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 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

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].

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

☐ 4. Reproduction and Fertility Effects1 (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. Environmental 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 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]. 

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 confidential 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 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 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 identity 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 Office 

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 14

 
FIFRA/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. 

2249.01, 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 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 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 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 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 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. 

Draft, June 25, 2015 Page 3 of 14
FIFRA/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 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 Effects2

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.

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 14

 
FIFRA/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 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,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 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 Effects1 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.

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 14

 
FIFRA/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 Section IV.A. of this 

Order, and the specific applicable dates as identified on page 1 of this Order. If you do not respond to 

this Order, or 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 activities:

(1) Read this Order. 

(2) Determine and plan activities necessary to respond to the order.

(3) Submit an Initial Response Form 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

Draft, June 25, 2015 Page 6 of 14
FIFRA/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 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 

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

guideline 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 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 Consortium/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 14

 
FIFRA/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 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 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 consortium

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 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 the 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.

If the task force or consortium fails to submit the data or meet the requirements of the Order in a timely 

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 commitment 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 permitted 

by confidentiality requirements 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.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 evaluate 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 will 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 14
FIFRA/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 know, 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 chemical 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 misleading 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 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 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 

apportionment 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 therefore determine the procedures that are best suited to your individual circumstances, 

and the most acceptable approach to identifying and sharing test costs.

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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

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 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 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: http://www.epa.gov/endo.

V.A. Format for Submissions

The EPA will develop standard data evaluation formats, referred to as Study Profile Templates (SPTs),

and Data Entry Spreadsheet Templates (DESTs) and Standard Evaluation Procedures (SEPs) to assist

registrants in 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,

5 describes the EPA's preferred method for organizing 

and formatting submittals of data supporting a pesticide registration. 

V.B. Transmittal Documents

In Order for the 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:

5 http://www.epa.gov/PR_Notices/pr2011-3.pdf

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FIFRA/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 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 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 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 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 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 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 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.

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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 ingredient 

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 of the requirements in this Order 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 Order shall (either 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 Order issued under FFDCA section 408(p)(5)(A), (2) the 

circumstances of the violation; (3) the extent and gravity of the violation(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 validity of this Order, 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.

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FIFRA/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 Testing, Initial Response Form for Individual Order Recipients, 

 EPA Form No. ####-##

Attachment C – EDSP Tier 2 Testing, Initial Response Form for Consortia/Task Forces, 

 EPA Form No. ####-##-C

Draft, June 25, 2015 Page 14 of 14