[EPA ICR NO. 2488.01; ATTACHMENT C(3)] April 15, 2013

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

(As of April 15, 2013)

NOTE: This template was developed by EPA to provide guidance to EPA staff and 

managers who will be preparing the Tier 1 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.

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). 

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]. 
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Introduction

This Order is issued pursuant to sections 408(p)(3) and (5) of the FFDCA [21 U.S.C. 

346a(p)(3), (5)] and section 1457 of the Safe Drinking Water Act [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 (CBI), 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 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, you will 

notice, however, 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. The Information Collection Request (ICR) document prepared by EPA is 

identified under EPA ICR No. 2249.02 and OMB Control No. 2070-0176. The public reporting 

burden for this collection of information is estimated to average 3403 hours per Order recipient, 

or 296,820 hours when annualized over 3 years. 

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)]. SDWA section 1457 authorizes EPA to require testing under the FFDCA section 

408(p) screening program of any substance that may be found in sources of drinking water based 

on a determination that a substantial population may be exposed to such substance. [42 U.S.C 

300j-17].

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 
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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

On (Month, Day), 2013, EPA published a final list of the chemicals that may be found in 

sources of drinking water to undergo EDSP Tier 1 screening (XX FR XXXXX). The chemical 

identified on page 1 of this Order is 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 section 408(p)(3) of the FFDCA, 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 the 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 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 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). OSRI 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 and select “Test Methods and Guidelines.” 

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 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 proposed 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 EPA’s 

Central Data Exchange (CDX) System . 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 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 (see 

http://www.epa.gov/ocspp and select “Test Methods and Guidelines” 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 described in 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; 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.
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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 the Order 

recipients 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 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.
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(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 the “opt-out” 

option is agreeing to cease all sale and distribution 

of the chemical.

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 final report to the 

Agency in the time frame required by this Order, you may seek additional time to meet the 

requirement. To do so, you must submit a request for an extension to the Agency using the 

electronic system identified in Unit V. of this Order. You will receive an acknowledgement or 

notice from the system to confirm the Agency’s receipt of your electronic request. Your request 

must occur before the applicable deadline and include: (1) a detailed description of the expected 

difficulty; and (2) a proposed 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 remains. The Agency will 

respond to your request through the electronic system. If EPA does not grant your request, the 

original deadline remains. Normally, extensions should 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 or in accordance with the instructions provided in this Order. In no event shall an 

extension request be considered if it is submitted at or after the lapse of the applicable deadline.
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IV.B. Options for Responding to the 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 Including which option you will 

use to fulfill the 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 transmittal 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 

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 Practice (GLP) rule (40 CFR part 792) 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

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 

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 and select “Test Methods

and Guidelines”). 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.

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.
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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 (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 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 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 CFR152.93] [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 Task Force or Offer to Join a 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 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 Initial Response 

Form for Consortium /Task Force (Enclosure 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 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 task force or 

consortium must follow the delivery instructions in Section V.D. of this Order to submit the 

consortium/taskforce’s initial response and accompanying information to EPA by the due date 

for the consortia response that is indicated on page 1 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 notification to the 
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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.

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. 

(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

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 

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

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: Recipient responds according to one of three other response 

options. 
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As part of the Initial Response, you may also ask EPA to reconsider some or all of the 

testing specified in this order if:

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

endocrine disruptor and that additional screening under the EDSP is unnecessary. 

(2) 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”).

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

the screening assays. In the last data collection, chemicals used by EPA as a “positive control” to 

validate one or more of the screening assays were only required to submit the assays for which 

the chemical did not serve as a positive control (e.g., if the chemical served as a positive control 

in the validation of two assays, the order recipient would not be required to generate additional 

data for those two assays). EPA generally expects that it would continue this policy. 

For more information on these response options, see the existing policies and procedures 

that were published in the Federal Register in April 2009 (74 FR 17560, Apr. 15, 2009) and the 

policies and procedures for the SWDA chemicals that were published in the Federal Register in 

Month 2013 (XX FR XXXXX, MO. DAY, 2013). 

The Agency intends to make a determination on any claim and respond to the recipient 

within 90 days of receipt. If EPA cannot verify the claim, the original requirements and 

deadlines in the order would remain. If EPA were to verify the claim, EPA would consider the 

response to fully satisfy the order and no further response would be required.

IV.C. 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 occur 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 within 

90 days of receipt. If EPA does not grant your request, the original deadline remains.
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IV.D. 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. 

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.

IV.E. 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 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. Submitting Data to the Agency

You must submit all correspondence related to this Order to EPA electronically using the 

CDX, the point of entry for electronic environmental submissions to the Agency, including your 

initial response from the consortium, any progress reports, the final report, supporting data, and 

other related information.

V.A. Format for Submissions

EPA has developed standard data evaluation formats or templates for 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/.
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In addition, the Agency requires Order recipients to submit completed study profiles,

supporting data, and all related correspondence requests electronically CDX, the point of entry 

on the Environmental Information Exchange Network (Exchange Network) for environmental 

submissions to the Agency.

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 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 Initial Response Form that you submit via CDX, 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.
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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.

iii. A statement of compliance or non-compliance with respect to GLP standards as 

required in 40 CFR part 792, as applicable. 

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

that is not in English.

V.D. Transmittal Instructions

All correspondence related to this Order must be transmitted to EPA electronically using 

CDX. In order to use CDX, you must first register with CDX. CDX registration enables EPA to 

authenticate user identities and verify user authorizations. To register in CDX, the CDX 

registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) 

would agree to the Terms and Conditions, provide information about the user and organization, 

select a user name and password, and follow the procedures outlined in the guidance document 

for CDX online, available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.

To access the EDSP electronic reporting tool in CDX and related instructions, go to the 

EPA EDSP Internet homepage at http://www.epa.gov/endo and follow the appropriate 

links, or go directly to CDX at https://cdx.epa.gov/.

Section VI. Submit a Progress Report

Unless EPA has notified you that the requirements of this Order have been satisfied, you 

must submit a progress report to EPA, using the provided electronic reporting tool, 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 of up to $37,500 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 $37,500 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]
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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. Challenges to 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 if the Administrator 

determines that a substantial population may be exposed to such substance”” must be made 

pursuant to SDWA section 1448 [42 U.S.C. 300j-7(a)]. 

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:

Paul Lewis, Branch Chief, CITB (7405M)

Environmental Protection Agency

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

telephone number: (202) 564–6738; fax number: (202) 564–4745

e-mail address: lewis.paul@epa.gov

Hannah Holsinger

Environmental Protection Agency

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

telephone number: (202) 564-0403; fax number: (202) 564-3767

e-mail address: holsinger.hannah@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: _____________________
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Signature: ________________________________________

Maria Doa, Director

Chemical Control Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

Enclosure:

Enclosure A – List of EDSP Order Recipients for this Chemical 

Enclosure B – EPA Form No. 6300-6: FFDCA §408(p) Order/SDWA §1457 - Initial Response 

Form for Individual Order Recipients (As of March 27, 2013)

Enclosure C – EPA Form No. 6300-6-C: FFDCA §408(p) Order/SDWA §1457 - Initial 

Response Form for Consortium (As of March 27, 2013)