[ E PA ICR N o . 2488.01; Attachment C(1) ] April 15, 2013

Page 1 of 16 FIFRA/ FFDCA § 408(p) Order Template f o r Pesticide Active Ingredients ( As of April 15 , 2013 )

NOTE: This te mplate 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 require 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 

### ®

S ummary Information A bout this Order and the Order Recipient:

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

Chemical Common Name: [ Insert chemical name.]

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

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 day s 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.]

EPA Contact : [ Insert name of the Chemical Review Manager (first name, last name).]

EPA Contact Phone Number: [ Insert Area Code, Phone No.]

EPA Contact E

- Mail Address : [ Insert Chemical Review Manager E

- Mail (first name, last name) ]

.

Dear Sir or Madam:

This Order requires you and other registrants of pesticide products containing the chemical named above to submit certain data or otherwise respond as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). This chemical is identified as a pesticide active ingredient. Pursuant to section 408(p)(3) of the Federal Food, Drug and Cosmetic ActPage 2 of 16 (FFDCA) , which mandates that all pesticide chemicals be tested under the Endocrine Disruptor Screening Program (EDSP) these data are necessary to m aintain the continued registration of your product(s) containing the listed pesticide active ingredient(s). [21 U.S.C. 346a (p)(3), (5)].

If you do not respond to this Order, or if you fail to otherwise comply with its requirements, then the registrat ion of product(s) subject to this Order will be subject to suspension, pursuant to FFDCA section 408 (p)(5)(C)(i) and section 3(c)(2)(B)(iv) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

.



### Introduction

This Order is issued pursuant to sections 408(p)(3) and (5) of FFDCA [21 U.S.C. 346a(p)(3) and (5)] and section 3(c)(2)(B) of FIFRA [7 U.S.C. 136a(c)(2)(B)]. FFDCA s ection 201(q)(1) defines “pesticide chemical” as “any substance that is a pesticide within the meaning

of the Federal In secticide, Fungicide, and Rodenticide Act

, including all active and inert ingredients of such pesticide” [21 U.S.C. 231(q)(1)].

To facilitate the formation of consortia to develop the data required by this Order , and to

the extent that the information is not protected as confidential business information (CBI) , we have provided each Order recipient with a list of the other recipients of an Or der for this chemical. (See Enclosure A). EPA intends to announce the issuance of this Order and the

availabili ty of a l ist of all Or der recipients for this chemical in the Federal Register . The list of Order recipients for this chemical will be publicly available on the Agency's W eb site, along with the status of the Orders, including recipients’ responses. EPA intends to update th is

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.

The in formation collection requirements described in this draft document are awaiting

approv al 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 prepare d 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 f or t his 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 effe ct in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate” [21 U.S.C. 346a(p)]. Section 408(p)(3) specifically requires that the Administrator “shall provide for the testing of all p esticide chemicals.” [21 U.S.C. 346a(p)(3)].

Section 201 of the FFDCA defines “pesticide chemical” as “any substance that is a pesticide within the meaning of [FIFRA], including all active and inert ingredients of such pesticide.” [21 U.S.C. 231(q)(1)]

.Page 3 of 16 Section 408(p)(5) of the FFDCA provides that the Administrator shall issue an o rder to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program, and submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation o f the information.

Section 3(c)(2)(B) of the FIFRA provides that registrants must submit additional data, upon notification that the Administrator has determined that additional data are required to maintain an existing pesticide registration. [7 U.S.C . 136a(c)(2)(B)]. In light of the directive in section 408(p)(3) that EPA is to provide for the endocrine screening of all pesticide chemicals, EPA considers that such data have been statutorily determined to be necessary to maintain an existing pesticide registration.



### Section II. Why You a re Receiving t his Order

On ( Month

, Day )

, 2013

, EPA published a final second list of the chemicals to undergo

EDSP Tier 1 s creening ( XX FR XXXXX ). The pesticide active ingredient identified on page 1

of this Order is include d on th at list, and you are receiving this Order because you are identified

as a registrant of a pesticide product that contains that ingredient . 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

This Order identifies the screening assays that will identify substances that have the potential to interact with the endocrine system. These screening assays are part of Tier 1 screening under the EDSP. The pu rpose 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

horm one 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 iss ue 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 endocri ne 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 effect s observed.Page 4 of 16 

### 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

natural hormone or block access of the hormone to t he 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 characte ristics, 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

- androgeni c 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 scr een 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

.Page 5 of 16 Steroidogenesis (Human Cell Line

– H295R)

- The Stero idogenesis 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 f or 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 immat ure female rats.



### 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 rele vant 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 thy roid 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 s ystem). 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 eff ect that could be due to effects on the estrogen, androgen or thyroid systems.

See also the discussion in Section IV. of this Order.

T he assays identified in Section III.A. of this Order must be conducted using the test protocols that have been validate d 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 W eb 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, y ou may not deviate from an approved testing protocol unless you first consult with the Agency and obtain Agency approval of any deviation. If you wish to use a protocol that differs from those identified in this Order, you must submit a detailed description of the proposed protocol (including a precise description of any deviations from the proto col attached to 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 th at the protocol has been scientifically validated or the deviation is such that the final study is nonetheless properly considered to have been scientifically validated. If the Agency rejects your proposed protocol you will be notified in EPA’s Central Da ta 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 “Test

Methods and Guidelines” at http://www.epa.gov/ocspp ), and provide a cogent and completePage 6 of 16 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 de scribed in 40 CFR part 16 0 , which require you to follow certain practices when conducting studies , an d when you submit data to EPA you must provide a GLP compliance statement indicating : a) that the data were generated using GLPs; b) describe in detail “all differences” between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study was conducted in accordanc e with the GLPs.



### III.C

**. Generating the Data** 

**– Applicable Timeframes** 

You are required to submit the data or otherwise satisfy the data requirements specified in

this Order and submit the data to EPA no later than 24 months from issuance of this Order (see page 1 of this Order). The Agency set this due date after considering the amount of time one might reasonably expect is needed to complete each assay, including the planning activities before beginning the test, actual performance of the test, analy zing test results, and completing the final study report for that assay (see Table 1) . EPA also added 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 fina l 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 submi t 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 applicable 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, then thePage 7 of 16 registration of the product(s) subject to this Order will be subject to suspension pursuant to FFDCA section 408 (p)(5)(C)(i) and FIFRA section 3(c)(2)(B)(iv)

.

To comply with this Order, you are expected to engage in the following activities:

(1) Read this Order. (2) Determine and p lan a ctivities necessary to respond to the O rder. (3) Submit an Initial Response Form to EPA, identifying the response opti on you 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

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

. (6 ) Generate the data. (7) Compile and review the data 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 VII . 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 discussed in more

detail in the next S ection of this Order

. Please note that in calculati ng the due date for the Initial Response, the Agency has included an additional 10 calendar days to ac count for processing the

final O rder 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.

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 b y 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, y ou must explain any technical orPage 8 of 16 laboratory difficulties and provide related documentation from the laboratory performi ng 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 b e 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 wit h 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.



### IV

**. B.**  **Options f**  **or Responding t**  **o t**  **he Order** 

You have several options for responding to this O rder. To report your commitment to act in response to th is O rder , 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 th e Initial Respon se Form for Individual Order Recipients (Enclosure B), which EPA has pre

- populate d with basic information about this Order, the

chemical and your contact information. Foll ow the transmittal instructions in S ection 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 160) 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 thi s 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 th e 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

o f 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 limi ted to those presented in EPA’sPage 9 of 16 harmonized test guideline compendium (see “Test Methods and Guidelines” at http://www.epa.gov/ocspp ). Deviations from the protocols validated for the Tier 1 assays, must be identified, along with an explanation for the dev iations, 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 decidin g 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 Age ncy comments, concerns or issues were addressed in the final protocol and study.

If you choose to cite a study that has been previously submitted to EPA, that study must have been previously classified by EPA as acceptable (i.e., the study was not reject ed 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 pag e 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 E PA for another purpose.

EPA will review any existing study submitted or cited in response to this Order to determine whether the study is acceptable and whether the study satisfies the requirements of this Order. The Agency will notify you in writing o f its determination. If the Agency determines that the study is acceptable, the Initial Response Form is the only response you are required to complete to satisfy this Order and EPA will notify you in writing that the Order is satisfied . If, however, EPA determines that the study is not acceptable, you must still satisfy the requirements of this Order. You should be aware that if the Agency determines that the study is not acceptable, the Agency will require you to comply with this Order, normally withou t 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

su bmit 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 cos ts 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 taskPage 10 of 16 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 o r 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 foll ow the delivery instructions in S ection V.D. of this Order to submit th e consortium/task force’s initial response and accompanying information to EPA by the due date for the consortia response that is indicated on page 1 o f 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

contact for the task force or consortium that this Order has b een 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 include s 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 $25,000 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 j ointly submit the data, each Order recipient is still subject to penalties of up to $25,000 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 othe r requirements set forth in this Order.

The Agency has provided a list of the other manufacturers and/or importers, to the extent permi tted by confidentiality requirements that have received an EDSP Order for this chemical

. (Enclosure A). This l ist is i ntended to help O rder 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 t o t he Order

You may c laim th at you are not subject to this O rder if you do not manufacture or import the chemical 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 Agency intends to make a determination and respond to your request within 90 days of receipt. If EPA can not verify your claim, the origi nal 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.Page 11 of 16 Option 5: Voluntarily Cancel the Pesticide Registration(s)

In place of submitting the data required in this Order, you may request the voluntary cancellation of your product(s) containing the pesticide active ingredient(s) that is the subject of this Order. If you wish to voluntarily cancel your product, you must submit a request for voluntary cancellation under FIFRA section 6(f )

. You must submit your request within 90 days of the issuance of this Order using the Agency’s existing procedures for a voluntary cancellation (see 40 CFR 152.99).

In response to yo ur request to voluntary cancel your product(s) registrations , EPA will initiate the standard process for voluntary cancellation, which includ es publication of a Federal Register notice announcing the proposed voluntary cancellation, as required by FIFRA se ction 6(f). The Agency has standard provisions for sale or use of existing stocks of a pesticide, but you may propose an alternative. If you propose alternative provisions for sale or use of existing stocks, EPA will review your proposal and respond, pri or to publication of the FIFRA section 6(f) notice.

If you choose this option and cancel your registrations, the Initial Response Form is the only response you are required to complete to satisfy this Order. When the product's pesticide registration(s ) is cancelled, the Agency will notify you that you have satisfied the Order

.

Option 6 : Reformulate the P roduct(s) to E xclude this C hemical from the

F ormulation

In place of submitting the data required in this Order, you may submit an application to amend the formulation of your registered product by removing as an ingredient of your product the chemical that is the subject of this Order. Submitting such an application will initiate the existing procedures for reform ulation. If you choose this option, the Initial Response Form is the only response required to satisfy the Order as long as you complete the procedures and reformulate your product(s). When you product's formulation has been changed, the Agency

will noti fy you that you have satisfied the Order

.

Option 7: C laim a **Formulators’ Exemption**

If you are a product registrant who purchases the chemical from another Order recipient for the chemical identified on page 1 of this Order, and that Order recipient has agreed to generate the data, you may be eligible for a formulator's exemption. EPA will confirm claims of eligibility. A response asserting the formulator's exemption would no longer be considered an appropriate response to a n O rder if the supplier o f the chemical fails to comply with the O rder (i.e., it fails to submit the data either individually or jointly with other recipients or it fails to comply with the terms of a compensation agreement or the binding decision of a neutral third party regardin g the terms of compensation). If EPA confirms your eligibility for this option, the Initial Response Form is the only response you are required to complete to satisfy this Order. If, however, EPA determines that you are not eligible, you must comply with the Order and the original deadline remains.

Option 8 : Other Response OptionsPage 12 of 16 As part of your Initial Response, you may also ask EPA to reconsider some or all of the testing specified in this Order if:

a) You can demonstrate (supported by appropriate data ) that the chemical is an endocrine disruptor an d that additional screening or testing under the EDSP is

unnecessary.

b) You can demonstrate (supported by appropriate data) that the chemical meets the standard for an exemption under FFDCA section 408(p)(4) ( i.e., “that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen”).

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

. EPA will only accept th ese data in satisfaction of that part of

the O rder related to those assays for which the chemical was used to complete the testing as part of the validation effort.

The Agency intends to make a determination on your claim and respond to you 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 respo nse to be satisfaction of the

Order and will close out this Order.



### IV. **C . Procedures for Challenging this Order** 

If you wish to challenge the validity of any of the provisions of this Order, including the requirement to conduct any test or use the specific test protocols required by this Order, you must submit to the Agency a detailed explanation of the basis for you r 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 gran t your request, the original deadline remains.



### IV

**. D** 

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

Cost sharing is the process by which two or more recipients of a n EDSP O rder contribute to the generation of data (or the compensation for existing data). Contributions ma y be in cash or in kind and apportionment of costs is subject to negotiation between the participants . EPA encourages all recipients of an Order for a particular substance to jointly submit data and share data generation costs. All other parties who are also subject to this Order are listed in Enclosure

A , unless that information is protected as CBI , and will be made publicly available on the Agency’s Web site

.

EPA has not established specific coordination procedures by which you must collectively

gene rate data. You may therefore determine the procedures that are best suited to your individual circumstances, and the most acceptable approach to identifying and sharing test costs.

If you are aware of another manufacturer of the chemical listed on page 1 of this Order

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

to send that manufacturer an O rder for this chemical within 90 days of your notification.Page 13 of 16 

### IV

**. E** 

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

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 obt ained from a person and is privileged or confidential” [5 U.S.C. 552]. Any information that you wish to have EPA protect as CBI should be clearly identified as such. Note that substantive criteria must be met to support a claim for CBI , as specified in 40 CFR 2.208.



### Section V

. Procedures f or Submitting Data t o t he Agency

You must submit all correspondence related to this Order to EPA electronically using CDX, the point of entry for electronic environmental submissions to the Agency, including your

ini tial response, the 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 writing its d ata evaluation records (DERs) of studies submitted under FIFRA and FFDCA to EPA. 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 o f the templates improves 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/

.

In addition, Pesticide Registration (PR) Notice 2011

- 3 Standard Format for Data

Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)

. This PR Notice discusses both the recommended and the required procedures for submitting FIFRA and FFDCA data http://www.epa.gov/PR_Notices/pr2011

- 3.pdf

.

The Agency requires O rder Recipients to submit completed study profiles, supporting

data , and all related correspondence request electronically using CDX, the point of entry on the Environmental Information Exchange Network (Exchange Network) for environmental submissions to the Agency.



### V.B. Tran **smittal Document s** 

In order for EPA to effectivel y track the compliance of each O rder recipient, each

submission in satisfaction 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.Page 14 of 16 • T he Order number identified on page 1 of this Order

.

• A list of the individual documents included in the submission.



### V.C. Submitti **ng 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 n ot resubmit any documents that you previously submitted to EPA. Instead, in your Initial R esponse Form that you submit via CD X , 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 mus t 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 addre ssed.

• 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 ano ther 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, inclusiv e page numbers, and date of publication.

ii. Upon submission to EPA, each document must be accompanied by a signed and dated document containing the appropriate statement(s) regarding any data confidentiality claims as

described in PR

- Notice 2011

- 3

.

iii . A statement of compliance or non

- compliance with respect to GLP standards as required in 40 CFR part 160, as applicable.

iv. A complete and accurate English translation must be included for any information that is not in English.



### V. D. **Transmittal Instructions** 

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 toPage 15 of 16 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 pro cedures 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 th is O rder (the specific due date for you is ide ntified on page 1 of this Order)

. Your progress report sh ould 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 s chedu le for complying with the O rder. Please include the

tra nsmittal document described in S ection V.B . of this Order

. 

### Section V II. Recordkeeping Requirements

You must retain 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 Agency in support of a registration or in support of a tolerance petition, all underlyi ng raw data, and interpretations and evaluations thereof. Consistent with 40 C.F.R 169.2(k), this includes all test reports submitted to the Agency in support of a registration or in support of a tolerance petition,

all underlying raw data, and interpreta tions and evaluations thereof. Under FIFRA section 8, all producers of pesticides, devices, or active ingredients used in producing pesticides subject to FIFRA, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, are required to maintain certain records. As such, any recipients who are pesticide registrants or who otherwise submit their data in support of a pesticide registration will be held to the recordkeepi ng standards in 40 CFR part

169. These records shall be retained as long as the registration is valid and the producer is in business, and made available to EPA or its agent for inspection.



### Section V II I. Consequences of Failure t o Comply w ith t his Order

FFDCA section 408(p)(5)(C)(i) requires EPA to issue to any registr ant that fails to comply with an O rder issued under section 408(p) “a notice of intent to suspend the sale or distribution of the substance by the registrant.” The proposed suspension “s hall become final at

the end of the 30

- day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing

or the Administrator determines tha t the registrant has complied” with the O rder issued under section 408(p)

. [21 U.S.C. 346a(p)(5)(C)(i)]. If a hearing is requested, the only matter for resolution at the hearing shall be whether the registran t has failed to comply with an O rder issued

un der section 408(p)(5)(A). [21 U.S.C. 346a(p)(5)(C)(ii)].Page 16 of 16 Any suspension issued under FFDCA section 408(p)(5)(C)(ii), shall be terminated only upon the Administrator’s determination that the registrant has complied fully with the terms of

th is O rder. [21 U.S.C. 346a(p)(5)(C)(iii)].



### Section IX. Additional Information

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

site a t http://www.epa.gov/endo

.

If you have any questions about the requirements and procedures established in this Order, please contact your EPA Chemical Review Manager as identified on page 1 of this order

or go to http://www.epa.gov/endo

.



### Secti on X. Conclusion

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

, and FIFRA section 3(c)(2)(B) [7 U.S.C. 136a(c)(2)(B)], the U

. S

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

.

Date:

_____________________

Signature: ________________________________________ Richard P. Keigwin, Jr.

, Director

Pesticide Re

- e valuation Division, Office of Pesticide Programs Office of Chemical Safety and Pollution Prevention

U.S. Environmental Protection Agency

Enclosures

Enclosure A

– List of EDSP Order Recipients for this Chemical

Enclosure B

– EPA Form 6300

- 05: FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- in (DCI)

- Initial Response Form for Individual Order Recipients (As of March 27

, 2013)

Enclosure C

– EPA Form 6300

- 05

- C: FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- in (DCI)

- Initial Response Form for Consortium /Task Force (As of March 27

, 2013)