### Attachment C – (1)
FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 10, 2009

Page 1 of 17 NOTE: This template was developed by EPA to provide guidance to EPA staff and managers who will be preparing the Tier 1 Orders that will be issued under the Endocrine Disruptor Screening Program (EDSP), as well as for the recipi ents of the Tier 1 Orders. This template is not a rule or regulation, nor doe s it create or confer legal ri ghts or impose any legally binding requirements on EPA or any party. In preparing a final Tier 1 Or der, EPA may depart from the guidance presented in this template where ci rcumstances warrant and without prior notice. Orders will be generated individually for each chemical and each order recipient. EPA will insert the information in blue type an 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: [Insert date, calculated as 90 cal endar days from issuance + 10 calendar days for final processing and mailing.]

Due Date for Consortia Documentation: [Insert date, calculated as 150 calendar days from issuance + 10 calendar days fo r final processing and mailing.] 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 iden tify the company in the system.]

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

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

Dear Sir or Madam:

This Order requires you and other manufactur ers and importers of the chemical named above to submit certain data or otherwise respon d as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). This chemi cal is identified as an “other ingredient” in a pesticide product(s) (also referred to as an inert ingredient). Thes e data are required by section 408(p)(3) of the Federal Food, Drug and Cosmet ic Act (“FFDCA”), which mandates that all pesticide chemicals, including inert ingredient s, be tested under th e 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 acco rdance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 10, 2009

Page 2 of 17 

### Introduction

This Order is issued pursuant to secti ons 408(p)(3) and (5) of the FFDCA [21 U.S.C. 346a(p)(3), (5)]. FFDCA Section 201(q)(1) defines “pes ticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insectic ide, Fungicide, and Rodenticide Act (“FIFRA”), including all active a nd inert ingredients of such pesticide” [21 U.S.C. 231(q)(1)].

To facilitate the formation of consortia to deve lop the required data, and to the extent that the information is not protected as confidential business information, we have provided each Order recipient with a list of the other recipients of orders for this chemical. (See Enclosure A). EPA intends to publish the list of all order recipients in the Federal Register and will then post the list on the Agency's website , along with the status of th e 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 cons ortium and can check on the status of responses from the other order recipients for this chemical on the Web site.

[If the recipient has claimed CBI for his identify in relation to this chemical, include the following additional sentences here: You will not ice, however, that your company is included on the list only as “Company X” due to previous CBI claims applicable to your information. So that other order recipients can identify and contac t you to join forces, EPA recommends that you either declassify your identity information so th at it can be included, or you identify an agent who will act on your behalf in all matters relating to this Order. If you choose to designate an agent, EPA will make the name of the agent (i nstead of the company) public by including it on the list of recipients of FFDCA section 408(p) test orders and DCI notices.]

The information collection requirements descri bed in this document have been approved by the Office of Management and Budget (OMB ) under the Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA is identified under EPA ICR No. 2249.01, and OMB Control No. 2070- [# will be inserted when obtained] . The public reporting burden for this collecti on of information is estimated to average [# will be inserted when ICR is approved] hours per order.

This Order is organized as follows:

Introduction................................................................................................................... .................. 2 Section I. The Authority for this Order....................................................................................... ... 3 Section II. Why You Are Receiving This Order............................................................................ 3 Section III. Data Requi red By This Order ..................................................................................... 4 III.A. Data Required – The Tier 1 Battery......................................................................... 4 III.B. Conducting the Battery - Testing Protocols ............................................................. 6 III.C. Generating the Data – Applicable Timeframes........................................................ 7 Section IV. Responding to the Order........................................................................................... .. 7 IV.A. Schedule For Responding To The Order ................................................................. 8 IV.B. Options for Responding to the Order....................................................................... 9 Option 1: Generate Data ......................................................................................... 9 Option 2: Submit or Cite Existing Data.................................................................. 9FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 3 of 17 Option 3: Form a Task Force or Offer to Join a Task Force................................ 10 Option 4: Claim Not Su bject To the Order.......................................................... 11 Option 5: Discontinue the Manufacture or Import of the Chemical.................... 11 Option 6: Stop Sales into the Pesticide Market ................................................... 12 Option 7: Other Response Options ...................................................................... 12 IV.D. Procedures for Challenging this Order .................................................................. 13 IV.E. Procedures for Cost Sharing................................................................................... 13

IV.F. Procedures for Data Protection............................................................................... 13 Section V. Submitting Da ta to the Agency.................................................................................. 14

V.A. Format for Submissions .......................................................................................... 14

V.B. Transmittal Documents ........................................................................................... 14 V.C. Submitting Individual Study or Test Result Documents......................................... 14 V.D. Mailing Instructions ................................................................................................ 15 Section VI. Submit a Progress Report ......................................................................................... 1 5 Section VII. Recordkeeping Requirements.................................................................................. 16 Section VIII. Consequences of Fail ure to Comply with this Order............................................. 16

Section IX. Additional Information ............................................................................................ . 16

Section X. Conclusion ......................................................................................................... ........ 17



### Section I. The Authority for this Order

FFDCA section 408(p)(1) requires EPA “t o develop a screening program, using appropriate validated test systems and other scie ntifically 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) specifi cally requires that the Admini strator “shall provide for the testing of all pesticide chemical s.” [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], incl uding all active and inert ingredients of such pesticide.” [21 U.S.C. 231(q)(1)].

Section 408 (p)(5) provides that the Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which te sting is required unde r this subsection, to conduct testing in accordance with the screening program, and submit information obtained from the testing to the Administrator, within a reasonabl e time period that the Administrator determines is sufficient for the generation of the information.



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

On [insert date of FR publication] , 2009, EPA published a final list of the chemicals to undergo EDSP Tier 1 screening ( [inert FR citation] ). The chemical identified on page 1 of this Order is included on that list, which identifie s the high production volume chemicals used as pesticide inerts (HPV/inerts) that are included in the initial screeni ng of chemicals under the EDSP. You are receiving this Order because you are identified as a manufacturer and/orFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 4 of 17 importer of the chemical identified on page 1 of this Order. As su ch, pursuant to section 408(p)(3) of the FFDCA, you are su bject to this Order.



### Section III. Data Required By This Order

This Order identifies the screening assays that will identify substances that have the potential to interact with the endocrine system. These screening assays are part of Tier 1 screening under the EDSP. The purpose of Tier 1 screening (also referred to as “screening”) is to identify substances that have the potential to interact with the estr ogen, androgen, or thyroid hormone systems using a battery of assays. Th e 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 Ti er 1 screening assays, upon examining the screening data submitted, EPA may issue a subseque nt Order to require additional testing of this

chemical under Tier 2 of the EDSP to:

• Determine whether a substance may cause endoc rine-mediated effects through or involving estrogen, androgen, or thyroid hormone systems, or such other endocrine effect as the Administrator may designate;

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

and

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

the test and the effects observed.



### III.A. Data Required – The Tier 1 Battery

[NOTE: The availability of the final Tier 1 screening battery will be announced in the Federal Register before any 408(p) orders will be issued. Until that is done , the list of assays presented in this template is only a list of the assays that are expected to be in the battery based on the proposed Tier 1 screening battery that underwent peer review by the FIFRA Scientific Advisory Panel (SAP) in March 2008. When the orders are issued, the order will reflect the final Tier 1 Battery.]

On [insert date of FR publication] , 2009, ( [inert FR citation] ), EPA announced the final Tier 1 screening battery. The following is a list of the endocrine disrupto r screening battery that 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 re sult in developmental effects.

Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is involved in the development of male sexual char acteristics. The AR Binding a ssay identifies chemicals thatFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 5 of 17 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 the site and thus block hormone controlled activity.

Aromatase (Human Recombinant) - Aromatase is an enzyme complex responsible for estrogen biosynthesis that converts androge ns 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 chem ical to bind to the

estrogen receptor.

Estrogen Receptor Transcriptional Activ ation (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 ab ility 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-gonada l (HPG) axis includi ng (anti-)estrogenic, (anti-)androgenic, aromatase inhibition, and steroid modulating effects. The assay examines abnormalities associated with survival, reproductive behavior, secondary sex characteri stics, histopathology, and fecundity (i.e., number of spawns, number of eggs/spawn, fertilit y, and development of offspring) of fish exposed to test chemicals.

Hershberger (Rat) - The Hershberger assay is designed to detect androgenic and anti-androgenic effects. In this in vivo assay, the weight of several androgen-depe ndent 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 dur ing 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 i nvolves the use of rats to screen for androgenic, anti-androgenic, and thyroid activity in males during sexual maturation. This assay examines abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.

Steroidogenesis (Human Cell Line – H295R) - The Steroidogenesis in vitro assay detects interference with the body' s production of male and female steroid sex hormones. This assay is a cell-based assay using the H295R human adreno cortical carcinoma cell line which can detect inducers of enzymes responsible for steroid synt hesis 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, uterin e weight changes are measured in ovariectomised

or immature female rats.FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 6 of 17 

### III.B. Conducting the Battery - Testing Protocols

Pursuant to section 408(p)(1), testin g conducted for the EDSP must be based on “validated test systems and other scientifically relevant informati on.” 21 U.S.C. § 346a (p)(1). “Other scientifically relevant information” is information that informs the determination as to whether the substance may have an effect that is similar to an effect produced by a substance that interacts with the estrogen, andr ogen, and/or thyroid hormonal sy stems (e.g., information that identifies substances as having the potential to interact with the es trogen, androgen, and/or thyroid system(s); information demonstrating whether substances have an effect on the functioning of the endocrine system). OSRI may e ither be functionally equivalent to information obtained from the Tier 1 assays—t hat is, data from assays that perform the same function as EDSP Tier 1 assays—or may include data that pr ovide information on a potential consequence or

effect that could be due to eff ects 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 validat ed 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 av ailable on the Agency’s web site at: [insert URL to website, which will include a list of the Protocol s and links to the appropriate documents in the Docket]

.

If you choose to generate the data to respond to this Order, you ma y 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 di ffers from those identified in this Order, you must submit a detailed descri ption of the proposed protocol (including a precise description of any deviations from the protoc ol attached to this Order) and your reason for wishing to use it. Because section 408(p)(1) of the FFDCA requires th at the screening be conducted with validated 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 ha ve been scientifically validated . If the Agency rejects your protocol you will be notified in writing. More over, you should be awar e that rejection of a proposed protocol will not be a basis for exte nding the deadline for submission of data.

If you choose to cite or submit existing da ta, including other scie ntifically relevant information, you must indicate whether the inform ation provided follows an accepted scientific methodology or protocol, including but not limited to those presen ted in EPA’s harmonized test guideline compendium (see http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left), and provide a cogent and complete rationale for why you believe the information is sufficient to satisfy part or al l of this Order. EPA’s decisi ons 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.

You must also adhere to the good laborato ry 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 comp liance statement indicating a) that the dataFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 7 of 17 were generated using GLPs; or b) describe in detail “all differences” between the GLPs and the practices used; or c) confirm that you did not sp onsor or conduct the st udy 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 otherw ise satisfy the data requirements specified in

this Order and submit them to EPA no later than [Insert date, calculated as 24 months from issuance] . The Agency set this due date after considering the amount of time one might reasonably expect each assay to complete, incl uding the planning activit ies before beginning the test, actual performance of the te st, analyzing test results, and completing the final study report for that assay (see Table 1). EPA also included several months for overall planning, and several months after the last test is completed to allow ample time for the Order recipients to prepare the final report for submission to EPA.

Table 1 – Estimated Timeframes for Completing the Individual Assay Reports

Assay Timeframes

Amphibian Metamorphosis (Frog) 15 months Androgen Receptor Binding (Rat Prostate) 6 months Aromatase (Human Recombinant) 6 months Estrogen Receptor Binding 6 months Estrogen Receptor Transcriptional Activati on (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 thes e assays, and the due date for submitting the final report to EPA provides you with ample flexib ility for Order recipients to join forces and complete this battery within the timeframe provided.



### Section IV. Responding to the Order

You must respond to this or der within the timeframes es tablished pursuant to section IV.A., and the specific applicable dates as identified on page 1 of this Order. If you do not respond to this Order, or if you fail to otherw ise comply with its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601].

To comply with this Order, you are expect ed to engage in th e following activities:

(1) Read this Order. (2) Determine and plan activities necessary to respond to the order.FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 8 of 17 (3) Submit an Initial Response Form to EPA, identifying the response option you intend

to use. See section IV.B. (4) If you decide to generate the data, Read a nd, if applicable, discu ss the protocols. See

section III.B. (5) Submit a Progress Report. See section VI. (6) Generate the data. (7) Compile and review the data for submission. See section V. (8) Complete paperwork to assemble the submission package. See section V. (9) Submit Final Report/Data to EPA. See section V. (10) Maintain record s. See section VII.



### IV.A. Schedule For Responding To The Order

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

detail in the next section. Pleas e note that in calculating the due date for the Initial Response, the Agency has included an additiona l 10 calendar days to account for processing the final order package for delivery to the Post Office. In ge neral, your basic schedule is summarized on page 1

of this Order and is based on the timeframes id entified in Table 2, which are discussed elsewhere

in this Order:

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 (+ 10 calendar days for processing) Individual Recipient’s Initial Response

Within 150 calendar days of the Order’s issuance (+ 10 calendar days for processing) Consortia Documentation & Consortia’s Initial Response Within 12 months from Order’s issuance A Progr ess 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 data/reports to the Agency in the time frame required by this Order and intend to seek additional time to meet the requirement, you must submit a written request to the Agency before the applicable deadline. Your written request must include: (1) a detailed description of the expected difficulty and (2) proposed schedule including alternative dates fo r meeting such requirements on a step-by-step basis. You must explain any t echnical or laboratory difficulties and provide documentation from the laboratory performing the testing. While EPA is consid ering your request, the original deadline remains. The Agency w ill respond to your request in wr iting; extensions can only be granted in writing. If EPA does not grant your request, the original deadline remains. Normally, extensions can be requested only in cases of extraordinary testing problems beyond the expectation or control of the re gistrant, manufacturer, or import er. Extensions will not beFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 9 of 17 considered if the request for extension is not ma de in a timely fashion; in no event shall an extension request be considered if it is submitted at or after the lapse of the subject deadline.



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

You have several options for responding to th is 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 complete the Initial Response Form for Individual Order Recipients (Enclosure B), which EPA has pre-populated with basic information about this Order, the chemical and your contact information. Follow the mailing instructions in section V.D. of this Order to submit this form to EPA by the due date for the initial response that is indicated on page

1 of this Order.

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

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 (G LP) rule (40 CFR part 160) and the tests must be conducted according to protocol requirements id entified in Section III.B. In submitting the data, you must follow the procedures described in this Order.

Option 2: Submit or Cite Existing Data

If you choose to submit or cite an existing st udy in response to this Order (including data previously submitted to the Agency), your Initia l Response must include either the data or a reference to the data for each test that is requi red, along with a rationale that explains how the study you cited or submitted satisfies part or all of this Order. Existing studies are studies that predate issuance of this Order. In order to be accepted as satisfaction of the requirements imposed in this Order, the Agency expects that any such hazard-related data would be of high quality and achieves the objective of Tier 1 as says to provide reasona ble assurance that a chemical does or does not have the potential to interact with the estroge n, androgen, or thyroid systems. EPA’s decisions about whether the data cited or submitted satisfies part or all of the Tier 1 Order will be based on the weight of evidence from all relevant information available to the Agency.

The submitted or cited study must have b een conducted in accordance with accepted scientific methodology or protoc ol, including but not limited to those presented in EPA’s harmonized test guideline compendium (see h ttp://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left). 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, th e 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.FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 10 of 17 If EPA has previously reviewed a prot ocol for a study you are submitting or citing, you must identify any action taken by the Agency on the protocol and must indicate the manner in which all Agency comments, concerns or issues were addressed in the final protocol and study.

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

EPA will review any existing study submitted or cited in response to this Order to determine whether the study is accep table and whether the study satis fies 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 th e only response you are required to complete to satisfy this Order and EPA will notif y you in writing that the Order is satisfied. If, however, EPA determines that the study is not acce ptable, 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 comp ly with this Order, normally without an extension of the required date of submission. The Agency ma y 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 th e original data submitter, you may need to submit an offer to pay compensation to the orig inal 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’ sh ares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties (e.g., through binding arbitration or through a state or federal court action)], unless you have receive d 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 consor tium 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 fo rce or consortium must complete the Initial Response

Form for Consortium /Task Force (Enclosure C) to provide the primary contact for the task force or consortium, the list of participants, and an indication of the task force or consortium’s planned response for each assay, al ong with documentati on of its formation (such as a copy of the joint agreement or a written statement by all th e parties that an agreem ent exists). The joint agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms. The designated lead for the task force or consortium must follow the mailing instructions in section V.D. of this Order to submit this formFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 11 of 17 and accompanying information to EPA by the due date for the consortia response that is indicated on page 1 of this Order.

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

the contact for the task force or consortium that th is Order has been satisfied, which in turn will

close out the Orders for e ach 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 ag reement and provide a reasonable share of the test costs, and that includes a reasona ble process for resolving any dis putes of the appropriate share

of the test costs.

If the task force or consortium fails to s ubmit 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 Ag ency will generally not grant time extensions for the submission of data. Thus, if you agree to join tly submit the data, each Order recipient is still subject to penalties of up to $25,000 per day, unle ss some party with whom you are in agreement makes a commitment to generate the data and s ubmits the data in accordance with the deadlines and all other requirements set forth in this Order.

The Agency has provided a list of the other manufacturers and/or impor ters, to the extent permitted by confidentiality requirements, that ha ve received an EDSP Order for this chemical. (Enclosure A). This list is intended to help or der 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 th is order if you do not manufacture or import the chemical identified on page 1 of this Orde r or you believe the order was otherwise sent to you in error. An explanation of the basis for the claim, along with appr opriate information to substantiate that claim, must accompany your In itial Response so that EPA can evaluate the claim. The Agency intends to make a determ ination and respond to your request in writing within 90 days of receipt. If EPA can not ve rify your claim, the or iginal requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be

satisfaction of the Order and will close out this Order.

Option 5: Discontinue the Manuf acture or Import of the Chemical

If you have already, or otherwise are in th e process of discontinuing the manufacture or import of this chemical, you may satisfy the Or der by submitting documentation to this effect with your initial response. If EPA can not ve rify your claim, the or iginal 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.FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 12 of 17 Option 6: Stop Sales into the Pesticide Market

Rather than entirely disc ontinuing 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 six months after the issuance of the test order, all sale and distributi on 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 pesticid e product. In addition, you must certify that you

will include in all contracts for sale or distributio n of the material, a provision that contractually prohibits the purchaser of your chemical from using the substance in the formulation of a pesticide product. As part of your Initial Re sponse, 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 Orde r. If you choose this option, the Initial Response Form, with supporting informa tion, 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 pe rform 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 frame that had originally been require d 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 Response 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 appropria te data) that the chemical is an endocrine disruptor and that additional screening or testi ng under the EDSP is

unnecessary.

b) You can demonstrate (supported by appropriate data) that the chemical meets the standard for an exemption unde r 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 ‘‘posit ive control’’ to validate one or more of the screening assays. EPA will only accept thes e data in satisfaction of that part of the test order related to those assays for wh ich the chemical was used to complete the testing as part of the validation effort.

The Agency intends to make a determina tion on your claim and respond to you in writing within 90 days of receipt. If EPA can not ve rify your claim, the or iginal requirements andFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 13 of 17 deadlines in this Order remain. If your claim is verified, EPA will consider your response to be

satisfaction of the Order and will close out this Order.



### IV.D. Procedures for Challenging this Order

If you wish to challenge the validity of any of the provisions of this Order, including the requirement to conduct any test or use the specif ic test protocols requ ired by this Order, you must submit to the Agency a detailed explanatio n of the basis for your challenge that provides sufficient information for the Agency to evalua te the issue. While EPA is considering your submission, the original deadline remains. The Agency intends to respond to your request in writing within 90 days of receipt. If EPA doe s not grant your request, the original deadline

remains.



### IV.E. Procedures for Cost Sharing

Cost sharing is the process by which two or mo re recipients of a te st order contribute to the generation of data (or the compensation for ex isting 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 tes ting orders for a particular subs tance 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 protect ed as confidential business information.

EPA has not established specific coordinati on procedures by which you must collectively generate data. You may therefore determine the pro cedures that are best su ited 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, and EPA intends to

send that manufacturer an order w ithin 90 days of your notification.



### IV.F. Procedures for Data Protection

If (a) a tolerance or exemp tion 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 s ubject to the requirements of FI FRA section 10. All other

confidential business informati on submitted in response to a 408( p) order (i.e., data not in support of a registration or tolera nce/tolerance exempti on) is subject to the Trade Secrets Act 18 U.S.C. § 1905.

FOIA requires agencies to make information available to the pub lic upon request, except for information that is “specifically made confid ential by other statutes” or data that are “trade

secrets and commercial or financial informati on obtained from a person and is privileged or confidential” [5 U.S.C. § 552]. Any informa tion that you wish to have EPA protect as

confidential business information should be clearly identified as such. Note that substantive criteria must be met to support a claim confidenti ality of business information, as specified in 40 CFR § 2.208.FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 14 of 17 

### Section V. Submitting Data to the Agency

V.A. Format for Submissions

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

.

In addition, Pesticide Regist ration (PR) Notice 86–5, entitled Standard Format for Data Submitted Under the Federal Insecticide, Fungici de, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) , describes EPA’s preferred method for organizing and formatting submittals of data supporting a pesticide registration ( http://www.epa.gov/PR_Notices/pr86-5.html ).

The Agency also encourages FFDCA section 408(p) test order re cipients to submit completed study profiles and supporting data in an electronic format (PDF) whether submitting one or several studies. For more information, go to the electronic data submissions website at http://www.epa.gov/oppfead1/eds/edsgoals.htm

.



### V.B. Transmittal Documents

In order for EPA to effectively track th e compliance of each order recipient, each submission in satisfaction of a 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 FFDCA section 408(p) test order number.

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



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

Unless otherwise specified by the Agency, each submission must be in the form of individual documents or studies. Do not resubmit any documents that you previously submitted to EPA. Instead, as part of your Initial Respons e Form, please provide a c itation 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:FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 15 of 17 • The FFDCA section 408(p) test order number.

• The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.

• The author(s) of the study.

• The date the study was completed.

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

project numbers or other identifying codes.

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

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

review.

• If the study is a reprint of a published doc ument, 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 86-5.

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 tran slation must be included for any information that is not in English.



### V.D. Mailing Instructions

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

EPA as follows:

Mail To: Document Processing Desk (SRRD-EDSP) , Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, D.C.

20460

Deliver To: Document Processing Desk (SRRD-EDSP), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agenc y, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are on ly accepted 8:30 a.m. to 4 p.m., Monday through Friday, exclud ing legal holidays.



### Section VI. Submit a Progress Report

Unless EPA has notified you in writing that the requirements of this Order have been satisfied, you must submit a progress report to EP A 12 months after the is suance of this Order (the specific due date for you is identified on page 1 of this Order). Y our progress report shouldFFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 16 of 17 provide a brief description of the status of your planned activities fo r each assay, and, if applicable, a description of any problems encount ered or expected difficulties in meeting the schedule for complying with the order. Please include the transmittal document described in

section V.B.



### Section VII. Recordkeeping Requirements

You must retain copies of the generation of the data and other information documenting your compliance with this Order. This include s 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 avai lable to EPA or its agent for inspection.



### Section VIII. Consequences of Failur e to Comply with this Order

Failure to comply with any of the requirem ents in this order renders you liable for the penalties and sanctions of up to $25,000 per viola tion. Each day that th e violation continues constitutes a separate violation. Any person who knowingly or willfully viol ates this order shall (either in addition to or in lie u 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 will be entitled to an administrative hearing held

on the record in accordance with section 554 of th e Administrative Procedures Act (APA). 15 U.S.C. §2615(a)(1)-(2)(A). Before issuing a fina l penalty order, EPA must provide notice of its intention to assess the penalty, in cluding a draft of the final pena lty order, and provide you with the opportunity to request a heari ng within 15 days of the date th e 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 vi olation; (3) the extent and gravity of the violation(s); (4) your ability to pa y; (5) the effect on your ability to continue to do business; (6) any history of prior violations; and (7) the degree of culpability [15 U.S.C. § 2615(a)(2)(B)]. In this hearing, you may not raise any challenge to the validity of this order, or any test required by

this order.



### Section IX. Additional Information

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

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

.

If you have any questions about the require ments and procedures established by this Order, please contact one of the following EPA people:FFDCA 408(p) Order Template fo r Pesticide Inert Ingredients As of April 3, 2009

Page 17 of 17 William Wooge

Office of Science Coordination a nd Policy (OSCP), Mailcode 7201M Environmental Protection Agency 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001 telephone number: (202) 564–8476; fax number: (202) 564–8482

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

Jane Smith Office of Pesticide Programs (OPP), Mailcode 7508P Environmental Protection Agency 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001 telephone number: (703) 308-0048; fax number: (703) 305-8005

e-mail address: smith.jane-scott@epa.gov



### Section 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 St ates Environmental Protection Agency hereby issues this testing Order to take effect on the date of my signature.

Date: _____________________

Signature: ________________________________________ [Insert Name and Title of Authorized Agency Official] Office of Prevention, Pesticides and Toxic Substances U.S. Environmental Protection Agency

Enclosures

Enclosure A – List of EDSP Order Recipients for this Chemical Enclosure B – The Initial Respons e Form for Individual Responders Enclosure C – The Initial Response Form for Consortium /Task Force