Document ID: EPA-HQ-OPPT-2013-0171-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-08-05T04:00Z

Note:	This template was developed by EPA to provide guidance to EPA staff and managers who will be preparing the Tier 2 test Orders that will be issued under the Endocrine Disruptor Screening Program (EDSP), as well as for the recipients of the Orders. 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 any party.  In preparing a final Order, EPA may depart from the guidance presented in this template where circumstances warrant and without prior notice. Orders will be generated individually for each chemical and each Order recipient. EPA will insert the information in blue type and brackets when the Order is generated.
                              As of June 25, 2015
E-Mailed  -  Confirmation of Receipt Required
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Summary Information About this 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):	[Insert 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].
☐
4. Reproduction and Fertility Effects (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.]
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EPA Contact E-Mail Address:	[Insert Chemical Review Manager E-Mail.]
Dear Sir or Madam:
This Order requires you and other registrants of pesticide products containing the pesticide active ingredient (PAI) named above to submit certain data or otherwise respond as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). This chemical is identified as a pesticide chemical. Pursuant to sections 408(p)(3) and (5) of the Federal Food, Drug and Cosmetic Act (FFDCA), which mandates that all pesticide chemicals be tested under the Endocrine Disruptor Screening Program (EDSP), these data are necessary, to maintain the continued registration of your product(s) containing the listed pesticide active ingredient(s). [21 U.S.C. 346a(p)(3), (5)].
If you do not respond to this Order, or if you fail to otherwise comply with its requirements, then the registration of product(s) subject to this Order will be subject to suspension, pursuant to FFDCA section 408(p)(5)(C)(i) and section 3(c)(2)(B)(iv) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Introduction
This Order is issued pursuant to sections 408(p)(3) and (5) of FFDCA [21 U.S.C. 346a(p)(3) and (5)] and section 3(c)(2)(B) of FIFRA [7 U.S.C. 136a(c)(2)(B)]. 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 confidential business information (CBI), 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 recipients 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 information with subsequent publication(s) and posting(s) as appropriate. You are encouraged to join a consortium and you may check on the status of responses from the other Order recipients for this chemical on the Web site. 
The information collection requirements described in this document have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA is identified under EPA ICR No. 2279.01, and OMB Control No: 2070-####. The public reporting 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 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 by 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 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 the 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 accordance 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 3(c)(2)(B) of the FIFRA provides that registrants must submit additional data, upon notification that the Administrator has determined that additional data are required to maintain an existing pesticide registration. [7 U.S.C. 136a(c)(2)(B).] In light of the directive in section 408(p)(3) that EPA is to provide for the endocrine screening of all pesticide chemicals, EPA considers that such data have been statutorily determined to be necessary to maintain an existing pesticide registration. 
Section II.  Why You are Receiving 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 will 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 substance 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 axis, 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 endocrine-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 mean that when the substance is used, it will cause adverse effects in humans or ecological systems. 
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 response 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 the 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 responses, 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 concentration-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, Medaka 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 female 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 
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 generations 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." [21 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 functionally 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 discussion 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.
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 submit 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 choose 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, 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 evidence 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 40 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 required 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 expect 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 Reproduction Toxicity Study), or 
2) OECD TG 443 (Extended One-Generation Reproductive Toxicity Study) are acceptable alternative tests.
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 Section IV.A. of this Order, and the specific applicable dates as identified on the first page of this Order. If you do not respond to this Order, or if you fail to otherwise comply with its requirements, then the registration of the product(s) subject to this Order will be subject to suspension pursuant to FFDCA section 408 (p)(5)(C)(i) and FIFRA section 3(c)(2)(B)(iv). 
To comply with this Order, you are expected to engage in the following activities:
   1) Read this Order. 
   2) Determine and plan activities necessary to respond to the Order.
   3) Submit the completed EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients to EPA, identifying the response option you intend to use. See Section IV.B. of this Order.
   4) If you decide to generate the data, read and, if applicable, discuss the protocols. See Section III.B. of this Order.
   5) Submit a Progress Report. See Section VI. 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 Section V. of this Order.
   9) Submit Final Report/Data 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 included 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 Initial Response
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 conduct) 
Final study report and submission of the data to EPA
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 date 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 meeting 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 request, 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 difficulties 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 your 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 the Agency and/or OSRI), your Initial Response 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 Agency 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 evaluation of all relevant information available to the Agency.
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 guideline compendium. 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 Agency 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 Agency on the protocol and must indicate the manner in which all Agency comments, concerns or issues were addressed in the final protocol and study.
If you choose to cite a study that has been previously submitted to EPA, that study must have been previously classified by EPA as acceptable (i.e., the study was not rejected by the Agency for any reason related to completeness or quality) or it must be a study which has not yet been reviewed by the Agency. 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 study has been reviewed by the Agency, you must provide the Agency'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 this Order to determine whether the study is acceptable and whether the study satisfies the requirements of this Order. The Agency will notify you in writing of its determination. If the Agency determines that the study is acceptable, the EDSP Tier 2 Testing, 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 Agency determines that the study is not acceptable, the Agency will require you to comply with this Order, normally without an extension of the required due date for submission of the data. The Agency 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. 
Option 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 Testing, 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 Consortia/Task Forces (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 response for each test, along with documentation of its formation (such as a copy of the joint agreement 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 the task force or consortium must follow the instructions in Section V.D. of this Order to submit your responses and accompanying information to EPA by the due date for the consortia response that is indicated on the first page of this Order.
Once the task force or consortium submits the data and EPA has completed its initial review to accept the data in satisfaction of this Order, EPA will provide written notification to the contact for the task force or consortium that this Order has been satisfied, which in turn will close out the Orders for each of the participants in the consortium/task force.
If you are unable to join a task force or consortium, you must provide EPA with 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 provide 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.
To the extent permitted by confidentiality requirements, the Agency has provided a list of the other pesticide registrants that have received an EDSP Order for this chemical. (Attachment A). This list 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 satisfy the requirements in this Order. The consequences of failing to comply with the Order are set forth in Section VIII of 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 EPA can evaluate the claim. The Agency intends to make a determination and respond to your request 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 the Order satisfied and will close out the Order. 
Option 5:  Voluntarily Cancel the Pesticide Registration(s) 
In place of submitting the data required in this Order, you may request the voluntary cancellation of your product(s) containing the pesticide active ingredient(s) that is the subject of this Order. If you wish to voluntarily cancel your product, you must submit a request for voluntary cancellation under FIFRA section 6(f). You must submit your request within 90 days of the issuance of this Order using the Agency's existing procedures for a voluntary cancellation (see 40 CFR 152.99). 
In response to your request to voluntary cancel your product(s) registrations, EPA will initiate the standard process for voluntary cancellation, which includes publication of a Federal Register notice announcing the proposed voluntary cancellation, as required by FIFRA section 6(f). The Agency has standard provisions for sale or use of existing stocks of a pesticide, but you may propose an alternative. If you propose alternative provisions for sale or use of existing stocks, EPA will review your proposal and respond in writing, prior to publication of the FIFRA section 6(f) notice. 
If you choose this option and cancel your registrations, the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients is the only response you are required to complete to satisfy this Order. When your product(s) is cancelled, the Agency will consider the Order satisfied and will close out the Order.
Option 6:  Reformulate the Product(s) to Exclude this Chemical from the Formulation 
In place of submitting the data required in this Order, you may submit an application to amend the formulation of your registered product by removing as an ingredient of your product the chemical that is the subject of this Order. Submitting such an application will initiate the existing procedures for reformulation. If you choose this option, the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients is the only response required to satisfy the Order as long as you complete the procedures and reformulate your product(s). When your product's formulation has been changed, the Agency will consider the Order satisfied and will close out the Order.
Option 7:  Claim a Formulators' Exemption
If you are a pesticide product registrant who purchases the chemical from another Order recipient for the chemical identified on the first page of this Order, and that Order recipient has agreed to generate the data, you may be eligible for a formulator's exemption. EPA will confirm claims of eligibility. A response asserting the formulator's exemption would no longer be considered an appropriate response to an Order if the supplier of the chemical fails to comply with the Order (i.e., it fails to submit the data either individually or jointly with other recipients, or it fails to comply with the terms of a compensation agreement or the binding decision of a neutral third party regarding the terms of compensation). If EPA confirms your eligibility for this option, the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients is the only response you are required to complete to satisfy this Order. If, however, EPA determines that you are not eligible, you must comply with the Order and the original deadline remains. 
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 for 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 explanation 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 EPA is considering your submission, the original deadline remains. If EPA does not grant your request, the original deadline remains. If your claim is verified, EPA will consider your response to be satisfaction of the Order and will close out this Order.
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 apportionment of costs is subject to negotiation between the participants. 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. 
EPA has not established specific coordination procedures by which you must collectively generate data. You may therefore determine the procedures that are best suited to your individual circumstances, and the most acceptable approach to identifying and sharing test costs.
At any time, if you are aware of another registrant of the chemical listed on the first page of this Order who is not listed on Attachment A or is new to the pesticide market, and you provide EPA with this information, EPA will send that registrant an Order for this chemical within 90 days of your notification.
IV.E.  Procedures for Data Protection
If (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 pesticide 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 exemption) 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 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 Order 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:  www.epa.gov/endo.
V.A.  Format for Submissions
EPA has developed standard data evaluation formats, referred to as Study Profile Templates (SPTs), and Data Entry Spreadsheet Templates (DESTs)  as well as Standard Evaluation Procedures (SEPs) to assist registrants with their submissions. These templates describe the layout and scope 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 2011-3, entitled, Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA, describes EPA's preferred method for organizing and formatting submittals of data supporting a pesticide registration. 
V.B.  Transmittal Documents
In Order for EPA to effectively track the compliance of each Order recipient, each submission in satisfaction of an Order issued under FFDCA section 408(p) must be accompanied by a transmittal document that includes the following information:
   * Identity of the submitter.
   * The date on which the submission package was prepared for transmittal to EPA.
   * The Order number identified on the first page 1 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 EPA. Instead, in your EDSP Tier 2 Testing, 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 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 study.
      * 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, full 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 publication.
   ii. Upon submission to 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 with 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 VI.  Submit a Progress Report
Unless EPA has notified you in writing that the requirements of this Order have been satisfied, you must submit a progress report to EPA 12 months after the issuance of this Order (the specific due date for you is identified 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 schedule for complying with the Order. See Section V for submission instructions.
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.  Consistent with 40 C.F.R §169.2(k), 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. Under FIFRA section 8, all producers of pesticides, devices, or active ingredients used in producing pesticides subject to FIFRA, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, are required to maintain certain records. As such, any recipients who are pesticide registrants or who otherwise submit their data in support of a pesticide registration will be held to the recordkeeping standards in 40 CFR part 169. These records shall be retained as long as the registration is valid and the producer is in business, and made available to EPA or its agent for inspection.
Section VIII.  Consequences of Failure to Comply with this Order
FFDCA section 408(p)(5)(C)(i) requires EPA to issue to any pesticide registrant that fails to comply with an Order issued under section 408(p) "a notice of intent to suspend the sale or distribution of the substance by the registrant." The proposed suspension "shall become final at the end of the 30-day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied" with the Order issued under section 408(p). [21 U.S.C. 346a(p)(5)(C)(i).] If a hearing is requested, the only matter for resolution at the hearing shall be whether the registrant has failed to comply with an Order issued under section 408(p)(5)(A). [21 U.S.C. 346a(p)(5)(C)(ii).]
Any suspension issued under FFDCA section 408(p)(5)(C)(ii), shall be terminated only upon the Administrator's determination that the registrant has complied fully with the terms of this Order. [21 U.S.C. 346a(p)(5)(C)(iii).]
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.
Section X.  Conclusion
Under the authority in FFDCA section 408(p) [21 U.S.C. 346a(p)], and FIFRA section 3(c)(2)(B) [7 U.S.C. 136a(c)(2)(B)], 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 Testing, Initial Response Form for Individual Order Recipients, 
                          EPA   Form No. ####-##
Attachment C  -  EDSP Tier 2 Testing, Initial Response Form for Consortium/Task Force, 
                          EPA Form No. ####-##-C