[ EPA ICR N o . 2488.01; Attachment C(2) ] April 15, 2013

Page 1 of 16 FIFRA/ FFDCA § 408(p) Order Template f o r Pesticide Inert Ingredients ( 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 lega lly 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 

### ®

Summary Information about this Order and the Order Recipient:

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

Chemical Common Name: [Insert chemical name.]

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

Date Issued: [Insert date of signature. This serves as the issuance date.] Due Date for Initial Response: [Ins ert date, calculated as 90 calendar days from issuance plus 10 calendar days for final processing and mailing (i.e., total 100 calendar days from issuance). ]

Due Date for Consortia Documentation: [Insert date, calculated as 150 calendar days from

issuance plus 10 calendar days for final processing and mailing (i.e., total 160 calendar days from issuance) .] Due Date for Progress Report: [Insert date, calculated as 12 months from issuance.]

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

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

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

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

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 manufacturers and importers of the chemical named above to submit certain data or otherwise respond as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). This chemical is identified as an “other ingredient” in a pesticide product(s) (also referred to as an inert ingredient). These data are required by sectionPage 2 of 16 408(p)(3) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), which mandates that all pesticide chemicals, including inert ingredients, b e tested under the Endocrine Disruptor Screening Program (EDSP). [21 U.S.C. 346a (p)(3),(5)].

If you do not respond to this Order, or if you fail to otherwise comply with its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].



### Introduction

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

i s a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 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 required data, 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 orders for this chemical. (See Enclosure A). EPA intends to publish t h e list of all order recipients in the Federal Register and will then post the list on the Agency's W eb site, along with the status of the Orders, including recipients’ responses. EPA intends to update the list with subsequent publication(s) and posting(s) as appropriate. You are encouraged to join a consortium and can check on the status of responses from the other order recipients for this chemical on the Web site.

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 pub lic reporting burden for this collection of information is estimated to average 3403 hours per order recipient,

or 296,820 hours when annualize over 3 years.



### Section I. The Authority for this Order

FFDCA section 408(p)(1) requires EPA “to develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate” [21 U.S.C. 346a(p)]. Section 408(p)(3) specifically requires that the Administrator “shall provide for the testing of all pesticide chemicals.” [21 U.S.C. 346a(p)(3)].

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

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



### Section II. Why You Are Receiving This Order

On ( Month Day ) , 2013 , E PA published a final second list of the chemicals to undergo EDSP Tier 1 screening ( XX FR XXXXX ). The chemical identified on page 1 of this Order is included on that list, which identifies the high production volume chemicals used as pesticide inerts (HPV /inerts) that are included in the initial screening of chemicals under the EDSP. You are receiving this Order because you are identified as a manufacturer and/or importer of the chemical identified on page 1 of this Order. As such, pursuant to section 40 8(p)(3) of the FFDCA, you are subject to this Order.



### Section III. Data Required By This Order

This Order identifies the screening assays that will identify substances that have the potential to interact with the endocrine system. These screening ass ays are part of Tier 1 screening under the EDSP. The purpose of Tier 1 screening (also referred to as “screening”) is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of ass ays. 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, and rogen, or thyroid hormone systems, or such other endocrine effect as the Administrator may designate;

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

and

• Establish the relationship between doses of an endocrine

- active substance administered in

the test and the effects observed.



### III.A. Data Required

**– The Tier 1 Battery** 

The following is a list of the endocrine disruptor screening battery that you must sub mit to the Agency in response to this Order:Page 4 of 16 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 consequen tly 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 bindin g to hormone receptors to either mimic the action of the

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 biosyn thesis 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 effec ts. The assay examines abnormalities associated with survival, reproductive behavior, secondary sex characteristics, histopathology, and fecundity (i.e., number of spawns, number of eggs/spawn, fertility, and development of offspring) of fish exposed to t est 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 i mmature 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 marke rs, as well as thyroid tissue.

Male Pubertal (Rat)

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

anti

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

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

Steroidogenesis (Human Cell Line

– H295R)

- The Steroidogenesis in vitro assay detects interference with the body's production of male and female steroid sex hormones. This assay is a

cell

- based assa y 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.Page 5 of 16 Uterotrophic (Rat)

- The Uterotrophic assay involves the use of female rats to screen f or estrogenic effects. In this in vivo assay, uterine weight changes are measured in ovariectomised

or immature 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 relevant information.” 21 U.S.C. 346a (p)(1). “Other scientifically relevant information” (OSRI) is information that informs the determination as to whether the substance may have an effe ct that is similar to an effect produced by a substance that interacts with the estrogen, androgen, and/or thyroid hormonal systems (e.g., information that identifies substances as having the potential to interact with the estrogen, androgen, and/or thyroi d system(s); information demonstrating whether substances have an effect on the functioning of the endocrine system). OSRI may either be functionally equivalent to information obtained from the Tier 1 assays

— that is, data from assays that perform the same function as EDSP Tier 1 assays

— or may include data that provide information on a potential consequence or effect that could be due to effects on the estrogen, androgen or thyroid systems.

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

The assays identified in Section III.A. of this Order must be conducted using the test protocols that have been validated and made available for use by the Order recipients that are completing the assays to generate new data to respond to this Order. All of the app licable 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, you may not deviate from an approved testing protocol unless you first consult with the Agency and obtain Agency approval of any deviation. If you wish to use a protocol that differs from those identified in this Order, you must submit a detailed description of the proposed protocol (including a precise description of any deviations from the protocol 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 v alidated tests, in order for EPA to approve the use of your proposed protocol, you must demonstrate that the protocol has been scientifically validated or the deviation is such that the final study is nonetheless properly considered to have been scientific ally validated. If the Agency rejects your protocol you will be notified in EPA’s Central Data Exchange (CDX) System . Moreover, you should be aware that rejection of a proposed protocol will not be a basis for extending the

deadline for submission of data.

If you choose to cite or submit existing data, including OSRI , you must indicate whether the information provided follows an accepted scientific methodology or protocol, including but not limited to those presented in EPA’s harmonized test guidelin e compendium (see “Test

Methods and Guidelines” at http://www.epa.gov/ocspp) , and provide a cogent and complete rationale for why you believe the information is sufficient to satisfy part or all of this Order.

EPA’s decisions about whether the information satisfies part or all of the Tier 1 Order will be based on the weight of evidence from all relevant information available to the Agency. See the instructions for submitting your response, which appear in Section IV. of this Order.Page 6 of 16 You must also adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160, which require you to follow certain practices when conducting studies, and when you submit data to EPA you must provide a GLP compliance statement indicating : a) that the

data we re generated using GLPs; or b) describe in detail “all differences” between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study was conducted in accordance with the GLPs.



### III.C. Generating the Data

**– Applicable Timeframes** 

You are required to submit the data or otherwise satisfy the data requirements specified in this Order and submit them to EPA no later than 24 months after the issuance (see page 1) . The Agency set thi s due date after considering the amount of time one might reasonably expect each assay to complete, including the planning activities before beginning the test, actual performance of the test, analyzing test results, and completing the final study report f or that assay (see Table 1). EPA also included several months for overall planning, and several months after the last test is completed to allow ample time for the Order recipients to prepare the final report for

submission

to EPA.

Table 1

– Estimated Timeframes for Completing the Individual Assay Reports

Assay Timeframes

Amphibian Metamorphosis (Frog) 15 months Androgen Receptor Binding (Rat Prostate) 6 months Aromatase (Human Recombinant) 6 months Estrogen Receptor Binding 6 months Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa

- 9903)) 6 months

Fish Short

- term Reproduction 12 months Hershberger (Rat) 9 months Female Pubertal (Rat) 15 months Male Pubertal (Rat) 15 months Steroidogenesis (Human Cell Line

– H295R) 6 months Uterotrophic (Rat) 9 months

There is no set sequence for completing these assays, and the due date for submitting the final report to EPA provides you with ample flexibility for Order recipients to join forces and complete this battery within the timeframe provided.



### Section IV. R esponding to the Order

You must respond to this order within the timeframes established pursuant to section IV.A., 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, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].Page 7 of 16 To comply with this Order, you are expected to engage in the following activities:

(1) Read this Ord er. (2) Determine and plan activities necessary to respond to the order. (3) Submit an Initial Response Form to EPA, identifying the response option you intend

to use. See section IV.B

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

section III.B

. of this Order. (5) Submit a Progress Report. See section VI

. of this Order. (6) Generate the data. (7) Compile and review the data for submission. See section V

. of this Order

. (8) Complete paperwork to assemble the submission package. See section V

. of this

Order. (9) Submit Final Report/Data to EPA. See section V

. of this Order. (10) Maintain records . See section VII

. of this Order.



### IV.A. Schedule For Responding To The Orde **r**

Your schedule for responding may vary based on the response options discussed in more

detail in the next section of this Order. Please note that in calculating the due date for the Initial Response, the Agency has included an additional 10 calendar day s to account for processing the final order package for delivery to the Post Office. Your basic schedule is summarized on page 1

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

Table 2

– Basis for Establishing the Due Dates in this O rder

Timeframes for Due Dates: What is Due: Within 90 calendar days of the Order’s issuance ( plus 10 calendar days for processing) Individual Recipient’s Initial Response

Within 150 calendar days of the Order’s issuance ( plus 10 calendar days for processing) Consortia Documentation & Consortia’s Initial Response

Within 12 months from Order’s issuance A Progress Report describing the status of an Order Recipient’s compliance with the Order. On or before 6 (six) months of the Order’s

issuance A Manufacturer/Importer that chooses the “opt

- out” option is agreeing to cease all sale and distribution of the chemical in the pesticide market.

24 months from Order’s issuance Final Study Report and submission of the data to

EPA

In general, the Agency will not consider any requests for extending the deadlines for the Initial Response or Progress Report. However, the Agency will consider extending the final report due date when the circumstances warrant it. If you cannot submit the final report to the Agency in the time frame required by this Order , you may seek additional time to meet the requirement . To do so, you must submit a request for an extension to the Agency using the electronic system identified in Unit V. of this Order. You will receive an acknowledgement or notice from the system to confirm the Agency’s receipt of your electronic request. Your request

must occur before the applicable deadline and include: (1) a det ailed 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 pro vide related documentation from the laboratory performing the testing. While EPA is considering your request, the original deadline remains. The Agency will respond to your request through the electronic system If EPA does not grant your request, the

or iginal deadline remains. Normally, extensions should be requested only in cases of extraordinary testing problems beyond the expectation or control of the registrant, manufacturer, or importer. Extensions will not be considered if the request for extensi on 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.



### IV.B. Options **for Responding to the Order**

You have several options for responding to this order. To report your commitment to act in response to the test order, you must submit an Initial Response to EPA within 90 days of the

issuance of this Order.

Please complet e the Initial Response Form for Individual Order Recipients (Enclosure B), which EPA has pre

- populated with basic information about this Order, the chemical and your contact information. Follow the transmittal instructions in section V.D. of

this Order to submit this form to EPA by the due date for the initial response that is indicated on page 1 of this Order.

You have several potential response actions from which to choose, each response option involves specific procedures that you must follow:

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) ru le (40 CFR part 160) and the tests must be conducted according to protocol requirements identified in s ection 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 Exis ting 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) ) , y our Initial Response must include either the

data or a reference to the data for each test that is re quired, 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 i n this Order, the Agency expects that any such hazard

- related data would

be of high quality and achieves the objective of Tier 1 assays to provide reasonable assurance that a chemical does or does not have the potential to interact with the estrogen, andro gen, or thyroid systems. EPA’s decisions about whether the data cited or submitted satisfies part or all of the Tier 1 Order will be based on the weight of evidence from all relevant information available to the Agency

.

The submitted or cited study must have been conducted in accordance with accepted scientific methodology or protocol, including but not limited to those presented in EPA’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 deviations, including an explanation as to why, notwithstanding the deviations, the protocol used should still be considered as providing an accepted scientific methodology or protocol, and any other information you think the Agency should consider in deciding whether to accept the data in satisfaction of this Order.

If EPA has previously reviewed a protocol for a study you are submitting or citing, y ou must identify any action taken by the Agency on the protocol and must indicate the manner in which all Agency comments, concerns or issues were addressed in the final protocol and study.

If you choose to cite a study that has been previously submitted to EPA, that study must have been previously classified by EPA as acceptable (i.e., the study was not rejected by the Agency for any reason related to completeness or quality) or it must be a study which has not yet been reviewed by the Agency. With resp ect to any studies for which you wish to select this option you must provide EPA with a copy of the title page along with the identification number of the study you are citing (MRID number), and, if the study has been reviewed by the Agency, you must provi de the Agency's classification of the study. Do not resubmit a study that has previously been submitted to EPA for another purpose.

EPA will review any existing study submitted or cited in response to this Order to determine whether the study is accept able and whether the study satisfies the requirements of this Order. The Agency will notify you in writing of its determination. If the Agency determines that the study is acceptable, the Initial Response Form is the only response you are required to

com plete 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 determ ines that the study is not acceptable, the Agency will require you to comply with this Order, normally without an extension of the required date of submission. The Agency may determine at any time that a study is not valid and needs to be repeated.

If you are citing a study of which you are not the original data submitter, you may need to submit an offer to pay compensation to the original data submitter. Consequently, you should simultaneously include an offer to pay [in accordance with 40 CFR 152.93 ] [which includes an offer to resolve any dispute over the recipients’ shares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties (e.g., through binding arbitration or through a state or federal court act ion)], 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 da ta, 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.Page 10 of 16 The designated lead for the task force or co nsortium 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 ea ch 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 arrangem ent between the parties or the mechanism to resolve the terms. The designated lead for the task force or

consortium must follow the transmittal instructions in section V.D. of this Order to submit this form and accompanying information to EPA by the due d ate for the consortia response that is indicated on page 1 of this Order.

Once the task force or consortium submits the data and EPA has completed its initial review to accept the data in satisfaction of this Order, EPA will provide notification to the

co ntact 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.

If you are unable to join a task force or consortium, you must provide EPA with documentary evidence that you made a reasonable offer to join or share in the testing costs. Such evidence may be : (1) your letter offering to join in an agreement, or (2) your letter that contains a legally binding offer to join in an agreement and provide a reasonable share of the test costs, and that includes a reasonable process for resolving any disputes of the appropriate share

of the test costs.

If the task force or consortium fails to submit the data or meet the requirements of the Order in a timely and adequate manner, you will normally be subject to penalties of up to $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 da ta. Thus, if you agree to jointly 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 wit h the deadlines and all other requirements set forth in this Order.

The Agency has provided a list of the other manufacturers and/or importers, to the extent permitted by confidentiality requirements that have received an EDSP Order for this chemical. (E nclosure A). This list is intended to help order recipients identify other companies with whom they could form agreements to develop data jointly.

Option 4: Claim Not Subject To the Order

You may claim that you are not subject to this order if you do not manufacture or import the chemical identified on page 1 of this Order or you believe the order was otherwise sent to you in error. An explanation of the basis for the claim, along with appropriate information to substantiate that claim, must accompany your Initial Response so that EPA can evaluate the claim. The Agency intends to make a determination and respond to your request in writing within 90 days of receipt. If EPA cannot verify your claim, the original requirements and

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

satisfaction of the Order and will close out this Order.Page 11 of 16 Option 5: Discontinue the Manufacture or Import of the Chemical

If you have already, or otherwise are in the process of discontinuing the manufacture or import of this chemical, you may satisfy the Order by submitting documentation to this effect with your initial response. If EPA cannot verify your claim, the original requirements and deadlines in this Order remain. If y our claim is verified, EPA will consider your response to be

satisfaction of the Order and will close out this Order

.

Option 6: Stop Sales into the Pesticide Market

Rather than entirely discontinuing all manufacture or import of this chemical, you may instead commit not to sell the chemical for use in the pesticide market. As part of your Initial Response, you must document your commitment that on or before a date si x months after the issuance of the test order, all sale and distribution of the pesticide inert ingredient that is the subject of the test order to any person who you know or reasonably should know, intends to use the substance in the formulation of a pest icide product. In addition, you must certify that you will include in all contracts for sale or distribution of the material, a provision that contractually prohibits the purchaser of your chemical from using the substance in the formulation of a pesticid e product. As part of your Initial Response, you must provide a copy of the contract provision and your commitment to include this contractual provision in any contracts entered

into on or after a date six months after the issuance of this Order. If you choose this option, the Initial Response Form, with supporting information, is the only form you are required to complete.

If you do not fulfill the commitments made in your Initial Response, you will be subject to enforcement action for failing to comply with the FFDCA section 408(p) order, in accordance with section 408(p)(5)(D). Having failed to perform the actions necessary for this response option, you will be obliged to immediately comply with the order

— i.e ., to provide the data,

within the time fram e that had originally been required by the order. In addition, the recipient would potentially be subject to penalties, pursuant to 18 U.S.C.1001, for willfully making any false or misleading statements to the Federal government.

Option 7: Other Respo nse Options

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

a) You can demonstrate (supported by appropriate data) that the chemical is an endocrine disruptor and that additional sc reening 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”).Page 12 of 16 c) Your chemical was used by EPA as a ‘‘positive control’’ to validate one or more of the screening assays. EPA will o nly accept these data in satisfaction of that part of the test order related to those assays for which the chemical was used to complete the testing as part of the validation effort.

The Agency intends to make a determination on your claim and respond to you within 90 days of receipt. If EPA cannot verify your claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the

Order and will close out this Order.



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

If you wish to challenge the validity of any of the provisions of this Order, including the requirement to conduct any test or use the specific test protocols required by this Order, you must submit to the Agency a detailed explanation of the basis for your challenge that provides sufficient information for the Agency to evaluate the issue. While EPA is considering your submission, the original deadline remains. The Agency intends to respond to your request within 90 days of receipt. If EPA does not grant your request, the original deadline remains.



### IV. **D . Procedures for Cost Sharing** 

Cost sharing is the process by which two or more recipients of a test order contribute to the generation of data (or the compensati on 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 testing orders 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 generate data. You may therefore determine the procedures that are best suited to your individual circumstances, and the most acceptable approach to sharing test costs.

If you are aware of another manufacturer of any of the products listed on Enclosure A who has not received an order, and you provide EPA with this information, EPA intends to send that manufacturer an order within 90 days of your notification.



### IV. **E . Procedures for Data Protection** 

If (a) a tolerance or exemption has been established for your chemical, (b) an application for a tolerance or exemption is pending; or (c) you have partnered with pesticide registrants (either technical or end

- use), or otherwise joined a consortium with a pesticide registrant, EPA considers such data to be subject to the requirements of FIFRA section 10. All other confidential business information submitted in response to a 408(p) order (i.e., data not in support of a registration or tolerance/tolerance exemption) is subject to the Trade Secrets Act 18 U.S.C. 1905.Page 13 of 16 The Freedom of Information Act ( FOIA ) requires agencies to make information available to the public upon request, except for information that is “specifically made confidential by other

statutes” or data that are “trade secrets and commercial or financial information obtained from a person and is privileged or confidential” [5 U.S.C. 552]. Any information that you wish to have EPA protect as confidential business information (CBI) should be clearly identi fied 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

**V.A. Format for Submissions**

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 initial response, the initial response from the consortium, any progress reports, the final report, supporting data, and other related infor mation.

EPA has developed standard data evaluation formats, or templates for writing its data evaluation records (DERs) of studies submitted under FIFRA and FFDCA to EPA. These templates describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary for an efficient agency review is outlined. Additional details ab out these templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/

.

In addition, Pesticide Registration (PR) Notice 2011

- 3 Standard Format f or 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 FIF RA and FFDCA data http://www.epa.gov/PR_Notices/pr2011

- 3.pdf

.

The Agency requires Order Recipients to submit completed study profiles, supporting data, and all related correspondence request electr onically using the 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 rec ipient, each

submission in satisfaction of a n Order issued under FFDCA section 408(p) test order must be accompanied by a transmittal document that includes the following information:

• Identity of the submitter.

• The date on which the submission package was prepared for transmittal to EPA.

• The Order number identified on page 1 of this Order.

• A list of the individual documents included in the submission.Page 14 of 16 

### V.C. Submitting Individual Study or Test Result Documents

Unless otherwise specified by the Agen cy, each submission must be in the form of individual documents or studies. Do not resubmit any documents that you previously submitted to EPA. Instead, in your Initial Response Form that you submit via CDX , please provide a

citation or reference to the previously submitted documents with sufficient information to allow the Agency to identify the previously submitted document.

Each study or document submitted to EPA must include the following:

i. A title page including the following information:

• Th e Order number identified on page 1 of this Order

.

• The title of the study, including identification of the substance(s) tested and the test

name or data requirement addressed.

• The author(s) of the study.

• The date the study was completed.

• If the stu dy was performed in a laboratory, the name and address of the laboratory,

project numbers or other identifying codes.

• If the study is a commentary on or supplement to another previously submitted

study, full identification of the other study with which i t should be associated in

review.

• If the study is a reprint of a published document, all relevant facts of publication,

such as the journal title, volume, issue, inclusive page numbers, and date of publication.

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

described in PR

- Notice 2011

- 3.

iii. A statement of compliance or non

- compliance with respect to GLP standards as

requ ired 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 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,Page 15 of 16 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 a ccess 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 th e requirements of this Order have been satisfied, you must submit a progress report to EPA using the provided electronic reporting tool, 12 months after the issuance of this Order (the specific due date for you is identified on page 1 of this Order). Your progress report should provide a brief description of the status of your planned activities for each assay, and, if applicable, a description of any problems encountered or expected difficulties in meeting the schedule for complying with the order. Pleas e include the

transmittal document described in section V.B

. of this Order.



### Section VII. Recordkeeping Requirements

You must retain copies of the generation of the data and other information documenting your compliance with this Order. This includes all test reports submitted to the Agency in support of a registration or in support of a tolerance petition, all underlying raw data, and interpretations and evaluations thereof (see 40 CFR part 169). These records shall be retained as long as the inert ingredient is contained in a pesticide product with a valid registration and the producer is in business, and be made available to EPA or its agent for inspection.



### Section VIII. Consequences of Failure to Comply with this Order

Failure to comply with an y of the requirements in this order renders you liable for the penalties and sanctions of up to $25,000 per violation. Each day that the violation continues constitutes a separate violation. Any person who knowingly or willfully violates this order shall (either in addition to or in lieu of) be subject to a fine of not more than $25,000 per day of violation, or to imprisonment for not more than one year, or both. [21 U.S.C. 346a(p)(5)(D), citing 15 U.S.C. 2615]

Before such penalties are assessed, you wi ll be entitled to an administrative hearing held on the record in accordance with section 554 of the Administrative Procedures Act (APA). 15 U.S.C. 2615(a)(1)

- (2)(A). Before issuing a final penalty order, EPA must provide notice of its

intention to asses s 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 section 408(p)(5)(A), (2) the circumstances of the violation; (3) the extent and gravity of the violation(s ); (4) your ability to pay; (5) the effect on your ability to continue to do business; (6) any history of prior violations; and (7) the degree of culpability [15 U.S.C. 2615(a)(2)(B)]. InPage 16 of 16 this hearing, you may not raise any challenge to the validity of th is order, or any test required by

this order.



### Section IX. Additional Information

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

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

.

If you have any questions about the requirements and procedures established in this Order, please contact 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 of section 408(p) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. 346a (p) , the United States Environmental Protection Agency hereby issues this testing Order to take effect on the date of my signatur e.

Date: _____________________

Signature: ________________________________________ Richard P. Keigwin, Jr., Director

Pesticide Re

- evaluation 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)