External Public Review DRAFT Document

Page 1 of 14 **Draft Docum** **ent for**  **Public Review**
- EPA is releasing this draft document solely for the purpose of public review and comment. This draft document is not now, and has not yet been, formally disseminated by EPA . It does not represent and should not be construed to represent any Agency policy or determination. Please submit comments to **Docket ID # EPA** **- HQ** **- OPP**  **- [insert docket #]**  at www.regulations.gov
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**PESTICIDE REGISTRA TION (PR) NOTICE 20**  **1 2**  **- X** 

******* **Dec ember**  **12 , 201**  **2 DRA**  **FT***** **NOTICE TO MA** **NUF ACTURERS,**  **PRODUCERS, FORMULA TORS A** **ND**

**REGISTRA NTS OF PESTICIDE PRODUCTS**  **AT TENTION:**  Persons Responsible for Federal Registration , Reregistration and

Registration Review of Pesticide Products **SUBJECT:** Guidance for Antimicrobial Pesticide Products with Mold - Related

Label Claims This N otice presents the Agency’s guidance on product performance ( efficacy ) data and labeling for “mold - related” pesticide products . Mold - related pesticides are antimicrobial pesticides that bear a label claim to inhibit or destroy mold or mildew growth on hard, nonporous and porous surfaces in indoor environments (hereafter referred to as a “mold - related pesticides ” )
. A “fungicide ” is a substance or mixture of substances that destroys fungi (including yeasts) and /or fungal spores pathogenic to man or other animal s in the inanimate environment
. A “fungistat” is a substance or mixture of substances that inhibits the growth of fungi in the inanimate environment
. 1 In accordance with 40 CFR Part 161 .640, footnote 1 , EPA pursuant to FIFRA require s the submission of efficacy data for fungicides
. EPA also require s the submission of efficacy data when any specific species of fung us is listed on the label of fungicides , or when “ residual” or “preve ntion” claims are made for fungicides
. For fungistats , registrants must conduct efficacy studies but are not required under 40 CFR Part 161 to submit them to EPA , except upon request. This Notice is intend ed to improve protection of public health through labeling claims that are supported by valid efficacy data and through proper labeling of mold related pesticides. To do this, the Notice explains when the Agency expects to require 1 EPA Product Performance Test Guidelines. OPPTS 810.2000: General Consideration for Public Health Uses of Antimicrobial Agents. Draft. November 5, 2009. At www.regulations.gov , docket EPA- HQ - OPPT - 2009 - 0576.External Public Review DRAFT Document

Page 2 of 14 applicants or registrants to submit efficacy data in support of the registration of mold related pesticide products. In addition, t his notice also provides guidance on the appropriate labeling of mold - related pesticides more generally
. Finally, t his notice also provides guidance addressing label language for fungicides , fungistats, and produ cts us ed for mold remediation, products used on nonporous and porous surfaces, products with residual activity , products used for mold prevention, and products used in heating, ventilation, air conditioning and refrigeration (HVAC&R) systems. Once again, by providing this guidance, the Agency is seeking to improve protect ion of public health through proper use of mold - related pesticides
. Applicants or registrants who wish to register or amend antimicrobial products with mold - related claims are encouraged to refer to the guidance in this notice and , as needed, consult with EPA prior to submitting an application
. **I. PR Notice Provides Non**  **- binding Guidance**  This PR Notice provides general guidance to EPA and to pesticide registrants and applicants, and the public. At places in this guidance, the Agency uses the word “should.” Use of “should” is intended to connote a sense of something being optional and not mandatory. This guidance is not binding on ei ther EPA or any outside parties, and the EPA may depart from the guidance where circumstances warrant and without prior notice. In their submissions, registrants and applicants may propose alternatives to the recommendations described in this notice, and the Agency will assess them for appropriateness on a case - by- case basis and will respond in writing. **II. Scope**  **of the Guidance Provided by this PR Notice**  This guidance concerns only mold - related pesticides , i.e., pesticide products that claim to inhibit, prevent or destroy mold or mildew growth indoors on nonporous and porous surfaces
. Wh ile there are mold - related pesticides that are registered for use outdoors, such products may have different data requirements and labeling, and are outside the scope of this guidance. If a product has both indoor and outdoor uses, only the indoor uses are covered by the guidance provided by this n otice. **II I**  **. Definitions**  For purposes of this guidance, the following terms are defined as follows: **Fungi**
–A kingdom of non - photosynthesizing eukaryotes that can be single - celled (e.g., yeasts) or multicellular (e.g., mold ). **Fungicid e** —A substance or mixture of substances that destroys fungi (includingExternal Public Review DRAFT Document

Page 3 of 14 yeasts) and /or fungal spores pathogenic to man or other animal s in the inanimate environment. Because a fungicide destroys pathogenic fungi, its use is considered to be for public health - related purposes . EPA has historically considered a fungicide to be a public health related antimicrobial beca use it has killing or “cidal” properties which must be demonstrated using a pathogenic fungus. **F ungistat** 
—A substance or mixture of substances that inhibits the growth of fungi in the inanimate environment. Because a fungistat is not potent enough to destroy fungi , its use is considered to be for aesthetic or cosmetic (non - public health) purposes only and not for public health related purposes . **M ildew** 
—Any of various fungi or oomycete organisms that form a white or grayish coating on surfaces, such as plant leaves, cloth, or leather, especially under damp, warm conditions. 2 For purposes of this document , mildew can be a fungus that grows on moist , indoor surfaces
. **Mold**
—A fungal growth that forms and spreads on various kinds of damp or decaying organic matter. 3 Mold can grow on surfaces of water- damaged materials, or on materials present in a moist, indoor environment. **P revention** 
–A claim that a fungicide is intended to inhibit the growth of mold on an uncontaminated surface with efficacy that continu es for more than seven days (as supported by efficacy data)
. **R esidual activity**  is a claim that a fungicide is inten ded to destroy existing mold on a contaminated surface and leave a pesticidal residue that further inhibits subsequent fungal growth for more than seven days ( as supported by efficacy data )
. Since fungicidal efficacy tests measure fungicidal activity for seven (7) days, residual activity is a claim that a product is effective for a period of more than seven (7) days and that is based on testing that demonstrates that the product i s efficacious for such period
. A residual activity claim should be made only for a fungicide because a fungicide will destroy existing mold , but a fungistat will not
. **I V**  **. Efficacy** 

**Data Requirements for Mold**  **- R** **elated P esticides**  According to Agency regulations established in 1984 (40 CFR Part 1 61. 6 40 4 ), EPA require s that the registration of all antimicrobial pesticide products be supported by efficacy data generated by the registrant, but waive s the requirement for registrants to submit such efficacy data in support of registration unless the product bears a claim to 2 Source: The American Heritage® Science Dictionary. 3 Sou rce: http://www.cdc.gov/niosh/topics/indoorenv/mold.html. 4 These regulations were originally designated as Part 158. The antimicrobial data requirements regulation currently is designated as 40 CFR Part 161. This is an interim situation until now- prop osed am endm ents to Part 158 resulting in Part 158 W become final and effective.External Public Review DRAFT Document

Page 4 of 14 control microorganisms that pose a threat to human health and whose presence cannot be readily observed by the user. This waiver policy means that for products intend ed to destroy microorganisms that pose a threat to public health ( i.e., **fungicides** ), the efficacy data must be submitted to EPA
. However, for pesticide products not intended for use against microorganisms that pose a threat to human health ( i.e., **fungistats** ), efficacy data are not required to be submitted to EPA but must be kept in the registrant’s records in case EPA requests it
. **A. Fungicides and Public Health Related Claims**  EPA has historically considered **f ungicid**  **es** to be public health related antimicrobials because they have killing or “cidal” properties which from an efficacy standpoint under 40 CFR Part 161’s product performance data requirements need to be demonstrated using a pathogenic fungus before a product i s considered acceptable for use against microorganisms pathogenic to man or other animal s . Accordingly, EPA has require d efficacy data to be submitted for fungicides and has reviewed such data prior to registering such products or claims
. For example, a common fungicidal claim is for control of athlete’s foot fungus ( Trichophyton mentagrophytes ) on inanimate surfaces , and standard EPA test protocol s are available for use by registrants to generate efficacy data to support this claim
. 5 EPA has also historically required , pursuant to its data requirements, the submission of efficacy data to support **r esidual**  **activity** and **prevention** claims for fungicides (see Unit 1 for definitions of these terms)
. For decades, EPA has considered a claim on a fungicide label that lists a specific species of a pathogenic mold to be public health related (see EPA’s guidance in DIS/TSS 6 at http://www. epa .gov/oppad001/dis_tss_docs/dis - 06.htm ) . Consistent with 40 CFR Part 1 61. 640 , EPA pursuant to FIFRA requires such efficacy data to be submitted
. As explained below , EPA now considers most species of mold to be potentially public health related
. B ecause EPA does not consider fungistats acceptable for use against microorganisms pathogenic to humans, EPA does not currently expect to approve the listing of a ny specific species of fungus on a fungistat label. Moreover, EPA will require efficacy data (pursuant to 40 CFR part 161.640, footnote 1) to be submitted to support the listing of any specific species of fungus on the label of a fungicide
. 6 Some examples of specific, indoor mold species that may be added to a fungicide based on submitted data include : o Aspergillus versicolor o Aspergillus niger o Penicillium chrysogenum
5 Pesticide Assessment Guidelines - Subdivision G: Product Performance, U.S. Environmental Protection Agency, W ashington, D.C., September, 1982. Available from U. S. Department of Commerce, National Technical Information Service, PB83 - 153924.External Public Review DRAFT Document

Page 5 of 14 o Penicillium aurantiogriseum o Stachybotrys chartarum o Stachybotrys atra o Chaetomium globulosum **B. Fungistats and Non**  **- Health Related Claims**  M ore than 1,000 antimicrobial pesticide products are registered with mold - related claims. Of these, t he vast majority are **fungistats** , which EPA has historically not considered to be public health related antimicrobials because they have only inhibitory or “static” properties instead of killing or “cidal” properties. EPA’s longstanding position in implementing its product performance data requirements has been that elimination (i.e., “kills” or “destroys”) or significant reduction in the number of microorganisms (as achieved by bactericides, fungicides and virucides) must be demonstrated before a product is considered acceptable for use against microorganisms pathogenic to man and other a nimal s . Accordingly, fungistats a re not considered to be appropriate for public health uses . Typically, registrants conduct efficacy testing for fungistats using a standard EPA protocol for Aspergillus niger
. Under 40 CFR Part 161 , efficacy data for fungistats have not been required to be submitted to EPA and EPA has not reviewed such data for fungistats because EPA does not consider fungistats acceptable for use against microorganisms pathogenic to humans, as explained above . Most fungistats are registered for use in residential (e.g., bath and shower areas) and commercial areas, institutions , hospitals and food processing plants. EPA has not historically viewed most molds to be of potential public health concern because of the lack of scientific evidence in the past that most molds posed a risk of adverse effects to human health. However , EPA is now aware of a growing body of published scientific studies that document a wide range of adverse human health effects related to a wide range of molds. Many of these studies are cited by the Centers for Disease Control and Prevention (CDC) (www.cdc.gov/mold/faqs.pdf ; http://www.cdc.gov/niosh/topics/indoorenv/mold.html ; http://www.cdc.gov/mold /basics .html ). The available data indicate that exposure to most molds may exacerbate allergies or upper respiratory disease in healthy individuals and especially those with impaired host defenses. Therefore, EPA conclude s that most species of mold are potentially public health related
. A bibliography listing 7 8 human health effects related studies associated with molds is available in the electronic docket for this PR Notice (Docket ID No. EPA- HQ - OPP - 2010 - 0539) . Hard copies of these studies are available in the EPA docket for viewing ( see Docket ID No. EPA- HQ - OPP 2010 - 0539 FR Notice of Availability). **V .**  **Labeling and/or Efficacy**  **Data Options**  **for Mold**  **- R** **elated P esticides**  The Agency believes that mold claim products that are intended only for aesthetic purposes (i.e., fungistats) should be clearly distinguishable from products thatExternal Public Review DRAFT Document

Page 6 of 14 are intended for public health purposes (i.e., fungicides)
. Accordingly, the Agency has developed the following labeling options for applicants and registrants to consider , and follow as appropriate . N otably, these are not the only possible options, but rather are provided solely for illustration and guidance purposes. As a result, it is certainly the case that the Agency will entertain on a case - by- case basis other labeling options along these lines t hat any applicant/registrant might wish to present to the Agency.

**A. Products Intended for A** **esthetic or Cosmetic**  **Purposes Only (Fungistats)**  For fungistats , applicants and registrants should consider options along the lines of the following: **Option 1 –**  **Include the term**  **“Fungistat” and a**  **Limitation Statement**  First, fungistat product label s should bear the word “**fungistat**” on the front panel. Second, fungistat p roduct label s should also bear the following limitation statement :

“ This product is intended to reduce, control or inhibit the growth of mold for aesthetic or cosmetic purposes only.” The limitation statement should be placed as close as possible to t he mold label claim (i.e., “fungistat”)
. The product label may not list a specific species of mold or make residual claims; any such listing or claims should be deleted from the label
. **Option 2 -**  **Delete All**  **Mold Claims**  A pplicants or registrants should delete a ll mold claims from the label. **B. Products Making**  **a Fungicidal**  **Claim** For products making a fungicidal claim (as defined in Unit I I I ), applicants and registrants should consider such options as the following: **Option 1 -**  **Submit the Appropriate Product Performance Data** To register a new fungicidal product , applicants should submit supporting efficacy data ( see EPA’s product performance data requirements at 40 Part 161 and also the guidance in DIS/TSS 6 at http://www. EPA .gov/oppad001/dis_tss_docs/dis - 06.htm )
. For currently registered fungicidal products , t his type of data should have already been submitted to EPA . If such data have not already been not submitted, registrants should contact the Agency
.External Public Review DRAFT Document

Page 7 of 14 **Option 2 -**  **Delete the Fungicidal**  **Claim** If registrants decide not to submit efficacy data for a currently registered fungicidal product for which appropriate efficacy data were not previously submitted to EPA , registrants should delete the fungicidal claim from the label . If the product is to be converted to a fungistat, then registrants should consider opti ons along the lines of Option 1 under Unit I V .A. above.

**C .**  **Products Making a**  **Fungicidal Residual**  **Activit y**  **Claim** For products making a fungicidal residual activity claim (as defined in Unit I I I ), applicants and registrants should implement one of the following two options: **Option 1 -**  **Submit the Appropriate Product Performance Data** If a product makes a **residual activity** claim of more than seven days , then the applicant or registrant should submit supporting efficacy data. Residual activity products may be used to treat indoor areas that may not routinely be visible to the dwelling occupants, such as the treatment of building framing that is covered by wallboard
. Because EPA believes that products with residual activity claims are for public health purposes, the product should be labeled as a fungicide. **Option 2 -**  **Delete the Residual Activity**  **Claim** If applicants or registrants do not choose to submit efficacy data, then the residual activity claim should be deleted from the label.

**D .**  **Products Making a**  **Prevention Claim for Fungicides**  For products making a prevention claim (as defined in Unit I II ), applicants and registrants should implement one of the following two options : **Option 1 -**  **Submit the Appropriate Product Performance Data for**  **Fungicides** If a product claims **prevent ion**  of mold growth on a fungicide label , then applicants or registrants should submit efficacy data for a designated period of time under conditions conducive to fungal contamination
. The Agency believes the prevention claim should be limited to new articles or surfaces that are uncontaminated. **Option 2 -**  **Delete the Prevention Claim** If applicants or registrants do not choose to submit efficacy data to support a prevention claim for a fungicide , then the y should delete the mold prevention claim. TheExternal Public Review DRAFT Document

Page 8 of 14 labeling of a fungistat may not bear a prevention claim; any such c laim (s) appearing on the labeling of a currently registered fungistat should be removed. **V I**  **. Other**  **Label ing Guidance**  **A. Fungicide**  **Products Used for Mold Remediation**  **on Hard, Nonporous Surfaces**  For products intended for mold remediation on hard, non - porous surfaces , product labels should include comprehensive remediation steps in order to assure that the source of the problem (e.g., leaking water or flood water) has been fixed so that the mold problem will not return , and that appropriate pre - cleaning steps are followed. Following are some basic elements that applicants/registrants should consider including in the Directions for Use section of labels for products intended for mold remediation on hard, nonporous surfaces
. Applicants and registrants may consult EPA’s website (www.epa.gov/mold ) for additional information on mold cleanup. 1. Directions to correct the source of moisture which has led to the mold problem. 2. Instructions to clean contaminated surfaces prior to applying the product , including directions to remove visible mold growth and the cleaning method ( s ) to be used . Different surfaces may require different cleaning methods
. 3. Instructions on when to dispose of or destroy contaminated or damaged items
. 4. Surface drying directions and equipment that may help the drying process
. 5. Direction s on how to apply the pesticide , including a pplication rate , contact time, and equipment (paint brush, low pressure hand wand, airless sprayer, backpack sprayer or others)
. 6. Square footage that a specific amount of product will treat (e. g. , 1 gallon will treat 250 sq. ft.) 7. Personal protective equipment needed to li mit exposure to mold hyphae, fragments and spores or the pesticide. (See http://www.bt.cdc.gov/disasters/mold/report/pdf/2005_moldtable5.pdf and http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5508a1.htm ) 8. Reentry restrictions, if any
. 9. G uidance as to when a homeowner should consider using a professional to remediate mold damage. **B .**  **Fungicidal Products Used on**  **Porous Surfaces** Mold - related pesticides registered for use on porous surfaces (e.g., ceiling tiles, wallboard , insulation and carpet ) should bear use directions in addition to those listed in Unit V I .A. that state specifically how the product is to be applied to such surfaces. Further, the label use directions should direct the user to assess whether a mold contaminated porous material is treatable. If a porous material is not treatable, the label should instruct the user to remove and dispose of such porous material rather tha n treatExternal Public Review DRAFT Document

Page 9 of 14 it . A sample label statement that should be considere d by applicants and registrants is:

“Assess whether contaminated porous materials may be effectively treated. Remove and properly dispose of any untreatable porous materials .” **C. Fungicidal**  **Prod ucts with Residual**  **Ac tiv**  **ity or Prevention**  **Claim s**  Mold - related pesticides with residual or prevention claims should bear use directions in addition to the remediation use instructions listed in Unit V I .A. that are unique to those claims. For example, products with residual activity claims and prevention claims should indicate the period of time after treatment that the product will be effective . For residual products, the following statement should also be considered : “If mold growth re appears, reapply
. ” **D .**  **Fungicidal Products Used by**  **Homeowners** For mold - related pesticides intended for use by consumers , applicants or registrants should consider adding to the label the following guid ance for homeowners (see http://www.epa.gov/mold/moldguide.html ):

” If the moldy area is less than a 3 ft. by 3 ft. patch, then the consumer can usually handle the cleanup. “

” If mold growth extends over an area greater than 10 square feet, consider hiring a professional for reme diation. Mold damage caused by clean water may be handled by a non - professional; however, mold damage resulting from contaminated water should be handled by a professional who has experience cleaning buildings damaged by contaminated water. ”

” If you have health concerns, consult a health professional prior to mold cleanup and pesticide application. Take precautions to limit your exposure to mold and mold spores. We ar protective equipment, such as a N - 95 respirator, to limit your exposure to airborne mold. Gloves and goggles must also be worn to protect your hands and eyes. ” **E .**  **Fungicidal Products Used**  **in Schools and Commercial**  **Buildings** For mold - related pesticides intended for use in schools and commercial buildings , applicants or registrants should consider incorporating applicable guidance found in the EPA publication “Mold Remediation in Schools and Commercial Buildings” (see http://www.epa.gov/mold_remediation.html ).External Public Review DRAFT Document

Page 10 of 14 **F .**  **Fungicidal Products Used In Heating**  **, Ventilation**  **, Ai**  **r Conditioning and Refrigeration**  **Sy ste**  **ms (HVA** **C &R** **)** A few mold - related pesticides are registered for use in HVAC&R systems. For these products , applicants or registrants should consider includ ing the following statement on the product label to provide guidance to the end - user .

“ If you know or suspect mold has contaminated the HVAC&R system, do not operate the system. Operating a HVAC&R system that has been contaminated with mold may cause the mold to spread throughout the building. Prior to the use of a pesticide, inspection and proper cleaning of the components to be treated must be performed
. If your state requires licensing or cert ification of persons who inspect or clean such components, the inspection and cleaning must be done by a licensed or certified person
. ” **V I**  **I .**  **What Registrants and A pplicants Should Do**  Applicants and registrants who opt to implement label ing changes discussed in this PR Notice should respond along the lines described in Units V and V I via the notification, amendment or new registration processes as described below
. **A. Ad**  **option of the Fungistat Label Changes**  **through Notification** 1. Option 1 Label Changes
. Registrants who adopt the label changes consistent with or along the lines of those set forth in Unit V .A., Option 1, of this Notice should submit a notification (according to PR Notice 98 - 10) for each product. EPA will revi ew

the notification to ensure that the label changes do nothing more than make the types of changes described in this guidance . The registrant should submit one copy of the label (with changes clearly marked in a way that can be photocopied) along with a completed Application for Registration form (EPA Form 8570 - 1), which is available for downloading a t http://www.epa.gov/opprd001/forms/. 2. Delete all mold claims
. Registrants who wish to delete all mold claims as described in Unit V .A. ,Option 2, should submit an amendment to delete those claims (see Unit V I I .B. below)
. **B . A** **pplication for Amendment**External Public Review DRAFT Document

Page 11 of 14 Registrants of existing products covered by this Notice who want to add or revise label statements (other than the fungistat label statements d escribed in Unit V .A. , Option 1 ) should submit an application for amended registration. A n application for amendment includes the following items: i. A completed EPA application form 8570 - 1; ii. T hree copies of the draft label ( highlighting the changes made on one copy ); and iii. A description on the application, such as, "Amended consistent with PR Notice 20 1 2 -X ." The registrant should c learly identify in the amendment how the registrant is responding to this notice . For example , a dd under Section II. “Explanation” of EPA Form 8570 - 1 the chosen option, such as: ( 1 ) “D elete the mold claim , ” ( 2 ) “Add a fungistat limitation statement that is a modification of the statement provided in PR Notice 201 2 -X , ” and (3 ) “Delete the fungicidal claim and add the fungistat claim and limitation statement.” The Pesticide Registration Improvement Act of 2003 (PRIA) established a new registration service fee system for applications for registration, amended registration, an d associated tolerance actions. Under this system, registration service fees are charged for covered applications received by the Agency on or after March 23, 2004. However, applications for EPA- initiated amendments (either with or without data) are not s ubject to a PRIA fee. Therefore, an application to amend a registration submitted solely for the purpose of responding to this Notice will not be subject to a registration service fee , provided that the only changes being proposed to the labeling for the registered product are those undertaken in response to this Notice. **C .**  **Ap plication for New Registration**  EPA expects that beginning on the effective date of this Notice each applicant for registration of new mold - related products will follow the guidance described in this Notice to the extent appropriate for the product. **V I**  **I I**  **. Implementation**  EPA will consider this guidance when reviewing all applications for new pesticide product registrations, for amendments to registered products, and for reregistration and registration review of registered products. [ Note : The Agency is actively considering itsExternal Public Review DRAFT Document

Page 12 of 14 options for implementing this guidance with respect to currently registered pesticide products. Among the options the Agency is considerin g is w hether to provid e a target date by which the registrants of currently registered products could , if affected, adopt labeling changes described in this notice and/or submit efficacy data to support fungicidal claims, as applicable. Persons reviewing this d raft notice may submit comments or suggestions on this issue within the time frame described in the Federal Register Notice of Availability. EPA would be interested in obtaining input from registrants and other interested stakeholders on what the tradeoffs would be of setting a specific implementation date versus not setting such a date in terms of the costs of making labeling changes, level playing field issues, and other relevant issues. EPA would also be interested in knowing the life cycles of labels, how often registrants normally amend their labels , and to what extent the changes recommended in this notice could implemented with minimal impacts. ] **I X**  **. A ddresses to Use**  Registrants should send notifications and amendments to one of the following addresses: **U.S. Postal Service Deliveries** The following official mailing address should be used for all correspondence or data submissions sent to OPP by U.S. mail: Document Processing Desk (AMEND) or (NOTIF) [as applicable] Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency 1200 Pennsylvania Ave., N W Wa shington, D.C. 20460 - 0001 **PLEA SE NOTE:**  Do not address mail to be sent through the U.S. Postal Service (USPS) to the Arlington, Virginia address. USPS will return it to you causing delay in processing your actions. There is no U.S. Postal Service delivery at the Virginia address. **Personal/Cou rier Service Deliveries**  Deliveries in person or by a commercial courier for the regulatory divisions will be accepted at OPP’s Document Processing Desk (7504 P ) in One Potomac Yard, Room S -4900. Couriers and delivery personnel must present a valid picture identification card to gain access to the building. The following address should be used for all correspondence or data submissions that are hand - carried or sentExternal Public Review DRAFT Document

Page 13 of 14 by courier service Monday through F riday, from 8:00 AM to 4:30 PM, excluding Federal holidays: Document Processing Desk (AMEND) or (NOTIF) [as applicable] Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S -4900, One Potomac Yard 2777 South Crystal Drive Arlington, Virginia 22202 -4501 **X .**  **Paperwork Reduction A ct**  **Notice** The information collection activities associated with the activities described in this PR Notice are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The corresponding Information Collection Request (ICR) document for pesticide applications and amendments and the labeling requirements for pesticides are discussed in the Application for New and Amended Pesticide Registration, EPA ICR# 0277, OMB control number 2070 - 0060. The annual average reporting and recordkeeping burden for a registration applicant respondent are estimated to range from 14 to 646 hours, depending upon the type of activity. For “Type A” activities, which include new active ingredients and new uses, the estimated annual applicant burden average is 194 hours per application. For “Type B” activities, which include amendments and notifications, the estimated annual applicant burden average is 14 hours per application. The respondent burden estimate for “Type C” reduced risk products is an average of 646 hours per product. A copy of the most recent version of EPA ICR number 0277 is available under Docket ID No. EPA- HQ - OPP -2008 - 0191
. This docket can be a ccessed at www.regulations.gov. Under the PRA, “burden” means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency. For this collection, it is the time reading the regulations, plann ing the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing and maintaining the data. Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to , a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations codified in Chapter 40 of the CFR, after appearing in the preamble of the final rule, are listed in 40 CFR part 9, and are displayed either by publication in the Federal Register or by otherExternal Public Review DRAFT Document

Page 14 of 14 appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolid ated in 40 CFR part 9. For the ICR activity contained in this PR Notice, EPA is displaying the applicable OMB control number in the PR Notice above, and the applicable OMB control number also appears on the pesticide application. **X I**  **. For**  **Further Information** If you wish to obtain further information on this N otice or have questions, you may contact Jeff Kempter ( kempter.carlton@epa.gov ) i n the Antimicrobials Division , Mail Code 7510P , (703) 30 5 - 5448
.

_______________________________ Ste ven Bradbury , Ph
. D
. , Director Office of Pesticide Programs