FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

Note: This template was developed by EPA to provide guidance to EPA staff and managers who will be preparing the Tier 2 test Order s that will be issued under the Endocrine Disruptor Screening Program (EDSP), as wel l as for the recipients of the Order s. This template is not a rule or regulation, nor does it create or confer legal rights or impose any legally binding requirements on

EPA or an y party. In preparing a final Order , EPA may depart from the guidance presented in this template where circumstances warrant and without prior notice. Order s will be generated individually for each chemical and each Order recipient. EPA will insert the information in blue type and brackets when th e Order is generated.

As of June 25 , 2015



### E

- M AIL ED



### – C ONFIRMATION OF 

### R ECEIPT 

### R EQUIRED



### Summary Information About thi s Order and the Order Recipient

Order /DCI # :

................................ ................ [Insert sequential number as assigned by the system.]

Chemical Common Name :

.......................... [Insert chemical name.]

Pesticide Chemical code # :

........................... [Insert pesticide chemical code .]

CAS ( Chemical Abstracts Service ) # :

......... [Insert CAS #]

Company Name :

................................ ........... [Insert name.]

Company #(s ):

................................ ............... [I nsert number assigned to identify the company in the system.]

Company Address :

................................ ....... [Insert address where Order will be directed.]

Company Contact Person :

.......................... [Insert the name of the contact person.]

Date Issued :

................................ ................... [Insert the issuance date.]

Due Date for Initial Response :

.................... [Insert date, calculated as 90 calendar days from issuance plus 10 calendar days for final processing and receipt ( i.e.

, total 100 calendar days from issuance).]

Due Date for Consortia Documentation :

... [Insert date, calculated as 150 calendar days from issuance plus 10 calendar days for final processing and mailing ( i.e. , total 160 calendar days from issuance).]

Due Date for Progress Report :

.................... [Insert date, calculated as 12 months from issuance.]

Required Tier 2 Studies and Due Dates (below) :

☐ 1. Japanese Quail Two

- Generation Toxicity Test (890.2100) [Insert date, calculated as 24 months from issuance or Not Required as applicable].
☐ 2. Medaka Extended One

- Generation Reproduction Test (890.2200) [Insert date, calculated as 24 months from issuance or Not Required as applicable].
☐ 3. Larval Amphibian Growth and Development Test (890.2300) [Insert date, calculated as 24 months from issuance or Not Required as applicable].

Draft

, June 25 , 2015 Page 1 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

☐ 4. Reproduction and Fertility Effects 1 (870.3800) [Insert date, calculated as 48 months from issuance or Not Required as applicable].

EPA Contact: [Insert name of the Chemical Review Manager (first name last name). ]
EPA Contact Phone Number: [Insert Area Code, Phone No.]

EPA Contact E

- Mail Address: [Insert Chemical Review Manager E

- Mail

. ]

Dear Sir or Madam:

This Order requires you and other manufacturers and importers of the chemical named above to submit certain data or otherwise respond as noted herein to the U. S. Environm ental Protection Agency (EPA,
the Agency ). This chemical is identified as an “other ingredient” in a pesticide product(s) (also referred to as an inert ingredient). These data are required by section 408(p)(3) of the Federal Food, Drug and
Cosmetic Act (“FFDCA”), which mandates that all pesticide chemicals, including inert ingredients, be tested under the Endocrine Disruptor Screening Program (EDSP). [21 U.S.C. 346a (p)(3),(5)].

If you do not respond to this Order, or if you fail to otherwise comply wit h its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].

Introduction

This Order is issued pursuant to sections 408(p)(3) and (5) of the FFDCA [21 U.S.C. 346a(p)(3), (5)]. FFDCA section 201(q)(1) defines “pesticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide” [21 U.S.C. 231(q)(1)].

To facilitate the formation of consortia to develop the data required by this Order, and to the extent that the information is not protected as confiden tial business information, we have provided each Order recipient with a list of the other recipients of an Order for this chemical. (See Attachment A). EPA intends to announce the issuance of this Order and the availability of a list of all Order recipie nts for this
chemical in the Federal Register

. The list of Order recipients for this chemical will be publicly available on the Agency's Web site, along with the status of the Orders, including recipients’ responses. EPA intends to update this informatio n with subsequent publication(s) and posting(s) as appropriate. You are encouraged to join a consortium and can check on the status of responses from the other Order recipients for this chemical on the Web site.

If you have previously claimed your ident ity in relation to this chemical as CBI (confidential business information), you will, however, notice that your company is included on the list only as “Company X.” So that other Order recipients can identify and contact you to collaborate on responding to this Order, EPA recommends that you either declassify your identity information so that it can be made publicly available, or you identify an agent who will act on your behalf in all matters relating to this Order. If you choose to designate an agent, EPA will make the name of the agent (instead of the company) public by including it on the list of recipients of FFDCA section 408(p) Orders under the EDSP.

The information collection requirements described in this document have been approved by the Offi ce of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.

1 Test guidelines 1) OECD TG 416 (Two

- Generation Reproduction Toxicity Study), or 2) OECD TG 443 (Extended One

- Generation Reproductive Toxicity Study) are acceptable alternative tests.

Draft

, June 25 , 2015 Page 2 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

The Information Collection Request (ICR) document prepared by EPA is identified under EPA ICR No.
2249

. 0 1 , and OMB Control No. 2070

- ####. The public reporti ng burden for this collection of
information is estimated to range between 204 and 8,148 hours, depending on the respondent category and activities, with an estimated cost between 17,783 and 557, 218.

Section I. The Authority for this Order

FFDCA section 408(p)(1) requires the EPA " to develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced b y a naturally occurring estrogen, or such other effects as [EPA] may designate " [21 U.S.C. 346a(p)]. Section 408(p)(3) specifically requires that the EPA " shall provide for the testing of all pesticide chemicals. " [21 U.S.C. 346a(p)(3)].

Section 201 of the FFDCA defines " pesticide chemical " as " any substance that is a pesticide within the meaning of [FIFRA], including all active and inert ingredients of such pesticide. " [21 U.S.C. 231(q)(1)

. ]

Section 408(p)(5) of the FFDCA provides that th e Administrator shall issue an Order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accor dance with the screening program, and submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation of the
information.

Section II. Why You are Receiv ing this Order

You are receiving this Order because you have previously received and fulfilled a Tier 1 screening
Order and for which, based on those data, the Agency determined Tier 2 testing is required as such, pursuant to section 408(p)(3) of the FFDCA , you are subject to this Order

.

Section III. Data Required by this Order

This Order identifies the Tier 2 testing required to be conducted for the chemical named on the first page of this Order. The purpose of the EDSP is to provide information that wil l allow the Agency to evaluate the risks associated with the use of a chemical and take appropriate steps to mitigate any risks of concern. The necessary information includes identifying any adverse effects that might result from the
interaction of a subst ance with the endocrine system and establishing a dose

- response curve. Specifically, the purpose of Tier 2 testing, which consists of a group of individual in vivo tests designed to include males and females with an intact hypothalamic

- pituitary

- gonadal a xis, multiple pathways of exposure and life

- stages, and various taxa, to further identify and characterize chemical

- induced interactions with estrogen, androgen and thyroid hormones for risk assessment. Tier 2 testing is designed to identify any adverse en docrine

- related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect for risk assessment to inform regulatory
decisions. The fact that a substance is identified for Tier 2 testing does not me an that when the substance is used, it will cause adverse effects in humans or ecological systems.

Draft

, June 25 , 2015 Page 3 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

III.A. Data Required

– The Tier 2 Tests

The following is a list of Tier 2 tests of which some or all maybe required for submission to the Agency in respons e to this Order (see page 1of this Order for the specific tests you are required to conduct):

1. OCSPP Guideline 890. 2100

, Japanese Quail Two

- Generation Toxicity Test This test guideline is designed to provide concentration

- response information concerning t he adverse effects of a test substance delivered via dietary exposures on avian reproductive and thyroid function, including gonadal function, mating behavior, secondary sex characteristics, reproductive output, fertility, hatchability, biochemical respons es, histopathology of several tissues, and growth and development relevant to all life stages of the first and second generations.

2. OCSPP Guideline 890. 2200 , Larval Amphibian Growth and Development Test This test guideline is designed to provide concentra tion

- response information concerning the adverse effects from aqueous exposures of a test substance in amphibians on larval development and metamorphosis, and juvenile growth and development, including thyroid, gonad and liver.

3. OCSPP Guideline 890.2300, Me daka Extended One

- Generation Reproduction Test This test guideline is designed to provide concentration

- response information concerning the adverse effects from aqueous exposures of a test substance in fish on the integrity and performance of male
and fem ale reproductive systems, including fecundity, fertility, secondary sex characteristics, biochemical liver responses, histopathology of several tissues and growth and development that are relevant to all life stages, and subsequent generations.

4. OCSPP Guideline 870.3800, Reproduction and Fertility Effects 2
This test guideline is designed to provide dose

- response information to assess the potential for adverse effects from oral exposure of a test substance in rodents on the integrity and performance of male and female reproductive systems, including gonadal function, the estrous cycle, mating behavior, conception, gestation, parturition, lactation, weaning, and growth and development that are relevant to adults and offspring of the first and second gener ations in utero and post

- partum.

III.B. Conducting the Tests

– Tier 2 Testing Protocols

Pursuant to section 408(p)(1) of the FFDCA, testing conducted for the EDSP must be based on "validated test systems and other scientifically relevant information." [2 1 U.S.C. 346a (p)(1).] "Other scientifically relevant information" (OSRI) is information demonstrating whether substances has/does not have an effect on the functioning of the endocrine system. Other scientifically relevant information may either be functi onally equivalent to information obtained e.g. , for pesticide registration,

— or may include data that provide information on a potential consequence or effect that could be due to effects on the estrogen, androgen or thyroid systems. See also the discussio n in Section IV of this Order.

The Tier 2 tests identified in Section III.A of this Order must be conducted using the test guidelines that have been validated and made available for use by the Order recipients that are completing the testing to generate new data to respond to this Order . All of the applicable testing guidelines have been validated and are available on the Agency’s Web site at: http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm

, or, http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm

.

2 Test guidelines 1) OECD TG 416 ( Two

- Generation Reproduction Toxicity Study) , or 2) OECD TG 443 ( Extended One

- Generation Reproductive Toxicity Study ) are acceptable alternative tests

Draft

, June 25 , 2015 Page 4 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

If you choose to generate the data to respond to this Order, you may not deviate from an approved testing protocol unless you first consult with the Agency and obtain Agency approval of any deviation. If you wish to use a protocol that differs from those attached to this Order, you must su bmit a detailed description of the proposed protocol (including a precise description of any deviations from the protocol identified in this Order) and your reason(s) for wishing to use it. Because section 408(p)(1) of the FFDCA requires that the screening be conducted with validated tests, in Order for EPA to approve the use of your proposed protocol, you must demonstrate that the protocol has been scientifically validated or the deviation is such that the final study is nonetheless properly considered to have been scientifically validated. If the Agency rejects your protocol you will be notified in writing. Moreover, you should be aware that rejection of a proposed protocol will not be a basis for extending the deadline for submission
of data.

If you choos e to cite or submit existing data, including other OSRI, you must indicate whether the information provided follows an accepted scientific methodology or protocol, including but not limited to those presented in EPA's harmonized test guideline compendium, 3 and provide a cogent and complete rationale for why you believe the information is sufficient to satisfy part or all of this Order. EPA's decisions about whether the information satisfies part or all of the Tier 2 Order will be based on the weight of evid ence from all relevant information available to the Agency. See the instructions for submitting your response, which appear in Section IV of this Order.

You must also adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 and

4 0 CFR part 792 , which require you to follow certain practices when conducting studies, and when you submit data to EPA you must provide a GLP compliance statement indicating a) that the data were generated using GLPs; b) describe in detail "all differences " between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study
was conducted in accordance with the GLPs.

III.C. Generating the Data

– Applicable Timeframes

You are requir ed to submit the data or otherwise satisfy the data requirements specified in this Order and submit the data to EPA on the dates indicated on first page of this Order. The Agency set this due date after considering the amount of time one might reasonably e xpect is needed to complete each test, including the planning activities before beginning the test, actual performance of the test, analyzing test results, and completing the final study report for that test (see Table 1). EPA also included several
months for overall planning, and several months after the last test is completed to allow ample time for the Order recipients to prepare the final report for submission to EPA.

Table 1

– Estimated Timeframes for Completing the Individual Tests and Reports

OCSPP Guideline # OCSPP Guideline Test Timeframes (months)

890. 2100 Japanese Quail Two

- Generation Toxicity Test 24

890. 2200 Medaka Extended One

- Generation Reproduction Test 24

890. 2300 Larval Amphibian Growth and Development Test 24

870.3800 Reproduction and Fertility Effects 1 48

1 Test guidelines 1) OECD TG 416 (Two

- Generation Repr oduction Toxicity Study), or

2) OECD TG 443 (Extended One

- Generation Reproductive Toxicity Study) are acceptable alternative tests.

3 http://www.epa.gov/ ocspp/pubs/frs/home/guidelin.htm

, or , http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm

Draft

, June 25 , 2015 Page 5 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

There is no set sequence for completing these tests, and the due date for submitting the final report to EPA provides you with ample flexibility for Order recipients to join forces and complete this battery within the timeframe provided. Order recipients may also submit data before the due date.

Section IV. Responding to the Order

You must respond to this Order within the timeframes established pursuant to S ection IV. A

. of this Order, and the specific applicable dates as identified on page 1 of this Order . I f you do not respond to this Order, o r if you fail to otherwise comply with its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].

To comply with this Order, you are expected to engage in the following activi ties: (1) Read this Order. (2) Determine and p lan a ctivities necessary to respond to the order. (3) Submit an Initial Response Form to EPA, identifying the response option you intend to use.

See S ection IV. B. of this Order

. (4) If you decide to generate the data, Read and, if applicable, discuss the protocols. See S ection
III.B. of this Order

. (5) Submit a Progress Report. See S ection V I. of this Order

. (6 ) Generate the data. (7) Compile and review the data for submission . See Section V . of this Order

. (8) Complete paperwork to assemble the submission package

. See S ection V . of this Order

. (9) Submit F inal Report/D ata to EPA

. See Section V. of this Order

. (10) Maintain records

. See Section VII. of this Order

.

IV.A. Schedule for Responding to the Order

Your schedule for responding may vary based on the response options discussed in more detail in the next Section of this Order. Please note that in calculating the due date for the Initial Response, the Agency has inclu ded an additional 10 calendar days to account for processing the Order should electronic (email) delivery and confirmation of receipt of the Order fail, such that, the Agency must rely on paper issuance and delivery by the post office. Your basic schedule is summarized on the first page of this Order and is based on the timeframes identified in Table 2, below:

Table 2

– Basis for Establishing the Due Dates in this Order

Timeframes for Due Dates What is Due Within 90 calendar days of the Order 's issuance ( plus 10 calendar days for processing) Individual recipient's initial response

Within 150 calendar days of the Order 's issuance (plus 10 calendar days for processing) Consortia documentation and consortia's I nitial

R esponse Within 12 months from Order 's issuance A progress report describing the status of an
Order Recipient's compliance with the Order

Within 24 to 48 months from Order 's issuance date depending on the studies required (see page 1of this Order for the specific tests you are required to

con duct) Final study report and submission of the data to

EPA

Draft

, June 25 , 2015 Page 6 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

In general, the Agency will not consider any requests for extending the deadlines for the Initial Response or progress report. However, the Agency will consider extending the final report due da te when circumstances warrant it. If you cannot submit your final study report to the Agency in the time frame required by this Order, and intend to seek additional time, you must submit a time extension request to the Agency before the applicable deadline using the procedures described in Section V. of this Order. Your request must occur before the applicable deadline and include: (1) a detailed description of the expected difficulty; and (2) a proposed submission schedule including alternative dates for m eeting the requirements of this Order on a step

- by

- step basis. In your description, you must explain any technical or laboratory difficulties and provide related documentation from the laboratory performing the testing. While EPA is considering your reques t, the original deadline will remain in effect. The Agency will respond to your request in writing. If EPA does not grant your request, the original deadline stands. Generally, extensions should be requested only in cases of extraordinary testing difficult ies beyond the expectation or control of the registrant. Extensions will not be considered if the request is not made in a timely fashion or in accordance with the instructions provided in this Order. Under no circumstances will a time extension request be considered on or after the study due date. The status of all Orders including time extensions are available on our website at www.epa.gov/endo.

IV.B. Options for Responding to the Order

You have several options for responding to this Order. To report you r commitment to act in response to this Order, you must submit an Initial Response to EPA within 90 days of the issuance of this Order. See Section V. of this Order for submission procedures. You have several potential response actions from
which to choose , each response option involves specific procedures that you must follow if you choose that response option:

Option 1: Generate Data

If you choose to individually generate new data for each test specified in this Order, you must comply
with the procedures prescribed in this Order. All data generated and submitted must comply with the Good Laboratory Practices (GLP) set out in FIFRA in 40 CFR part 160. The tests must be conducted according to guidelines identified in Section III.B. of this Order. In submitting the data, you must follow the new procedures described in Section V. of this Order.

Option 2: Submit or Cite Existing Data

If you choose to submit or cite an existing study in response to this Order (including data previously
submitted to th e A gency and/or OSRI ), your I nitial R esponse must include either the study data or a reference to the data for each test that is required, along with a rationale that explains how the study you cited or submitted satisfies part or all of this Order . Existing studies are studies that predate issuance of
this Order . In Order to be accepted in satisfaction of the requirements imposed in this Order , the A gency expects that any such hazard

- related data would be of high quality and achieves the objective of Tier 2 testing to provide reasonable assurance that a chemical does or does not result in adverse endocrine
related effects. EPA 's decisions about whether the data cited or submitted satisfies part or all of the
Tier 2 Test Order will be based on an eva luation of all relevant information available to the A gency.

The submitted or cited study must have been conducted in accordance with accepted scientific methodology or protocol, including but not limited to those presented in EPA 's harmonized test

Draft

, June 25 , 2015 Page 7 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

guideli ne compendium. 4 Deviations from the protocols validated for the Tier 2 tests, must be identified, along with an explanation for the deviations, including an explanation as to why, notwithstanding the deviations, the protocol used should still be considered as providing an accepted scientific methodology or protocol, and any other information you think the A gency should consider in deciding whether to accept the data in satisfaction of this Order

.

If EPA has previously reviewed a protocol for a study you are submitting or citing, you must identify any action taken by the A gency on the protocol and must indicate the manner in which all A gency comments, concerns or issues were addressed in the final protocol and study.

If you choose to cite a study that has bee n previously submitted to EPA , that study must have been previously classified by EPA as acceptable ( i.e. , the study was not rejected by the A gency for any reason related to completeness or quality) or it must be a study which has not yet been reviewed by the A gency. With respect to any studies for which you wish to select this option you must provide EPA with a copy of the title page along with the identification number of the study you are citing (Master Record Identification [MRID] number), and, if the s tudy has been reviewed by the A gency, you must provide
the A gency's classification of the study. Do not resubmit a study that has previously been submitted

to EPA for another purpose.

EPA will review any existing study submitted or cited in response to th is Order to determine whether the study is acceptable and whether the study satisfies the requirements of this Order . The A gency will notify you in writing of its determination. If the A gency determines that the study is acceptable, the

EDSP Tier 2 Test ing, Initial Response Form for Individual Order Recipients is the only response you are required to complete to satisfy this Order and EPA will notify you in writing that the Order is satisfied. If, however, EPA determines that the study is not acceptable, you must still satisfy the requirements of this Order . You should be aware that if the A gency determines that the study is not acceptable, the A gency will require you to comply with this Order , normally without an extension of the required due date for submission of the data. The A gency may determine at any time that a study is not valid and needs to be repeated.

If you are citing a study of which you are not the original data submitter, you may need to submit an offer to pay compensation to the original data submitter. Consequently, you should simultaneously include an offer to pay [in accordance with 40 CFR 152.93] [which includes an offer to resolve any dispute over the recipients' shares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties ( e.g. , through binding arbitration or through a state or federal court action)], unless you have received confirmation from EPA that no such compensation is necessary.

Opti on 3: Form a Consortium/ Task Force or Offer to Join a Consortium/ Task Force

If you choose to form a task force or consortium to share in the cost of producing the required data, all participants of the task force or consortium must submit their own EDSP Tier 2 Test ing, Initial Response Form for Individual Order Recipients providing the name of the party who will be submitting the data on your behalf.

The designated lead for the task force or consortium must complete the EDSP Tier 2 Testing, Initial Response Form for Consort ium /Task Force ( Attachment C) to provide the primary contact for the task force or consortium, the list of participants, and an indication of the task force or consortium ' s planned

4 http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm

, or , http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm

Draft

, June 25 , 2015 Page 8 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

response for each test , along with documentation of its formation (such as a copy of the joint agreem ent or a written statement by all the parties that an agreement exists). The joint agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms. The designated lead for t he task force or consortium must follow the submission
instructions in Section V.D. of this Order to submit the EDSP Tier 2 Testing, Initial Response Form for
Consortium/Task Force and accompanying information to the EPA by the due date for the consorti um response that is indicated on the first page of this Order

.

Once the task force or consortium submits the data and the EPA has completed its initial review to accept the data in satisfaction of this Order

, the EPA will provide written notification to the c ontact for
the task force or consortium that this Order has been satisfied, which in turn will close out the Order s for each of the participants in the consortium/task force.

If you are unable to join a task force or consortium, you must provide the EPA wi th documentary evidence that you made a reasonable offer to join or share in the testing costs. Such evidence may be : (1) your letter offering to join in an agreement, or (2) your letter that contains a legally binding offer to join in an agreement and pro vide a reasonable share of the test costs, and that includes a reasonable process for resolving any disputes of the appropriate share of the test costs.

If the task force or consortium fails to submit the data or meet the requirements of the Order in a tim ely and adequate manner, you will normally be subject to penalties of up to $ 37 ,500 per day, unless you commit to submit, and do submit, the required data by the dates specified in this Order . In such cases,
the Agency will generally not grant time extensions for the submission of data. Thus, if you agree to jointly submit the data, each Order recipient is still subject to penalties of up to $ 37 ,500 per day, unless some party with whom you are in agreement makes a commi tment to generate the data and submits the data in accordance with the deadlines and all other requirements set forth in this Order

.

The Agency has provided a list of the other manufacturers and/or importers, to the extent permi tted by confidentiality requ irements that have received an EDSP Order for this chemical . (Attachment A).
This l ist is intended to help order recipients identify other companies with whom they could form agreements to develop data jointly, or otherwise collaborate on a response to sa tisfy the requirements
in this Order. Option 4: Claim Not Subject to the Order

You may claim that you are not subject to this Order if you do not manufacture or import the chemical and/or you are not a pesticide registrant of the chemical identified on the first page of this Order or you believe the Order was otherwise sent to you in error. An explanation of the basis for the claim, along with appropriate information to substantiate that claim, must accompany your Initial Response so that
the EPA can evalua te the claim. The Agency intends to make a determination and respond to your request in writing within 90 days of receipt. If the EPA cannot verify your claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA wil l consider the Order
satisfied and will close out the Order

.

Option 5: Discontinue the Manufacture or Import of the Chemical

If you have already, or otherwise are in the process of discontinuing the manufacture or import of this chemical, you may satisfy the Order by submitting documentation to this effect with your Initial Response . If EPA cannot verify your claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the Order and
will close out the Order

.

Draft

, June 25 , 2015 Page 9 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

Option 6: Stop Sales into the Pesticide Market

You may commit not to sell the chemical for use in the pesticide market. As part of your Initial Response , you must document your commitment that on or before a date six months after the issuance of
the test Order , all sale and distribution of the pesticide inert ingredient that is the subject of this Order to any person who you know, or reasonably should kno w, intends to use the substance in the formulation of a pesticide product. In addition, you must certify that you will include in all contracts for sale or distribution of the material, a provision that contractually prohibits the purchaser of your chemic al from using the substance in the formulation of a pesticide product. As part of your Initial Response , you must provide a copy of the contract provision and your commitment to include this contractual provision in any contracts entered into on or after a date six months after the issuance of this Order

. If you choose this option, the Initial Response Form, with supporting information, is the only response you are required to complete under this Order

.

If you do not fulfill the commitments made in your Initial Response , you will be subject to enforcement action for failing to comply with the FFDCA section 408(p) Order , in accordance with section 408(p)(5)(D). Having failed to perform the actions necessary for this response option, you will be obliged to immediately comply with the Order

— i.e ., to provide the data, within the time frame that had originally been required by the Order . In addition, you may be subject to potential penalties, pursuant to 18 U.S.C. §1001, for willfully making any false or misl eading statements to the Federal government.

The Agency intends to make a determination on your claim and respond to you in writing within 90 days of receipt. If EPA cannot verify your claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the Order and
will close out this Order.

IV. C . Procedures f or Challenging this Order

If you wish to challenge the validity of any of the provisions of this Order , including the requirement to conduct any test or use the specific test protocols required by this Order , you must submit to the Agency a detailed explan ation of the basis for your challenge that provides sufficient information for the Agency
to evaluate the issue. The Agency intends to respond to your request in writing within 90 days of receipt. While the EPA is considering your submission, the original deadline remains.

IV. D . Procedures for Cost Sharing

Cost sharing is the process by which two or more recipients of an EDSP Order contribute to the generation of data (or the compensation for existing data). Contributions may be in cash or in kind and

app ortionment of costs is subject to negotiation between the participants . The EPA encourages all recipients of an Order for a particular substance to jointly submit data and share data generation costs. All other parties who are also subject to this Order are listed in Enclosure A, unless that information is protected as CBI , and will be made publicly available on the Agency ' s Web site.

The EPA has not established specific coordination procedures by which you must collectively generate data. You may there fore determine the procedures that are best suited to your individual circumstances, and the most acceptable approach to identifying and sharing test costs.

Draft

, June 25 , 2015 Page 10 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

If you are aware of another manufacturer of the chemical listed on the first page of this Order who is not listed on Enclosure A, and you provide the EPA with this information, and the EPA intends to send that
manufacturer or importer an Order for this chemical within 90 days of your notification.

IV. E . Procedures for Data Protection

I f (a) a tolerance /tolerance exemption has been established for your chemical, (b) an application for a
tolerance /tolerance exemption is pending; or (c) you have partnered with pesticide registrants (either
technical or end

- use), or otherwise joined a consortium with a pest icide registrant, the EPA considers such data to be subject to the requirements of FIFRA section 10. All other confidential business information submitted in response to a 408(p) Order ( i.e. , data not in support of a registration or
tolerance/tolerance exe mption) is subject to the Trade Secrets Act [ 18 U.S.C. 1905 ]

.

The Freedom of Information Act (FOIA) requires agencies to make information available to the public upon request, except for information that is " specifically made confidential by other statutes " or data that

are " trade secrets and commercial or financial information obtained from a person and is privileged or
confidential " [5 U.S.C. 552]. Any information that you wish to have the EPA protect as CBI should be clearly identified as such. Note that substantive criteria must be met to support a claim for CBI , as specified in 40 CFR 2.208.

Section V. Procedures for Submitting Data to the Agency

You must submit all correspondence related to this O rder to EPA ( including your initial response, the initial response from the consortium, progress reports, the final report , etc.) in accordance with the instructions provided on our website: http:// www.epa.gov/endo.

V.A. Format for Submissions

The EPA will develo p standard data evaluation formats

, referred to as Study Profile Templates (SPTs)

, and Data Entry Spreadsheet Templates (DESTs) and Standard Evaluation Procedures (SEPs) to assist registrant s in their submissions . These templates describe the layout and sc ope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary
for an efficient Agency review is outlined and the submissions of these templates should be in a format that can be manipulated ( i.e. , Microsoft Word and Excel , or similar formats ). Additional details about these templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/

.

In addition, Pesticide Registration (PR) Notice 20 11

- 3, entitled

, Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA

, 5 describes the EPA' s preferred method for organizing and formatting submittals of data supporting a pesticide registration.

V.B. Transmittal Document s

In Order for the EPA to effectively track the compliance of each Order recipient, each submission in

sat isfaction of an Order issued under FFDCA section 408(p) must be accompanied by a transmittal document that includes the following information:

5 http://www.epa.gov/PR_Notices/pr2011

- 3.pdf

Draft

, June 25 , 2015 Page 11 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

• Identity of the submitter.

• The date on which the submission package was prepared for transmittal to the EPA

.

• The Order number identified on the first page of this Order

.

• A list of the individual documents included in the submission.

V.C. Submitting Individual Study or Test Result Documents

Unless otherwise specified by the Agency , each submission must be in the form of individual documents or studies. Do not resubmit any documents that you previously submitted to the EPA . Instead, in your EDSP Tier 2 Test ing, Initial Response Form for Individual Order Recipients that you submit , please provide a citation or reference to the previously submitted documents with sufficient information to
allow the Agency to identify the previously submitted document.

Each study or document submitted to the EPA must include the following:

i. A title page including the following information:

• The Order number identified on the first page of this Order

.

• The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.

• The author(s) of the s tudy.

• The date the study was completed.

• If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes.

• If the study is a commentary on or supplement to another previously submitted study, ful l identification of the other study with which it should be associated in review.

• 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 publicatio n. ii. Upon submission to the EPA , each document must be accompanied by a signed and dated document containing the appropriate statement(s) regarding any data confidentiality claims as
described in PR

- Notice 11

- 3

. iii. A statement of compliance or non

- compliance wi th respect to GLP standards as required in

40 CFR part 160, as applicable.
iv. A complete and accurate English translation must be included for any information that is not in English.

V.D Transmittal Instructions

For instructions on submitting your information electronically or on paper, please see our instructions at: http://www.epa.gov/endo/pubs/toresources/index.htm#submit

.

Section V I. Submit a Progress Report

Unless the EPA has notified you in writing that the requirements of this Order have been satisfied, you must submit a progress report to the EPA 12 months after the issuance of this Order (the specific due date for you is ident ified on the first page of this Order ). Your progress report should provide a brief description of the status of your planned activities for each test , and, if applicable, a description of any problems encountered or expected difficulties in meeting the sc hedule for complying with the Order

. See Section V for submission instructions.

Draft

, June 25 , 2015 Page 12 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

Section VII. Recordkeeping Requirements

You must retain copies of the generation of the data and other information documenting your compliance with this Order . This includes all test reports submitted to the Agency in support of a registration or in support of a tolerance petition, all underlying raw data, and interpretations and evaluations thereof (see 40 CFR part 169). These records shall be retained as long as the inert i ngredient is contained in a pesticide product with a valid registration and the producer is in business, and be made available to EPA or its agent for inspection.

Section VIII. Consequences of Failure to Comply with this Order

Failure to comply with any o f the requirements in this O rder renders you liable for the penalties and sanctions of up to $ 37 ,000 per violation. Each day that the violation continues constitutes a separate violation. Any person who knowingly or willfully violates this O rder shall (e ither in addition to or in lieu of) be subject to a fine of not more than $ 37 ,000 per day of violation, or to imprisonment for not more than one year, or both. [21 U.S.C. §346a(p)(5)(D), citing 15 U.S.C. §2615]

Before such penalties are assessed, you will be entitled to an administrative hearing held on the record in accordance with section 554 of the Administrative Procedures Act (APA). 15 U.S.C. §2615(a)(1)

- (2)(A). Before issuing a final penalty order, EPA must provide notice of its intention to assess the penalty, including a draft of the final penalty order, and provide you with the opportunity to request a hearing within 15 days of the date the notice has been received. 15 U.S.C. §2615(a)(2)(A). See also, 40 C.F.R. §§ 22.13

- 22.14.

If a hearing is requested, the only matters for resolution at the hearing shall be the following: (1) whether you have failed to comply with an O rder issued under FFDCA section 408(p)(5)(A), (2) the circumstances of the violation; (3) the extent and gravity of the viola tion(s); (4) your ability to pay; (5) the effect on your ability to continue to do business; (6) any history of prior violations; and (7) the degree of culpability [15 U.S.C. § 2615(a)(2)(B)]. In this hearing, you may not raise any challenge to
the validi ty of this O rder , or any test required by this Order

.

Section IX. Additional Information

Additional information and details about the EDSP may be found on the Agency ' s Web site at http://www.epa.gov/endo

.

If you have any questions about the requirements and procedures established in this Order , please

contact the Chemical Review Manager listed on the first page of this document.

Draft

, June 25 , 2015 Page 13 of 14FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Inerts

Section X. Conclusion

Under the authority in FFDCA section 408(p) [21 U.S.C. 346a(p)], the U.S. Environmental Protection Agency hereby issues this Order to take effect on the date of my signature.

Signature:

________________________________________ __________________ [Insert Name]

, Director Date
Pesticide Re

- evaluation Division, Office of Pesticide Programs Program
Office of Chemical Safety and Pollution Prevention
U.S. Environmental Protection Agency

Attachments
Attachment A

– List of EDSP Tier 2 Testing Order recipients for this chemical
Attachment B

– EDSP Tier 2 Test ing

, Initial Response Form for Individual Order Recipi ent s , EPA Form No. ####

- ##
Attachment C

– EDSP Tier 2 Test ing

, Initial Response Form for Consorti a /Task Forc e s , EPA Form No. ####

- ##

- C

Draft

, June 25 , 2015 Page 14 of 14