DCN: 50-940002948

UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES REGULATION OF ANEWCHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION

In the matter of:

DowElanco Premanufacture Notice Number:

P-93-1649

Consent Order and Determinations supporting Consent Order

### -iiTABLE OF CONTENTS

Preamble I. Introduction II. SummaryofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. InformationRequired to Evaluate Health Effects

Consent Order I. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation II. Recordkeeping III. Modification and Revocation ofConsentOrder IV. EffectofConsent Order

AttachmentA - Definitions-iiiI. INTRODUCTION Under the authority of §5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e», the Environmental Protection Agency ("EPA" or lithe Agency") issues the attached Order, regarding premanufacture notice (IlPMN") P-93-1649 submittedby The DowElanco (lithe company"), to take effectupon expiration of the PMNreview period. Under §15 ofTSCA, it is unlawful for any person to fail or refuse to comply with anyprovision of §5 or any order issued under §5. Violators maybe sUbject to various penalties and to both criminal and civil liability pursuant to §16, and to specific enforcement and seizure pursuant to §17.

II. SUMMARY OFTERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: (a) submit to EPA the following toxicity testing 14 weeks before manufacturing or importing an aggregate production volume of [ ] kilograms of the PMN substance: dermal developmental toxicity study, rats (as described in 40 CFR 798.4900); (b) submit to EPA the following toxicity testing 14 weeks before manufacturing or importing an aggregate production volume of [ ] kilograms of thePMN substance: 90-day dermal subchronic study, rats (as described in 40 CFR 798.2250), with functional observational battery, motor activity, and neuropathology (all described in NTIS: PB91-154617);-iv- (c) provide its workers personal protective equipment to prevent dermal exposure; (d) demonstrate that each itemof chemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area; (e) label the PMN substance and provide Material Safety Data Sheets (MSDSs) and worker training in accordance with the provisions ofthe Hazard Communication Program section; (f) not use the PMN substance for other than industrial uses; (g) distribute the PMN substance only to a personwho agrees to follow the same restrictions (except the testing requirements) and to not further distribute the PMN substance until it has been completely reacted; and (h) maintain certain records.

III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): Chemical identity, impurities, production volume, processing and use information. Chemical Identity: Specific: [ ]. Generic: Alkylated-urea.

specific: [ ]

# . Generic: Process rawmaterial.

### -vMaximum 12-Month ProductionVolume: [ Test Data Submittedwith PMN: None. ] kg/yr.

IV. EPA'S ASSESSMENT OFRISK Health Effects Summary: Concerns: Neurotoxicity and developmental toxicity. Basis: For neurotoxicity: data submittedunderTSCA §8(e) [ ]

# . For developmental toxicity: data on tetramethylurea. Absorption: Expected via all routes (inhalation, dermal, and GI tract)

. Exposure Summary: Import Use 

### # sites N/A 1 

### # Persons/site N/A 6-14 

### # Days/Year N/A 5 Amt. Dermal Exp. N/A 3900 mg/day Amt. Inhal. Exp. N/A 0.26 mg/day

## *

* Inhalation exposures during industrial uses ofthe PMN substance are not expected to pose significant risks. However, other non-industrial uses ofthe substancemight result in higher

or less controlled exposures. Environmental Effects Summary: Low concern. Toxicity values are predicted to be greater than 100 parts permillion (ppm) for the-viaquatic toxicity base set (fish, daphnids, and algae). Concentration of concern is greater than 1 ppm. Environmental Release Summary: To water: 1 kg/day, 130 days per year and 2.3 kg/day,S days per year. This release is not expected to result in surface water concentrations exceeding the concentration of concern. To landfill: 760 kg/yr.



## v. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order: A. EPA is unable to determine the potential for neurotoxicity and developmental toxicity from dermal exposure to the PMN substance. EPA therefore concludes, pursuant to §5(e)(1)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthe humanhealth effects ofthe PMN substance. B. In light ofthe potential risk ofneurotoxicity and developmental toxicityposedby the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, and the Agency's conclusion that issuing the Orderwill not result in any significant loss ofbenefits to society, EPA has concluded, pursuant to §5(e)(1)(A)(ii)(I) of TSCA, that uncontrolledmanufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.-viiVI. INFORMATIONREQUIRED TO EVALUATE HEALTH EFFECTS The Orderprohibits the company from exceeding a specified production volume unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section.WASHINGTON, 20460

OFFICEOF PREVENTION,PESTICIDESAND TOXICSUBSTANCES

CONSENT ORDER I. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSIONAND EVALUATION OF INFORMATION The DowElanco (lithe company") is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing of the chemical substance [ ] (lithe PMN substance") in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation of the neurotoxicity and developmental toxicity effects of the SUbstance, and the completion ofEPA's review of, and regulatory action based on, that information, except under the following conditions:

AecycledIRecyclablilll PrintlldwithSay/CanotaInkonpaperthat containsatleas!50%recycilldfiber-2- TESTING (a) Any information on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk of injury to health or the environment required to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall reference the appropriate PMN identificationnumber for this substance and shall contain a statement that the substance is sUbject to this Consent Order. Additional information regarding section 8(e) reporting requirements canbe found in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).

(b) The Company shall notify, inwriting, the EPALaboratory Data Integrity Assurance Division, Office ofcompliance Monitoring (EN-342), u.S. Environmental ProtectionAgency, 401 M Street, S.W., Washington, D.C. 20460, ofthe following information within 10 days of scheduling any study required to be performed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: 1. The date when the study is scheduled to commence; 2. The name and address of the laboratory which will conduct the study; and 3. The name and telephone number of a person at the Company or the laboratorywhom EPAmay contact regarding the study.-3-

4. The appropriate PMN identification number for each substance and a statement that the substance is sUbject to this Consent Order.

(c) Each study required to beperformed pursuant to this Order mustbe conducted according to TSCAGood Laboratory Practice standards at 40 CFR Part 792 and using methodologies generally accepted at the time the study is initiated. Before starting to conduct any such study, the Companymust obtain approval of test protocols from EPAby sUbmitting written protocols. EPAwill respond to the Companywithin 4weeks ofreceiving the written protocols. Published test guidelines specified in paragraph (d) (e.g., 40 CFR 797 or 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.

(d) The Company is prohibited frommanufacturing or importing the PMN substance beyond the following aggregate manufacture and import volumes ("the production limits"), unless the Company conducts the following studies on the PMN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section:Production Limit -4- study Guideline [ ] kg dermal developmental toxicity study, rats 40 CFR 798.4900 ] kg 90-day dermal subchronic study, rats 40 CFR 798.2250 with functional observational battery, motor activity, and neuropathology NTIS: PB91-154617 (e) The Company shall: (1) conduct each study in good faith, with due care, and in a scientificallyvalidmanner; (2) promptly furnish to EPA the results ofany interimphase of each study; and (3) sUbmit, in triplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report of each study and all underlying data ("the report and data") to EPA no later than 14 weeks prior to exceeding the applicable production limit. The report shall be submitted to EPA in accordance with the standards for the reporting of study results in 40 CFR 792.185. underlying data shall be submitted to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "TestReport" SUbparagraphs in the applicable test guidelines. However, with regard to those SUbparagraphs, the word "shall" will be used inplace ofthe word "should" to make clear that the submission of such information is mandatory. EPAwill require the submissionofraw data such as slides and laboratory notebooks only ifEPA finds, on the basis of professional jUdgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items. When the tests required pursuant to the terms ofthis Order are not covered by-5- test guidelines in Parts 797 and 798 above, EPA shall, inwriting to the Company, describe the type ofdata required to adequately evaluate the test data.

(f) The Company is not required to conduct a study specified in paragraph (d) ofthis Testing section ifnotified in writingby EPA that it is unnecessary to conduct that study.

(g) IfEPA finds that the data generated by a study are scientifically equivocal, the Companymay continue to manufacture and import the PMN substancebeyond the applicable production limit. To seekrelief from any otherrestrictions of this Order, the Companymaymake a second attempt to obtain unequivocal data by reconducting the study under the conditions specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation oftherisks presentedby the PMN substance, only bymutual consent ofEPA and the Company.

(h)(1) Except as described in sUbparagraph (h)(2), if, within 6 weeks of EPA's receipt ofa test report and data, the Company receives written notice that EPA finds that the data generated by

a study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit.-6- (2) The Companymay continue to manufacture and import the PMN substance beyond the applicable production limit only if so notified, inwriting, by EPA in response to the Company's compliance with either ofthe following sUbparagraphs (h) (2)(i)

or (h)(2)(ii). (i) The Companymay reconduct the study in compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by sUbparagraph (e)(3), the Company shall comply with sUbparagraph (e)(3). Ifthere is insufficient time for the company to comply with sUbparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in triplicate to EPAwithin a reasonable period of time, all

as specified by EPA in the notice described in sUbparagraph (h)(1). EPAwill respond to the Company, inwriting, within 6 weeks ofreceiving the Company's report and data. (ii) The Company may, within 4weeks ofreceiving from EPA the notice described in sUbparagraph (h)(1), submit to EPA a written report refuting EPA's finding. EPAwill respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.

(i)(1) Except as described in sUbparagraph (i)(2), if the Company becomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, or have-7- prevented, development ofscientifically valid data under the conditions specified inparagraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substancebeyond the applicable production limit. (2) The Companymay submit to EPA, within 2 weeks offirst becoming aware of such circumstances, a written statement explaining why circumstances clearlybeyond the control ofthe Company or laboratorywill cause or have caused development of scientifically invalid data. EPAwill notify the Company of its response, inwriting, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allow the company to continue to manufacture and import the PMN substance beyond the applicable production limit,

or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by sUbparagraph (e)(3), the Company shall comply with sUbparagraph (e)(3). Ifthere is insufficient time for the Company to comply with sUbparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in triplicate to EPAwithin a reasonable period of time, all as specifiedby EPA in the notice described in sUbparagraph (i)(2)

. EPAwill respond to the Company, in writing, within 6 weeks of-8- receiving the Company's report and data, as to whether the company may continue to manufacture and importbeyond the applicable production limit.

(j) (l) EPAmay notify the Company inwriting that EPA finds that the data generated by a study are scientificallyvalid and unequivocal and indicate that, despite the terms of this Order, the PMN substance will ormay present an unreasonable risk of injury to human health orthe environment. EPA's notice may specify that the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution,

use and/or disposal ofthe PMN substance to mitigate exposures to

or to better characterize the risks presented by the PMN substance. within 2 weeks from receipt of such a notice, the Companymust cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (2) within 2 weeks from receipt ofthe notice described in sUbparagraph (j)(1), the Company complies with such requirements

as EPA's notice specifies; or (3) within 4 weeks fromreceipt ofthe notice described in sUbparagraph (j)(1), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and dispose of the PMN substance in accordance with the terms ofthis Order-9- pending EPA's response to the company's written report. EPAwill respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the company shall complywith any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance.

(k) Regardless ofthe satisfaction ofany other conditions in this Testing section, the Companymust continue to obey all the terms ofthis Consent Orderuntil otherwise notified inwriting by EPA. The Companymay, based upon submitted test data or other relevant information, petition EPA to modify orrevoke provisions ofthis Consent Orderpursuant to Part III. ofthis Consent Order.

PROTECTIONINTHEWORKPLACE (a) Duringmanufacturing, processing, and use ofthe PMN substance at any site controlled by the Company, the companymust establish a programwhereby: (1) Each person who is reasonably likely to be dermally exposed in the work area to the PMN substance through direct handling of the substance or through contactwith equipment on which the substance may exist, or because the substancebecomes airborne in a form listed in sUbparagraph (a)(6) of this section, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to-10- the substance in the specific work area where it is selected for

use. Each such itemofpersonal protective equipmentmustbe selected and used in accordance with 29 CFR 1910.132 and 29 CFR 1910.133. (2) In addition to the personal protective equipment described in sUbparagraph (a)(1) ofthis section, the following items are required: (i) Gloves. (ii) Full body chemical protective clothing. (iii) Chemical goggles or equivalent eye protection. (iv) clothingwhich covers any other exposed areas of the arms, legs and torso. clothingprovided under this sUbparagraph (a)(2)(iv) need notbe tested or evaluated under the requirements of sUbparagraph (a)(3). (3) The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides

an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work

area by anyone or a combination ofthe following: (i) Testing thematerial used to make the chemical protective clothing and the construction of the clothing to establish that the protective clothing will be impervious for the expected duration and conditions of exposure. The testingmust sUbject the chemical protective clothing to the expected conditions of exposure, including the likely combinations of chemical substances to which the clothing may be exposed in the-11- work area. Permeation testing shall be conducted according to the American Society for Testing andMaterials (ASTM) F739 "Standard TestMethod for Resistance ofProtective clothing Materials to Permeation by Liquids or Gases." Results shall be recorded as a cummulativepermeation rate as a function oftime, and shall be documented in accordance withASTM F739 using the format specified inASTM Fl194-89 "Guide for Documenting the Results of Chemical PermeationTesting on Protective clothing Materials." Gloves may not be used for a time period longer than they are actually tested andmustbereplaced at the end of each work shift. (ii) Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or ofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substances in the work area.

(b) If the PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions ofthis protection in the workplace section if the concentration of the PMN substance in the mixture does not exceed 1.0 percentby weight or volume, or 0.1 percentbyweight or volume ifparagraph (g) of the Hazard Communication Program section of this Order identifies cancer as a potential human health hazard of the PMN substance. This exemption does not apply ifthe Company has-12-

reason to believe that during intended use orprocessing in the work area, the PMN substance in the mixturemay be reconcentrated above the 1.0 or 0.1 percent level, whichever is applicable.

HAZARD COMMUNICATIONPROGRAM (a) written hazard communicationprogram. The Company shall develop and implement a written hazard communication program for the PMN substance in eachworkplace. The writtenprogramwill, at a minimum, describe howthe requirements ofthis section for labels, MSDSs, and other forms ofwarningmaterial will be satisfied. The Companymustmake the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company may rely on an existing hazard communication program, inclUding an existingprogram established under the occupational Health and Safety Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), to complywith this paragraph provided that the existinghazard communicationprogram satisfies the requirements ofthis section. The writtenprogram shall include the following: (1) Alist ofchemical substances known to be present in the work area which are SUbject to a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 40 C.F.R. Part 721, SUbpart E. The listmust be maintained in each work area where the PMN substance is known to be present and-13- must use the identity provided on the MSDS for the substance required under paragraph (c) ofthis section. The listmay be compiled for the workplace or for individual work areas. Ifthe Company is required eitherby another Order issued under section 5(e} ofTSCA, orby a TSCA section 5(a}(2) SNUR at 40 CFR Part 721, sUbpart E, to maintain a list of substances, the lists shall be combined with the listunder this sUbparagraph. (2) The methods the Companywill use to inform employees of the hazards of non-routine tasks involving the PMN substance (e.g., cleaning ofreactorvessels), and the hazards associated with the PMN substance contained inunlabeled pipes in theirwork

area.(3) The methods the Companywill use to inform contractors ofthe presence ofthe PMN substance in the Company's workplace and ofthe provisions ofthis Order if employees ofthe contractor work in the Company's workplace and are reasonably likely to be exposed to the PMN substance while in the company's workplace.

(b) Labeling. (1) The Company shall**~nsure** that each container ofthe substance in the workplace is labeled in accordance with this sUbparagraph (b)(1). (i) The label shall, at a minimum, contain the following information:-14- (A) Astatementofthe health hazards(s} and precautionarymeasure(s}, ifany, identified inparagraph (g) of this section orby the Company, for the PMN substance. (B) The identitybywhich the PMN substancemay be commonly recognized. (C) Astatementofthe environmental hazard(s} and precautionary measure(s}, ifany, identified inparagraph (g) of this section, orby the Company, for the PMN substance. (D) Astatementof exposure and precautionary measure(s}, ifany, identified inparagraph (g) of this section,

or by the Company, for the PMN substance. (ii) The Company mayuse signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu ofaffixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b) (1)(i) of this section. Any writtenmaterials mustbe readily accessible to the employees in their work areas throughout eachwork shift. (iii) The Companyneed not label portable containers into which the PMN substance is transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer. (iv) The Company shall not remove or deface an existing label on containers ofthe PMN substance obtained from persons outside the Company unless the container is immediately-15- relabeled with the information specified in sUbparagraph (b)(1)(i) ofthis section. (2) The Company shall ensure that each container ofthe substance leaving its workplace for distribution in commerce is labeled in accordance with this sUbparagraph (b)(2). (i) The label shall, at a minimum, contain the following information: (A) The informationprescribed in subparagraph (b) (1)(i) ofthis section. (B) The name and address ofthe manufactureror a responsible party who canprovide additional information on the substance for hazard evaluation and any appropriate emergency procedures. (ii) The label shall not conflictwith the requirements ofthe Hazardous Materials TransportationAct (18 U.S.C. 1801 et. seq.) and regulations issued under thatActby the Department ofTransportation. (3) The label, or alternative forms ofwarning, shall be legible and prominently displayed. (4) The label, or alternative forms ofwarning, shall be printed in English; however, the informationmay be repeated in other languages. (5) Ifthe label or alternative form ofwarning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either sUbject to another TSCA section 5(e) Order applicable to the Company, or sUbject to a-16- TSCA section Sea)(2) SNUR at 40 CFR Part 721, sUbpart E, or defined as a "hazardous chemical" under the occupational Safety and HealthAdministration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Companymay prescribe on the label, MSDS,

or alternative form ofwarning, the measures to control worker exposure or environmental release which the Company determines provide the greatest degree ofprotection. However, should these control measures differ from the applicable measures required under this Order, the Companymust seek a determination of equivalency for such alternative control measures pursuant to 40 CFR 721.30 before prescribing themunder this sUbparagraph (b)(S).

(c) Material Safety Data Sheets. (1) The Companymust obtain

or develop anMSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label ofthe PMN substance under this section, and, ifnot claimed confidential, the chemical and common name ofthe PMN substance. Ifthe chemical and commonname are claimed confidential, a generic chemical name mustbe used. (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vapor pressure, flash point)

.-17- (iii) The physical hazards of the substance known to the company, including the potential for fire, explosion, and reactivity. (iv) The potential human and environmental hazards as specified in paragraph (g) of this section. (v) signs and symptoms of exposure, and any medical conditions which are expected to be aggravated by exposure to the PMN substance known to the Company. (vi) The primary routes ofexposure to the PMN substance.(vii) Precautionarymeasures to control worker exposure and/or environmental release required by this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide sUbstantially the same degree ofprotection as the identified control measures. (viii) Any generally applicable precautions for safe handling and use ofthe PMN substance which are known to the Company, including appropriate hygienic practices, protective

measures during repair andmaintenance ofcontaminated equipment, and procedures for response to spills and leaks. (ix) Any generally applicable control measures which

are known to the Company, such as appropriate engineering controls, workpractices, orpersonal protective equipment. (x) Emergency first aidprocedures known to the Company.-18- (xi) The date ofpreparation ofthe MSDS or of its last revision. (xii) The name, address, and telephone number ofthe Company or another responsible partywho canprovide additional information on the chemical substance and any appropriate emergencyprocedures. (3) Ifno relevant information is found or known for any given category on the MSDS, the Companymust mark the MSDS to indicate that no applicable informationwas found. (4) Where mUltiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially the same, butthe specific composition varies from mixture to mixture) and similar hazards, the Companymayprepare

oneMSDS to apply to all of these mUltiple mixtures. (5) Ifthe Companybecomes aware ofany significantnew information regarding the hazards ofthe PMN substance orways to protect against the hazards, this new informationmustbe added to theMSDS within 3 months from the time the Company becomes

aware of the new information. Ifthe PMN substance is notbeing manufactured, imported, processed, orused in the Company's workplace, the Companymust add the new information to the MSDS before the PMN substance is reintroduced into the workplace. (6) The Company must ensure that persons receiving the PMN substance from the Company are provided an appropriate MSDS with their initial shipment andwith the first shipment after an MSDS is revised. The Company may eitherprovide the MSDS with the-19- shipped containers or send it to the personprior to or at the time of shipment. (7) The Companymustmaintain a copy ofthe MSDS in its workplace, and must ensure that it is readily accessible during eachwork shift to employees when they are in theirwork areas. (8) TheMSDS may bekept in any form, including as operatingprocedures, andmay be designed to cover groups of substances in a work areawhere itmay be more appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required informationmust be provided for the PMN substance and must be readily accessible during eachwork shift to employees when they are in theirwork

areas. (9) TheMSDS mustbeprinted in English; however, the informationmay be repeated in other languages.

(d) Employee information and training. The Company must ensure that employees are provided with information and training on the PMN substance. This information and training must be provided at the time ofeach employee's initial assignment to a work area containing the PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) The informationprovided to employees under this paragraph shall include: (i) The requirements ofthis section.-20- (ii) Any operations in the work area where the PMN substance is present. (iii) The location and availability of the written hazard communicationprogramrequired under paragraph (a) ofthis section, including the list of substances required by sUbparagraph (a)(1) ofthis section andMSDSs required by paragraph (c) ofthis section. (2) The training provided to employees shall include: (i) Methods and observations thatmay be used to detect the presence orrelease ofthe PMN substance in or from an employee's work area (such as monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor ofthe substance whenbeing released). (ii) The potential human health and environmental hazards ofthe PMN substance as specified inparagraph (g) of this section. (iii) Themeasures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Company has implemented to protect employees and the environment from exposure to the PMN substance, including appropriate workpractices, emergencyprocedures, personal protective equipment, engineering controls, and other

measures to control worker exposure and/or environmental release required under this Order, or alternative control measures which EPAhas determined under 40 CPR 721.30 provide the same degree of protection as the specified control measures.-21- (iv) The requirements ofthe hazard communication program developed by the Company under this section, including an explanation ofthe labeling system and the MSDS required by this section and guidance on obtaining and using appropriate hazard information.

(e) Low concentrations inmixtures. Ifthe PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions of this section ifthe concentration ofthe PMN substance in the mixture does not exceed 1.0 percent by weight orvolume, or 0.1 percent byweight or volume if paragraph (g) ofthis section identifies cancer as a potential human health hazard ofthe PMN substance. However, this exemption does not apply if the Companyhas reason to believe that during intended use or processing in the work area, the PMN substance in the mixture maybe reconcentrated above the 1.0 or 0.1 percent level, whichever is applicable.

(f) Existing hazard communication program. The Company need not take additional actions ifexisting programs and procedures satisfy the requirements of this section.

(g) Human health, environmental hazard, exposure, and precautionary statements. The following human health and environmental hazard and precautionary statements shall appear on

### -22- each label as specified in paragraph (b) and theMSDS as specified in paragraph (c) ofthis section: (1) 

### Human health hazard statements. This substance may

cause: (i) central nervous systemeffects. (ii) developmental effects. (2) Human hazardprecautionary statements. When using this substance:(i) avoid skin contact. (ii) avoid ingestion. (iii) use skinprotection. (5) Eachhuman and environmental hazard and precautionary statement on the label preparedpursuant to paragraph (b) ofthis sectionmustbe followed by the statement: "See the MSDS for details."

MANUFACTURING (a)(1) The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substanceby any otherperson. (2) SUbparagraph (a)(1) shall expire 75 days after promulgation ofa final significantnew use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCAunless the Company is notified on orbefore that day of an action in a Federal Court seekingjUdicial review of the SNUR. Ifthe Company is so notified, sUbparagraph (a)(1) shall not expire until EPA notifies the Company in writing that all Federal Court-23- actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (3) When EPApromulgates a final SNUR for the PMN substance and sUbparagraph (a)(1) expires in accordance with sUbparagraph (a)(2), the Company shall notify eachpersonwhom it causes, encourages or suggests to manufacture or import the PMN substance ofthe existence of the SNUR. Suchnotificationmustbe in writing and must specifically include all limitations contained in the SNURwhich are defined as significant new uses, and which would invoke significant newuse notification to EPA for the PMN substance. Such notice must also reference the pUblication of the SNUR for this PMN substance in either the Federal Register or the Code ofFederal Regulations. USE (a) The Company shall use the PMN substance only for industrial applications. DISTRIBUTION (a) The Company shall distribute the PMN substance outside the Company, including for disposal, only to a person who has agreed in writing prior to the date of distribution, to: (1) Not further distribute the PMN substance to any other person, including for disposal, until after the PMN substance has been completelyreacted. (2) Comply with the same requirements and restrictions, if any, required ofthe Company in the Protection in the Workplace section of this Order.-24- (3) Complywith the same requirements and restrictions, if any, required ofthe Company in the Hazard Communication Program section of this Order. (4) Use the PMN substance only for industrial applications.

(b) If, at any time after commencing distribution in commerce of the PMN substance, the Company obtains knowledge that a recipient ofthe substance has failed to complywith any ofthe conditions specified in paragraph (a) ofthis Distribution section or, after paragraph (a) expires in accordancewith sUbparagraph (c)(I), has engaged in a significantnewuse ofthe PMN substance (as defined in 40 CFR Part 721, SUbpart E) without sUbmitting a significant

newuse notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each ofthe following: (1) That the Companyhas, within 5 working days, notified the recipient inwriting that the recipient has failed to comply with any ofthe conditions specified inparagraph (a) ofthis Distribution section, or has engaged in a significant newuse of the PMN substance without sUbmitting a significant newuse notice to EPA. (2) That, within 15 working days ofnotifying the recipient of the noncompliance, the Company received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms ofparagraph (a) ofthis Distribution section and will comply with those terms, or is aware ofthe terms ofthe-25- significant new use rule for the PMN substance and will not engage in a significant new use without sUbmitting a significant

newuse notice to EPA. (3) If, after receiving a statementofassurance from a recipient under sUbparagraph (b) (2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to complywith any ofthe conditions specified in paragraph (a) of this Distribution section, or has engaged in a significant new

use ofthe PMN substancewithout sUbmitting a significantnewuse notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substance to that recipient only upon written notification from the Agency.

(c)(1) Paragraph (a) ofthis Distribution section shall

expire 75 days afterpromulgation of a final SNUR for the PMN substance under section 5(a)(2) ofTSCA, unless the Company is notified on orbefore that day ofan action in a Federal Court seekingjUdicial review ofthe SNUR. If the Company is so notified, paragraph (a) ofthis Distribution section shall not expire until EPA notifies the Company inwriting that all Federal Court actions involving the SNURhave beenresolved and the validity of the SNUR affirmed. (2) When EPApromulgates a final SNUR for the PMN substance and paragraph (a) of this Distribution section expires in accordance with sUbparagraph (c)(1), the Company shall notify-26- eachperson to whom it distributes the PMN substance of the existence of the SNUR. Such notificationmust be inwriting and must specifically include all limitations contained in the SNUR which are defined as significant newuses, and which would invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the pUblication ofthe SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations.

II. RECORDKEEPING (a) The Company shall maintain the following records until 5 years after the date they are created and shall make them available for inspection and copying by EPA in accordance with section 11 ofTSCA:

A. RECORDS (1) Records documenting the aggregate manufacture and importationvolume of the PMN substance and the corresponding dates ofmanufacture and import; (2) Records documenting the names and addresses (including shipment destination address, ifdifferent) of all persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date;-27- (3) Records documenting establishment and implementation of

a program for the use ofany applicable personal protective equipmentrequired pursuant to the Protection in theWorkplace section ofthis Order; (4) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substance; (5) Records documenting establishment and implementationof the hazard communicationprogramrequired by the Hazard Communication program section ofthis Order; (6) copies of labels required under the Hazard Communication Program section ofthis Order; (7) Copies ofmaterial safety data sheets required by the Hazard Communication Program section ofthis Order; (8) Records documenting compliance with any applicable manufacturing, use, and distribution restrictions in the Manufacturing, Use, and Distribution sections of this Order, including distributees' written agreement to comply with the Distribution section of this Order; (9) The Company shall keep a copy ofthis Order at each of its sites where the PMN substance is manufactured, imported, processed orused.-28- III. MODIFICATIONAND REVOCATIONOF CONSENT ORDER The Companymay petition EPA at any time, based upon new information on the health effects of, or human exposure to, the PMN sUbstance, to modify or revoke substantive provisions ofthis Order. The exposures and risks identifiedby EPA during its review ofthe PMN substance and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPAwill consider all relevant information available at the time the Agencymakes that determination, including, where appropriate, any reassessment of the test data or other information that supports the findings in this order, an examination ofnew test data or other information

or analysis, and any otherrelevant information. EPAwill issue a modification or revocation ifEPA determines that the activities proposed therein will not present

an unreasonable risk of injury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. In addition, the Company maypetition EPA at any time to make othermodifications to the language ofthis Order. EPAwill issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent of this Order as issued.-29- IV. EFFECT OF CONSENT ORDER By consenting to the entry ofthis Order, the Companywaives its rights to file objections to this Orderpursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end of the reviewperiod pursuant to section 5(e)(1)(B) of TSCA, and to challenge the validity ofthis Order, ormodifications made thereto, in any sUbsequent action. consenting to the entry ofthis Order, and agreeing to be bound by its terms, does not constitute an admission by the Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights that the companymay have under TSCA.

Lynn R. Goldman, M.D. AssistantAdministr or for Prevention, Pesticides and Toxic Substances Date

Date

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### VicePresident GlobalAgriculturalProductsR&D Company: DowElanco CompanyATTACHMENT A DEFINITIONS

"Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the International Union ofPure and Applied Chemistry or the chemicalAbstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items of clothing that provide a protectivebarrierto prevent dermal contact with chemical substances of concern. Examples can include, but are not limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. "Company" means the person or persons sUbject to this Order. "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other thanby its chemical name. "container" means anybag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. Forpurposes ofthis section, pipes orpiping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediate use." Achemical substance is for the "immediate use" of a person if it is under the control of, and used only by, the person who transferred it from a labeled container and will only be usedby thatperson within the work shift in which it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, permeation, orpenetration of the chemical protective clothing under the conditions of, and the duration of, exposure. "MSDS" means material safety data sheet, the written listing of data for the chemical substance.-2- "Non-industrial use" means use other than at a facility where chemical substances ormixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedby the Company relevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the body to prevent contactwith, and exposure to, an identified chemical substance or substances in the workarea. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included in this definition. "scientifically invalid" means any significant departure from the EPA-approved protocol or the Good Laboratory Practice standards at 40 CFR Part 792 withoutprior or sUbsequentAgency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "scientifically equivocal data" means data which, although developed in apparent conformitywith the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally**inconsi~tent,** 9r otherwise insufficient to permit a reasoned evaluation ofthe potential risk of injury to human health or the environment ofthe PMN substance. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.