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

Page 1 of 16 SDWA/ FFDCA § 408(p) Order Template f o r SDWA Chemicals ( As of April 15 , 2013 )

NOTE: This te m plate was developed by EPA to provide guidance to E P A staff and

m anagers who will be prepa r ing t h e Tier 1 Or d ers th a t will be issued u n der the End o crine

Di s ru p tor Screening P rogram (EDSP), as well as for the recipients of the Orders. This

te m plate is not a rule or regulation, nor does it create or confer legal rights or impose any legally binding req uire m ents on EPA or any party. In prepar i ng a final Order, EPA m ay depart from the guidance presented in this te mplate where c i rcu m stances warrant and without prior notice. Orders will be gener a ted individ u ally for each c h e m ical and each ord e r

r e cipie n t. EPA will insert the infor m ation in blue type a n d brackets when the Order is generated.



### F I R S T C L A S S M A I L



### – R E T U R N 

### R E C E I P T 

### ®

Summary Information A bout 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 d ate of signature

. This serves as the issuance date. ] Due Date for Initial Response: [ Insert d ate, 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 f or 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 Ord er 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 A gency ).

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].Page 2 of 16 

### 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 conf idential business information (CBI) , we have provided each Order recipient with a list of the other recipients of an O rder for th is

chemical

. ( See Enclosure A ). EPA intends to announce the issuance of this Order and the availability of a list of all O rde r recipients for this chemical in the Federal Register

. The list of Order recipients for this chemical will be publicly available on the A gency 's W eb 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 O rder recipients for

this chemical on the Web site.

If you have previously c laimed your identi t y in relation to this chemical as CBI

, y ou will

notice , however, that your company is included on the list only as “Company X

. ” So that other

O rder 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 n ame of the agent (instead of the company) public by including it on the list of recipients of FFDCA section 408(p) O rders 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 p roduced 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 source s 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 whi ch 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 fromPage 3 of 16 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 a re Receiving t his Order

On (Month, Day) , 201 3

, EPA published a final list of the chemicals that may be found in sources of drinking water to undergo EDSP Tier 1 s creening ( XX FR XXXXX )

. The chemical identified on page 1 of this Order is included on th at 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, p ursuant to section 408(p)(3) of the FFDCA, you are subject to this Order

.



### Section III. Data Required b y t his Order

Th is 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 substan ces 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, u pon 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 f ollowing is a list of t he EDSP Tier 1 b attery that identifies the data you must submit

to the A gency in response to this Order:

Amphibian Metamorphosis (Frog)

- The Amphibian Metamorphosis assay involves the use of tadpoles to determine if chemicals affe ct 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. T he AR Binding assay identifies chemicals that affect the endocrine system by binding to hormone receptors to either mimic the action of thePage 4 of 16 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 chem ical 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 includin g (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 s pawns, 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 b ody'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.Page 5 of 16 

### 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 t he 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 ide ntifies 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 equivale nt 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 recipie nts that are completing the assays to generate new data to respond to this Order . All of the applicable test ing protocols have been validated and are available on the A gency ’s W eb site at: http://www.epa.gov/ocspp an d select “Test Methods and Guidelines

. ”

If you choose to generate the data to respond to this Order, y ou may not deviate from an approved testing protocol unless you first consult with the A gency and obtain A gency 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 scientificall y validated or the deviation is such that the final study is nonetheless properly considered to have been scientifically validated. If the A gency rejects your protocol you will be notified in EPA’s Central Data Exchange (CDX) System . Moreover, you shoul d 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 cogen t 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 relev ant information available to the A gency

. 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 t o follow certain practices whe n 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

pract ices 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.Page 6 of 16 

### 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 consideri ng the amount of time one might reasonably expect i s 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 (s ee 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 C ompleting 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 timefr ame provided. Order recipients may also submit data

before the due date.



### Section IV. Responding to t h e Order

You must respond to this O rder within the timeframes established pursuant to S ection

IV. A

. of this Order

, and the specific a pplicable dates as identified on page 1 of this Order . I f 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 p lan a ctivities necessary to respond to the order. (3) Submit an I nitial R esponse Form to EPA , identifying the response option y ou intend

to use. See S ection IV. B . of this Order

. (4) If you decide to generate the data, r ead and , if applicable, discuss the protocols. See

S ection III.B . of this Order

.Page 7 of 16 (5) Submit a Progress Report. See S ection V I . of this Order

. (6 ) Generate the data. ( 7 ) Compile and review the d ata for submission

. See S ection V . of this Order

. (8 ) Complete paperwork to assemble the submission package

. See S ection V . of this

Order

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

. See S ection V . of this Order

. (10 ) Maintain records

. See S ection VI I . of this Order

.



### IV

**. A.**  **Schedule f**  **or Responding t**  **o t**  **he Order** 

Your schedule for responding may vary based on the response option s discus sed in more

detail in the next S ection of this Order

. Please note that in calculating the due date for the Initial Response, the A gency has included an additional 10 calendar days to account for processing the final order package for delivery to the Post Office. Y our 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 15 0 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 Or der’s issuance Final Study Report and submission of the data to

EPA

In general, the A gency will not consider any requests for extending the deadlines for the Initial Response or Progress Report. However, the A gency will consider extending the final

rep ort due date when the circumstances warrant it. If you cannot submit the final report to the

A gency 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 th e A gency 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, y ou must explain any technical or laboratory d ifficulties and provide related documentation from the laboratory performing the testing. While EPA is considering your request, the original deadline remains. The A gency 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 th e request for extension is not made in a timely fashion or in accordance with the instructions provided in this Order. I n no event shall an extension request be considered if it is submitted at or after the lapse of the applicable deadline.Page 8 of 16 

### IV.B. Options **for Resp onding 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. o f

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 f ollow 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 A gency and / or OSRI ) , y our 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 stu dies are studies that predate issuance of this Order. In order to be accepted as satisfaction of the requirements imposed in this Order, the A gency expects that any such hazard

- related data would

be of high quality and achieves the objective of Tier 1 ass ays 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 b e based on the weight of evidence from all relevant information

available to the A gency

.

The submitted or cited study must have been conducted in accordance with accepted scientific methodology or protocol, including but not limited to those presented in EPA’s harmonized test guideline compendium (see http://www.epa.gov/ocspp and select “Test Methods

and Guidelines”). Deviations from the protocols validated for th e 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 A gency should consider in deciding whether to accept the data in satisfaction of this Order.

If EPA has previously reviewed a protocol for a study you are submitting or citing, you must identify any action taken b y the A gency on the protocol and must indicate the manner in

which all agency comments, concerns or issues were addressed in the final protocol and study.Page 9 of 16 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

A gency for any reason related to completeness or quality) or it must be a study which has not yet been reviewed by the A gency

. With respect to any studies for which you wi sh 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 A gency
, you must provide the A gency 's classification of t he 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 satisfie s the requirements of this

Order. The A gency will notify you of its determination. If the A gency 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 notif y 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 A gency determines that the study is not acceptable, the A gency will re quire you to comply with this Order, normally without an extension of the required due

date for submission of the data . The A gency may determine at any time that a study is not valid and needs to be repeated.

If you are citing a study of which you are not the original data submitter, you may need to submit an offer to pay compensation to the original data submitter. Consequently, you should simultaneously include an offer to pay [in accordance with 40 CFR152.9 3] [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 ac tion)], 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 d ata, 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 arrang ement 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 accompanyin g 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 wi ll provide notification to thePage 10 of 16 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 conso rtium, 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 th e 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 A gency 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 A gency has provided a list of the other manufacturers and/or importers, to the extent permi tted by confidentia lity requirements

, that have received an EDSP Order for this chemical

. (Enclosure A). This l ist is intended to help order recipients identify other companies with whom they could form agreements to develop data jointly , or otherwise collaborate on a respo nse to satisfy the requirements in this Order

.

Option 4: Claim Not Subject t o t he Order

You may claim that you are not subject to this O rder if y ou do not manufacture or import

the chemical or substance identified on page 1 of this Order or you believe the O rder 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 A gency 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

deadline s in this Order remain. If your claim is verified, EPA will consider your response to be

satisfaction of the Ord er 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 I nitial R esponse. 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 c lose out this Order.

Option 6: Recipient responds according to one of three other response

options

**.**Page 11 of 16 As part of the Initial Response, you may also ask EPA to reconsider some or all of the testing specified in th is 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 valid ate 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 c ontrol (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 A gency 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 wo uld 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**  **f or 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 su ch 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 t he 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 A gency a detailed explanation of the basis for your challenge that provides

sufficient information for the A gency to evaluate the issue. While EPA is considering your submission, the original deadline remains. The A gency intends to respond to your request with in

90 days of receipt . If EPA does not grant your request, the original deadline remains.Page 12 of 16 

### IV

**. D** 

**. Procedures**  **f or Cost Sharing** 

Cost sharing is the process by which two or more recipients of a n Order contribute to the generation of data (or the compensatio n 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 O rder for a particular substance to jointly submit data and share data genera tion 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 A gency ’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 O rder for this chemical within 90 da ys of your notification.



### IV

**. E** 

**. Procedures**  **f or Data Protection** 

All confidential business information submitted in response to a 408(p) O rder 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 an d 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 im proves the likelihood of a successful submission, since the information necessary for an efficient A gency review is outlined. Additional details about these templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/

.Page 13 of 16 In addition

, t he A gency requires O rder 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 sa tisfaction of an O rder 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.

• T he O rder 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 A gency , each submission must be in the form of

individual documents or studies. Do n ot 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 suff icient information to allow

the A gency 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 O rder 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 perform ed 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.Page 14 of 16 ii. Upon submission to EPA, each document must be acc ompanied 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 c omplete 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 mus t 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 a ccess the EDSP electronic reporting tool in CDX and related instructions , go to the

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

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

. 

### Section V I . 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 th is O rder (the specific due date for you is identified on page 1 of this Order)

. Your progress report sh ould provide a brief description of the status of your planned

acti vities for each assay, and, if applicable, a description of any problems encountered or expected difficulties in meeting the schedule for complying with the O rder. Please include the

transmittal document described in Se ction V. B

. of this Order

.



### Section V I I . Recordkeeping Requirements

You must re tain copies of the generation of the data and other information documenting your compliance with this Order

. T his includes all test reports submitted to the A gency
, 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 VI I I . Consequences o f Failure t o Comply w ith t his Order

Failure to comply with any of the requirements in this O rder 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 O rder 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),

citi ng 15 U.S.C. 2615]Page 15 of 16 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 p enalty 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 c ircumstances 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 1 448 [42 U.S.C. 300j

- 7(a)].

Section IX. 

### Additional Information

Additional information and details about the EDSP may be found on the A gency ’s Web

site a t 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 pe ople :

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: ____________

_________Page 16 of 16 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 f or this Chemical

Enclosure B

– EPA Form No. 6300

- 6: FFDCA §408(p) Order/SDWA §1457

- Initial Respons e 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)