FFDCA §408(p) Order Template for Manufacturers/Importers of SDWA Chemicals

Draft - September 22, 2010

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FIRST CLASS MAIL – RETURN RECEIPT®

Summary Information About this Order and the Order Recipient:

Order #: [Insert sequential number as assigned by the system.]

Chemical Common Name: [Insert chemical name.]

CAS #: [Insert number assigned to identify the chemical named above.]

Date Issued: [Insert date of signature. This serves as 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 mailing (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.]

Due Date for Final Submission: [Insert date, calculated as 24 months from issuance].

Company Name: [Insert name.]

Company #(s): [Insert number assigned to identify the company in the system.]

Address: [Insert address where Order will be directed to.]

Contact Person: [Insert the name of the contact person.]

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 a substance that may be 

found in sources of drinking water and to which EPA has determined that a substantial 

population may be exposed. 

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 FFDCA [21 U.S.C. 

346a(p)(3), (5)] based on an EPA determination under section 1457 of the Safe Drinking Water 

Act (SDWA) [42 U.S.C. 300j-17]. 

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 Enclosure A). EPA intends to announce the issuance of this Order and the availability of a 
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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 website, 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 check 

on the status of responses from the other Order recipients for this chemical on the website at 

www.epa.gov/endo. 

If you have previously claimed your identity in relation to this chemical as confidential 

business information (CBI), you will notice that your company is included on the list only as 

“Company X.” 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 so that other Order recipients can identify and contact you to 

collaborate on responding 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

EDSP orders. 

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. 2249.01, and OMB Control No. 2070-0176. The public reporting 

burden for this collection of information is estimated to average ____ hours per Order recipient, 

or ____ hours when annualized over 3 years. Your feedback on this estimate will help facilitate 

the Agency’s review of the assumptions and estimates before renewal of the OMB approval for 

this ICR is sought. Completing the enclosed questionnaire is optional, and the responses 

provided will only be considered in the Agency’s review of the burden estimates when 

developing the renewal request for this ICR. See Enclosure D.

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 1457 of SDWA authorizes EPA to “provide for testing under the screening 

program authorized by section...[408(p)] in accordance with the provisions of section... [408(p)] 

of Title 21, of any other substance that may be found in sources of drinking water... if a 

substantial population may be exposed to such substance.” [42 USC § 300j-17.] 

Section 408(p)(5) of 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. 
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Section II. Why You are Receiving this Order

On April 15, 2009 and ____ __, 2010, EPA published finalized lists of the chemicals to 

undergo EDSP Tier 1 screening ((74 FR 17560 and __ FR ____), including chemicals that may

be found in sources of drinking water (i.e., a SDWA chemical). The chemical identified on page 

1 of this Order is a SDWA chemical included on that list. You are receiving this Order because 

you are identified as a manufacturer and/or importer of the chemical identified on page 1 of this 

Order. As such, pursuant to FFDCA section 408(p)(3) and SDWA section 1457, you are subject 

to this Order. 

Section III. Data Required by this Order

This Order identifies the screening assays that will identify substances that have the 

potential to interact with the endocrine system. These screening assays are part of Tier 1 

screening under the EDSP. The purpose of Tier 1 screening (also referred to as “screening”) is 

to identify substances that have the potential to interact with the estrogen, androgen, or thyroid 

hormone systems using a battery of assays. The fact that a substance may interact with a 

hormone system, however, does not mean that when the substance is used, it will cause adverse 

effects in humans or ecological systems. 

Although this Order only identifies the Tier 1 screening assays, upon examining the 

screening data submitted, EPA may issue a subsequent Order to require additional testing of this 

chemical under Tier 2 of the EDSP to:

 Determine whether a substance may cause endocrine-mediated effects through or involving 

estrogen, androgen, or thyroid hormone systems, or such other endocrine effect as the 

Administrator may designate;

 Determine the consequences to the organism of the activities observed in screening assays; 

and

 Establish the relationship between doses of an endocrine-active substance administered in 

the test and the effects observed. 

III.A. Data Required – The Tier 1 Battery

The following is a list of the EDSP Tier 1 Battery that identifies the data you must submit 

to the Agency in response to this Order: 

Amphibian Metamorphosis (Frog) - The Amphibian Metamorphosis assay involves the use of 

tadpoles to determine if chemicals affect the hypothalamic-pituitary-thyroid (HPT) axis during 

metamorphosis and consequently result in developmental effects.

Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is involved in the 

development of male sexual characteristics. The AR Binding assay identifies chemicals that 

affect the endocrine system by binding to hormone receptors to either mimic the action of the 
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natural hormone or block access of the hormone to the site and thus block hormone controlled 

activity.

Aromatase (Human Recombinant) - Aromatase is an enzyme complex responsible for estrogen 

biosynthesis that converts androgens into estrogens, estradiol, and estrone. The Aromatase in 

vitro assay focuses on this portion of the steroidogenic pathway to detect substances that inhibit 

aromatase activity.

Estrogen Receptor Binding - The estrogen receptor (ER) is involved in female maturation and 

reproductive function. The ER Binding assay measures the ability of a chemical to bind to the 

estrogen receptor.

Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) - The estrogen 

receptor (ER) is involved in female maturation and reproductive function. The ER 

Transcriptional Activation is a cell-based assay that measures the ability of a chemical to bind to 

the ER and activate transcription resulting in the synthesis of the enzyme luciferase.

Fish Short-term Reproduction - The Fish Short-term Reproduction assay screens for disturbances 

in the hypothalamic-pituitary-gonadal (HPG) axis including (anti-)estrogenic, (anti-)androgenic, 

aromatase inhibition, and steroid modulating effects. The assay examines abnormalities 

associated with survival, reproductive behavior, secondary sex characteristics, histopathology, 

and fecundity (i.e., number of spawns, number of eggs/spawn, fertility, and development of 

offspring) of fish exposed to test chemicals.

Hershberger (Rat) - The Hershberger assay is designed to detect androgenic and anti-androgenic 

effects. In this in vivo assay, the weight of several androgen-dependent tissues, including 

accessory sex glands, are measured in castrated or immature male rats.

Female Pubertal (Rat) - The Pubertal Female assay involves the use of rats to screen for 

estrogenic and thyroid activity in females during sexual maturation. This assay examines 

abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.

Male Pubertal (Rat) - The Pubertal Male assay involves the use of rats to screen for androgenic, 

anti-androgenic, and thyroid activity in males during sexual maturation. This assay examines 

abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.

Steroidogenesis (Human Cell Line – H295R) - The Steroidogenesis in vitro assay detects 

interference with the body's production of male and female steroid sex hormones. This assay is a 

cell-based assay using the H295R human adrenocortical carcinoma cell line which can detect 

inducers of enzymes responsible for steroid synthesis as well as chemicals that inhibit it.

Uterotrophic (Rat) - The Uterotrophic assay involves the use of female rats to screen for 

estrogenic effects. In this in vivo assay, uterine weight changes are measured in ovariectomised 

or immature female rats.
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III.B. Conducting the Battery - Testing Protocols

Pursuant to FFDCA section 408(p)(1), 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” is information that informs the determination as to 

whether the substance may have an effect that is similar to an effect produced by a substance that 

interacts with the estrogen, androgen, and/or thyroid hormonal systems (e.g., information that 

identifies substances as having the potential to interact with the estrogen, androgen, and/or 

thyroid system(s); information demonstrating whether substances have an effect on the 

functioning of the endocrine system). Other scientifically relevant information may either be 

functionally equivalent to information obtained from the Tier 1 assays—that is, data from assays 

that perform the same function as EDSP Tier 1 assays—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 assays identified in Section III.A. of this Order must be conducted using the test 

protocols that have been validated and made available for use by the Order recipients that are 

completing the assays to generate new data to respond to this Order. All of the applicable testing

protocols have been validated and are available on the Agency’s Web site at: 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series890.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 planned deviation. If you wish to use a protocol that differs from those identified in 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 for 

wishing to use it. Because FFDCA section 408(p)(1) requires that the screening be conducted 

with validated tests, in order for EPA to approve the use of your proposed alternate protocol, you 

must demonstrate that the alternate 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 alternate protocol you will be notified in writing. Moreover, you 

should be aware that rejection of a proposed alternate 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 scientifically relevant 

information, 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 (see http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm), 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 1 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. Good Practices 

have been set out both in FIFRA for pesticides in 40 CFR 160 and for TSCA chemicals in 40 

CFR 792. Test order recipients would need to follow appropriate GLPs, including protocol 

requirements and procedures for submitting the data described in this Order. When you submit 

data to EPA you must provide a GLP compliance statement indicating a) that the data were 
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generated using GLPs; or 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 no later than 24 months from issuance of this Order (see 

page 1 of this Order). The Agency set this due date after considering the amount of time one 

might reasonably expect is needed to complete each assay, including the planning activities 

before beginning the test, actual performance of the test, analyzing test results, and completing 

the final study report for that assay (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 you to 

prepare the final report for submission to EPA. 

Table 1 – Estimated Timeframes for Completing the Individual Assay Reports

Assay Timeframes

Amphibian Metamorphosis (Frog) 15 months

Androgen Receptor Binding (Rat Prostate) 6 months

Aromatase (Human Recombinant) 6 months

Estrogen Receptor Binding 6 months

Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) 6 months

Fish Short-term Reproduction 12 months

Hershberger (Rat) 9 months

Female Pubertal (Rat) 15 months

Male Pubertal (Rat) 15 months

Steroidogenesis (Human Cell Line – H295R) 6 months

Uterotrophic (Rat) 9 months

There is no set sequence for completing these assays, and the due date for submitting the 

final report to EPA provides you with ample flexibility to join forces and complete this battery

within the timeframe provided. You 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.
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(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 

final order package for delivery to the Post Office. Your basic schedule is summarized on page 1 

of this Order and is based on the timeframes identified in Table 2:

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 & 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.

On or before 6 (six) months of the Order’s 

issuance

A Manufacturer/Importer that chooses to cease all 

manufacture and import of the chemical has agreed 

to do so.

24 months from Order’s issuance 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 the circumstances warrant it. If you cannot submit the data/reports to the 

Agency in the time frame required by this Order and intend to seek additional time to meet the 

requirement, you must submit a written request to the Agency before the applicable deadline. 

Your written request must include: (1) a detailed description of the expected difficulty and (2) 

proposed schedule including alternative dates for meeting such requirements on a step-by-step 

basis. You must explain any technical or laboratory difficulties and provide documentation from 

the laboratory performing the testing. While EPA is considering your request, the original 

deadline remains. The Agency will respond to your request in writing; extensions can only be 

granted in writing. If EPA does not grant your request, the original deadline remains. Normally, 

extensions can be requested only in cases of extraordinary testing problems beyond the 

expectation or control of the registrant, manufacturer, or importer. Extensions will not be 

considered if the request for extension is not made in a timely fashion; in no event shall an 

extension request be considered if it is submitted at or after the lapse of the subject deadline.
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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. 

Please complete the Initial Response Form for Individual Order Recipients

(Enclosure B), which EPA has pre-populated with basic information about this Order, the 

chemical and your contact information. Follow the mailing instructions in Section V.D. of this 

Order to submit this form to EPA by the due date for the initial response that is indicated on page 

1 of this Order.

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 (corresponds to 2.1.A. in the Initial Response Form)

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 GLP and the tests must be conducted according to protocol requirements

identified in Section III.B. of this Order. In submitting the data, you must follow the procedures 

described in Section V. of this Order.

Option 2: Submit or Cite Existing Data (corresponds to 2.1.B., 2.1.C., and 2.2.

in the Initial Response Form)

If you choose to submit or cite an existing study in response to this Order (including data 

previously submitted to the Agency and/or other scientifically relevant information), your Initial 

Response must include either the 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 as 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 1 assays to 

provide reasonable assurance that a chemical does or does not have the potential to interact with 

the estrogen, androgen, or thyroid systems. EPA’s decisions about whether the data cited or 

submitted satisfies part or all of the Tier 1 Order will be based on the weight of evidence from 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 (see

http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm). Deviations from the protocols validated 

for the Tier 1 assays, 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.
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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, 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 Initial Response Form 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 [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 or Offer to Join a Consortium (corresponds to 

2.1.D. in the Initial Response Form)

If you choose to form a consortium to share in the cost of producing the required data, all 

participants of the consortium must submit their own 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 consortium must complete the Initial Response Form for 

Consortium (Enclosure C) to provide the primary contact for the consortium, the list of 

participants, and an indication of the consortium’s planned response for each assay, 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 consortium must follow the mailing instructions in 

Section V.D. of this Order to submit the consortium initial response and accompanying 

information to EPA by the due date for the consortia response that is indicated on page 1 of this 

Order.
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Once the 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 

consortium that this Order has been satisfied, which in turn will close out the Orders for each of 

the participants in the consortium.

If you are unable to join a 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.

If the 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, 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, 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. 

(Enclosure 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 (corresponds to 2.3. in the Initial 

Response Form)

You may claim that you are not subject to this Order if you do not manufacture or import 

the chemical or substance identified on page 1 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 can not 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.

Option 5: Discontinue the Manufacture or Import of the Chemical

(corresponds to 2.4. in the Initial Response Form)

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 can not 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.

Option 6: Other Response Options
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As part of your Initial Response, you may also ask EPA to reconsider some or all of the 

testing specified in this Order if:

a) You can demonstrate (supported by appropriate data) that the chemical is an 

endocrine disruptor and that additional Tier 1screening under the EDSP is

unnecessary. 

b) You can demonstrate (supported by appropriate data) that the chemical meets the 

standard for an exemption under FFDCA section 408(p)(4) (i.e., “that the substance 

is not anticipated to produce any effect in humans similar to an effect produced by a 

naturally occurring estrogen”).

c) Your chemical was used by EPA as a ‘‘positive control’’ to validate one or more of 

the screening assays. EPA will only accept these data in satisfaction of that part of 

the Order related to those assays for which the chemical was used to complete the 

testing as part of the validation effort.

The Agency intends to make a determination on your claim and respond to you in writing 

within 90 days of receipt. If EPA can not 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.D. Procedures for Challenging this Order

If you wish to challenge the validity of the factual predicate for issuance of the Order, 

specifically the EPA determination that the chemical or substance for which testing is required 

by this Order is a “substance that may be found in sources of drinking water” and/or that “a 

substantial population may be exposed to such substance,” you may do so under SDWA section 

1448 [42 U.S.C. 300j-7(a)] by filing a petition for review in the United States Court of Appeals 

for the circuit in which you reside or transact business within 45 days of the date that begins 10 

days after the date of this Order.

If you wish to challenge the validity of any other 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. While EPA is considering your 

submission, the original deadline remains. The Agency intends to respond to your request in 

writing within 90 days of receipt. If EPA does not grant your request, the original deadline 

remains.

IV.E. Procedures for Cost Sharing

Cost sharing is the process by which two or more recipients of an 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 confidential business information, and will be made 

publicly available on the Agency’s Web site. 
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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 costs.

If you are aware of another manufacturer or importer of the chemical listed on page 1 of 

this Order who is not listed on Enclosure A, and you provide EPA with this information, EPA 

intends to send that manufacturer or importer an Order for this chemical within 90 days of your 

notification. Note that EPA does not intend to send test orders to manufacturers or importers who 

meet the de minimis criteria discussed in the EDSP Revised Policies and Procedures for 

Screening SDWA Chemicals (XX FR XXXXX).

IV.F. Procedures for Data Protection

All confidential business information submitted in response to a 408(p) Order 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 confidential business information should be clearly identified as such. Note that 

substantive criteria must be met to support a claim confidentiality of business information, as 

specified in 40 CFR §2.208.

Section V. Submitting Data to the Agency

V.A. Format for Submissions

Note: The format for this orders is under development, but is expected to be similar in 

concept to the format used for the FIFRA/FFDCA orders. The following language is specific to 

those FIFRA/FFDCA orders and is retained as an example of the expected language for a 

SDWA/FFDCA order.

EPA has developed standard data evaluation formats or templates for writing its data 

evaluation records (DERs) of studies submitted under FIFRA and FFDCA to EPA that may be 

used to respond under this order. 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. Additional details about these 

templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/.

In addition, Pesticide Registration (PR) Notice 86–5, entitled Standard Format for Data 

Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain 

Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), describes EPA’s preferred 

method for organizing and formatting submittals of data supporting a pesticide registration 

(http://www.epa.gov/PR_Notices/pr86-5.html). 
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The Agency also encourages Order recipients to submit completed study profiles and 

supporting data in an electronic format (PDF) whether submitting one or several studies

V.B. Transmittal Documents

In order for EPA to effectively track the compliance of each order recipient, each 

submission in satisfaction of this Order 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 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, as part of your Initial Response Form, 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 page 1 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.
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iii. A statement of compliance or non-compliance with respect to GLP standards as 

applicable. 

iv. A complete and accurate English translation must be included for any information 

that is not in English.

V.D. Mailing Instructions

Your response to this Order and all related correspondence must be mailed or delivered to 

EPA using one of the following methods: 

Mail To: Document Control Office (7407M), Office of Pollution Prevention and Toxics 

(OPPT), U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460

Deliver To: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, U.S. EPA, 

1200 Pennsylvania Ave. NW, Washington, D.C. 20460-0001. [Deliveries are only accepted 

from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.]

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 page 1 of this Order). Your progress report should 

provide a brief description of the status of your planned activities for each assay, and, if 

applicable, a description of any problems encountered or expected difficulties in meeting the 

schedule for complying with the Order. Please include the transmittal document described in

Section V.B of this Order. 

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, all

underlying raw data, and interpretations and evaluations thereof. These records shall be retained 

as long as the chemical is produced 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. 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 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 
Page 15 of 16

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 one of the following EPA people:

Susan Sharkey

Environmental Protection Agency

1200 Pennsylvania Ave., NW, Washington, DC 20460–0001

telephone number: (202) 564–4775; fax number: (202) 564–8789

e-mail address: ssharkey.susan@epa.gov

William Wooge 

Environmental Protection Agency

1200 Pennsylvania Ave., NW, Washington, DC 20460–0001

telephone number: (202) 564-8476; fax number: (202) 564-8482

e-mail address: wooge.william@epa.gov

Section X. Conclusion

Under the authority in FFDCA section 408(p) [21 U.S.C. 346a(p)], the United States 

Environmental Protection Agency hereby issues this Order to take effect on the date of my 

signature.

Date: _____________________

Signature: ________________________________________

Jim Willis, Director

Chemical Control Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

Enclosures
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Enclosure A – List of EDSP Order Recipients for this Chemical 

Enclosure B – The Initial Response Form for Individual Responders

Enclosure C – The Initial Response Form for Consortium

Enclosure D – Optional Questionnaire: Level of Effort for Recipients of Tier 1 Screening Orders