Document ID: EPA-HQ-OPPT-2007-1080-0042
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-11-17T05:00Z

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.]

CAS #:  [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 a substance that may be found
in sources of drinking water and to which EPA has determined that a
substantial population may be exposed.  

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

Introduction

	This Order is issued pursuant to sections 408(p)(3) and (5) of FFDCA
[21 U.S.C. 346a(p)(3), (5)] based on an EPA determination under section
1457 of the Safe Drinking Water Act (SDWA) [42 U.S.C. 300j-17].  

	To facilitate the formation of consortia to develop the data required
by this Order, and to the extent that the information is not protected
as 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 website,
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 check on the status of responses from the other Order recipients for
this chemical on the website at www.epa.gov/endo.  

	If you have previously claimed your identity in relation to this
chemical as confidential business information (CBI), you will notice
that your company is included on the list only as “Company X.”  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 so that other Order
recipients can identify and contact you to collaborate on responding 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 EDSP orders.  

	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. 2070-0176.  The public
reporting burden for this collection of information is estimated to
average ____ hours per Order recipient, or ____ hours when annualized
over 3 years.  Your feedback on this estimate will 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.

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 1457 of SDWA authorizes EPA to “provide for testing under the
screening program authorized by section…[408(p)] in accordance with
the provisions of section… [408(p)] of Title 21, of any other
substance that may be found in sources of drinking water… if a
substantial population may be exposed to such substance.” [42 USC §
300j-17.] 

	Section 408(p)(5) of 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. 

Section II.  Why You are Receiving this Order

	On April 15, 2009 and  ____ __, 2010, EPA published finalized lists of
the chemicals to undergo EDSP Tier 1 screening ((74 FR 17560 and __ FR
____), including chemicals that may be found in sources of drinking
water (i.e., a SDWA chemical).  The chemical identified on page 1 of
this Order is a SDWA chemical included on that list.  You are receiving
this Order because you are identified as a manufacturer and/or importer
of the chemical identified on page 1 of this Order.  As such, pursuant
to FFDCA section 408(p)(3) and SDWA section 1457, 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

The following is a list of the EDSP Tier 1 Battery that identifies the
data you must submit to the Agency in response to this Order: 

Amphibian Metamorphosis (Frog) - The Amphibian Metamorphosis assay
involves the use of tadpoles to determine if chemicals affect the
hypothalamic-pituitary-thyroid (HPT) axis during metamorphosis and
consequently result in developmental effects.

Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is
involved in the development of male sexual characteristics.  The AR
Binding assay identifies chemicals that affect the endocrine system by
binding to hormone receptors to either mimic the action of the natural
hormone or block access of the hormone to 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.

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 FFDCA section 408(p)(1), 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/ocspp/pubs/frs/publications/Test_Guidelines/series890
.htm.  

	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 FFDCA section 408(p)(1) 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/ocspp/pubs/frs/home/guidelin.htm), and provide a
cogent and complete rationale for why you believe the information is
sufficient to satisfy part or all of this Order.  EPA’s decisions
about whether the information satisfies part or all of the Tier 1 Order
will be based on the weight of evidence from all relevant information
available to the Agency.  See the instructions for submitting your
response, which appear in Section IV. of this Order.

	You must also adhere to the good laboratory practice (GLP) standards.
Good Practices have been set out both in FIFRA for pesticides in 40 CFR
160 and for TSCA chemicals in 40 CFR 792.   Test order recipients would
need to follow appropriate GLPs, including protocol requirements and
procedures for submitting the data described in this Order.  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 you to prepare the final
report for submission to EPA.  

Table 1 – Estimated Timeframes for Completing the Individual Assay
Reports

Assay	Timeframes

	Amphibian Metamorphosis (Frog)	15 months

Androgen Receptor Binding (Rat Prostate)	6 months

Aromatase (Human Recombinant)	6 months

Estrogen Receptor Binding	6 months

Estrogen Receptor Transcriptional Activation (Human Cell Line
(HeLa-9903))	6 months

Fish Short-term Reproduction	12 months

Hershberger (Rat)	9 months

Female Pubertal (Rat)	15 months

Male Pubertal (Rat)	15 months

Steroidogenesis (Human Cell Line – H295R)	6 months

Uterotrophic (Rat)	9 months

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

Within 90 calendar days of the Order’s issuance (plus 10 calendar days
for processing)	Individual Recipient’s Initial Response 

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

Within 12 months from Order’s issuance	A Progress Report describing
the status of an Order Recipient’s compliance with the Order. 

On or before 6 (six) months of the Order’s issuance	A
Manufacturer/Importer that chooses to cease all manufacture and import
of the chemical has agreed to do so.

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 for
meeting such requirements on a step-by-step 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 (corresponds to 2.1.A. in the Initial Response
Form)

	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 GLP 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 (corresponds to 2.1.B., 2.1.C.,
and 2.2. in the Initial Response Form)

	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 harmonized test guideline
compendium (see http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm). 
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, 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 [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 Consortium or Offer to Join a Consortium (corresponds
to 2.1.D. in the Initial Response Form)

	If you choose to form a consortium to share in the cost of producing
the required data, all participants of the 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 consortium must complete the Initial
Response Form for Consortium (Enclosure C) to provide the primary
contact for the consortium, the list of participants, and an indication
of the 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 consortium must follow the
mailing instructions in Section V.D. of this Order to submit the
consortium 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 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 consortium that this
Order has been satisfied, which in turn will close out the Orders for
each of the participants in the consortium.

	If you are unable to join a 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 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, 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, 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 (corresponds to 2.3. in the
Initial Response Form)

	You may claim that you are not subject to this Order if you do not
manufacture or import the chemical or substance 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 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
(corresponds to 2.4. in the Initial Response Form)

	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:  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:

You can demonstrate (supported by appropriate data) that the chemical is
an endocrine disruptor and that additional Tier 1screening under the
EDSP is unnecessary. 

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”).

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 the factual predicate for
issuance of the Order, specifically the EPA determination that the
chemical or substance for which testing is required by this Order is a
“substance that may be found in sources of drinking water” and/or
that “a substantial population may be exposed to such substance,”
you may do so under SDWA section 1448 [42 U.S.C. 300j-7(a)] by filing a
petition for review in the United States Court of Appeals for the
circuit in which you reside or transact business within 45 days of the
date that begins 10 days after the date of this Order.

If you wish to challenge the validity of any other the provisions of
this Order, including the requirement to conduct any test or use the
specific test protocols required by this Order, you must submit to the
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. Note that EPA does not intend to send test orders to
manufacturers or importers who meet the de minimis criteria discussed in
the EDSP Revised Policies and Procedures for Screening SDWA Chemicals
(XX FR XXXXX).

	

IV.F.  Procedures for Data Protection

	All confidential business information submitted in response to a 408(p)
Order 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

Note:  The format for this orders is under development, but is expected
to be similar in concept to the format used for the FIFRA/FFDCA orders. 
The following language is specific to those FIFRA/FFDCA orders and is
retained as an example of the expected language for a SDWA/FFDCA order.

 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 that may be used to respond under this order.
These templates describe the layout and scope of information that should
be contained within a study profile and can serve as guides for
preparation of study documents.  Use of the templates 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:   HYPERLINK
"http://www.epa.gov/pesticides/regulating/studyprofile_templates/" 
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 (  HYPERLINK
"http://www.epa.gov/PR_Notices/pr86-5.html" 
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

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.

• 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.

	iii.  A statement of compliance or non-compliance with respect to GLP
standards as applicable.  

	iv.  A complete and accurate English translation 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 using one of the following methods: 

Mail To:  Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), U.S. EPA, 1200 Pennsylvania Ave. NW,
Washington, D.C. 20460

Deliver To:  OPPT Document Control Office (DCO), EPA East Bldg., Rm.
6428, U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460-0001.
[Deliveries are only accepted from 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, all underlying raw data, and
interpretations and evaluations thereof.  These records shall be
retained as long as the chemical is produced and the producer is in
business, and be made available to EPA or its agent for inspection.

Section 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.  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 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 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   HYPERLINK "http://www.epa.gov/endo" 
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6telephone number: (202) 564–4775; fax number: (202) 564–8789

e-mail address: ssharkey.susan@epa.gov 

William Wooge 

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

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:   ________________________________________

		

		Jim Willis, Director

		Chemical Control Division

		Office of Pollution Prevention and Toxics

		U.S. Environmental Protection Agency

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

Enclosure D – Optional Questionnaire: Level of Effort for Recipients
of Tier 1 Screening Orders

Page   PAGE  15  of   NUMPAGES  16 

FFDCA §408(p) Order Template for Manufacturers/Importers of SDWA
Chemicals

Draft - September 22, 2010

Page   PAGE  1  of   NUMPAGES  16