrator determines that the tolerance is no longer safe.

            § 176.13
            Modification of a time-limited tolerance.

            If additional emergency or crisis exemptions are authorized that would extend use beyond the date originally authorized, or if EPA determines that the duration of a time-limited tolerance is insufficient to allow treated commodities to clear the channels of trade, EPA may modify the time-limited tolerance by publication of a final rule in the Federal Register. EPA will use the same criteria and procedures for modification as for establishing tolerances under this part.

            § 176.15
            Effect of a tolerance.
            The establishment of a tolerance under this part does not alter the requirement that any applicant comply with procedures established in part 166 of this chapter for emergency exemptions of FIFRA.

          Pt. 178
          PART 178—OBJECTIONS AND REQUESTS FOR HEARINGS

              Subpart A—General Provisions
              Sec.
              178.3
              Definitions.

              Subpart B—Procedures for Filing Objections and Requests for Hearing
              178.20
              Right to submit objections and requests for a hearing.
              178.25
              Form and manner of submission of objections.
              178.27
              Form and manner of submission of request for evidentiary hearing.
              178.30
              Response by Administrator to objections and to requests for hearing.
              178.32
              Rulings on requests for hearing.
              178.35
              Modification or revocation of regulation or prior order.
              178.37
              Order responding to objections on which a hearing was not requested or was denied.

              Subpart C [Reserved]

              Subpart D—Judicial Review
              178.65
              Judicial review.
              178.70
              Administrative record.

            Authority:
            21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

            Source:
            55 FR 50291, Dec. 5, 1990, unless otherwise noted.

            Subpart A—General Provisions

              § 178.3
              Definitions.
              For the purposes of this part:

                Administrator means the Administrator of the Agency, or any officer or employee of the Agency to whom the Administrator delegates the authority to perform functions under this part.

                Agency means the United States Environmental Protection Agency.

                Assistant Administrator means the Agency's Assistant Administrator for Chemical Safety and Pollution Prevention, or any officer or employee of the Agency's Office of Chemical Safety and Pollution Prevention to whom the Assistant Administrator delegates the authority to perform functions under this part.

                FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 301-392.
              [55 FR 50291, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 FR 46292, Aug. 3, 2012]

            Subpart B—Procedures for Filing Objections and Requests for Hearing

              § 178.20
              Right to submit objections and requests for a hearing.

              (a) On or before the 60th day after the date of publication in the Federal Register of an order under part 180 of this chapter establishing, modifying, or revoking a regulation, or denying all or any portion of a petition, a person adversely affected by such order or petition denial may submit, in accordance with § 178.25, one or more written objections to the order (or to the action that is the subject of the order).
              (b) A person may include with any such objection a written request for an evidentiary hearing on such objection in accordance with § 178.27
              (c) A person who submits objections need not request a hearing. For instance, if the person's objections are of a purely legal or policy nature, a hearing request would be inappropriate; the purpose of an evidentiary hearing is to resolve factual disputes. The Administrator will rule on the objections, whether or not a hearing is requested.
              (d) As a matter of discretion, the Administrator may order a hearing on an objection even though no person has requested a hearing.
              [55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

              § 178.25
              Form and manner of submission of objections.
              (a) To be considered by the Administrator, an objection must:
              (1) Be in writing.
              (2) Specify with particularity the provision(s) of the order, regulation, or denial objected to, the basis for the objection(s), and the relief sought.
              (3) Be signed by the objector.
              (4) State the objector's name and mailing address.
              (5) Be accompanied by the fee prescribed by § 180.33(i) of this chapter, if the objection is to an order or regulation issued under part 180 of this chapter.
              (6) Be submitted to the hearing clerk.

              (7) Be received by the Hearing Clerk not later than the close of business of the 60th day following the date of the publication in the Federal Register of the order to which the objection is taken (or, if such 60th day is a Saturday, Sunday, or Federal holiday, not later than the close of business of the next government business day after such 60th day).
              (b) Submissions to the hearing clerk shall be made as follows:
              (1) Mailed submissions should be addressed to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
              (2) For hand/courier delivery the Office of the Hearing Clerk is located at Suite 350, 1099 14th St., NW., Washington, DC 20005.
              [55 FR 50291, Dec. 5, 1990, as amended at 69 FR 39864, July 1, 2004; 70 FR 33359, June 8, 2005; 71 FR 35546, June 21, 2006]

              § 178.27
              Form and manner of submission of request for evidentiary hearing.
              To be considered by the Administrator, a request for an evidentiary hearing must meet the criteria in § 178.32, and must:

              (a) Be submitted as a part of, and specifically request an evidentiary hearing on an objection that complies with the requirements of § 178.25.
              (b) Include a statement of the factual issue(s) on which a hearing is requested and the requestor's contentions on each such issue.
              (c) Include a copy of any report, article, survey, or other written document (or the pertinent pages thereof) upon which the objector relies to justify an evidentiary hearing, unless the document is an EPA document that is routinely available to any member of the public.
              (d) Include a summary of any evidence not described in paragraph (a)(3) of this section upon which the objector relies to justify an evidentiary hearing.
              (e) Include a discussion of the relationship between the factual issues and the relief requested by the objection.

              § 178.30
              Response by Administrator to objections and to requests for hearing.
              The Administrator will respond to objections, and to requests for a hearing on such objections, as set forth in this section.
              (a) Denial of objections that are improperly submitted or that seek an unavailable form of relief. The Administrator will by order issued under § 178.37 deny each objection and each request for a hearing that is included with such an objection, if:
              (1) The objection is found not to conform to § 178.25.
              (2) The action requested by the objection is inconsistent with any provision of FFDCA.
              (3) The action requested by the objection is inconsistent with any generic, e.g., non-chemical specific, interpretation of a provision of FFDCA in any regulation in this chapter (the proper procedure in such a case is for the person to petition for an amendment of the regulation involved).
              (b) Denial of improperly submitted requests for hearing. The Administrator will then determine whether any objection that has not been denied under paragraph (a) of this section was accompanied by a request for an evidentiary hearing that conforms to § 178.27. The Administrator will deny under § 178.37 each request that does not conform to § 178.27.
              (c) Grouping of certain related objections. If the Administrator then finds (1) That two or more undenied objections are substantially similar, or are related in such a way that any judicial review of the Administrator's action on those objections should occur at the same time, and (2) that one or more of those objections was accompanied by an undenied request for an evidentiary hearing on that objection, the Administrator will treat those objections as a group and will rule on them only after ruling under § 178.32 on the associated request for hearing.
              (d) Rulings on objections for which a request for hearing has been granted. If the Administrator rules under § 178.32 that an evidentiary hearing should be held on an objection, the Administrator will resolve the issues raised by any other objection grouped with it under paragraph (c) of this section in conjunction with the evidentiary hearing upon which the hearing request was granted, unless the Administrator for good cause determines otherwise.
              (e) Rulings on objections for which no request for hearing was received, or for which each request for hearing was denied. Except as provided in paragraphs (c) and (d) of this section, if no hearing was requested on an objection, or if each such request that was made is denied under the criteria of paragraphs (a) or (b) of this section or § 178.32(b), the Administrator will rule on the objection under § 178.37.

              § 178.32
              Rulings on requests for hearing.

              (a) In the case of each request for an evidentiary hearing that was not denied under § 178.30(a) or (b), the Administrator will determine whether such a hearing on one or more of the objections is justified, and will publish in the Federal Register the determination in an order issued under § 178.37 or a Notice of Hearing issued under § 179.20 of this chapter. If some requests for a hearing are denied and others pertaining to the same order or regulation are granted, the denial order and the hearing notice may be combined into a single document and shall be issued at the same time unless the Administrator for good cause determines otherwise.

              (b) A request for an evidentiary hearing will be granted if the Administrator determines that the material submitted shows the following:
              (1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted on issues of policy or law.
              (2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiary hearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions, nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged.
              (3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to justify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative with respect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the action would be the same even if the factual issue were resolved in the manner sought.
              (c) Where appropriate, the Administrator will make rulings on any issues raised by an objection which are necessary for resolution prior to determining whether a request for an evidentiary hearing should be granted.

              § 178.35
              Modification or revocation of regulation or prior order.
              (a) If the Administrator determines upon review of an objection or request for hearing that the regulation or prior order in question should be modified or revoked, the Administrator will publish an order setting forth any revision to the regulation or prior order that the Administrator has found to be warranted.
              (b) The Administrator will provide an opportunity for objections and requests for hearing on such order to the extent required by law. Such objections to the modification or revocation of the regulation, and requests for a hearing on such objections, may be submitted under §§ 178.20 through 178.27.
              (c) Objections and requests for hearing that are not affected by the modification or revocation will remain on file and be acted upon in accordance with this part.
              [55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

              § 178.37
              Order responding to objections on which a hearing was not requested or was denied.
              (a) The Administrator will publish in the Federal Register an order under FFDCA section 408(g)(2)(B) or section 408(g)(2)(C) setting forth the Administrator's determination on each denial of a request for a hearing, and on each objection submitted under § 178.20 on which:
              (1) A hearing was not requested.
              (2) A hearing was requested, but denied.
              (b) Each order published under paragraph (a) of this section must state the reasons for the Administrator's determination. If the order denies a request for a hearing on the objection, the order also must state the reason for that denial (e.g., why the request for a hearing did not conform to § 178.27, or why the request was denied under § 178.32).
              (c) Each order published under paragraph (a) of this section must state its effective date.
              [55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

            Subpart C [Reserved]

            Subpart D—Judicial Review

              § 178.65
              Judicial review.

              An order issued under § 178.37 is final agency action reviewable in the courts as provided by FFDCA section 408(h), as of the date of publication of the order in the Federal Register. The failure to file a petition for judicial review within the period ending on the 60th day after the date of the publication of the order constitutes a waiver under FFDCA section 408(h) of the right to judicial review of the order and of any regulation promulgated by the order.
              [70 FR 33359, June 8, 2005]

              § 178.70
              Administrative record.
              (a) For purposes of judicial review, the record of an administrative proceeding that culminates in an order under § 178.37 consists of:
              (1) The objection ruled on (and any request for hearing that was included with the objection).
              (2) Any order issued under § 180.7(g) of this chapter to which the objection related, and:
              (i) Any regulation or petition denial that was the subject of that order.
              (ii) The petition to which such order responded.
              (iii) Any amendment or supplement of the petition.
              (iv) The data and information submitted in support of the petition.
              (v) The notice of filing of the petition.
              (3) Any order issued under § 180.29(f) of this chapter to which the objection related, the regulation that was the subject of that order, and each related Notice of Proposed Rulemaking.
              (4) Any comments submitted by members of the public in response to the Notice of Filing or Notice of Proposed Rulemaking, any data or information submitted as part of the comments, the Administrator's response to comments and the documents or information relied on by the Administrator in issuing the regulation or order.
              (5) All other documents or information submitted to the docket for the rulemaking in question.
              (6) The order issued under § 178.37.
              (b) The record will be closed as of the date of the Administrator's decision unless another date for closing of the record is specified in the order issued under § 178.37.
              [55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

          Pt. 179
          PART 179—FORMAL EVIDENTIARY PUBLIC HEARING

              Subpart A—General Provisions
              Sec.
              179.3
              Definitions.
              179.5
              Other authority.

              Subpart B—Initiation of Hearing
              179.20
              Notice of hearing.
              179.24
              Ex parte discussions; separation of functions.

              Subpart C—Participation and Appearance; Conduct
              179.42
              Notice of participation.
              179.45
              Appearance.
              179.50
              Conduct at oral hearings or conferences.

              Subpart D—Presiding Officer
              179.60
              Designation and qualifications of presiding officer.
              179.70
              Authority of presiding officer.
              179.75
              Disqualification of deciding officials.
              179.78
              Unavailability of presiding officer.

              Subpart E—Hearing Procedures
              179.80
              Filing and service.
              179.81
              Availability of documents.
              179.83
              Disclosure of data and information.
              179.85
              Purpose of preliminary conference.
              179.86
              Time and place of preliminary conference.
              179.87
              Procedures for preliminary conference.
              179.89
              Motions.
              179.90
              Summary decisions.
              179.91
              Burden of going forward; burden of persuasion.
              179.93
              Testimony.
              179.94
              Transcripts.
              179.95
              Admission or exclusion of evidence; objections; offers of proof.
              179.97
              Conferences during hearing.
              179.98
              Briefs and arguments.

              Subpart F—Decisions and Appeals
              179.101
              Interlocutory appeal from ruling of presiding officer.
              179.105
              Initial decision.
              179.107
              Appeal from or review of initial decision.
              179.110
              Determination by Administrator to review initial decision.
              179.112
              Decision by Administrator on appeal or review of initial decision.
              179.115
              Motion to reconsider a final order.
              179.117
              Designation and powers of judicial officer.

              Subpart G—Judicial Review
              179.125
              Judicial review.
              179.130
              Administrative record.

            Authority:
            21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

            Source:
            55 FR 50293, Dec. 5, 1990, unless otherwise noted.

            Subpart A—General Provisions

              § 179.3
              Definitions.

                Administrator means the Administrator of the Agency, or any officer or employee of the Agency to whom the Administrator has delegated the authority to perform functions under this part.

                Agency means the United States Environmental Protection Agency.

                Assistant Administrator means the Agency's Assistant Administrator for Chemical Safety and Pollution Prevention, or any officer or employee of the Agency's Office of Chemical Safety and Pollution Prevention to whom the Assistant Administrator has delegated the authority to perform functions under this part.

                FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 301-392.

                FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136-136y.

                Judicial Officer means a person who has been designated by the Administrator under § 179.117 to serve as a judicial officer.

                OCSPP means the Agency's Office of Chemical Safety and Pollution Prevention.

                Office of the Administrator means the Agency's Administrator and Deputy Administrator and their immediate staff, including the judicial officer.
              [55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 FR 46292, Aug. 3, 2012]

              § 179.5
              Other authority.
              Questions regarding procedural matters arising under this part or part 178 of this chapter that are not addressed by this part or part 178 of this chapter shall be resolved by the Administrator or presiding officer, as appropriate.

            Subpart B—Initiation of Hearing

              § 179.20
              Notice of hearing.

              (a) If the Administrator determines under § 178.32 of this chapter that a hearing is justified on any issue, the Administrator will file with the hearing clerk and publish in the Federal Register a Notice of Hearing. The Notice of Hearing will set forth:
              (1) The docket number for the hearing.
              (2) Each order, regulation, or petition denial that is the subject of the hearing, and a statement specifying any part of any such regulation or order that has been stayed in the Administrator's discretion.
              (3) The identity of each person whose request for a hearing has been granted, and of any other person whose petition under § 180.7 of this chapter occasioned the order that the hearing concerns.
              (4) A statement of the issues of fact on which a hearing has been found to be justified.
              (5) A statement of the objections whose resolution depends on the resolution of those issues of fact.
              (6) A statement that the presiding officer will be designated by the Chief Administrative Law Judge.
              (7) The time within which notices of participation should be filed under § 179.42.
              (8) The date, time, and place of the preliminary conference, or a statement that the date, time, and place will be announced in a later notice, and the place of the hearing.
              (9) The time within which parties must submit written information and views under § 179.83.
              (10) Designations with respect to separation of functions published under § 179.24(b)(2).
              (b) The statement of the issues of fact on which a hearing has been justified determines the scope of the hearing and the matters on which evidence may be introduced. The issues may be revised by the presiding officer. A party may obtain interlocutory review by the Administrator of a decision by the presiding officer to revise the issues to include an issue on which the Administrator has not granted a request for a hearing or to eliminate an issue on which a request for a hearing has been granted.
              (c) A hearing is deemed to begin on the date of publication of the Notice of Hearing.
              [55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

              § 179.24
              Ex parte discussions; separation of functions.
              (a) Any person may meet or correspond with any officer or employee of the Agency concerning a matter under parts 178 or 180 of this chapter prior to publication of a Notice of Hearing under § 179.20.
              (b) Upon publication of a Notice of Hearing, the following separation of function rules apply:
              (1) OCSPP, as a party to the hearing, is responsible for presentation of its position at the hearing and in any pleading or oral argument before the Administrator. The Pesticides and Toxic Substances Division of the Office of General Counsel shall advise and represent OCSPP with respect to the hearing and in any pleading or oral argument before the Administrator. An employee or other representatives of OCSPP may not participate in or advise the Administrator or any of his representatives on any decision under this part, other than as witness or counsel in public proceedings, except as provided by paragraph (b)(2) of this section. There is to be no other communication between representatives of OCSPP and the presiding officer or any representative of the Office of the Administrator concerning the merits of the hearing until after issuance of the decision of the Administrator.
              (2) The Administrator may designate persons who otherwise would be regarded as representatives of OCSPP, to serve as representatives of the Office of the Administrator on matters pertaining to the hearing, and may also designate persons who otherwise would be regarded as representatives of the Office of the Administrator to serve as representatives of OCSPP. Such designations will be included in the Notice of Hearing published under§ 179.20.
              (3) The Office of the Administrator is responsible for the final decision of the matter, with the advice and participation of anyone in the Agency other than representatives of OCSPP.
              (c) Between the date of publication of the Notice of Hearing and the date of the Administrator's final decision on the matter, communication concerning the matter involved in the hearing will be restricted as follows:
              (1) No person outside the Agency may have an ex parte communication with the presiding officer or any representative of the Office of the Administrator concerning the merits of the hearing. Neither the presiding officer nor any representative of the Office of the Administrator may have any ex parte communication with a person outside the Agency concerning the merits of the hearing.
              (2) A written communication contrary to this section must be immediately served on all other participants and filed with the hearing clerk by the presiding officer at the hearing, or by the Administrator, depending on who received the communication. An oral communication contrary to this section must be immediately recorded in a written memorandum and similarly served on all other parties and filed with the hearing clerk. A person, including a representative of a party in the hearing, who is involved in an oral communication contrary to this section, must, to the extent necessary to determine the substance of the communication, be made available for cross-examination during the hearing with respect to the substance of that communication. Rebuttal testimony pertinent to a written or oral communication contrary to this section will be permitted.
              (d) The prohibitions specified in paragraph (c) of this section also apply to a person who, in advance of the publication of a Notice of Hearing, knows that the notice has been signed. The prohibitions become applicable to such a person as of the time the knowledge is acquired.
              (e) The making of a communication contrary to this section may, consistent with the interests of justice and the policies underlying the FFDCA, result in a decision adverse to the person knowingly making or causing the making of the communication.
              [55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 70 FR 33359, June 8, 2005; 77 FR 46292, Aug. 3, 2012]

            Subpart C—Participation and Appearance; Conduct

              § 179.42
              Notice of participation.
              (a) OCSPP shall be a party to a hearing under this part. Any other person may participate as a party in such a hearing to the extent specified by this section.

              (b) A person desiring to participate in a hearing must file with the hearing clerk within 30 days after publication of the Notice of Hearing under § 179.20, a Notice of Participation in the following form:

                Notice of Participation
                Docket No. __________
                Under 40 CFR part l79, please enter the participation of: ____________
                (Name) _________________
                (Street address) _____________
                (City and State) _____________
                (Telephone number) __________
                Service on the above will be accepted by: ____________
                (Name) _________________
                (Street address) _____________
                (City and State) _____________
                (Telephone number) __________
                Signed: ________________
                Date: ____________

              (c) An amendment to a Notice of Participation must be filed with the hearing clerk and served on all parties.
              (d) No person may participate in a hearing who has not filed a written Notice of Participation or whose participation has been stricken under paragraph (f) of this section.
              (e) The presiding officer may permit the late filing of a Notice of Participation upon a showing of good cause. Arrangements and agreements previously made in the proceeding shall apply to any party admitted late.
              (f) The presiding officer may strike the participation of a person for failure to comply with any requirement of this subpart. Any person whose participation is striken may obtain interlocutory review thereof by the Administrator.
              [55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 FR 46292, Aug. 3, 2012]

              § 179.45
              Appearance.
              (a) A party to a hearing may appear in person or by counsel or other representative in the hearing.
              (b) The presiding officer may strike a person's right to appear in the hearing for violation of the rules of conduct in § l79.50.

              § 179.50
              Conduct at oral hearings or conferences.
              The parties and their representatives must conduct themselves with dignity and observe the same standards of practice and ethics that would be required of parties in a judicial proceeding. Disrespectful, disorderly, or contumacious language or conduct, refusal to comply with directions, use of dilatory tactics, or refusal to adhere to reasonable standards of orderly and ethical conduct during any hearing constitute grounds for immediate exclusion from the proceeding by the presiding officer.

            Subpart D—Presiding Officer

              § 179.60
              Designation and qualifications of presiding officer.
              The presiding officer in a hearing will be an administrative law judge qualified under 5 U.S.C. 3l05 and designated by the Agency's chief administrative law judge.

              § 179.70
              Authority of presiding officer.
              The presiding officer shall conduct the hearing in a fair and impartial manner subject to the precepts of the Administrative Procedure Act. The presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to:
              (a) Specify and change the date, time, and place for conferences, and issue and modify a schedule for the hearing.

              (b) Establish an orderly manner for developing evidentiary facts at preliminary conferences under § 179.87, for making rulings on oral testimony and cross-examination under § 179.93, and for making other similar evidentiary rulings in accord with these regulations.

              (c) Prepare statements of the areas of factual disagreement among the participants.
              (d) Hold conferences to settle, simplify, or determine the issues in a hearing or to consider other matters that may expedite the hearing.
              (e) Administer oaths and affirmations.
              (f) Control the course of the hearing and the conduct of the participants.
              (g) Examine witnesses and strike their testimony if they fail to respond fully to proper questions.
              (h) Rule on, admit, exclude, or limit evidence.
              (i) Set the time for filing pleadings.
              (j) Rule on motions and other procedural matters.
              (k) Rule on motions for summary decision under § l79.90.
              (l) Conduct the hearing in stages if the number of parties is large or the issues are numerous and complex.
              (m) Strike the participation of any person under § l79.42(f), or exclude any person from the hearing under § l79.50, or take other reasonable disciplinary action.
              (n) Take any other action for the fair, expeditious, and orderly conduct of the hearing that is not in conflict with law or these rules.

              § 179.75
              Disqualification of deciding officials.
              (a) A deciding official in a hearing under this part (including, e.g., the Administrator, judicial officer, or presiding officer) shall not decide any matter in connection with which he or she has a financial interest in any of the parties, or a relationship that would make it otherwise inappropriate for him or her to act.
              (b) A party may request that a deciding official disqualify himself/herself and withdraw from the proceeding. The party may obtain interlocutory review by the Administrator of a denial of such a request made to any deciding official other than the Administrator.
              (c) A deciding official who is aware of grounds for disqualification shall withdraw from the proceeding.

              § 179.78
              Unavailability of presiding officer.

              If the presiding officer is unable to act for any reason, his or her powers with respect to the hearing will be assigned by the Chief Administrative Law Judge to another presiding officer. The substitution will not affect the hearing, i.e., the testimony of the witnesses will not be taken anew except as the new presiding officer may order upon the request of a party where the credibility of a witness is of particular importance.

            Subpart E—Hearing Procedures

              § 179.80
              Filing and service.
              (a) All documents required or authorized to be filed by a party to a hearing under this part regarding any matter to be decided by the presiding officer, the judicial officer, or the Administrator shall be filed in triplicate with the hearing clerk, in the manner specified by § 178.25(b) of this chapter. Each filing shall prominently note the docket number. To determine compliance with deadlines in a hearing, a document is considered filed on the date it is actually received by the hearing clerk. When this part allows a response by a party to a submission and prescribes a period of time for the filing of the response, an additional 3 days are allowed for the filing of the response if the submission is served by mail.
              (b) Each notice, order, decision, or other document issued under this part by the presiding officer, the judicial officer, or the Administrator shall be filed with the hearing clerk. The hearing clerk shall immediately serve all parties with a copy of such order, decision, or other document.
              (c) At the same time that a party files any document with the hearing clerk, the party shall serve a copy thereof on each other party, unless the presiding officer specifies otherwise. Each filing shall be accompanied by a certificate of service, or a statement that service is not required. Service on a party is accomplished by mailing a submission to the address shown in the Notice of Participation or by personal delivery.

              (d) The presiding officer may grant an extension of time for the filing of any pleading, document, or motion (1) Upon timely motion by a party, for good cause shown, and after consideration of prejudice to other parties, or (2) upon the presiding officer's own motion.
              (e) A motion by a party for an extension may only be made after serving a copy of the motion on all other parties, unless the movant can show good cause why doing so is impracticable. The motion shall be filed in advance of the date on which the pleading, document, or motion is due to be filed, unless the failure of the party to make a timely motion for an extension was the result of excusable neglect.

              § 179.81
              Availability of documents.
              (a) All orders, decisions, pleadings, transcripts, exhibits, and other docket entries shall become part of the official docket and shall be retained by the hearing clerk. Except as otherwise provided by paragraph (b) of this section or part 2 of this chapter, all documents that are a part of the official docket shall be made available to the public for reasonable inspection during Agency business hours. Copies of such documents may be obtained by members of the public as provided in part 2 of this chapter.
              (b) Whenever any information or data are required to be produced or examined in a hearing and any party makes a business confidentiality claim regarding such information under part 2 of this chapter, the availability of such information to the other parties or to the public shall be determined by EPA in accordance with part 2 of this chapter, including specifically the procedures and principles set forth in § 2.30l(g)(3) and (g)(4) of this chapter. The presiding officer shall make the determinations with respect to the matters referred to in § 2.301(g)(3) and (g)(4) to the extent provided, and shall take such steps as are necessary for the protection of information entitled to confidential treatment or otherwise exempt from public disclosure, including issuance of protective orders to parties or taking testimony in a closed hearing.

              § 179.83
              Disclosure of data and information.
              (a) Within 60 days of the publication of the Notice of Hearing under § l79.20, or, if no party will be prejudiced, within another period set by the presiding officer, the Assistant Administrator shall file with the hearing clerk, in accordance with § 179.80, the following documents numbered and organized in the manner prescribed by the presiding officer:
              (1) The portions of the administrative record of the proceeding developed under part 178 of this chapter, and under part 180 of this chapter, that are relevant to the issues in the hearing.
              (2) All documents in the files of OCSPP containing factual information or expert opinion, whether favorable or unfavorable to the position of OCSPP, which relate to the issues involved in the hearing. For purposes of this paragraph, “files” means the principal files in OCSPP in which documents relating to each of the issues in the hearing are ordinarily kept. Documents that are internal memoranda reflecting the deliberative process, or are attorney work product, or were prepared specifically for use in connection with the hearing, are not required to be submitted.
              (3) All other documentary data and information upon which OCSPP plans to rely upon in the hearing.
              (4) A narrative position statement on the factual issues in the Notice of Hearing and the nature of the supporting evidence that OCSPP intends to introduce.
              (5) A signed statement that, to the best knowledge and belief of the Assistant Administrator, the submission complies with this section.
              (b) Within 70 days of the publication of the Notice of Hearing or, if no party will be prejudiced, within another period of time set by the presiding officer, each party other than OCSPP shall submit to the hearing clerk in accordance with § 179.80 the following documents, numbered and organized in the manner prescribed by the presiding officer:

              (1) Any objections that the administrative record filed under paragraph (a)(l) of this section is incomplete.

              (2) All documents (other than those filed under paragraph (a) of this section) in the party's files containing factual information or expert opinion, whether favorable or unfavorable to the party's position, that relates to the issues involved in the hearing. For purposes of this paragraph, “files” means the party's principal files in which documents relating to each of the issues in the hearing are ordinarily kept. Documents that are attorney work product, or were prepared specifically for use in connection with the hearing, are not required to be submitted.
              (3) All other documentary data and information the party plans to rely upon in the hearing.
              (4) A narrative position statement on the factual issues in the Notice of Hearing and the nature of the supporting evidence the party intends to introduce.
              (5) A signed statement that, to the best knowledge and belief of the party, the submission complies with this section.
              (c) Submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the presiding officer, upon a showing that the material contained in the supplement was not reasonably known by or available to the party when the submission was made or that the relevance of the material contained in the supplement could not reasonably have been foreseen.
              (d) If a party fails to comply substantially and in good faith with this section, the presiding officer may infer that such failure was for the purpose of withholding information that is unfavorable to the party's position, and may make such further adverse inferences and findings with respect to such failure as are warranted.
              (e) Parties may reference each other's submissions. To reduce duplicative submissions, parties are encouraged to exchange and consolidate lists of documentary evidence. If a particular document is bulky or in limited supply and cannot reasonably be reproduced, and it constitutes relevant evidence, the presiding officer may authorize submission of a reduced number of copies.
              (f) The presiding officer will rule on questions relating to this section.
              [55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 70 FR 33359, June 8, 2005; 77 FR 46292, Aug. 3, 2012]

              § 179.85
              Purpose of preliminary conference.
              The presiding officer will conduct one or more preliminary conferences for the following purposes:
              (a) To determine the areas of factual disagreement to be considered at the hearing.
              (b) To establish any necessary procedural rules to control the course of the hearing and the schedule for the hearing.
              (c) To group parties with substantially similar interests, for purposes of presenting evidence, making objections, cross-examination, and presenting oral argument.
              (d) To obtain stipulations and admissions of facts.
              (e) To take other action that may expedite the hearing.

              § 179.86
              Time and place of preliminary conference.
              A preliminary conference will commence at the date, time, and place announced in the Notice of Hearing, or as otherwise specified by the Administrator or presiding officer in a subsequent notice. The preliminary conference may not commence until after expiration of the time for filing notices of participation under § 179.42. The presiding officer may specify that two or more such conferences shall be held.

              § 179.87
              Procedures for preliminary conference.
              Parties in a hearing must appear at the preliminary conference(s) prepared to present a position on the matters specified in § 179.85. A preliminary conference may be held by telephone, or other electronic means, if appropriate.

              (a) To expedite the hearing, parties are encouraged to prepare in advance for the conference. Parties should cooperate with each other and should request information and begin preparation of testimony at the earliest possible time. Failure of a party to appear at the preliminary conference or to raise matters that could reasonably be anticipated and resolved at that time will not delay the progress of the hearing, and constitutes a waiver of the rights of the party regarding such matters as objections to the agreements reached, actions taken, or rulings issued. Such failure to appear may also be grounds for striking the party's participation under § 179.42(f).
              (b) Each party shall bring to the preliminary conference the following specific information, which will be filed with the hearing clerk under § 179.80:
              (1) Any additional information to supplement the submission which may have been filed under § 179.83, and/or which may be filed if approved under § 179.83(c).
              (2) A list setting forth each person who has been identified as a witness whose oral or written testimony will be offered by the party at the hearing, with a full curriculum vitae for each and a summary of the expected testimony (including a list of the principal exhibits on which the witness will rely) or a statement as to when such a summary will be furnished. A party may amend its witness and document list to add, delete, or substitute witnesses or documents.
              (c) The presiding officer may hold preliminary conferences off the record in an effort to reach agreement on disputed factual or procedural questions.
              (d) The presiding officer shall issue and file under § 179.80 a written order reciting the actions taken at each preliminary conference and setting forth the schedule for the hearing. The order will control the subsequent course of the hearing unless modified by the presiding officer for good cause.

              § 179.89
              Motions.
              A motion, unless made in the course of a preliminary conference or a transcribed oral hearing before the presiding officer, must be filed in the manner prescribed by § 179.80 and include a draft order. A response may be filed within 10 days of service of a motion. The moving party has no right to reply, except as permitted by the presiding officer. The presiding officer shall rule upon the motion.

              § 179.90
              Summary decisions.
              (a) After the hearing commences, a party may file a written motion, with or without supporting affidavits or brief, for a summary decision on any issue in the hearing. Any other party may, within 10 days after service of the motion, which time may be extended for an additional 10 days for good cause shown, serve opposing affidavits or brief or countermove for summary decision. The presiding officer may set the matter for argument and call for the submission of briefs if not submitted by the parties.
              (b) The presiding officer will grant the motion if the objections, requests for hearing, other pleadings, affidavits, and other material filed in connection with the hearing, or matters officially noticed, show that there is no genuine disagreement as to any material fact bearing on the issue and that a party is entitled to summary decision.
              (c) Affidavits should set forth facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated. When a properly supported motion for summary decision is made, a party opposing the motion may not rest upon mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must demonstrate specifically that there is a genuine issue of material fact for the hearing.
              (d) Should it appear from the affidavits of a party opposing the motion that for sound reasons stated, facts essential to justify the opposition cannot be presented by affidavit, the presiding officer may deny the motion for summary decision, order a continuance to permit affidavits or additional evidence to be obtained, or issue other just order.
              (e) If a summary decision is not rendered upon all issues or for all the relief asked, and evidentiary facts need to be developed, the presiding officer will issue an order specifying the facts that appear without substantial controversy and directing further evidentiary proceedings. The facts so specified will be deemed established.
              (f) A party may obtain interlocutory review by the Administrator of a summary decision of the presiding officer.

              § 179.91
              Burden of going forward; burden of persuasion.
              (a) The party whose request for an evidentiary hearing was granted has the burden of going forward in the hearing with evidence as to the issues relevant to that request for a hearing.
              (b) The party or parties who contend that a regulation satisfies the criteria of section 408 of the FFDCA has the burden of persuasion in the hearing on that issue, whether the proceeding concerns the establishment, modification, or revocation of a tolerance or exemption from the requirement for a tolerance.
              [55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

              § 179.93
              Testimony.
              (a) The presiding officer will conduct such proceedings as are necessary for the taking of oral direct testimony and for the conduct of oral examination of witnesses by the parties. The presiding officer shall limit oral examination to prevent irrelevant, immaterial or unduly repetitious examination.
              (b) Direct testimony shall be submitted in writing, except that the presiding officer may order direct testimony to be presented orally in those unusual cases where the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form of a verified statement of fact or opinion prepared by the witness, in narrative form or in question-and-answer form. Written direct testimony may incorporate exhibits. Such a verified statement or exhibit may not be admitted into evidence sooner than 14 days (or such other reasonable period as the presiding officer may order) after the witness has delivered to the presiding officer and each party a copy of the statement or exhibit. The admissibility of the evidence contained in such a statement is subject to the same rules as if such testimony had been given orally.
              (c) Oral cross-examination of witnesses will be permitted. Each exhibit that a party intends to rely upon in cross-examining a witness shall be furnished to the other parties not later than 3 days (or such other reasonable period as the presiding officer may order) before such exhibit is used in the cross-examination.
              (d) Witnesses shall give testimony under oath or affirmation.

              § 179.94
              Transcripts.
              (a) The hearing clerk shall make arrangements to have all oral testimony stenographically reported or recorded and transcribed, with evidence that is admitted in the form of written testimony or exhibits attached or incorporated as appropriate.
              (b) Unless the presiding officer orders otherwise, parties shall have 15 days from the date that the transcript of particular oral testimony first becomes available to propose corrections in the transcript of that testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections.
              (c) As soon as practicable after the taking of the last evidence, the presiding officer shall certify:
              (1) That the original transcript is a true transcript of the oral testimony offered or received at the hearing, except in such particulars as the presiding officer specifies.
              (2) That the written testimony and exhibits accompanying the transcript are all the written testimony and exhibits introduced at the hearing, with such exceptions as the presiding officer specifies.
              (3) The transcript with attached or incorporated material, as so certified by the presiding officer, shall be submitted to and filed by the hearing clerk under § 179.80.
              (d) Copies of the transcript shall be available to the public in accordance with § 179.81; parties may make special arrangements through the hearing clerk to obtain copies on an ongoing, expedited basis.

              § 179.95
              Admission or exclusion of evidence; objections; offers of proof.

              (a) Written material identified as direct testimony or as an evidentiary exhibit and offered by a party in a hearing, and oral testimony, whether on direct or on cross-examination, is admissible as evidence unless the presiding officer excludes it (on objection of a party or on the presiding officer's own initiative) because it is irrelevant, immaterial, or unduly repetitive, or because its exclusion is necessary to enforce a specific requirement of this part relating to the admissibility of evidence.
              (b) If a party objects to the admission or rejection of any evidence or to the limitation of the scope of any examination or cross-examination, the party shall state briefly the grounds for such objection. The transcript shall include any argument or debate thereon, unless the presiding officer, with the consent of all the parties, orders that such argument not be transcribed. The ruling and the reasons given therefor by the presiding officer on any objection shall be a part of the transcript. An automatic exception to that ruling will follow.
              (c) Whenever evidence is deemed inadmissible, the party offering such evidence may make an offer of proof, which shall be included in the transcript. The offer of proof for excluded oral testimony shall consist of a brief statement describing the nature of the evidence excluded. If the evidence consists of a document or exhibit, it shall be inserted in the record in total. If the Administrator in reviewing the record under § 179.112 decides that the presiding officer's ruling in excluding the evidence was erroneous and prejudicial, the hearing may be reopened to permit the taking of such evidence, or, where appropriate, the Administrator may evaluate the evidence and proceed to a final decision.
              (d) Official notice may be taken of Agency proceedings, any matter that might be judicially noticed by the courts of the United States, or any other fact within the knowledge and experience of the Agency as an expert agency. Any party shall be given adequate opportunity to show that such facts are erroneously noticed by presenting evidence to the contrary.

              § 179.97
              Conferences during hearing.
              The presiding officer may schedule and hold conferences as needed to monitor the progress of the hearing, narrow and simplify the issues, and consider and rule on motions, requests, or other matters concerning the development of the evidence.

              § 179.98
              Briefs and arguments.
              (a) Promptly after the taking of evidence is completed, the presiding officer will announce a schedule for the filing of briefs. Briefs must include a statement of position on each issue, with specific and complete citations to the evidence and points of law relied on. Briefs must contain proposed findings of fact and conclusions of law.
              (b) The presiding officer may, as a matter of discretion, permit oral argument after the briefs are filed.

            Subpart F—Decisions and Appeals

              § 179.101
              Interlocutory appeal from ruling of presiding officer.
              (a) Except as provided in paragraph (b) of this section and in §§ 179.20(b), 179.42(f), 179.75(b), and 179.90(f), rulings of the presiding officer may not be appealed to the Administrator before the Administrator's consideration of the entire record of the hearing.
              (b) A ruling of the presiding officer is subject to interlocutory appeal to the Administrator if the presiding officer certifies on the record or by document submitted under § 179.80 that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any party or substantial harm to the public interest. When an order or ruling is not certified by the presiding officer, it shall be reviewed by the Administrator only upon appeal from the initial decision except when the Administrator determines upon the request of a party and in exceptional circumstances, that delaying review would be deleterious to vital public or private interests. Except in extraordinary circumstances, proceedings will not be stayed pending an interlocutory appeal. Where a stay is granted, a stay of more than 30 days must be approved by the Administrator.
              (c) Ordinarily, the interlocutory appeal will be decided on the basis of the submission made to the presiding officer, but the Administrator may allow further briefs and oral arguments. Any oral argument will be transcribed and the transcript will be prepared and certified in the same manner as provided in § 179.94.

              § 179.105
              Initial decision.
              (a) After the filing of briefs and any oral argument, the presiding officer shall prepare and file an initial decision on the issues of fact in the hearing and the objections relating to those issues.
              (b) The initial decision must be based on a fair evaluation of the entire record, and must contain:
              (1)(i) A conclusion that no change is warranted in the order or regulation to which objection was taken; or
              (ii) A conclusion that changes in the order or regulation are warranted, the language of the order or regulation as changed, and an effective date for the order or regulation as changed.
              (2) Findings of fact supported by reliable, probative and substantial evidence that has been found admissible by the presiding officer, and adequate citations to the record supporting those findings.
              (3) Conclusions on legal and policy issues, if such conclusions are necessary to resolve the objections.
              (4) A discussion of the reasons for the findings and conclusions, including a discussion of the significant contentions made by any party.
              (c) Except as otherwise provided by order of the Administrator filed in accordance with § 179.80, after the initial decision is filed, the presiding officer has no further jurisdiction over the matter and any motions or requests filed with the hearing clerk will be decided by the Administrator.
              (d) The initial decision becomes the final decision of the Administrator by operation of law unless a party files exceptions with the hearing clerk under § 179.107 or the Administrator files a notice of review under § 179.110.
              [55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]

              § 179.107
              Appeal from or review of initial decision.
              (a) A party may appeal an initial decision to the Administrator by filing exceptions with the hearing clerk, and serving them on the other parties, within the period specified in the initial decision. The period may not exceed 30 days, unless extended by the Administrator under paragraph (d) of this section.
              (b) Exceptions must specifically identify alleged errors in the findings of fact or conclusions of law or policy in the initial decision and, if errors in the findings of fact are alleged, must provide supporting citations to evidence of record. Oral argument before the Administrator may be requested in the exceptions.
              (c) Any reply to the exceptions is to be filed and served within the timeperiod specified in the initial decision. The timeperiod may not exceed 30 days after the end of the period (including any extensions) for filing exceptions, unless extended by the Administrator under paragraph (d) of this section.
              (d) The Administrator may extend the time for filing exceptions or replies to exceptions for good cause shown.
              (e) If the Administrator decides to hear oral argument, the parties will be informed of the date, time, and place; the amount of time allotted to each party, and the issues to be addressed.

              § 179.110
              Determination by Administrator to review initial decision.
              Within 10 days following the expiration of the time for filing exceptions (including any extensions), the Administrator may file with the hearing clerk, and serve on the parties, a notice of the Administrator's determination to review the initial decision. The Administrator may invite the parties to file briefs or present oral argument on the matter. The time for filing briefs or presenting oral argument will be specified in that or a later notice.

              § 179.112
              Decision by Administrator on appeal or review of initial decision.
              (a) On appeal from or review of the initial decision, the Administrator shall have the same powers as did the presiding officer in making the initial decision. On the Administrator's own initiative or on motion, the Administrator may remand the matter to the presiding officer for any further action necessary for a proper decision.

              (b) The scope of the issues on appeal to, or on review by the Administrator is the same as the scope of the issues before the presiding officer, unless the Administrator specifies otherwise.
              (c) After the filing of briefs and any oral argument, the Administrator will issue a final decision on the issues of fact in the hearing and the objections related to those issues. A final decision must contain the elements required for an initial decision by § 179.105(b).
              (d) The Administrator may adopt the initial decision as the final decision.

              (e) The Administrator's decision, or a summary of the decision and a notice of its availability, will be published in the Federal Register.

              § 179.115
              Motion to reconsider a final order.
              A party may file a motion requesting the Administrator to reconsider a final decision under this part. Any such motion must be filed within 10 days after service of the final decision, and must set forth the matters claimed to have been erroneously decided and the nature of the alleged errors. Such a motion shall not stay the effective date of the final decision unless specifically so ordered by the Administrator.

              § 179.117
              Designation and powers of judicial officer.
              (a) One or more judicial officers may be designated by the Administrator. A judicial officer shall be an attorney who is a permanent or temporary employee of the Agency or of another Federal agency. A judicial officer may perform other duties. A judicial officer who performs any duty under this part may not be employed by OCSPP, by the Pesticides and Toxic Substances Division of the Office of General Counsel, or by any other person who is a representative of OCSPP in the hearing. A person may not be designated as a judicial officer in a hearing if he or she performed any prosecutorial or investigative functions in connection with that hearing or any other factually related hearing.
              (b) The Administrator may delegate to the judicial officer all or part of the Administrator's authority to act in a given proceeding under this part. Such a delegation does not prevent the judicial officer from referring any motion or case to the Administrator when appropriate.
              [55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 FR 46292, Aug. 3, 2012]

            Subpart G—Judicial Review

              § 179.125
              Judicial review.

              (a) The Administrator's final decision is final agency action reviewable in the courts as provided by FFDCA section 408(h), as of the date of publication of the order in the Federal Register. The failure of a person to file a petition for judicial review within the period ending on the 60th day after the date of the publication of the order constitutes a waiver under FFDCA section 408(h) of the right to judicial review of the order and of any regulation promulgated by the order.
              (b) The record for judicial review of a final decision under this part consists of the record described in § 179.130.
              [55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]

              § 179.130
              Administrative record.
              (a) For purposes of judicial review, the record of a hearing that culminates in a final decision of the Administrator under § 179.105(d) or § 179.112(c) ruling on an objection shall consist of:
              (1) The objection ruled on (and any request for hearing that was included with the objection).
              (2) Any order issued under § 180.7(g) of this chapter to which the objection related, and:
              (i) The regulation or petition denial that was the subject of that order.
              (ii) The petition to which such order responded.
              (iii) Any amendment or supplement of the petition.
              (iv) The data and information submitted in support of the petition.
              (v) The notice of filing of the petition.
              (3) Any order issued under § 180.29(f) of this chapter to which the objection related, the regulation that was the subject of that order, and each related Notice of Proposed Rulemaking.

              (4) The comments submitted by members of the public in response to the Notice of Filing or Notice of Proposed Rulemaking, and the information submitted as part of the comments, the Administrator's response to comments and the documents or information relied on by the Administrator in issuing the regulation or order.
              (5) All other documents or information submitted to the docket for the rulemaking in question under parts 177 or part 180 of this chapter.
              (6) The Notice of Hearing published under § 179.20.
              (7) All notices of participation filed under § 179.42.
              (8) Any Federal Register notice issued under this part that pertains to the proceeding.
              (9) All submissions filed under § 179.80.
              (10) Any document of which official notice was taken under § 179.95.
              (b) The record of the administrative proceeding is closed:
              (1) With respect to the taking of evidence, when specified by the presiding officer.
              (2) With respect to pleadings, at the time specified in § 179.98(a) for the filing of briefs.
              (c) The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.
              [55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]

          Pt. 180
          PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

              Subpart A—Definitions and Interpretative Regulations
              Sec.
              180.1
              Definitions and interpretations.
              180.3
              Tolerances for related pesticide chemicals.
              180.4
              Exceptions.
              180.5
              Zero tolerances.
              180.6
              Pesticide tolerances regarding milk, eggs, meat, and/or poultry; statement of policy.

              Subpart B—Procedural Regulations
              180.7
              Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities or processed foods.
              180.8
              Withdrawal of petitions without prejudice.
              180.9
              Substantive amendments to petitions.
              180.29
              Establishment, modification, and revocation of tolerance on initiative of Administrator.
              180.30
              Judicial review.
              180.31
              Temporary tolerances.
              180.32
              Procedure for modifying and revoking tolerances or exemptions from tolerances.
              180.33
              Fees.
              180.34
              Tests on the amount of residue remaining.
              180.35
              Tests for potentiation.
              180.40
              Tolerances for crop groups.
              180.41
              Crop group tables.

              Subpart C—Specific Tolerances
              180.101
              Specific tolerances; general provisions.
              180.103
              Captan; tolerances for residues.
              180.106
              Diuron; tolerances for residues.
              180.107
              Triflumezopyrim; tolerance for residues.
              180.108
              Acephate; tolerances for residues.
              180.109
              Fenpicoxamid; Tolerances for residues.
              180.111
              Malathion; tolerances for residues.
              180.114
              Ferbam; tolerances for residues.
              180.116
              Ziram; tolerances for residues.
              180.117

                S-Ethyl dipropylthiocarbamate; tolerances for residues.
              180.123
              Inorganic bromide residues resulting from fumigation with methyl bromide; tolerances for residues.
              180.123a
              Inorganic bromide residues in peanut hay and peanut hulls; statement of policy.
              180.124
              Methyl bromide; tolerances for residues.
              180.127
              Piperonyl butoxide; tolerances for residues.
              180.128
              Pyrethrins; tolerances for residues.
              180.129
              o-Phenylphenol and its sodium salt; tolerances for residues.
              180.130
              Hydrogen Cyanide; tolerances for residues.
              180.132
              Thiram; tolerances for residues.
              180.142
              2,4-D; tolerances for residues.
              180.145
              Fluorine compounds; tolerances for residues.
              180.151
              Ethylene oxide; tolerances for residues.
              180.153
              Diazinon; tolerances for residues.
              180.155
              1-Naphthaleneacetic acid; tolerances for residues.
              180.163
              Dicofol; tolerances for residues.
              180.169
              Carbaryl; tolerances for residues.
              180.172
              Dodine; tolerances for residues.
              180.175
              Maleic hydrazide; tolerances for residues.
              180.176
              Mancozeb; tolerances for residues.
              180.178
              Ethoxyquin; tolerances for residues.
              180.181
              Chlorpropham; tolerances for residues.
              180.182
              Endosulfan; tolerances for residues.
              180.183
              Disulfoton; tolerances for residues.

              180.184
              Linuron; tolerances for residues.
              180.185
              DCPA; tolerances for residues.
              180.189
              Coumaphos; tolerances for residues.
              180.190
              Diphenylamine; tolerances for residues.
              180.191
              Folpet; tolerances for residues.
              180.198
              Trichlorfon; tolerances for residues.
              180.200
              Dicloran; tolerances for residues.
              180.202

                p-Chlorophenoxyacetic acid; tolerances for residues.
              180.204
              Dimethoate; tolerances for residues.
              180.205
              Paraquat; tolerances for residues.
              180.206
              Phorate; tolerances for residues.
              180.207
              Trifluralin; tolerances for residues.
              180.208
              Benfluralin; tolerances for residues.
              180.209
              Terbacil; tolerances for residues.
              180.210
              Bromacil; tolerances for residues.
              180.211
              Propachlor; tolerances for residues.
              180.212

                S-Ethyl cyclohexylethylthiocarbamate; tolerances for residues.
              180.213
              Simazine; tolerances for residues.
              180.215
              Naled; tolerances for residues.
              180.217
              Metiram; tolerances for residues.
              180.220
              Atrazine; tolerances for residues.
              180.222
              Prometryn; tolerances for residues.
              180.225
              Phosphine; tolerances for residues.
              180.226
              Diquat; tolerances for residues.
              180.227
              Dicamba; tolerances for residues.
              180.229
              Fluometuron; tolerances for residues.
              180.231
              Dichlobenil; tolerances for residues.
              180.235
              Dichlorvos; tolerances for residues.
              180.236
              Triphenyltin hydroxide; tolerances for residues.
              180.241
              Bensulide; tolerances for residues.
              180.242
              Thiabendazole; tolerances for residues.
              180.243
              Propazine; tolerances for residues.
              180.245
              Streptomycin; tolerances for residues.
              180.249
              Alachlor; tolerances for residues.
              180.252
              Tetrachlorvinphos; tolerances for residues.
              180.253
              Methomyl; tolerances for residues.
              180.254
              Carbofuran; tolerances for residues.
              180.258
              Ametryn; tolerances for residues.
              180.259
              Propargite; tolerances for residues.
              180.261
              Phosmet; tolerances for residues.
              180.262
              Ethoprop; tolerances for residues.
              180.269
              Aldicarb; tolerances for residues.
              180.272
              Tribuphos; tolerances for residues.
              180.274
              Propanil; tolerances for residues.
              180.275
              Chlorothalonil; tolerances for residues.
              180.276
              Formetanate hydrochloride; tolerances for residues.
              180.278
              Phenmedipham; tolerances for residues.
              180.284
              Zinc phosphide; tolerances for residues.
              180.287
              Amitraz; tolerances for residues.
              180.288
              2-(Thiocyanomethylthio) benzothiazole; tolerances for residues.
              180.289
              Methanearsonic acid; tolerances for residues.
              180.291
              Pentachloronitrobenzene; tolerance for residues.
              180.292
              Picloram; tole
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