Attachment C(2) - Order Template for Inerts

Attachment C(2)
FFDCA 408(p) Order Template for Pesticide Inert Ingredients
As of September 16, 2009
NOTE: This template was developed by EPA to provide guidance to EPA staff and managers
who will be preparing the Tier 1 Orders that will be issued under the Endocrine Disruptor
Screening Program (EDSP), as well as for the recipients of the Orders. This template is not a
rule or regulation, nor does it create or confer legal rights or impose any legally binding
requirements on EPA or any party. In preparing a final Order, EPA may depart from the
guidance presented in this template where circumstances warrant and without prior notice.
Orders will be generated individually for each chemical and each order recipient. EPA will
insert the information in blue type and brackets when the Order is generated.

FIRST CLASS MAIL – RETURN RECEIPT®
Summary Information about this Order and the Order Recipient:
Order #: [Insert sequential number as assigned by the system.]
Chemical Common Name: [Insert chemical name.]
Chemical #: [Insert number assigned to identify the chemical named above.]
Date Issued: [Insert date of signature. This serves as the issuance date.]
Due Date for Initial Response: [Insert date, calculated as 90 calendar days from issuance plus
10 calendar days for final processing and mailing (i.e., total 100 calendar days from issuance).]
Due Date for Consortia Documentation: [Insert date, calculated as 150 calendar days from
issuance plus 10 calendar days for final processing and mailing (i.e., total 160 calendar days
from issuance).]
Due Date for Progress Report: [Insert date, calculated as 12 months from issuance.]
Due Date for Final Submission: [Insert date, calculated as 24 months from issuance].
Company Name: [Insert name.]
Company #(s): [Insert number assigned to identify the company in the system.]
Address: [Insert address where Order will be directed to.]
Contact Person: [Insert the name of the contact person.]
Dear Sir or Madam:
This Order requires you and other manufacturers and importers of the chemical named
above to submit certain data or otherwise respond as noted herein to the U. S. Environmental
Protection Agency (EPA, the Agency). 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 section
408(p)(3) of the Federal Food, Drug and Cosmetic Act (FFDCA), which mandates that all
pesticide chemicals, including inert ingredients, be 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].
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Introduction
This Order is issued pursuant to sections 408(p)(3) and (5) of the FFDCA [21 U.S.C.
346a(p)(3), (5)]. FFDCA section 201(q)(1) defines “pesticide chemical” as “any substance that
is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act,
including all active and inert ingredients of such pesticide” [21 U.S.C. 231(q)(1)].
To facilitate the formation of consortia to develop the data required by this Order, and to
the extent that the information is not protected as confidential business information, we have
provided each Order recipient with a list of the other recipients of an Order for this chemical.
(See Enclosure A). EPA intends to announce the issuance of this Order and the availability of a
list of all Order recipients for this chemical in the Federal Register. The list of Order recipients
for this chemical will be publicly available on the Agency's Web site, along with the status of the
Orders, including recipients’ responses. EPA intends to update this information with subsequent
publication(s) and posting(s) as appropriate. You are encouraged to join a consortium and can
check on the status of responses from the other Order recipients for this chemical on the Web
site.
[If the recipient has claimed CBI for his identity in relation to this chemical, include the
following additional sentences here: You will notice, however, that your company is included on
the list only as “Company X” due to previous CBI claims applicable to your identity information
for this chemical. So that other Order recipients can identify and contact you to collaborate on
responding to this Order, EPA recommends that you either declassify your identity information
so that it can be made publicly available, or you identify an agent who will act on your behalf in
all matters relating to this Order. If you choose to designate an agent, EPA will make the name
of the agent (instead of the company) public by including it on the list of recipients of FFDCA
section 408(p) Orders and DCI notices under the EDSP.]
The information collection requirements described in this document have been approved
by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA is
identified under EPA ICR No. 2249.01, and OMB Control No. 2070-[# will be inserted when
obtained]. The public reporting burden for this collection of information is estimated to average
[# will be inserted when ICR is approved] hours per Order. Your feedback on this estimate
would help facilitate the Agency’s review of the assumptions and estimates before renewal of the
OMB approval for this ICR is sought. Completing the enclosed questionnaire is optional, and
the responses provided will only be considered in the Agency’s review of the burden estimates
when developing the renewal request for this ICR. See Enclosure D.
This Order is organized as follows:
Introduction..................................................................................................................................... 2
Section I. The Authority for this Order.......................................................................................... 3
Section II. Why You Are Receiving This Order............................................................................ 4
Section III. Data Required By This Order ..................................................................................... 4
III.A. Data Required – The Tier 1 Battery......................................................................... 4
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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.................................................................. 9
Option 3: Form a Task Force or Offer to Join a Task Force................................ 10
Option 4: Claim Not Subject To the Order.......................................................... 11
Option 5: Discontinue the Manufacture or Import of the Chemical.................... 12
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............................................................................... 14
Section V. Submitting Data to the Agency.................................................................................. 14
V.A. Format for Submissions .......................................................................................... 14
V.B. Transmittal Documents ........................................................................................... 14
V.C. Submitting Individual Study or Test Result Documents......................................... 15
V.D. Mailing Instructions ................................................................................................ 16
Section VI. Submit a Progress Report ......................................................................................... 16
Section VII. Recordkeeping Requirements.................................................................................. 16
Section VIII. Consequences of Failure to Comply with this Order............................................. 16
Section IX. Additional Information ............................................................................................. 17
Section X. Conclusion ................................................................................................................. 17

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 chemical” as “any substance that is a
pesticide within the meaning of [FIFRA], including all active and inert ingredients of such
pesticide.” [21 U.S.C. 231(q)(1)].
Section 408(p)(5) of the FFDCA provides that the Administrator shall issue an order to a
registrant of a substance for which testing is required under this subsection, or to a person who
manufactures or imports a substance for which testing is required under this subsection, to
conduct testing in accordance with the screening program, and submit information obtained from
the testing to the Administrator, within a reasonable time period that the Administrator
determines is sufficient for the generation of the information.

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Section II. Why You are Receiving this Order
On April 15, 2009, EPA published a final list of the chemicals to undergo EDSP Tier 1
screening (74 FR 17579). 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 408(p)(3) of the FFDCA, you are subject to
this Order.

Section III. Data Required by this Order
This Order identifies the screening assays that will identify substances that have the
potential to interact with the endocrine system. These screening assays are part of Tier 1
screening under the EDSP. The purpose of Tier 1 screening (also referred to as “screening”) is
to identify substances that have the potential to interact with the estrogen, androgen, or thyroid
hormone systems using a battery of assays. The fact that a substance may interact with a
hormone system, however, does not mean that when the substance is used, it will cause adverse
effects in humans or ecological systems.
Although this Order only identifies the Tier 1 screening assays, upon examining the
screening data submitted, EPA may issue a subsequent Order to require additional testing of this
chemical under Tier 2 of the EDSP to:
• Determine whether a substance may cause endocrine-mediated effects through or involving
estrogen, androgen, or thyroid hormone systems, or such other endocrine effect as the
Administrator may designate;
• Determine the consequences to the organism of the activities observed in screening assays;
and
• Establish the relationship between doses of an endocrine-active substance administered in
the test and the effects observed.

III.A. Data Required – The Tier 1 Battery
[NOTE: The availability of the final Tier 1 screening battery will be announced in the Federal
Register before any Orders are issued. Until that is done, the list of assays presented in this
template is 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 this will be revised to reflect the final Tier 1 Battery.]
The following is a list of the EDSP Tier 1 Battery that identifies the data you must submit
to the Agency in response to this Order:

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Amphibian Metamorphosis (Frog) - The Amphibian Metamorphosis assay involves the use of
tadpoles to determine if chemicals affect the hypothalamic-pituitary-thyroid (HPT) axis during
metamorphosis and consequently result in developmental effects.
Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is involved in the
development of male sexual characteristics. The AR Binding assay identifies chemicals that
affect the endocrine system by binding to hormone receptors to either mimic the action of the
natural hormone or block access of the hormone to the site and thus block hormone controlled
activity.
Aromatase (Human Recombinant) - Aromatase is an enzyme complex responsible for estrogen
biosynthesis that converts androgens into estrogens, estradiol, and estrone. The Aromatase in
vitro assay focuses on this portion of the steroidogenic pathway to detect substances that inhibit
aromatase activity.
Estrogen Receptor Binding - The estrogen receptor (ER) is involved in female maturation and
reproductive function. The ER Binding assay measures the ability of a chemical to bind to the
estrogen receptor.
Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) - The estrogen
receptor (ER) is involved in female maturation and reproductive function. The ER
Transcriptional Activation is a cell-based assay that measures the ability of a chemical to bind to
the ER and activate transcription resulting in the synthesis of the enzyme luciferase.
Fish Short-term Reproduction - The Fish Short-term Reproduction assay screens for disturbances
in the hypothalamic-pituitary-gonadal (HPG) axis including (anti-)estrogenic, (anti-)androgenic,
aromatase inhibition, and steroid modulating effects. The assay examines abnormalities
associated with survival, reproductive behavior, secondary sex characteristics, histopathology,
and fecundity (i.e., number of spawns, number of eggs/spawn, fertility, and development of
offspring) of fish exposed to test chemicals.
Hershberger (Rat) - The Hershberger assay is designed to detect androgenic and anti-androgenic
effects. In this in vivo assay, the weight of several androgen-dependent tissues, including
accessory sex glands, are measured in castrated or immature male rats.
Female Pubertal (Rat) - The Pubertal Female assay involves the use of rats to screen for
estrogenic and thyroid activity in females during sexual maturation. This assay examines
abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.
Male Pubertal (Rat) - The Pubertal Male assay involves the use of rats to screen for androgenic,
anti-androgenic, and thyroid activity in males during sexual maturation. This assay examines
abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.
Steroidogenesis (Human Cell Line – H295R) - The Steroidogenesis in vitro assay detects
interference with the body's production of male and female steroid sex hormones. This assay is a
cell-based assay using the H295R human adrenocortical carcinoma cell line which can detect
inducers of enzymes responsible for steroid synthesis as well as chemicals that inhibit it.
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Uterotrophic (Rat) - The Uterotrophic assay involves the use of female rats to screen for
estrogenic effects. In this in vivo assay, uterine weight changes are measured in ovariectomised
or immature female rats.

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” is information that informs the determination
as to whether the substance may have an effect that is similar to an effect produced by a
substance that interacts with the estrogen, androgen, and/or thyroid hormonal systems (e.g.,
information that identifies substances as having the potential to interact with the estrogen,
androgen, and/or thyroid system(s); information demonstrating whether substances have an
effect on the functioning of the endocrine system). Other scientifically relevant information may
either be functionally equivalent to information obtained from the Tier 1 assays—that is, data
from assays that perform the same function as EDSP Tier 1 assays—or may include data that
provide information on a potential consequence or effect that could be due to effects on the
estrogen, androgen or thyroid systems. See also the discussion in Section IV. of this Order.
The assays identified in Section III.A. of this Order must be conducted using the test
protocols that have been validated and made available for use by the Order recipients that are
completing the assays to generate new data to respond to this Order. All of the applicable testing
protocols have been validated and are available on the Agency’s Web site at:
http://www.epa.gov/oppts (select “Test Methods & Guidelines” on the left).
If you choose to generate the data to respond to this Order, you may not deviate from an
approved testing protocol unless you first consult with the Agency and obtain Agency approval
of any planned deviation. If you wish to use a protocol that differs from those identified in this
Order, you must submit a detailed description of the proposed protocol (including a precise
description of any deviations from the protocol identified in this Order) and your reason for
wishing to use it. Because section 408(p)(1) of the FFDCA requires that the screening be
conducted with validated tests, in order for EPA to approve the use of your proposed alternate
protocol, you must demonstrate that the alternate protocol has been scientifically validated or the
deviation is such that the final study is nonetheless properly considered to have been
scientifically validated. If the Agency rejects your alternate protocol you will be notified in
writing. Moreover, you should be aware that rejection of a proposed alternate protocol will not
be a basis for extending the deadline for submission of data.
If you choose to cite or submit existing data, including other scientifically relevant
information, you must indicate whether the information provided follows an accepted scientific
methodology or protocol, including but not limited to those presented in EPA’s harmonized test
guideline compendium (see http://www.epa.gov/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 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
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information available to the Agency. See the instructions for submitting your response, which
appear in Section IV. of this Order.
You must also adhere to the good laboratory practice (GLP) standards described in 40
CFR part 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
were generated using GLPs; or b) describe in detail “all differences” between the GLPs and the
practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore
know whether the study was conducted in accordance with the GLPs.

III.C. Generating the Data – Applicable Timeframes
You are required to submit the data or otherwise satisfy the data requirements specified in
this Order, and submit the data to EPA no later than 24 months from issuance of this Order (see
page 1 of this Order). The Agency set this due date after considering the amount of time one
might reasonably expect is needed to complete each assay, including the planning activities
before beginning the test, actual performance of the test, analyzing test results, and completing
the final study report for that assay (see Table 1). EPA also included several months for overall
planning, and several months after the last test is completed to allow ample time for the Order
recipients to prepare the final report for submission to EPA.
Table 1 – Estimated Timeframes for Completing the Individual Assay Reports
Assay

Timeframes

Amphibian Metamorphosis (Frog)
Androgen Receptor Binding (Rat Prostate)
Aromatase (Human Recombinant)
Estrogen Receptor Binding
Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903))
Fish Short-term Reproduction
Hershberger (Rat)
Female Pubertal (Rat)
Male Pubertal (Rat)
Steroidogenesis (Human Cell Line – H295R)
Uterotrophic (Rat)

15 months
6 months
6 months
6 months
6 months
12 months
9 months
15 months
15 months
6 months
9 months

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

Section IV. Responding to the Order
You must respond to this Order within the timeframes established pursuant to Section
IV.A. of this Order, and the specific applicable dates as identified on page 1 of this Order. If you
do not respond to this Order, or if you fail to otherwise comply with its requirements, you will be
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subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15
U.S.C. 2601].
To comply with this Order, you are expected to engage in the following activities:
(1) Read this Order.
(2) Determine and plan activities necessary to respond to the order.
(3) Submit an Initial Response Form to EPA, identifying the response option you intend
to use. See Section IV.B. of this Order.
(4) If you decide to generate the data, Read and, if applicable, discuss the protocols. See
Section III.B. of this Order.
(5) Submit a Progress Report. See Section VI. of this Order.
(6) Generate the data.
(7) Compile and review the data for submission. See Section V. of this Order.
(8) Complete paperwork to assemble the submission package. See Section V. of this
Order.
(9) Submit Final Report/Data to EPA. See Section V. of this Order.
(10) Maintain records. See Section VII. of this Order.

IV.A. Schedule for Responding to the Order
Your schedule for responding may vary based on the response options discussed in more
detail in the next Section of this Order. Please note that in calculating the due date for the Initial
Response, the Agency has included an additional 10 calendar days to account for processing the
final order package for delivery to the Post Office. Your basic schedule is summarized on page 1
of this Order and is based on the timeframes identified in Table 2:
Table 2 – Basis for Establishing the Due Dates in this Order
Timeframes for Due Dates:
Within 90 calendar days of the Order’s issuance
(plus 10 calendar days for processing)
Within 150 calendar days of the Order’s issuance
(plus 10 calendar days for processing)
Within 12 months from Order’s issuance
On or before 6 (six) months of the Order’s
issuance
24 months from Order’s issuance

What is Due:
Individual Recipient’s Initial Response
Consortia Documentation & Consortia’s Initial
Response
A Progress Report describing the status of an Order
Recipient’s compliance with the Order.
A Manufacturer/Importer that chooses the “opt-out”
option is agreeing to cease all sale and distribution
of the chemical in the pesticide market.
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 for meeting such requirements on a step-by-step
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basis. You must explain any technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing; 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 registrant, manufacturer, or importer. Extensions will not be
considered if the request for extension is not made 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 this Order. To report your commitment to act
in response to this Order, you must submit an Initial Response to EPA within 90 days of the
issuance of this Order.
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 if you choose that response option.
Option 1: Generate Data
If you choose to individually generate new data for each test specified in this Order, you
must comply with the procedures prescribed in this Order. All data generated and submitted
must comply with the Good Laboratory Practice (GLP) rule (40 CFR part 160) and the tests must
be conducted according to protocol requirements identified in Section III.B. of this Order. In
submitting the data, you must follow the procedures described in Section V. of this Order.
Option 2: Submit or Cite Existing Data
If you choose to submit or cite an existing study in response to this Order (including data
previously submitted to the Agency and/or other scientifically relevant information), your Initial
Response must include either the data or a reference to the data for each test that is required,
along with a rationale that explains how the study you cited or submitted satisfies part or all of
this Order. Existing studies are studies that predate issuance of this Order. In order to be
accepted as satisfaction of the requirements imposed in this Order, the Agency expects that any
such hazard-related data would be of high quality and achieves the objective of Tier 1 assays to
provide reasonable assurance that a chemical does or does not have the potential to interact with
the estrogen, androgen, or thyroid systems. EPA’s decisions about whether the data cited or
submitted satisfies part or all of the Tier 1 Order will be based on the weight of evidence from all
relevant information available to the Agency.
The submitted or cited study must have been conducted in accordance with accepted
scientific methodology or protocol, including but not limited to those presented in EPA’s
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harmonized test guideline compendium (see http://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, the protocol used should still be considered as providing an
accepted scientific methodology or protocol, and any other information you think the Agency
should consider in deciding whether to accept the data in satisfaction of this Order.
If EPA has previously reviewed a protocol for a study you are submitting or citing, you
must identify any action taken by the Agency on the protocol and must indicate the manner in
which all Agency comments, concerns or issues were addressed in the final protocol and study.
If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable (i.e., the study was not rejected by the
Agency for any reason related to completeness or quality) or it must be a study which has not yet
been reviewed by the Agency. With respect to any studies for which you wish to select this
option you must provide EPA with a copy of the title page along with the identification number
of the study you are citing (MRID number), and, if the study has been reviewed by the Agency,
you must provide the Agency's classification of the study. Do not resubmit a study that has
previously been submitted to EPA for another purpose.
EPA will review any existing study submitted or cited in response to this Order to
determine whether the study is acceptable and whether the study satisfies the requirements of this
Order. The Agency will notify you 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
complete to satisfy this Order and EPA will notify you in writing that the Order is satisfied. If,
however, EPA determines that the study is not acceptable, you must still satisfy the requirements
of this Order. You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Order, normally without an
extension of the required due date for submission of the data. The Agency may determine at any
time that a study is not valid and needs to be repeated.
If you are citing a study of which you are not the original data submitter, you may need to
submit an offer to pay compensation to the original data submitter. Consequently, you should
simultaneously include an offer to pay [in accordance with 40 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 action)], unless you have received confirmation from EPA that no
such compensation is necessary.
Option 3: Form a Task Force or Offer to Join a Task Force
If you choose to form a task force or consortium to share in the cost of producing the
required data, all participants of the task force or consortium must submit their own Initial
Response Form for Individual Order Recipients providing the name of the party who will be
submitting the data on your behalf.

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The designated lead for the task force or consortium must complete the Initial Response
Form for Consortium /Task Force (Enclosure C) to provide the primary contact for the task
force or consortium, the list of participants, and an indication of the task force or consortium’s
planned response for each assay, along with documentation of its formation (such as a copy of
the joint agreement or a written statement by all the parties that an agreement exists). The joint
agreement to produce the data need not specify all of the terms of the final arrangement between
the parties or the mechanism to resolve the terms. The designated lead for the task force or
consortium must follow the mailing instructions in Section V.D. of this Order to submit the
consortium/taskforce’s initial response and accompanying information to EPA by the due date
for the consortia response that is indicated on page 1 of this Order.
Once the task force or consortium submits the data and EPA has completed its initial
review to accept the data in satisfaction of this Order, EPA will provide written notification to
the contact for the task force or consortium that this Order has been satisfied, which in turn will
close out the Orders for each of the participants in the consortium/task force.
If you are unable to join a task force or consortium, you must provide EPA with
documentary evidence that you made a reasonable offer to join or share in the testing costs.
Such evidence may be (1) your letter offering to join in an agreement, or (2) your letter that
contains a legally binding offer to join in an agreement and provide a reasonable share of the test
costs, and that includes a reasonable process for resolving any disputes of the appropriate share
of the test costs.
If the task force or consortium fails to submit the data or meet the requirements of the
Order in a timely and adequate manner, you will normally be subject to penalties of up to
$25,000 per day, unless you commit to submit, and do submit, the required data by the dates
specified in this Order. In such cases, the Agency will generally not grant time extensions for
the submission of data. Thus, if you agree to 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 with the deadlines
and all other requirements set forth in this Order.
The Agency has provided a list of the other manufacturers and/or importers, to the extent
permitted by confidentiality requirements, that have received an EDSP Order for this chemical.
(Enclosure A). This list is intended to help order recipients identify other companies with whom
they could form agreements to develop data jointly, or otherwise collaborate on a response to
satisfy the requirements in this Order.
Option 4: Claim Not Subject to the Order
You may claim that you are not subject to this Order if you do not manufacture or import
the chemical 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 can not verify your claim, the original requirements and

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deadlines in this Order remain. If your claim is verified, EPA will consider your response to be
satisfaction of the Order and will close out this Order.
Option 5: Discontinue the Manufacture or Import of the Chemical
If you have already, or otherwise are in the process of discontinuing the manufacture or
import of this chemical, you may satisfy the Order by submitting documentation to this effect
with your Initial Response. If EPA can not verify your claim, the original requirements and
deadlines in this Order remain. If your claim is verified, EPA will consider your response to be
satisfaction of the Order and will close out this Order.
Option 6: Stop Sales into the Pesticide Market
You may 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 distribution of the pesticide inert ingredient that is the
subject of this Order to any person who you know, or reasonably should know, intends to use the
substance in the formulation of a pesticide 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
pesticide 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 response you are required to
complete under this Order.
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 frame that had originally been required by the Order. In addition, you may be
subject to potential 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 appropriate data) that the chemical is an
endocrine disruptor and that additional screening or testing under the EDSP is
unnecessary.
b)

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

Your chemical was used by EPA as a ‘‘positive control’’ to validate one or more of
the screening assays. EPA will only accept these data in satisfaction of that part of
the 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 in writing
within 90 days of receipt. If EPA can not verify your claim, the original requirements and
deadlines in this Order remain. If your claim is verified, EPA will consider your response to be
satisfaction of the Order and will close out this Order.

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 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 in
writing within 90 days of receipt. If EPA does not grant your request, the original deadline
remains.

IV.E. Procedures for Cost Sharing
Cost sharing is the process by which two or more recipients of an Order contribute to the
generation of data (or the compensation for existing data). Contributions may be in cash or in
kind and apportionment of costs is subject to negotiation between the participants. EPA
encourages all recipients of an Order for a particular substance to jointly submit data and share
data generation costs. All other parties who are also subject to this Order are listed in Enclosure
A, unless that information is protected as confidential business information, and will be made
publicly available on the Agency’s Web site.
EPA has not established specific coordination procedures by which you must collectively
generate data. You may therefore determine the procedures that are best suited to your individual
circumstances, and the most acceptable approach to identifying and sharing costs.
If you are aware of another manufacturer or importer of the chemical listed on page 1 of
this Order who is not listed on Enclosure A, and you provide EPA with this information, EPA
intends to send that manufacturer or importer an Order for this chemical within 90 days of your
notification.

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IV.F. 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.
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 should be clearly identified as such. Note that
substantive criteria must be met to support a claim confidentiality of business information, as
specified in 40 CFR §2.208.

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 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 about these templates are available at:
http://www.epa.gov/pesticides/regulating/studyprofile_templates/.
In addition, Pesticide Registration (PR) Notice 86–5, entitled Standard Format for Data
Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain
Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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 Order recipients 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 Web site at
http://www.epa.gov/oppfead1/eds/edsgoals.htm.

V.B. Transmittal Documents
In order for EPA to effectively track the compliance of each order recipient, each
submission in satisfaction of this Order must be accompanied by a transmittal document that
includes the following information:
• Identity of the submitter.
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• The date on which the submission package was prepared for transmittal to EPA.
• The Order number identified on page 1 of this Order.
• A list of the individual documents included in the submission.

V.C. Submitting Individual Study or Test Result Documents
Unless otherwise specified by the Agency, each submission must be in the form of
individual documents or studies. Do not resubmit any documents that you previously submitted
to EPA. Instead, as part of your Initial Response Form, please provide a citation or reference to
the previously submitted documents with sufficient information to allow the Agency to identify
the previously submitted document.
Each study or document submitted to EPA must include the following:
i. A title page including the following information:
• The Order number identified on page 1 of this Order.
• The title of the study, including identification of the substance(s) tested and the test
name or data requirement addressed.
• The author(s) of the study.
• The date the study was completed.
• If the study was performed in a laboratory, the name and address of the laboratory,
project numbers or other identifying codes.
• If the study is a commentary on or supplement to another previously submitted
study, full identification of the other study with which it should be associated in
review.
• If the study is a reprint of a published document, all relevant facts of publication,
such as the journal title, volume, issue, inclusive page numbers, and date of
publication.
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 translation must be included for any information
that is not in English.

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V.D. Mailing Instructions
Your response to this Order and all related correspondence must be mailed or delivered to
EPA using one of the following methods:
Mail To: Document Processing Desk (PRD-EDSP), Office of Pesticide Programs (7504P),
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, D.C.
20460
Deliver To: Document Processing Desk (PRD-EDSP), Office of Pesticide Programs
(7504P), U.S. Environmental Protection Agency, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted 8:30 a.m. to 4 p.m., Monday
through Friday, excluding 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 EPA 12 months after the issuance of this Order
(the specific due date for you is identified on page 1 of this Order). Your progress report should
provide a brief description of the status of your planned activities for each assay, and, if
applicable, a description of any problems encountered or expected difficulties in meeting the
schedule for complying with the Order. Please include the transmittal document described in
Section V.B of this Order.

Section VII. Recordkeeping Requirements
You must retain copies of the generation of the data and other information documenting
your compliance with this Order. This includes all test reports submitted to the Agency 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 any 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 will be entitled to an administrative hearing held
on the record in accordance with section 554 of the Administrative Procedures Act (APA). 15
U.S.C. §2615(a)(1)-(2)(A). Before issuing a final penalty order, EPA must provide notice of its
intention to assess the penalty, including a draft of the final penalty order, and provide you with
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the opportunity to request a hearing within 15 days of the date the notice has been received. 15
U.S.C. §2615(a)(2)(A). See also, 40 C.F.R. §§ 22.13-22.14.
If a hearing is requested, the only matters for resolution at the hearing shall be the
following: (1) whether you have failed to comply with an Order issued under FFDCA section
408(p)(5)(A), (2) the circumstances of the violation; (3) the extent and gravity of the
violation(s); (4) your ability to pay; (5) the effect on your ability to continue to do business; (6)
any history of prior violations; and (7) the degree of culpability [15 U.S.C. § 2615(a)(2)(B)]. In
this hearing, you may not raise any challenge to the validity of this Order, or any test required by
this Order.

Section IX. Additional Information
Additional information and details about the EDSP may be found on the Agency’s Web
site at http://www.epa.gov/endo.
If you have any questions about the requirements and procedures established in this
Order, please contact one of the following EPA people:
William Wooge
Office of Science Coordination and 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 in FFDCA section 408(p) [21 U.S.C. 346a(p)], the United States
Environmental Protection Agency hereby issues this Order to take effect on the date of my
signature.
Date: _____________________
Signature: ________________________________________
[Insert Name and Title of Authorized Agency Official]
Office of Prevention, Pesticides and Toxic Substances
U.S. Environmental Protection Agency
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Enclosures
Enclosure A – List of EDSP Order Recipients for this Chemical
Enclosure B – The Initial Response Form for Individual Responders
Enclosure C – The Initial Response Form for Consortium /Task Force
Enclosure D – Optional Questionnaire: Level of Effort for Recipients of Tier 1 Screening Orders

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