Policy and Procedures for EDSP Tier 1

Attachment B
17560

Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices

ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2007–1080; FRL–8399–9]
RIN 2070–AD61

Endocrine Disruptor Screening
Program; Policies and Procedures for
Initial Screening
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This document describes the
policies and procedures EPA generally
intends to adopt for initial screening of
chemicals under the Endocrine
Disruptor Screening Program (EDSP).
The EDSP is established under section
408(p) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), which requires
endocrine screening of all pesticide
chemicals and was established in
response to growing scientific evidence
that humans, domestic animals, and fish
and wildlife species have exhibited
adverse health consequences from
exposure to environmental chemicals
that interact with their endocrine
systems. In December 2007, EPA sought
comment on its draft policies and
procedures for initial screening under
the EDSP. Following review and
revision based on the public comments,
EPA is now describing the specific
details of the policies and procedures
that EPA generally intends to adopt for
initial screening under the EDSP,
including the statutory requirements
associated with and format of the test
orders, as well as EPA’s procedures for
fair and equitable sharing of test costs
and handling confidential data.
FOR FURTHER INFORMATION CONTACT:
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; email address: wooge.william@epa.gov.
SUPPLEMENTARY INFORMATION:

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I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you produce, manufacture,
use, or import pesticide/agricultural
chemicals and other chemical
substances; or if you are or may
otherwise be involved in the testing of
chemical substances for potential
endocrine effects. Potentially affected
entities, identified by the North
American Industrial Classification
System (NAICS) codes, may include, but
are not limited to:

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• Chemical manufacturers, importers
and processors (NAICS code 325), e.g.,
persons who manufacture, import or
process chemical substances.
• Pesticide, fertilizer, and other
agricultural chemical manufacturing
(NAICS code 3253), e.g., persons who
manufacture, import or process
pesticide, fertilizer and agricultural
chemicals.
• Scientific research and
development services (NAICS code
5417), e.g., persons who conduct testing
of chemical substances for endocrine
effects.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. To determine whether you
or your business may be affected by this
action, you should carefully examine
the applicability provisions in Unit
IV.E. of this document, and examine
section 408(p) of the FFDCA. If you
have any questions regarding the
applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2007–1080. All documents in the
docket are listed in the docket’s index
available at http://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
electronically at http://
www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine

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and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
2. Electronic access. In addition to
accessing the public docket for this
document through www.regulations.gov,
you can access other information about
the EDSP through the Agency’s website
at http://www.epa.gov/scipoly/
oscpendo/index.htm. You may also
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
http://www.epa.gov/fedrgstr.
II. Overview
A. What Action is the Agency Taking?
Following review of public comments
received on the Draft Policy and
Procedures in response to the Federal
Register notice of December 13, 2007
(72 FR 70842) (FRL–8340–3), EPA is
describing the policies and procedures
it generally intends to use to issue and
enforce orders pursuant to the authority
provided by section 408(p)(5) of the
Federal Food, Drug, and Cosmetic Act
(FFDCA). This document provides
specific details on the requirements
associated with section 408(p) of
FFDCA, format of the orders, and the
associated Agency policies and
procedures. This document also
describes the actions and/or procedures
that EPA intends to use to:
• Minimize duplicative testing (see
Unit IV.C.).
• Promote fair and equitable sharing
of test costs (see Unit IV.C.).
• Address issues surrounding data
compensation (see Unit IV.C.) and
confidentiality (see Unit IV.D.).
• Determine to whom orders would
generally be issued (see Unit IV.E.).
• Identify how order recipients
should respond to FFDCA section
408(p) test orders, including procedures
for challenging the orders (see Unit IV.F.
and H.).
• Ensure compliance with FFDCA
section 408(p) test orders (see Unit
IV.G.).
This document only addresses the
procedural framework applicable to
EPA’s implementation of FFDCA
section 408(p)(5), and it does not
address the tests or assays that will be
used to screen chemicals for their
potential to interact with the endocrine
system or the approach for selecting
chemicals under the EDSP. Elsewhere in
today’s Federal Register, the Agency is
publishing a document that presents the
final list of the first group of chemicals
to undergo Tier 1 screening.

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B. Does this Document Contain Binding
Requirements?
This document describes the
administrative policies and procedures
that EPA generally intends to use in
implementing the EDSP for initial
screening. While the requirements in
the statutes and the orders are binding
on EPA and the order recipients, this
document does not impose any binding
requirements. Although EPA tried to
develop policies that could be used in
subsequent data collection efforts, these
policies may be modified in response to
the Agency’s experience during initial
screening. The policies outlined in this
document are intended to further the
general goals of the program, and to the
extent the policies need to be amended
to further those programmatic goals,
EPA may do so. The policies and
procedures presented in this document
are not intended to be binding on either
EPA or any outside parties, and EPA
may depart from the policies and
procedures presented in this document
where circumstances warrant and
without prior notice.

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C. What is the Endocrine Disruptor
Screening Program (EDSP)?
The EDSP was established in 1998 to
carry out the mandate in section 408(p)
of the FFDCA (21 U.S.C. 346a et. seq.),
which directed EPA ‘‘to develop a
screening program . . . 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 endocrine effect
as the Administrator may designate.’’ If
a substance is found to have an
endocrine effect on humans, FFDCA
section 408(p)(6) directs the
Administrator to take action under
available statutory authority to ensure
protection of public health. That is, the
ultimate purpose of the EDSP is to
provide information to the Agency that
will allow the Agency to evaluate the
risks associated with the use of a
chemical and take appropriate steps to
mitigate any risks (Ref. 1). The
necessary information includes
identifying any adverse effects that
might result from the interaction of a
substance with the endocrine system
and establishing a dose-response curve
(Ref. 1). Section 1457 of the Safe
Drinking Water Act (SDWA) also
authorizes EPA to screen substances
that may be found in sources of drinking
water, and to which a substantial
population may be exposed, for
endocrine disruption potential. (42
U.S.C. 300j–17).
The Agency first proposed the basic
components of the EDSP on August 11,

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1998 (63 FR 42852) (FRL–6021–3). After
public comments, external consultations
and peer review, EPA provided
additional details on December 28, 1998
(63 FR 71542) (FRL–6052–9). The
design of the EDSP was based on the
recommendations of the Endocrine
Disruptor Screening and Testing
Advisory Committee (EDSTAC), which
was chartered under the Federal
Advisory Committee Act (FACA) (5
U.S.C. App.2, 9(c)). The EDSTAC was
comprised of members representing the
commercial chemical and pesticides
industries, Federal and State agencies,
worker protection and labor
organizations, environmental and public
health groups, and research scientists.
EDSTAC recommended that EPA’s
program address both potential human
and ecological effects; examine effects
on estrogen, androgen, and thyroid
hormone-related processes; and include
non-pesticide chemicals, contaminants,
and mixtures in addition to pesticides
(Ref. 1). In addition, because of the large
number of chemicals that might be
included in the program, EDSTAC also
recommended that EPA establish a
priority-setting approach for choosing
chemicals to undergo Tier 1 screening.
The Science Advisory Board (SAB)/
Scientific Advisory Panel Subcommittee
further recommended that initial
screening be limited to 50 to 100
chemicals.
Based on the EDSTAC
recommendations, EPA developed a
two-tiered approach to implement the
statutory testing requirements. The
purpose of Tier 1 screening (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.
The purpose of Tier 2 testing (referred
to as ‘‘testing’’), is to identify and
establish a dose-response relationship
for any adverse effects that might result
from the interactions identified through
the Tier 1 assays (Ref. 1).
EPA is implementing its EDSP in
three major parts developed in parallel.
This document deals only with one
component of the EDSP (i.e., the
administrative policies and procedures
related to the issuance of Tier 1 Orders).
The three parts are briefly summarized
as follows:
1. Assay validation. Under FFDCA
section 408(p), EPA is required to use
‘‘appropriate validated test systems and
other scientifically relevant
information’’ to determine whether

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substances may have estrogenic effects
in humans or other endocrine effects as
the Administrator may designate.
Validation is defined as the process by
which the reliability and relevance of
test methods are evaluated for the
purpose of supporting a specific use
(Ref. 2). The proposed EDSP Tier 1
Screening Battery of Assays was
presented to the FIFRA SAP during a
public meeting on March 25–27, 2008.
The FIFRA SAP report covering the
meeting is available at http://
www.epa.gov/scipoly/sap/meetings/
2008/march/minutes2008-03-25.pdf.
The final Tier 1 battery will be
announced in a separate Federal
Register document that the Agency
anticipates issuing in spring 2009. EPA
is also in the process of developing and
validating Tier 2 tests. The status of
each assay can be viewed on the EDSP
website in the Assay Status table: http://
www.epa.gov/scipoly/oscpendo/pubs/
assayvalidation/status.htm.
2. Priority setting. EPA described its
priority setting approach to select
pesticide chemicals for initial screening
on September 27, 2005 (70 FR 56449)
(FRL–7716–9), and announced the draft
list of initial pesticide active ingredients
and pesticide inerts to be considered for
screening under FFDCA on June 18,
2007 (72 FR 33486) (FRL–8129–3). The
first group of pesticide chemicals to
undergo screening is also referred to as
‘‘initial screening’’ in this document.
The Agency is publishing in today’s
Federal Register a final list of chemicals
that will be subject to initial screening.
EPA anticipates that it may, in the
future, modify its approach to selecting
chemicals for screening. Information
and factors that EPA may consider in
selecting chemicals could include:
Public input; the results of testing
chemicals on the initial list;
management considerations to increase
the integration of screening with other
regulatory activities within the Agency;
implementation considerations flowing
from a decision to extend screening to
additional categories of chemicals (e.g.,
non-pesticide chemical substances); and
the availability of new priority setting
tools (e.g., High Throughput Prescreening or Quantitative Structure
Activity Relationships models). More
information on EPA’s priority setting
approach and the list of chemicals is
available at http://www.epa.gov/scipoly/
oscpendo/pubs/prioritysetting.
3. Procedures. This Federal Register
document describes the administrative
policies and procedures that EPA
generally intends to use in
implementing the EDSP for initial
screening. Specifically, the general
policies and procedures relating to:

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• The issuance of FFDCA 408(p)
testing orders.
• Responses and related activities for
order recipients to use in responding to
an order.
• Joint data development, cost
sharing, data compensation, and data
protection.
• Other related procedures or
policies.
D. What Chemicals May Be Covered by
the EDSP?
FFDCA section 408(p)(3) specifically
requires that EPA ‘‘shall provide for the
testing of all pesticide chemicals.’’
Section 201 of FFDCA defines
‘‘pesticide chemical’’ as ‘‘any substance
that is a pesticide within the meaning of
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), including all
active and pesticide inert ingredients of
such pesticide.’’ (FFDCA section
201(q)(1), 21 U.S.C. 231(q)(1) (Note that
section 201(q) contains certain minor
exceptions that do not affect these
policies and procedures.)). Active
ingredients are the substances that
prevent, repel, suppress, control or kill
the target pests. (FIFRA section 2(a); 7
U.S.C. 136(a)) Pesticide inert ingredients
(also referred to as ‘‘other pesticide
ingredients’’) are any ingredients in a
pesticide product that are not active.
(FIFRA section 2(m); 7 U.S.C. 136(m)).
Pesticide inert ingredients may simply
dilute the active ingredient or they may
perform some function such as allowing
the product to adhere better to leaves or
other surfaces to improve contact with
the pests. Pesticide inert ingredients
also include fragrances, which may
mask the smell of residential pesticides,
and odorizers, which may act as
warning agents. Many of these
chemicals, including both pesticide
active and inert ingredients, also have
other, non-pesticidal uses.
FFDCA also provides EPA with
discretionary authority to ‘‘provide for
the testing of any other substance may
have an effect that is cumulative to an
effect of a pesticide chemical if the
Administrator determines that a
substantial population may be exposed
to such a substance.’’ (21 U.S.C.
346a(p)(3)).
In addition, EPA may provide for the
testing of ‘‘any other substance that may
be found in sources of drinking water if
the Administrator determines that a
substantial population may be exposed
to such substance.’’ (SDWA section
1457, 42 U.S.C. 300j–17).
Lastly, it is important to clarify that
the procedures and policies described in
this document do not in any way limit
the Agency’s use of other authorities or
procedures to require testing of

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chemicals for endocrine disruptor
effects. For example, section 4 of the
Toxic Substances Control Act (TSCA)
provides EPA with the authority to
require testing of TSCA chemical
substances, provided that the Agency
makes certain risk and/or exposure
findings. (15 U.S.C. 2603). Similarly,
section 3(c)(2)(B) of FIFRA grants EPA
the authority to require pesticide
registrants to submit additional data that
EPA determines are necessary to
maintain an existing registration. (7
U.S.C. 136a(c)(2)(B)).
As discussed in EPA’s priority setting
approach for the EDSP (70 FR 56449,
September 27, 2005), the Agency is
initially focusing its chemical selection
on pesticide chemicals, both active
ingredients and high production volume
chemicals used as a pesticide inert
ingredient in pesticides. If chemicals
identified for future screening and
testing under the EDSP are not used in
pesticides, the Agency intends to
consider whether the policies and
procedures identified in this document
would be appropriate for other
categories of substances.
E. How Will EDSP Data be Used?
In general, EPA intends to use the
data collected under the EDSP, along
with other information, to determine if
a pesticide chemical, or other
substances, may pose a risk to human
health or the environment due to
disruption of the endocrine system. The
determination that a chemical does or is
not likely to have the potential to
interact with the endocrine system (i.e.,
disruption of the estrogen, androgen, or
thyroid hormone systems) will be made
on a weight-of-evidence basis taking
into account data from the Tier 1 assays
and/or other scientifically relevant
information.
Chemicals that go through Tier 1
screening and are found to have the
potential to interact with the estrogen,
androgen, or thyroid hormone systems
will proceed to the next stage of the
EDSP where EPA will determine which,
if any, of the Tier 2 tests are necessary
based on the available data. Tier 2
testing is designed to identify any
adverse endocrine-related effects caused
by the substance, and establish a
quantitative relationship between the
dose and that endocrine effect.
III. Authority
A. What is the Statutory Authority for
the Policies Discussed in this
Document?
FFDCA section 408(p)(1) requires EPA
‘‘to develop a screening program, using
appropriate validated test systems and

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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)).
FFDCA section 408(p)(3) expressly
requires that EPA ‘‘shall provide for the
testing of all pesticide chemicals.’’
FFDCA section 201 defines ‘‘pesticide
chemical’’ as ‘‘any substance that is a
pesticide within the meaning of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), including all
active and pesticide inert ingredients of
such pesticide.’’ (FFDCA section
201(q)(1), 21 U.S.C. 231(q)(1)). The
statute also provides EPA with
discretionary authority to ‘‘provide for
the testing of any other substance that
may have an effect that is cumulative to
an effect of a pesticide chemical if the
Administrator determines that a
substantial population may be exposed
to such a substance.’’ (21 U.S.C.
346a(p)(3)).
FFDCA section 408(p)(5)(A) provides
that the Administrator ‘‘shall issue an
order to a registrant of a substance for
which testing is required [under FFDCA
section 408(p)], or to a person who
manufactures or imports a substance for
which testing is required [under FFDCA
section 408(p)], 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
Agency determines is sufficient for the
generation of the information.
FFDCA section 408(p)(5)(B) requires
that, ‘‘to the extent practicable, the
Administrator shall minimize
duplicative testing of the same
substance for the same endocrine effect,
develop, as appropriate, procedures for
fair and equitable sharing of test costs,
and develop, as necessary, procedures
for handling of confidential business
information. . . .’’ (21 U.S.C. 346a
(p)(5)(B)).
If a registrant fails to comply with a
FFDCA section 408(p)(5) test order, the
Administrator is required to issue ‘‘a
notice of intent to suspend the sale or
distribution of the substance by the
registrant. Any suspension proposed
under this paragraph shall become final
at the end of the 30–day period
beginning on the date that the registrant
receives the notice of intent to suspend,
unless during that period, a person
adversely affected by the notice requests
a hearing or the Administrator
determines that the registrant has
complied fully with this paragraph.’’ (21
U.S.C. 346a (p)(5)(C)). Any hearing is
required to be conducted in accordance

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with section 554 of the Administrative
Procedures Act (APA). (5 U.S.C. 554).
FFDCA section 408(p) explicitly
provides that ‘‘the only matter for
resolution at the hearing shall be
whether the registrant has failed to
comply with a test order under
subparagraph (A) of this paragraph.’’ (21
U.S.C. 346a (p)(5)(C)(ii)). A decision by
the Administrator after completion of a
hearing is considered to be a final
Agency action. (21 U.S.C. 346a
(p)(5)(C)(ii)). The Administrator shall
terminate a suspension issued with
respect to a registrant if the
Administrator determines that the
registrant has complied fully with
FFDCA section 408(p)(5). (21 U.S.C.
346a (p)(5)(C)(iii)).
FFDCA section 408(p)(5)(D) provides
that any person (other than a registrant)
who fails to comply with a FFDCA
section 408(p)(5) test order shall be
liable for the same penalties and
sanctions as are provided for under
TSCA section 16. (21 U.S.C. 346a
(p)(5)(D)). Such penalties and sanctions
shall be assessed and imposed in the
same manner as provided in TSCA
section 16. Under section 16 of TSCA,
civil penalties of up to $25,000 per day
may be assessed, after notice and an
administrative hearing held on the
record in accordance with section 554 of
the APA. (15 U.S.C. 2615(a)(1)–(2)(A)).
B. Other Statutory Authorities Relevant
to this Notice
A number of other statutory
provisions are discussed in this
document, and consequently, are
described below. This document does
not reopen in any way or otherwise
affect the existing policies or related
procedures that have been established
under these other provisions. The
following is a brief summary of these
other relevant authorities.
1. FIFRA. FIFRA section 3(c)(1)(F)
provides certain protections for people
who submit data to EPA in connection
with decisions under EPA’s pesticide
regulatory program. Specifically, FIFRA
section 3(c)(1)(F) confers ‘‘exclusive
use’’ or ‘‘data compensation’’ rights on
certain persons (‘‘original data
submitters’’) who submit data (in which
they have an ownership interest), in
support of an application for
registration, reregistration, or
experimental use permit, or to maintain
an existing registration. Applicants who
cite qualifying data previously
submitted to the Agency by the original
data submitter must certify that the
original data submitter has granted
permission to the applicant to cite data
or that the applicant has made an offer
of compensation to the original data

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submitter. In the case of ‘‘exclusive use’’
data, the applicant must obtain the
permission of the original data
submitter and certify to the Agency that
the applicant has obtained written
authorization from the original data
submitter. (Data are generally entitled to
‘‘exclusive use’’ for 10 years after the
date of the initial registration of a
pesticide product containing a new
active ingredient.) If data are not subject
to exclusive use but are compensable,
an applicant may cite the data without
the permission of the original data
submitter, so long as the applicant offers
to pay compensation for the right to rely
on the data. (Data are ‘‘compensable’’ for
15 years after the date on which the data
were originally submitted.) If an
applicant and an original data submitter
cannot agree on the appropriate amount
of compensation, either may initiate
binding arbitration to reach a
determination. If an applicant fails to
comply with either the statutory
requirements or the provisions of a
compensation agreement or an
arbitration decision, the application or
registration is subject to denial or
cancellation. (See also 7 U.S.C. 136a
(c)(1)(F)(ii)–(iii)).
FIFRA section 3(c)(2)(B) provides
that:
. . . [i]f the Administrator determines that
additional data are required to maintain in
effect an existing registration of a pesticide,
the Administrator shall notify all existing
registrants of the pesticide to which the
determination relates and provide a list of
such registrants to any interested person. (7
U.S.C. 136a(c)(2)(B)).

Continued registration of a pesticide
requires that its use not result in
‘‘unreasonable adverse effects on the
environment’’ defined as:
. . . (1) any unreasonable risk to man or the
environment, taking into account the
economic, social, and environmental cost
and benefits of the use of any pesticide, or
(2) a human dietary risk from residues that
results from a use of a pesticide in or on any
food inconsistent with the standard under
section 408 of the [FFDCA]. (7 U.S.C. 136
(bb)).

FIFRA section 3(c)(2)(B) contains a
mechanism by which recipients of
notices of data requirements (referred to
as ‘‘Data Call-In notices’’ or ‘‘DCI
notices’’) may jointly develop data and
provides that ‘‘[a]ny registrant who
offers to share in the cost of producing
the data shall be entitled to examine and
rely upon such data in support of
maintenance of such registration.’’ The
section establishes procedures to allow
registrants who received DCI notices to
use binding arbitration to resolve
disputes about each person’s fair share
of the testing costs.

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Further, FIFRA section 3(c)(1)(F)
makes clear that data submitted under
FIFRA section 3(c)(2)(B) are also
‘‘compensable’’ when cited in support
of an application for a registration. In
other words, a pesticide company that
chooses to rely on such data rather than
develop its own data must offer
compensation to the original data
submitter–usually the data generator.
Lastly, the Agency may suspend the
registration of a pesticide if the
registrant fails to take appropriate steps
to provide data required under a DCI
notice in a timely manner.
Finally, FIFRA section 3(c)(2)(D)
contains a provision, referred to as the
‘‘formulator’s exemption’’ that is
intended to simplify and promote equity
in the implementation of the data
compensation program under FIFRA
section 3(c)(1)(F). This exemption
relieves an applicant of the obligation to
submit a study, or to cite and obtain
permission or offer to pay data
compensation to cite the results of a
study if the study is relevant to the
safety assessment of a registered product
that the applicant buys from another
person and uses to make the applicant’s
product. Congress’ rationale for this
exemption is that the seller will recover
any data generation costs through the
purchase price of its product. Thus, if a
pesticide formulator applies to register a
product containing an active ingredient
that the formulator purchased from the
basic manufacturer of the active
ingredient, the formulator does not need
to submit or cite and offer to pay
compensation for any data specifically
relevant to the purchased product. The
Agency has extended the principles of
the formulator’s exemption to data
requirements under FIFRA section
3(c)(2)(B). Consequently, if the
formulator received a DCI notice
requiring data on the active ingredient,
the formulator could comply by
providing documentation that it bought
the active ingredient from another
registrant.
2. SDWA. SDWA section 1457
provides EPA with discretionary
authority to require testing, under the
FFDCA section 408(p) screening
program, ‘‘of any other substances that
may be found in sources of drinking
water if the Administrator determines
that a substantial population may be
exposed to such substance.’’ (42 U.S.C.
300j–17). Because SDWA section 1457
specifically mandates that EPA ‘‘may
provide for testing. . . in accordance
with the provisions of [FFDCA section
408(p)],’’ EPA may rely on many of the
procedures discussed in this document
to require testing under SDWA section
1457.

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3. Other sections of FFDCA. FFDCA
section 408(f) establishes procedures
that the Agency ‘‘shall use’’ to require
data to support the continuation of a
tolerance or exemption that is in effect.
The provision identifies three options:
• Issuance of a notice to the person
holding a pesticide registration under
FIFRA section 3(c)(2)(B) (FFDCA section
408(f)(1)(A)).
• Issuance of a rule under section 4
of TSCA (FFDCA section 408(f)(1)(B)).
• Publication of a notice in the
Federal Register requiring submission,
by certain dates, of a commitment to
generate the data ‘‘by one or more
interested persons.’’ (FFDCA section
408(f)(1)(C)).
Before using the third option,
however, EPA must demonstrate why
the data ‘‘could not be obtained’’ using
either of the first two options. FFDCA
section 408(f)(1) expressly provides that
EPA may use these procedures to
‘‘require data or information pertaining
to whether the pesticide chemical may
have an effect in humans that is similar
to an effect produced by a naturally
occurring estrogen or other endocrine
effects.’’ Finally, FFDCA section
408(f)(1)(B) provides that, in the event
of failure to comply with a rule under
TSCA section 4 or an order under
FFDCA section 408(f)(1)(C), EPA may,
after notice and opportunity for public
comment, modify or revoke any
tolerance or exemption to which the
data are relevant.
In addition, FFDCA section 408(i)
provides that ‘‘[d]ata that are or have
been submitted to the Administrator
under this section or FFDCA section 409
in support of a tolerance or an
exemption from a tolerance shall be
entitled to confidential treatment for
reasons of business confidentiality and
to exclusive use and data compensation
to the same extent provided by section
3 and section 10 of [FIFRA].’’

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IV. Policies and Procedures for Initial
Screening Under the EDSP
This Unit describes the policies and
procedures that EPA generally intends
to adopt for the initial screening
required under the EDSP. In general, the
Agency has tried to develop policies
that could be used in subsequent data
collection efforts, including those under
SDWA. However, these policies and
procedures may be modified as a result
of the Agency’s experience applying
them to the first chemicals to undergo
screening and testing under the EDSP.
In addition, EPA may modify these
policies and procedures during the
initial screening as circumstances
warrant.

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A. Background
On December 13, 2007 (72 FR 70842),
EPA announced availability of and
solicited public comment on EPA’s draft
policies and procedures for initial
screening under the EDSP. EPA held
two public workshops, one on
December 17, 2007, and another on
February 28, 2008, to discuss the
proposed policies and procedures with
stakeholders. Following review and
revision based on the public comments,
EPA is now describing the specific
details of the policies and procedures
that EPA generally intends to use for
initial screening under the EDSP.
After reviewing all of the public
comments received, EPA has decided to
make some changes and/or clarifications
to the draft policies and procedures. The
Agency’s responses to public comments
are discussed in more detail in the
document entitled Response to
Comments on the Endocrine Disruptor
Screening Program: Draft Policies and
Procedures for Initial Screening and
Testing (Ref. 3), a copy of which is in
the docket. The following is a
discussion of the major changes and/or
clarifications to the policies and
procedures.
1. Modified the response options for
inerts. The Agency originally proposed
to relieve a manufacturer or importer of
a pesticide inert ingredient of the
requirement to generate EDSP data only
if the manufacturer or importer agreed
to discontinue selling and distributing
the ingredient for any use, whether the
use was as a pesticide inert ingredient
in a pesticide product or for a nonpesticidal purpose. As explained more
fully in its Response to Comments
document, after considering all of the
comments, EPA is persuaded that it
should change the EDSP initial
screening policies and procedures and
allow a manufacturer or importer to
comply with an order by agreeing to
discontinue sale of the chemical into the
pesticide market. This change leads to
other modifications to the procedures to
ensure effective enforcement of data use
protections as well as maintaining a
‘‘level playing field.’’
Specifically, EPA intends to establish
a Pesticide Inert Ingredients Data
Submitters & Suppliers List (PIIDSSL) to
identify any entity who has submitted
compensable data on a pesticide inert
ingredient in response to a test order
issued under section 408(p). Pursuant to
FIFRA section 3(c)(1)(F), when a new
pesticide registration applicant’s
product contains a pesticide inert
ingredient on the PIIDSSL, EPA intends
to require the applicant to identify the
source of the pesticide inert ingredient.

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If the applicant’s source does not appear
on the PIIDSSL, EPA intends to require
the applicant either to switch to a
source on the PIIDSSL; offer to pay
compensation to the original data
submitter(s) on the PIIDSSL; or generate
their own data to support their
application.
The Agency also intends to continue
to issue ‘‘catch-up’’ orders to any
manufacturer or importer of a pesticide
inert ingredient who enters the market
place after EPA receives data in
response to an initial test order for that
ingredient. The Agency thinks that the
combination of procedures–issuance of
‘‘catch-up’’ orders and establishment of
the PIIDSSL–will result in a system that
effectively provides data use protections
to generators of endocrine data on
pesticide inert ingredients. EPA agrees
that industry will have a strong interest
in self-policing to ensure that
competitors are not reneging on their
commitment not to sell to the pesticide
market and EPA accepts the
commenters’ claims that the industry
can effectively identify for EPA any
companies that do not abide by a
commitment to cease sales into the
pesticide market. However, in the event
that significant problems arise, EPA
intends to reevaluate this policy, along
with evaluating options for responding.
For example, EPA considers that
reexamination of this policy would be
warranted if all manufacturers of a
particular inert ingredient opted out of
the pesticide market, given the likely
impact this would have on end-use
formulators. Another consideration
would be if EPA discovers that these
measures are ineffective at keeping the
chemical out of the pesticide market.
Under those circumstances, EPA may
consider reissuing FFDCA section
408(p) orders to the original
manufacturers, with the requirement
that the manufacturers and importers
provide data in response to the order
unless they agree to cease entirely all
manufacture or importation of the
chemical. EPA may also consider
issuing orders to end-use registrants, if
circumstances warrant.
2. Catch-up orders. The Agency
intends to issue ‘‘catch-up’’ orders for
15 years after the initial test order(s) for
the chemical is issued.
3. Clarifications. The Agency has
provided additional clarifications,
including the policies and statutory
interpretations relating to preenforcement review and informal
administrative review, and the
procedures related to the citation or
submission of other scientifically
relevant information.

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4. Paperwork activities and estimates.
The Agency has also revised the Initial
Response Form and the templates for
Tier 1 Orders, as well as the related
estimated paperwork burden and costs.

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B. Testing of Pesticide Chemicals Under
the EDSP
For the initial screening, EPA
generally intends to issue ‘‘Tier 1
Orders’’ pursuant to section 408(p)(5) of
FFDCA. This is consistent with the
December 1998 Notice, where EPA
indicated that it intended to rely
primarily on FFDCA and SDWA to
require testing, and would ‘‘use other
testing authorities under FIFRA and
TSCA to require the testing of those
chemical substances that the FFDCA
and SDWA do not cover.’’ (Ref. 1).
Because EPA is focusing on pesticide
chemicals in registered pesticide
products for initial screening, there is
no need to rely on TSCA or SDWA.
However, as discussed in Unit IV.C.–
IV.D., in order to address some of the
more complex issues surrounding joint
data development and the availability of
data compensation and data protection,
EPA intends to issue some orders jointly
under the authority of FFDCA section
408(p)(5) and FIFRA section 3(c)(2)(B).
A diagram that graphically depicts the
overall process is available in the
docket.
The Agency has developed two
templates for the Tier 1 Orders that
reflect the policies and procedures
discussed in this document, and which
outline the basic framework that EPA
generally intends to use to issue orders
for the EDSP initial screening. The test
orders differ according to whether the
recipient is a: (1) Pesticide registrant, or
(2) manufacturer and/or importer of a
pesticide inert ingredient (aka ‘‘other
ingredient’’). In addition, the templates
accommodate differences in the
Agency’s procedures for data
compensation, and for the minimization
of duplicative data, which varies based
on the Order recipient. Copies of the
Tier 1 Order templates are included in
the docket.
There are some pesticide active and
pesticide inert ingredients that are not
registered in the U.S. but for which
there are tolerances on foods imported
from other countries. When these
chemicals are to be tested in the future,
EPA may rely on FFDCA 408(f)(1) to
require ‘‘interested persons’’ to submit
data for the EDSP.

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C. What is EPA Doing To Minimize
Duplicative Testing and Promote Cost
Sharing and Data Compensation Under
EDSP?
One of the complex issues discussed
in the December 1998 Notice related to
joint data development, and how EPA
would implement the FFDCA section
408(p)(5)(B) directive that ‘‘[t]o the
extent practicable, the Administrator
shall minimize duplicative testing of the
same substance for the same endocrine
effect. . . .’’ As noted in the December
1998 Notice (63 FR 71563), EPA
originally contemplated that it would
adopt new procedures unique to the
EDSP.
After considering public comment on
its 2007 Draft Policies and Procedures
(72 FR 70842), EPA is adopting an
approach that follows closely the draft
procedures to promote cost sharing and
data compensation described in the
December 2007 document.
EPA’s approach to ‘‘minimize
duplicative testing of the same
substance’’ and to promote the ‘‘fair and
equitable sharing of test costs’’ is
intended to achieve the following goals
essentially the same outcome for all
inert ingredients as the outcome the
procedures under FIFRA section
3(c)(2)(B) and section 3(c)(1)(F) produce
for active ingredients. That is:
• The companies who are the basic
producers of an active ingredient or
pesticide inert ingredient would
typically bear the costs of testing. Those
who purchase a pesticide inert
ingredient from a basic producer (who
becomes/is an original data submitter)
or another ‘‘approved inert supplier’’
would not typically have to participate
in joint development of, or offer to pay
compensation for the right to rely on,
required EDSP data. See Unit IV.C.3.c.
• The recipients of the FFDCA
section 408(p) test orders have a
mechanism to resolve disputes and
enforce agreements to develop data
jointly and to share test costs. See Unit
IV.C.1.b.
• Subsequent entrants into the
marketplace are, for an appropriate
period of time, subject to the same data
requirements, with provisions that
would allow them to share the test costs
rather than submit duplicative data. See
Unit IV.C.2.
• The recipients of the FFDCA
section 408(p) test orders may cite or
submit existing data (i.e., other
scientifically relevant information) in
lieu of developing new data, and ask
EPA to determine whether the
information can be used to satisfy part
or all of the Tier 1 Order and/or

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otherwise inform the Tier 1
determination. See Unit IV.C.1.c.
EPA believes its approach will
achieve essentially the same outcome
for all inert ingredients as the outcome
the procedures under FIFRA section
3(c)(2)(B) and section 3(c)(1)(F) produce
for active ingredients.
In summary, EPA generally intends to
adopt a policy that encourages data
developers to join forces and agree on
how to share costs, and that also
encourages companies entering the
marketplace after the data are developed
to pay reasonable compensation to those
that developed the data. To the extent
permitted by FFDCA, EPA’s intended
policies and procedures for EDSP
resembles the policies and procedures
used for Data-Call-Ins under FIFRA.
1. Minimizing duplicative testing. As
a point of clarification, a substantial
amount of overlap exists between the
goal of minimizing duplicative testing
and the topic discussed in the next unit,
allowing parties to share the costs of
conducting the tests. Consequently,
some of the measures discussed in this
unit to minimize duplicative testing will
have certain implications for the
decisions pertaining to cost sharing, and
vice versa.
In developing its policy and
procedures, EPA draws on years of
experience with pesticide registrants.
This experience has shown that
reducing the costs of complying with a
test order is a powerful incentive in
bringing companies together to jointly
develop and submit data. However,
there may also be disincentives to joint
data development including the costs of
organizing a consortium. EPA policy
and procedures are primarily designed
to minimize the disincentives.
a. Recipients of 408(p) test orders. The
Agency recognizes that, as the number
of recipients of test orders increases,
organizational costs also increase. EPA
must balance the second goal mentioned
in FFDCA section 408(p)(5)(B)—
promoting ‘‘fair and equitable sharing of
test costs’’—with the organizational
costs of a large number of order
recipients. As is discussed more fully in
Unit IV.E., under FFDCA section 408(p),
EPA may issue orders to pesticide
registrants or manufacturers and
importers. While EPA could issue
orders to all the interested parties,
including the registrants of end-use
products containing the active or inert
ingredient this would greatly expand
the number of order recipients and
complicate the organization of
consortia. Under FIFRA, data generation
is typically undertaken by the technical
registrant, who is also a producer or
importer of the chemical. EPA generally

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intends to issue FFDCA 408(p) test
orders to the basic producers of active
or inert ingredients, balancing the goal
of fairness with the need to keep the
number of recipients low to avoid high
organizational costs.
Further, by issuing orders to
manufacturers and importers of inert
ingredients, EPA is able to avoid the
confidentiality issues associated with
inert ingredients. Most manufacturers
claim their inert ingredients to be
confidential; accordingly, EPA cannot
reveal the inert ingredients in pesticide
products and therefore generally could
not reveal the companies to whom an
order was issued. By issuing orders to
manufacturers and importers, EPA can,
with few exceptions, immediately
inform a recipient of the identity of all
other recipients, facilitating
communication and the formation of a
consortium.
b. Resolving disputes and enforcing
agreements. As described in the
December 2007 Draft Policy and
Procedures, the Agency has concluded
that FFDCA section 408(p)(5) does not
provide the authority to create
requirements for joint data
development, including a requirement
to use binding arbitration to resolve
disputes, as does FIFRA section 3. In
EPA’s view, FFDCA section 408(p)(5)(B)
merely establishes a qualified direction
that the Agency ‘‘[t]o the extent
practicable . . . minimize duplicative
testing . . . .’’ This, standing alone, does
not create new authority to compel
companies to use arbitration to resolve
disputes arising from an effort to
develop data jointly, nor does it even
authorize EPA to impose a requirement
for joint data development. Rather, EPA
believes that this provision directs the
Agency to create procedures that
operate within the confines of existing
statutory authorities.
While FFDCA section 408(p) does not
allow EPA to impose requirements
identical to those authorized by FIFRA
section 3, EPA has the authority under
FFDCA section 408(p) to develop
Agency procedures that would facilitate
joint data generation. Specifically, the
Agency has discretion to determine
what actions constitute compliance with
a FFDCA section 408(p) test order, and
EPA intends to apply this discretion in
a manner that creates strong incentives
for companies to voluntarily develop
data jointly. At the same time, however,
each recipient of an order under FFDCA
section 408(p) has a separate obligation
to satisfy the Tier 1 Order that they
received. EPA thinks that FFDCA
section 408(p) confers adequate
discretion to consider that a recipient

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has fulfilled its obligation to provide
data when:
• The recipient individually or jointly
submits results from the required
studies, or
• EPA judges that it would be
equitable to allow the recipient to rely
on, or cite, results of studies submitted
by another person.
The determination of whether it
would be equitable to allow citation to
another recipient’s data will be
necessarily based on a case-by-case
review of the specifics of the individual
circumstances. However, the Agency
believes that it would generally be
equitable to allow a recipient of a
FFDCA section 408(p) test order to rely
on the results of studies submitted by
another person where:
• The data generator has given
permission to the recipient to cite the
results, or
• Within a reasonable period after
receiving the FFDCA section 408(p) test
order, the recipient has made an offer to
commence negotiations regarding the
amount and terms of paying a
reasonable share of the cost of testing,
and has included 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).
The Agency believes this approach to
minimizing duplicative testing, which
parallels that used under FIFRA section
3(c)(2)(B), provides all recipients of
FFDCA section 408(p) test orders
adequate incentives to develop data
jointly. In the first instance, where the
data generator had granted permission
for another party to cite its data, the
equities are clear, and EPA has no
reason for refusing to allow it. In the
second instance, where the data
generator received an offer to commence
negotiations regarding the amount and
terms of compensation and to go to a
neutral decisionmaker with authority to
bind the parties failing successful
negotiations, EPA believes that the
company has demonstrated a good faith
effort to develop data jointly, and
consequently would typically consider
that the order recipient had complied
with the order. Based on EPA’s
experience under FIFRA, there would
be little or no reason for a data generator
to decline such an offer. Moreover, if
EPA did not adopt such an approach,
the end result would effectively confer
the sort of ‘‘exclusive use’’ property
rights established under FIFRA section
3(c)(1)(F), on a broad category of data,
and EPA does not believe that FFDCA
section 408(p)(5) creates such rights, or

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provides EPA with the authority to
create such rights.
These conditions would also apply to
recipients of ‘‘catch up’’ FFDCA 408(p)
orders, who enter the market after the
data have been submitted.
c. Submission/citation of existing
data. As under FIFRA, EPA provides the
recipients of FFDCA section 408(p) test
orders with the option of submitting or
citing existing data, along with a
rationale that explains how the cited or
submitted study satisfies the Tier 1
Order. Existing data may include data
that has already been generated using
the assay(s) specified in the Order, or
‘‘other scientifically relevant
information.’’ 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. Some ‘‘other
scientifically relevant information’’ may
be sufficient to satisfy part or all of the
Tier 1 Order and/or otherwise inform
the Tier 1 determination. The
submission or citation of other
scientifically relevant information in
lieu of the data specified in the Order
is discussed in Unit IV.F.1.b.
The Agency has written a paper
entitled EPA’s Approach for
Considering Other Scientifically
Relevant Information (OSRI) under the
Endocrine Disruptor Screening Program.
(Ref. 4). This paper was developed by
EPA to provide guidance to EPA staff
and managers who will be reviewing the
responses to Tier 1 Orders issued under
the EDSP, and may also be of interest to
parties considering whether to submit
other scientifically relevant information
to EPA. This paper provides general
guidance and is not binding on either
EPA or any outside parties. Anyone may
provide other scientifically relevant
information, and the Agency will assess
the information for appropriateness on a
case-by-case basis to determine whether
the information can be used to satisfy

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part or all of the Tier 1 Order and/or
otherwise inform the Tier 1
determination. EPA will respond to the
submitter in writing and will make its
determination publicly available. A
copy of the approach paper has been
placed in the docket for this policy
(Docket ID number EPA–HQ–OPPT–
2007–1080).
In summary, EPA believes this
approach to minimizing duplicative
testing, which parallels that used under
FIFRA section 3(c)(2)(B), provides all
recipients of FFDCA section 408(p) test
orders adequate incentives to develop
data jointly.
2. Promoting cost sharing and data
compensation. As noted in Unit IV.C.1.,
FFDCA section 408(p)(5)(B) directs the
Agency to ‘‘develop, as appropriate,
procedures for fair and equitable sharing
of test costs.’’ Informed by its
experience under FIFRA, EPA sees this
provision as containing two related
directives:
• Promotion of the sharing of costs by
companies that agree to develop data
jointly (‘‘cost sharing’’).
• Payment of compensation to a data
generator by a person whose activity
subsequent to the submission of the
required data would make such
payment equitable (‘‘data
compensation’’).
The first directive relates to sharing
the cost of developing data between
parties on the market when a test order
is issued. The second directive relates to
the payment by a person (who was not
part of a joint data development
agreement) to those that originally
generated and submitted data, in
exchange for relying on the results of
their previously submitted study. These
mirror the data generation and data
compensation processes that have been
followed for years under FIFRA, and the
Agency believes those processes are a
good starting point for dealing with
these issues in the context of FFDCA
section 408(p)(5) orders. Consistent with
FFDCA section 408(p)(5)(B), EPA
intends, ‘‘to the extent practicable,’’ to
‘‘develop procedures for fair and
equitable sharing of test costs’’ not only
by persons in business when the initial
FFDCA section 408(p) test orders were
issued, but also by persons who enter
the marketplace after the data are
submitted.
As discussed in Unit IV.C.1., EPA has
developed procedures to implement
FFDCA section 408(p) screening that
minimize duplicative testing; these
measures also have the effect of
substantially fostering cost sharing
among those who receive the initial test
order. By using an approach which
parallels that used under FIFRA section

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3(c)(2)(B), any disincentives for the
recipients of FFDCA section 408(p) test
orders to develop data jointly are
addressed. EPA’s experience with
FIFRA section 3(c)(2)(B) indicates that
when multiple registrants receive DCI
notices to produce the same data on the
same active ingredient, they form
consortia that work together to develop
the required data. If manufacturers and
importers receive FFDCA section 408(p)
test orders containing the provisions
previously discussed, EPA expects that
they would behave in the same manner.
a. Compensable data under the EDSP.
With respect to determining the extent
to which compensation for previously
submitted studies is warranted, the
threshold issue is what EDSP data will
be ‘‘compensable.’’ Given EPA’s
conclusion that FFDCA section
408(p)(5)(B) does not give EPA the
inherent authority to create new rights
to compensation, the threshold for what
is ‘‘compensable’’ requires
consideration of existing statutory
authority for compensation. To the
extent the data are otherwise covered by
any provision of FFDCA or FIFRA that
requires a person to offer compensation
for the right to cite or rely on data
submitted by another person in
connection with a pesticide regulatory
matter, EPA must continue to enforce
those provisions.
FFDCA section 408(i) provides that
data submitted under FFDCA section
408 ‘‘in support of a tolerance or an
exemption from a tolerance shall be
entitled to . . . exclusive use and data
compensation to the same extent
provided by section 3 of [FIFRA].’’ The
Agency considers any data generated in
response to requirements under FFDCA
section 408(p) on a pesticide chemical
for which there is an existing tolerance,
tolerance exemption, or pending
petition to establish a tolerance or an
exemption to be data submitted in
support of a tolerance or an exemption.
In fact, FFDCA section 408(b)(2)(D)(viii)
explicitly requires EPA to consider
‘‘such information as the Administrator
may require on whether the pesticide
chemical may have an effect in humans
that is similar to an effect produced by
a naturally occurring estrogen or other
endocrine effects,’’ as part of its
determination that a substance meets
the safety standard. (21 U.S.C.
346a(b)(2)(D)(viii)). Thus, EDSP data on
active and pesticide inert ingredients for
which there is a tolerance or tolerance
exemption are compensable as outlined
under FIFRA section 3(c)(1)(F).
Moreover, data establishing whether a
pesticide chemical (either active or
inert) has the potential to interact with
the endocrine system would be relevant

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to a FIFRA registration decision. Under
FIFRA, EPA has a continuing duty to
ensure that a pesticide meets the
registration standard; EPA must
consider all available data relevant to
this determination. (See 7 U.S.C. 136a
(bb) and 3(c)(5)). In the terms of FIFRA
section 3(c)(1)(F), such data ‘‘support or
maintain in effect an existing
registration.’’ Thus, data generated in
response to a FFDCA section 408(p) test
order are compensable as outlined in
FIFRA section 3(c)(1)(F) if the data are
submitted by a pesticide registrant
because FIFRA specifically grants those
rights to registrants.
Given EPA’s position that FFDCA
section 408(p)(5)(B) does not give EPA
the authority to modify FIFRA data
compensation rights, the fact that EDSP
data are potentially compensable under
FIFRA raises questions about the
interplay between the two statutes. For
example, unlike FIFRA section
3(c)(2)(B), FFDCA section 408(p) does
not give EPA the authority to enforce an
offer to pay compensation by
suspending the registration of a
noncompliant company. Thus, unless
and until such data are used in support
of a pesticide regulatory action under
FIFRA, if a recipient of a test order
made an offer but then refused to pay
compensation or to participate in
binding arbitration following the data
submitters acceptance of that offer, the
data generator’s only recourse would be
to seek any judicial remedies that may
be available. Consequently, rather than
leave recipients with any ambiguity,
EPA intends to issue orders to
registrants to conduct EDSP testing
pursuant to both FIFRA section
3(c)(2)(B) and FFDCA section 408(p).
In summary, most EDSP data are
compensable under FIFRA or FFDCA
section 408(i). Data for active and
pesticide inert ingredients that have a
tolerance or tolerance exemption or are
the subject of a pending petition are
compensable regardless of what
companies submit the data. EDSP data
generated from testing other active and
inert ingredients are also compensable
as long as, in the case of a joint
submission, at least one of the
submitters is a pesticide registrant or
applicant.
While much EDSP data are
compensable under FIFRA or FFDCA
section 408(i), some EDSP data will be
generated by chemical manufacturers
and importers of pesticide inert
ingredients that have neither a tolerance
nor tolerance exemption and are not the
subject of a pending tolerance petition.
(EPA refers to these substances as ‘‘nonfood use inerts.’’) Because such EDSP
data could not be considered ‘‘data

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submitted in support of a tolerance or
exemption,’’ the data submitted on such
substances in response to a FFDCA
section 408(p) test order are not entitled
to compensation under FFDCA section
408(i). Moreover, since FIFRA section
3(c)(1)(F) establishes compensation
rights only for data submitted by an
applicant or a registrant and inert
ingredients do not have separate or
technical registrations, data submitted
to EPA in response to a FFDCA section
408(p) order by a person who is neither
a registrant nor an applicant are not
compensable under FIFRA. However,
although data on a non-food use
pesticide inert are not compensable
when submitted by a non-registrant
pursuant to FFDCA section 408(p), such
data would become compensable when
submitted jointly by an applicant or
registrant to support initial or continued
registration of a pesticide product
containing that inert ingredient. That is,
if the submitters of data for a non-food
use inert ingredient include a product
registrant, EPA intends to consider the
data compensable.
In addition, EPA believes that the
internal procedures it has adopted
effectively provide manufacturers and
importers with the same opportunity for
cost sharing/compensation available to
all other order recipients.
Because EPA believes there are ways
to make all EDSP data generated on
pesticide inert ingredients compensable,
EPA must consider what procedures to
use to ensure persons who did not share
in the cost of testing, but who benefit
from the existence of such data, actually
pay compensation. Under FIFRA section
3(c)(1)(F), companies that apply for
registrations of pesticide products after
the data were submitted either would
have to offer to pay compensation for
the right to cite the data or would have
to generate comparable data.
Consequently, in the case of active
ingredients, everyone who benefits from
the existence of EDSP data on an active
ingredient either shares the cost of the
testing as part of the joint data
development under FIFRA section
3(c)(2)(B) or offers to pay compensation
to the original data submitter under
FIFRA section 3(c)(1)(F).
The same is not true for pesticide
inert ingredients. There is no
mechanism under either FIFRA or
FFDCA for directly requiring payment
of compensation by companies that start
to manufacture or import a pesticide
inert ingredient after an original data
submitter has provided EDSP data on
the pesticide inert ingredient. Such
companies are not subject to FIFRA data
compensation obligations because they
are not registrants or applicants for

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registration. Nonetheless, EPA believes
that, by using its discretion under
FFDCA section 408(p) to issue test
orders to new manufacturers or
importers of a substance for which
EDSP data had previously been
submitted, EPA can achieve
substantially the same ends.
FFDCA section 408(p)(5) provides
that ‘‘[t]he Administrator shall issue an
order 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 . . . .’’ Thus, under
FFDCA section 408(p)(5), following the
submission of required EDSP data on
the ingredient by manufacturers or
importers who were in the marketplace
when the initial test orders were issued,
EPA generally intends to issue a test
order to a manufacturer or importer who
begins to sell a pesticide inert ingredient
after the test orders requiring the data
were issued. The Agency refers to these
as ‘‘catch-up’’ test orders. As with the
initial FFDCA section 408(p) test order,
recipients could fulfill the testing
requirement either by submitting the
results of a new study or by citing the
data submitted by another person or by
agreeing not to sell into the pesticide
market. In furtherance of the goal of
‘‘fair and equitable sharing of test
costs,’’ the Agency would accept
citation of existing data under the same
circumstances that it would accept the
citation for recipients of the original
order—e.g., where the recipient of a
catch-up test order either had the
original data submitter’s permission or
the recipient had made an appropriate
offer to pay compensation to the original
data submitter that also determined how
disputes would be resolved.
Unless new manufacturers or
importers requested pesticide
registrations, EPA cannot readily
identify new entrants in the market.
EPA is largely relying on the
manufacturers and importers who are
part of the data submitters’ task force to
inform the Agency about new entrants
to the market, at which time EPA
intends to issue the FFDCA section
408(p) ‘‘catch-up’’ test orders. Currently,
EPA only intends to send ‘‘catch-up’’
FFDCA section 408(p) test orders to
subsequent entrants into the
marketplace within 15 years after the
initial EDSP test order(s) for the
chemical is issued—a time frame
matching the period of compensability
under FIFRA section 3(c)(1)(F).
b. Who provides compensation under
this approach? Although the procedures
described would result in having all
companies that manufacture or import a
pesticide inert ingredient share

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equitably in the cost of generating
required EDSP data, FIFRA imposes
additional compensation requirements
on the customers of such companies
who purchase the pesticide inert
ingredients for use in formulating their
registered pesticides. Specifically,
FIFRA section 3(c)(1)(F) requires an
applicant for a new or amended
registration to offer to pay compensation
to the original submitter of EDSP data if
the applicant’s product contains an
ingredient (active or inert) for which
EDSP data have been submitted.
For all compensable data, the Agency
interprets the formulator’s exemption to
be applicable. The formulator’s
exemption under FIFRA section
3(c)(2)(D) would only be applicable to
EDSP data generated on non-food use
pesticide inerts if the data are submitted
jointly by a registrant or applicant for
registration. However, EPA believes that
it can effectively achieve the same ends
through the internal procedures it
adopts, and through its discretion to
selectively issue FFDCA section 408(p)
test orders only to importers and
manufacturers of such pesticide inert
ingredients. The policy rationale
underlying FIFRA’s formulator’s
exemption is equally applicable in the
case of non-food use pesticide inerts.
Specifically, Congress believed that, so
long as the requirements apply equally
to manufacturers of a particular
ingredient, the price of their product
should also reflect any data
development costs. Accordingly,
requiring compensation of product
purchasers would have the effect of
requiring purchasers to pay data
development costs twice—once as a
condition of satisfying a FFDCA section
408(p) test order, and thereafter as part
of the price of the pesticide inert
ingredients they purchase to make their
products. (See 49 FR 30892, August 1,
1984). As a result, EPA has adopted the
following procedures to determine
whether the end-use formulators have
met their obligations to submit EDSP
screening data.
c. Determining whether compensation
obligations have been met. Currently,
EPA maintains a list of all data on active
ingredients that would support a
technical registration along with contact
information for the owners of the data.
This is the Data Submitters List. Product
applicants must identify the chemicals
in their product and, in the case of the
active ingredient(s), they must identify
the source of the ingredient(s). If the
source of the active ingredient is a
registered product that is labeled for the
same (or more) uses as the applicant’s
product, the applicant is entitled to
claim the formulators’ exemption from

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all data requirements relating to the
purchased product and need not submit
or cite such data. If the applicant is not
eligible for the formulators’ exemption,
an applicant must submit or cite
required data (for a technical product
registration, the required data are
typically data submitted on the active
ingredients to support a technical
registration). The citation is
accompanied by a certification that an
offer to pay was made to the owners of
the data. FIFRA requires that an
applicant/registrant agree to binding
arbitration to resolve disputes regarding
compensation. If the applicant or
registrant fails to fulfill either the terms
of a compensation agreement or an
arbitrator’s award, the owner of the data
may petition the Agency to cancel the
registration. These procedures are also
applicable to EDSP data that are subject
to FFDCA section 408(i).
The approach outlined here to
address compensation for EDSP data on
pesticide inert ingredients is consistent
with those adopted generically for all
food use pesticide inert data, as there is
no reason for creating separate
procedures for EDSP pesticide inert data
and all other food use pesticide inert
data.
First, for each pesticide inert
ingredient on which EPA receives EDSP
data, EPA intends to identify the data
submitter on a ‘‘Pesticide Inert
Ingredients Data Submitters & Suppliers
List’’ (PIIDSSL). This list identifies
every company that submits the
required EDSP data (original data
submitters). The PIIDSSL also contains
the names of every company that
fulfilled its obligation under a FFDCA
section 408(p) test order by offering to
share the cost of testing with other data
developers, as well as any other
company that the original data
submitter identifies as entitled to serve
as a source of the pesticide inert
ingredient from whom an applicant or
registrant may obtain the pesticide inert
without making an offer to compensate
the original data submitter (‘‘approved
inert suppliers’’ or ‘‘approved sources’’).
Second, under FIFRA section
3(c)(1)(F), the action of submitting an
application of a pesticide containing the
pesticide inert ingredient will trigger the
obligation for the applicant to provide
compensable EDSP data. The applicant
may satisfy this requirement by
submitting new data or citing existing
data. In most cases, however, EPA
expects an applicant to comply by
claiming that the pesticide inert
ingredient comes from an ‘‘approved
source’’ and therefore that the principles
of the formulator’s exemption apply. To
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EPA intends to require a pesticide
applicant to identify the source of
pesticide inert ingredients for which
there are compensable EDSP data. Then,
EPA would agree that the applicant had
adequately complied with FIFRA
section 3(c)(1)(F) and FFDCA section
408(p)(3)’s requirements if the person
identified as the source for the pesticide
inert ingredient appears on the PIIDSSL
as either an original data submitter or an
approved source for that pesticide inert
ingredient.
Third, on a case-by-case basis, EPA
may require current registrants to
identify the source of a pesticide inert
ingredient on which EDSP data have
been submitted. If the registrant of a
pesticide product identifies a source for
the pesticide inert ingredient that is not
on the PIIDSSL, the registrant would
have the choice of changing its supplier
of the pesticide inert ingredient to an
approved source on the PIIDSSL list.
(Note: EPA also intends to revise the
guidance presented in PR Notice 98–10
regarding notifications to provide that a
registrant may not change the source of
a pesticide inert ingredient on the
PIIDSSL in its formulation by
notification. Such a change must be
made through an application for
amended registration.) Should the
registrant not choose to obtain the
pesticide inert ingredient from an
approved source, EPA generally intends
to issue an order to the registrant,
requiring the registrant either to
generate the EDSP test data or offer to
pay compensation to the original data
submitter on the PIIDSSL.
D. What Procedures Apply for Handling
CBI?
FFDCA section 408(p)(5)(B) also
requires that EPA, to the extent
practicable, develop, as necessary,
procedures for the handling of CBI.
Many of the same considerations laid
out in Unit IV.C. are relevant to EPA’s
implementation of this directive. EPA
has therefore adopted a consistent
approach with respect to the handling of
CBI.
As with the directives to develop
procedures for sharing test costs and
minimizing duplicative testing, EPA
does not think that FFDCA section
408(p)(5)(B) provides the authority for
the Agency to either create new rights
or to modify existing rights to
confidentiality. Rather, EPA believes
that this provision directs the Agency to
create procedures that operate within
the existing confines of FFDCA section
408(i), FIFRA section 10, the Freedom of
Information Act (FOIA), and the Trade
Secrets Act.

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As explained in Unit IV.C., because
EPA considers much of the data
submitted in response to FFDCA section
408(p) orders to be submitted in support
of a tolerance or tolerance exemption,
such submissions are entitled to
confidential treatment to the same
extent as under FIFRA section 10,
pursuant to FFDCA section 408(i). In
addition, CBI submitted by pesticide
registrants in response to a FFDCA
section 408(p) test order is considered
as part of the registration process, and
is therefore considered to be submitted
in support of a registration. As such,
that information is directly subject to
FIFRA section 10. However covered,
information subject to FIFRA section 10
is provided certain protections that go
beyond those authorized by FOIA. For
example, FIFRA section 10(g) generally
prohibits EPA from releasing
information submitted by a registrant
under FIFRA to a foreign or
multinational pesticide producer, and
requires the Agency to obtain an
affirmation from all persons seeking
access to such information that they will
not disclose the information to a foreign
or multinational producer. FFDCA
section 408(i) extends the protection
available under FIFRA section 10 for
data submitted in support of a tolerance
or tolerance exemption.
All other CBI submitted in response to
a FFDCA section 408(p) test order (i.e.,
data not in support of a registration or
tolerance/tolerance exemption) is only
protected by the provisions of the Trade
Secrets Act which incorporates the
confidentiality standard in FOIA
Exemption 4. 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(b)(4)). Note that substantive criteria
must be met to claim confidentiality of
business information, as specified in 40
CFR 2.208.
As with EPA’s approach for data
compensation, EPA considers that data
submitted jointly with a registrant, or as
part of a consortium in which pesticide
registrants participate, to be data
submitted in support of a tolerance/
tolerance exemption or registration, and
therefore entitled to protection under
FIFRA section 10. However, if a nonregistrant chooses not to partner with a
registrant, such data is only subject to
the protections available under FOIA
and the Trade Secrets Act.

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E. Who Would Receive FFDCA Section
408(p) Test Orders Under the EDSP and
How Would They Be Notified?
Under FFDCA section 408(p)(5)(A),
EPA ‘‘shall issue’’ EDSP test orders ‘‘to
a registrant of a substance for which
testing is required . . . or to a person
who manufactures or imports a
substance for which testing is required.’’
EPA has identified the following
categories of potential test order
recipients:
• Technical registrants (basic
manufacturers of pesticide active
ingredients). Entities who manufacture
or import an active ingredient and hold
an active EPA registration (technical
registrants in most cases). Usually a
product with technical registration is
used in the formulation of other
pesticide products. However, EPA also
uses this term in this policy statement
to include registrants who use an
integrated system, that is, those who
produce their own active ingredient, as
well as those who use an unregistered
technical active ingredient. In the
interest of simplifying this document,
the phrase ‘‘technical registrant’’ will be
used to refer to:
(1) Registrants of a technical grade of
active ingredient; and
(2) Registrants whose products are
produced using an integrated system, as
defined in 40 CFR 158.153(g), (which
includes registrants who use an
unregistered technical active ingredient
to manufacture their pesticide product).
• End-use registrants (formulators/
customers). Registrants whose products
are formulated and sold for end use;
such product generally contain both an
active ingredient as well as pesticide
inert ingredients. The registrant does
not necessarily manufacture or import
the active pesticide ingredient or inert.
• Manufacturers/importers. Entities
who manufacture or import a pesticide
inert ingredient that do not necessarily
have to hold an EPA registration for the
sale of pesticide products. This also
includes those manufacturers of
pesticide products that are intended
solely for export, so long as another
company has a U.S. pesticide
registration for the chemical, or an
import tolerance exists for that
chemical.
1. Pesticide active ingredients. EPA
generally intends to send test orders
issued pursuant to FFDCA section
408(p) and FIFRA section 3(c)(2)(B) to
technical registrants of the pesticide
active ingredient. The Agency can easily
identify the technical registrants of
pesticide active ingredients. As
previously noted, a technical registrant
holds a registration for a specific active

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ingredient that it then formulates into
end-use (or retail) products or that its
customers purchase for formulation into
end-use products. Typically much of the
safety data EPA requires is conducted
on the technical grade active ingredient,
rather than on the end-use product. (See
generally, 40 CFR part 158).
Consequently, the ‘‘technical
registrants,’’ who are typically not
considered to be a small business, have
historically been responsible for
generating most of the data that support
pesticide registrations. Registrants of
end-use products generally rely on the
data generated by the technical
registrants in accordance with the
‘‘formulator’s exemption’’ in FIFRA
section 3(c)(2)(D).
Some active ingredients are
‘‘commodity chemicals,’’ that is, they
may be used both in non-pesticidal
products, such as drugs or cleaning
products, and as active ingredients in
pesticide products. When a company
produces such a commodity chemical
and that company does not sell or
distribute the chemical as a pesticide
within the meaning of FIFRA section
2(u) and 40 CFR 152.15, FIFRA does not
require registration of the chemical until
it is sold or distributed in a product that
is intended for a pesticidal purpose.
However, FFDCA section 408(p)(5)
specifies that EPA is to send test orders
to manufacturers and importers of ‘‘a
substance for which testing is required
under this subsection,’’ and does not
limit testing requirements only to
manufacturers/importers of a pesticide
chemical. Once EPA issues a test order
for a pesticide chemical, a person who
manufactures that chemical, even if not
for use as a pesticide, is clearly
manufacturing a substance for which
testing is required, and consequently, is
potentially subject to EPA’s authority
under the plain language of FFDCA
section 408(p)(5).
Since EPA’s goal is to follow as
closely as feasible its existing practices
for data generation under FIFRA, EPA
generally intends to issue FFDCA
section 408(p) test orders initially only
to current pesticide registrants (and if
there are any, only to technical
registrants). Such orders would be
issued under the authority of both
FFDCA section 408(p) and FIFRA
section 3(c)(2)(B). The Agency expects
to issue ‘‘catch-up’’ test orders to any
entity selling a commodity chemical
into the pesticide market. This will
occur when a commodity chemical
company is discovered to be selling into
the pesticide market for 15 years
subsequent to the initial issuance of the
testing orders.

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2. Pesticide inert ingredients. EPA
generally intends to send test orders
issued pursuant to FFDCA section
408(p) to current manufacturers and
importers; and ‘‘catch-up’’ FFDCA
section 408(p) test orders to
manufacturers and importers who
subsequently enter the marketplace for
15 years after the initial test order(s) for
the chemical is issued. For pesticide
inert ingredients, manufacturers/
importers include any company that
manufactures or imports the chemical
regardless of whether it is a registrant
and regardless of whether it directly
sells the chemical for use as a pesticide
inert.
For the purposes of discussion, EPA
identified two subclasses of pesticide
inerts:
• Food use pesticide inerts, i.e.,
pesticide inert ingredients with an
existing or pending tolerance or
tolerance exemption.
• Non-food use pesticide inerts.
a. Food-use pesticide inerts. If a
pesticide inert ingredient has an
existing or pending tolerance or
tolerance exemption, data compensation
and data confidentiality protection are
available pursuant to FFDCA section
408(i). For this class of pesticide inert
ingredients, EPA generally intends to
issue FFDCA section 408(p) test orders
to manufacturers and importers.
b. Non-food use pesticide inerts. EPA
generally intends to send the FFDCA
section 408(p) test orders only to
manufacturers/importers of the
substance used as a non-food use
pesticide inert ingredient. Note that
EDSP data submitted on non-food use
pesticide inerts are not covered by the
data compensation and data
confidentiality provisions of FFDCA
section 408(i) or by FIFRA, unless the
data are submitted by a registrant or a
consortium that includes at least one
registrant. Therefore, although EPA does
not currently intend to send initial test
orders to registrants, EPA encourages
non-registrant recipients who submit
data to partner with a registrant, so they
will receive added protections under
FIFRA for proprietary information or
compensation from applicants who use
the pesticide inert ingredient to
formulate their pesticide products. Bear
in mind, however, that even where
FIFRA’s compensation provisions do
not apply, EPA expects that the
Agency’s procedures (e.g., whereby
companies entering the market after
submission of the EDSP data would
receive ‘‘catch-up’’ FFDCA section
408(p) test orders) would lead to the
manufacturers and importers subject to
the initial FFDCA section 408(p) test

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orders receiving offers to share test costs
equitably.
3. How would EPA identify order
recipients? For FFDCA section 408(p)
test orders involving pesticide active
ingredients, the Agency intends to rely
on the Office of Pesticide Programs’
(OPP’s) Office of Pesticide Programs
Information Network (OPPIN). OPPIN is
an internal OPP database for query,
input and tracking of pesticide
products, ingredients, studies,
regulatory decisions and other
information. The OPPIN system is
typically used to produce study
bibliographies or lists of registered
products. EPA intends to use OPPIN to
identify registrants of the pesticide
active ingredients identified for initial
screening under the EDSP.
For FFDCA section 408(p) test orders
involving pesticide inerts, the Agency
intends to use OPPIN (where
applicable), information from the TSCA
Inventory Update Rule (IUR), and rely
on other databases to identify
appropriate manufacturers/importers
and end-use registrants. These other
databases may include publicly
available sources like Dun and
Bradstreet, online marketing material,
etc.
EPA intends to make public the list of
recipients of FFDCA section 408(p) test
orders and DCI notices and invite the
public to identify additional persons
who should have received the FFDCA
section 408(p) test order. Commenters
could either identify themselves or
another person as additional candidates
(with proper substantiation) for receipt
of a FFDCA section 408(p) test order. If
the identity of a company subject to the
test order is claimed as CBI, EPA
intends to offer the company an
opportunity to identify an agent who
would act on their behalf in all matters
relating to the EDSP program. For any
company that chooses to designate an
agent, the Agency intends to make the
name of the agent (instead of the
company) public by including it on the
list of recipients of FFDCA section
408(p) test orders and DCI notices. If the
identity of a company subject to the test
order is claimed as CBI, and yet the
company does not name an agent, that
company’s ability to obtain data
compensation from other parties (or rely
on compensable data submitted by other
parties) would likely be affected. EPA
generally intends to publish the list of
order recipients in the Federal Register
and post it on the Agency’s website.
EPA intends to update the list with
subsequent publication(s) and posting(s)
as appropriate. For example, the Agency
intends to post the status of the testing
orders, including the recipient’s

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response, on the Agency website so that
both order recipients and the public can
check on the status of responses to the
orders. This public listing is intended to
also facilitate the formation of consortia
to develop data jointly since recipients
would know all other entities required
to generate the same data.
4. How would EPA notify order
recipients? Order recipients would be
notified through their direct receipt of a
FFDCA section 408(p) test order via
first-class mail, with return receipt.
Each order recipient would receive an
‘‘EDSP Order Packet’’ that EPA expects
will contain the signed order, a list of
other order recipients for that chemical,
and the Initial Response Form, prepopulated with the recipient-specific
information and due dates for
complying with the order.
F. Potential Responses to a Test Order
In general, EPA expects that the
orders would direct recipients to utilize
the following procedures to respond
either to an initial FFDCA section
408(p) test order or to a ‘‘catch-up’’ test
order issued to a person who began to
manufacture or import a pesticide inert
ingredient for 15 years after the initial
test order(s) for the chemical is issued.
These options are also appropriate for
responding to test orders issued jointly
under the authority of FFDCA section
408(p) and FIFRA section 3(c)(2)(B).
1. Initial response. Each recipient
would be directed to provide an initial
response to EPA within 90 days of the
issuance of the order. This initial
response is intended to be used to report
the recipient’s commitment to act in
response to the test order in one of
several ways for each assay specified in
the order, and may indicate a different
response commitment for each assay.
To facilitate completion of this initial
response within the 90 days, EPA has
created two simple Initial Response
Forms that EPA intends to pre-populate
with basic information about the
chemical and recipient to connect it to
the specific order. One form is for use
by the Individual Order recipient and
the other is for use when a Consortium
provides their group’s response. EPA
intends to include both of the Initial
Response Forms in the EDSP Order
Packet that is sent to the recipients.
Please note that in calculating the due
date for the Initial Response Form, the
Agency intends to include an additional
10 calendar days to account for the
Agency processing of the final order
package for delivery to the Post Office.
An Order recipient may elect any of
these options for one or more of the
assays in the Order, and is not limited
to electing a single response for all

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assays, nor are they required to elect
different options for each assay. For
simplicity, however, the Response Form
is structured so that recipients indicate
their responses on an assay-by-assay
basis—even if the response is the same
for more than one of the assays.
Any recipient who did not fulfill the
commitments made in its initial
response would be subject to
enforcement action for its failure 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, the recipient would 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, the recipient
would potentially be subject to
penalties, pursuant to 18 U.S.C. 1001,
for willfully making any false or
misleading statements to the Federal
government.
The recipient of a test order has
several potential initial responses from
which it can choose. The 90–day initial
response options include the following.
a. Recipient indicates that it intends
to generate new data. Recipients would
choose this option to indicate that it
agrees to individually generate new data
for the test(s) specified in the Tier 1
Order. In the case of data pertaining to
a pesticide inert ingredient for which
there is no tolerance or exemption (a
‘‘non-food use’’ inert ingredient), the
recipient may negotiate an agreement to
have a registrant of a product containing
the pesticide inert ingredient submit the
data after it is generated so that the data
qualify for compensation under
FIFRA—the data generator and the
registrant could work out among
themselves the details of such an
agreement.
b. Recipient indicates that it is
submitting or citing existing data. The
recipient would choose this option to
indicate that it is submitting or citing
existing data (including citing data
previously submitted to the Agency)
that they believe is relevant to one or
more of the requests in the test order.
The recipient’s initial response would
include either the data or a reference to
the data for each assay specified in the
order. In submitting or citing existing
data, the order recipient or other party
should follow, as appropriate, relevant
format guidelines described in Unit
IV.F.4. and provide an explanation of
the relevance of the data to the order,
including, where appropriate, a cogent
and complete rationale for why it
believes the information is or is not
sufficient to satisfy part or all of the Tier
1 Order.

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Data compensation procedures may
apply to data previously submitted to
the Agency. If the data cited or
submitted are from a study that was not
conducted exactly as specified in the
protocols referenced in the test order or
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/oppts and
select ‘‘Test Methods & Guidelines’’ on
the left), the recipient would also
identify the deviations from the
applicable protocol(s), along with an
explanation for the deviations,
including an explanation as to why,
notwithstanding the deviations, the
protocol used for developing the cited
or submitted data should still be
considered as providing an accepted
scientific methodology or protocol, and
any other information relevant to a
decision to accept the data as
satisfaction of the Order.
EPA would review any existing
relevant information submitted or cited
(including other scientifically relevant
information) to determine whether the
information is acceptable (i.e., the study
was not rejected by the Agency for any
reason related to completeness or
quality) and satisfies the Order.
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. The Agency
would notify the recipient in writing of
its determination.
If the Agency determines that the
information cited or submitted as part of
the initial response received from an
Order recipient can be used to satisfy
the Tier 1 Order, which will be based
on the weight-of-evidence from all
relevant information available to the
Agency, the Initial Response Form is the
only response required.
If, however, EPA determines that the
information cited or submitted as part of
the initial response is insufficient to
satisfy the Tier 1 Order, although it may
satisfy part of the Order, the recipient
would still need to satisfy the remainder
of the Order.
As indicated previously, EPA intends
to use a weight-of-evidence basis, taking
into account data from the Tier 1 assays
and any other scientifically relevant
information available, to determine
whether the chemical has the potential
to interact with the endocrine system.
Chemicals that go through Tier 1
screening and are found to have the
potential to interact with the estrogen,
androgen, or thyroid hormone systems
will proceed to the next stage of the
EDSP where EPA will determine which,

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if any, of the Tier 2 tests are necessary
based on the available data. Tier 2
testing is designed to identify any
adverse endocrine-related effects caused
by the substance, and establish a
quantitative relationship between the
dose and that endocrine effect.
EPA is not currently able to provide
definitive examples of the specific
circumstances in which a chemical
would be able to go directly to Tier 2
testing; however, if an Order recipient
chooses to make such a request, EPA
will consider it, along with any
justification provided. In general, it may
in some cases be possible to determine
that a particular chemical has the
potential to interact with the endocrine
system and therefore could proceed to
Tier 2 even if Tier 1 data are limited.
However, if only some of the Tier 1 data
are available, there may not be sufficient
information to determine that some of
the Tier 2 data are not necessary. These
determinations will be made in a
weight-of-evidence judgment on a caseby-case basis and made publicly
available for consideration by others
with the same or similar circumstances.
c. Recipient indicates that it intends
to enter (or offer to enter) into an
agreement to form a consortium to
provide the data. The recipient would
choose this option to indicate that it
intends to enter (or has offered to enter)
an agreement with other order
recipients to form a consortium or task
force to comply with the test order. Each
consortium participant or potential
participant is expected to submit an
Initial Response Form within 90 days.
The lead for the consortium is expected
to submit documentation confirming the
formation of the consortium or task
force within 150 calendar days of
issuance of the Order/DCI, or as part of
their initial response. Such
documentation would include the
contact information for the primary
consortia contact, a list of participants,
and the intended consortia action/
response for each assay. EPA’s typical
practice has been that, if the consortia
fails to satisfy the order, all parties
would be held to have violated the test
order.
Alternatively, recipients may provide
EPA with documentation that they have
made an offer to join the consortium or
commence negotiations regarding the
amount and terms of paying a
reasonable share of the cost of testing,
and have included an offer to submit to
a neutral third party with authority to
bind the parties to resolve any dispute
over the recipient’s share of the test
costs, (e.g., through binding arbitration).
Note: EPA’s typical practice has been
that, if the required data are not

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generated by the person(s) to whom the
offer is made, all parties, including
those that have made offers to pay or
otherwise joined the consortium, would
be held to have violated the test order.
d. Recipient claims that they are not
subject to the test order. The recipient
would choose this option to indicate
that they are not subject to the order
because:
(i) In the case of a test order that
requires data on an active ingredient,
the recipient is not a pesticide
registrant, or
(ii) In the case of an initial test order
that requires data on a pesticide inert
ingredient, the recipient does not
currently manufacture or import the
chemical.
(iii) In the case of a ‘‘catch-up’’ order,
the recipient obtains the chemical solely
from persons who are either (1) the
original data submitter; (2) a person who
has complied with a test order by
offering compensation; or (3) a person
who is otherwise an approved source
(i.e., is listed on the PIIDSSL) for that
inert. An explanation of the basis for the
claim, along with appropriate
information to substantiate that claim, is
required to allow EPA to evaluate the
claim.
The recipient’s initial response would
include an explanation and
documentation supporting their claim.
If EPA verifies your claim of not being
subject to the order, the Initial Response
Form is the only response you are
required to complete to satisfy the order.
If, however, EPA cannot verify your
claim, you must still comply with the
order and the deadline(s) for responding
remain.
e. Recipient indicates that it intends
to voluntarily cancel their
registration(s). Registrants may request
voluntary cancellation of their product’s
pesticide registration(s) pursuant to
FIFRA section 6(f). Such a request must
be submitted within 90 days of the
issuance of the order. Doing so would
initiate the existing procedures for a
voluntary cancellation (see 40 CFR
152.99). Under those procedures, the
registrant may either adopt the standard
provisions for sale or use of existing
stocks of their pesticide, or may propose
an alternative procedure. If the recipient
chooses this option, the Initial Response
Form is the only response required to
satisfy the Order as long as the
Registrant completes the voluntary
cancellation procedures. When their
product’s pesticide registration(s) is
canceled, the recipient would be
considered to have satisfied the order.
f. Recipient indicates that it intends to
reformulate their product(s) to exclude
the chemical from the formulation. In

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place of submitting the data required in
this order, a registrant may submit an
application to amend the formulation of
its product by removing as an ingredient
of their product the chemical that is the
subject of the order. For example, this
may occur in the case of a pesticide
inert ingredient if EPA issues orders to
end-use registrants. Submitting such an
application would initiate the existing
procedures for reformulation, and such
a request must be submitted within 90
days of the issuance of the order. If the
recipient chooses this option, the Initial
Response Form is the only response
required to satisfy the order as long as
the registrant completes the
reformulation procedures. When their
product’s formulation has been
changed, the recipient would be
considered to have satisfied the order.
g. Recipient claims a formulator’s
exemption. A product registrant who
receives an order to test a chemical and
who purchases the chemical from
another recipient that has agreed to
generate the data may be eligible for a
formulator’s exemption. The recipient’s
initial response would include an
explanation and documentation
supporting their claim. EPA will
confirm such claims of eligibility. A
response asserting the formulator’s
exemption would no longer be
considered an appropriate response to a
test order if the supplier of the chemical
fails to comply with the test order (i.e.,
it fails to submit the data either
individually or jointly with other
recipients or it fails to comply with the
terms of a compensation agreement or
the binding decision of a neutral third
party regarding the terms of
compensation). If EPA confirms the
eligibility claim, the Initial Response
Form is the only response required to
satisfy this order. If, however, EPA
determines that the order recipient is
not eligible, the recipient must comply
with the order.
h. Recipient indicates that it has or is
in the process of discontinuing the
manufacture or import of the chemical.
The recipient of an order for a pesticide
inert ingredient (i.e., manufacturer/
importer) would choose this option to
indicate that they are in the process of
discontinuing the manufacture or
import of the chemical. The recipient’s
initial response would include an
explanation and documentation
supporting their claim. EPA intends to
verify such a claim. If EPA confirms the
claim, the Initial Response Form is the
only response required to satisfy this
order. If, however, EPA determines that
the claim is false, the recipient must
comply with the order.

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i. Recipient indicates that it does not
and will not sell the chemical for use in
pesticide products. The recipient of an
order for a pesticide inert ingredient
(i.e., manufacturer/importer) would
choose this option to indicate that they
do not currently or agree to no longer
sell their chemical for use in the
pesticide market. To elect this option,
the order recipient would indicate, as
part of its initial response, that they
commit to discontinue, on or before a
date 6 months after the issuance of the
test order, all sale and distribution of
the pesticide inert ingredient that is the
subject of the test order to any person
who the recipient knows or reasonably
should know, intends to use the
substance in the formulation of a
pesticide product. The order recipient
would also indicate that it will include
in all contracts for sale or distribution
of the material a provision that
contractually prohibits the purchaser
from using the substance in the
formulation of a pesticide product. As
part of its initial response, the order
recipient would be asked to provide a
copy of the contract provision and a
certification to include this contractual
provision in any contracts entered into
on or after a date 6 months after the
issuance of the test order.
j. Request an exemption under FFDCA
section 408(p)(4). EPA recognizes that
FFDCA section 408(p)(4) provides that
‘‘the Administrator may, by order,
exempt from the requirements of this
section a biologic substance or other
substance if the Administrator
determines that the substance is
anticipated not to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen.’’ In 1998,
the Agency assessed the need to develop
a specific list of substances to be
exempted from EDSP testing or an
exemption process for those substances
that might not be anticipated to produce
endocrine effects in humans (See Unit
VI.L. of the December 1998 notice at 63
FR 71542). In the 1998 FR notice, EPA
also provided several examples of
substances that might possibly be
exempted. As the EDSP has evolved and
more endocrine research has been
conducted, it has become evident that,
at this time, development of criteria to
exempt certain substances or to
otherwise identify any pre-determined
or blanket exemptions from endocrine
disruptor testing is premature.
For the initial screening, EPA is not
aware of sufficient data that would
allow the Agency to confidently
determine that a chemical meets the
statutory standard for an exemption—
i.e., that it is not anticipated to interact
with the endocrine system. Although a

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relatively broad range of toxicity data
are available for pesticide active
ingredients regulated under FIFRA, in
most cases EPA has not yet established
how the available data might be
confidently used to predict the
endocrine disruption potentials of these
chemicals. This may be due to the nonspecific nature of an effect or effects
observed, questions related to whether
the mode of action in producing a given
effect or effects is or are endocrine
system-mediated in whole or in part, or
the lack of relevant data to make a
judgment altogether.
However, if an order recipient
believes that this showing can be made
for its chemical, the Agency would
consider requests to issue such an
exemption order on a case-by-case or
chemical-by-chemical basis in response
to individual submissions. In order for
the Agency to make the necessary
statutory finding to issue the exemption,
the request would need to provide any
hazard-related information that you
believe would allow EPA to determine
that your chemical is anticipated to not
be an endocrine disruptor, i.e., is not
anticipated ‘‘to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen.’’
k. Other initial responses—(i) Preenforcement challenges to a test order.
A recipient may wish to challenge the
test order. Unit IV.H., describes the
informal process by which a recipient
may raise, and EPA may review,
objections to the issuance of a test order
or to specific provisions in the order. In
order for EPA to be able to respond to
the objections in a timely manner, the
recipient would need to state with
particularity the scope and basis of the
objection, providing sufficient detail to
allow the Agency to evaluate the
objection. For further information refer
to Units IV.H. and IV.I.
(ii) Additional EDSP screening is
unnecessary because the chemical is an
endocrine disruptor or was used as a
‘‘positive control’’ in the EDSP
validation effort. If an Order recipient
chooses to ask EPA to reconsider some
or all of the testing specified in the Tier
1 Order, EPA would review the request,
along with the appropriate information
supporting the claim that additional
EDSP screening of the chemical is
unnecessary because the chemical is an
endocrine disruptor or was used as a
‘‘positive control’’ in the EDSP
validation effort, on a case-by-case basis.
Based on the information currently
available, EPA generally expects that if
the chemical was used by EPA as a
‘‘positive control’’ to validate one or
more of the screening assays, only the
data submitted related to those assays

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for which the chemical was used to
complete the testing as part of the
validation effort would be sufficient to
satisfy the Tier 1 Order.
As discussed in detail in Unit
IV.F.1.b., under one of the response
options provided in the Tier 1 Order, a
recipient may choose to cite or submit
existing data they believe can be used to
satisfy part or all of the Tier 1 Order.
Existing data may be of several types.
An example may be an in vitro assay for
transcriptional activation that is
conducted with a different cell line and
by a different protocol. But more
generally, existing data may be other
scientifically relevant information.
Scientifically relevant information can
include data from studies other than the
EDSP Tier 1 assays, e.g., studies
conducted to satisfy a 40 CFR part 158
or part 161 data requirement, data from
other studies conducted to address an
identified issue, or data from studies
found in the scientific literature. In
addition to the Tier 1 Order recipient,
anyone can submit other scientifically
relevant information. To allow EPA to
review the submission of other
scientifically relevant information in a
timely fashion, the submitter of the
information should consider providing a
scientifically sound rationale that
explains how the submitted or cited
data provides the information needed to
satisfy part or all of the Tier 1 Order
and/or otherwise inform the Agency’s
Tier 1 determination.
2. Generate the data specified in the
Tier 1 Order. As indicated in the Initial
Response Form, the recipient’s next step
will vary depending upon their initial
response. The process diagram in the
docket outlines the overall process with
the various response options. In general,
assuming that the order recipient
indicated that they will generate the
data individually or as part of a
consortium, the next step in responding
to the order would be the generation of
the data as specified.
The tests would generally be
conducted using the test protocols cited
in the order because FFDCA requires
that the test method be validated. If,
however, an order recipient believes a
deviation from the required protocol is
needed, they would first consult with
the Agency before deviating from the
test protocol. All requests would be
submitted with a clear rationale to allow
the Agency to evaluate the request in a
timely manner. EPA intends to review
all protocol variations and send a
written response to the specific order
recipient in a timely fashion.
In addition, order recipients
generating data must adhere to the good
laboratory practice (GLP) standards

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described in 40 CFR part 160 when
conducting studies in response to a
FFDCA section 408(p) test order.
3. Submit a progress report. Unless
EPA has notified the recipient that they
have satisfied the order, EPA generally
intends to ask each order recipient to
submit a progress report to EPA 12
months after issuance of the order. Each
progress report would provide a brief
description of the status of the
recipients 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.
4. Submit the data specified in the test
order. Assuming that the order recipient
indicated that they would generate the
data individually or as part of a
consortium, the next step in responding
to the order would be the submission of
the data as specified. The Agency
generally intends for the order to
include a final submission due date of
24 months after the issuance of the
order. In establishing this timeframe, the
Agency considered:
(a) The timeframes set for the initial
response and consortia documentation;
(b) The duration of each assay in
terms of estimated timeframes for
planning, performing the tests and
documenting results; and
(c) The estimated timeframes for
preparing and completing the final data
submission to EPA.
EPA believes that having a single due
date allows the order recipients to
efficiently plan the activities necessary
for generating and submitting the data,
including entering into joint agreements
and sequencing the laboratory activities
as appropriate. Although EPA intends to
establish a single due date, if the order
recipient or consortia choose to submit
the results from each assay individually,
the order would be satisfied when the
Agency determines the results
submitted satisfy the order.
The Agency intends to use the same
submission procedures as those that are
currently used for submitting other data
in support of a pesticide registration,
with only a few modifications. Once the
data are generated, the recipient would
prepare a submission package for
transmittal to EPA. EPA intends for the
orders to include requirements on how
the data would be formatted or
presented for submission to EPA. In
general, EPA expects the orders to
include the following instructions.
a. Format for data submission. As part
of a cooperative NAFTA project, EPA
and the Canadian Pest Management
Regulatory Agency (PMRA) developed
standard data evaluation formats, or

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templates. The templates have been in
use by these agencies since 2002 for
writing their data evaluation records
(DERs) of studies submitted under
FIFRA and FFDCA to EPA and the
Canadian data codes (DACOs). Although
such templates do not currently reflect
the assays being considered for the
EDSP Tier 1 battery, the Agency intends
to review and, as necessary, develop
new or revised templates before the
deadlines for submission of the data
under the EDSP.
The DER that the agencies prepare
contains a study profile documenting
basic study information such as
materials, methods, results, applicant’s
conclusions and the evaluator’s
conclusions. The templates provide
pesticide registrants and the public an
opportunity to gain a better
understanding of the regulatory science
review and decision-making process.
The agencies encourage registrants to
include study profiles based on these
templates in their study documents for
all pesticide types. These templates
describe the layout and scope of
information that would 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
how to organize and format submittals
of data supporting a pesticide
registration (http://www.epa.gov/
PR_Notices/pr86-5.html). The Agency
has begun the process of updating the
guidance in PR Notice 86–5 to further
clarify the data submission process for
pesticide-related submissions and
intends to provide the public with an
opportunity to comment on the
proposed revisions to PR Notice 86–5
consistent with the procedures
described in PR Notice 2003–3, entitled
Procedural Guidance for EPA’s Office of
Pesticide Programs Procedures
Concerning the Development,
Modification, and Implementation of
Policy Guidance Documents; (http://
www.epa.gov/PR_Notices/pr2003-3.pdf).
The Agency also intends to encourage
FFDCA section 408(p) test order
recipients to submit completed study
profiles and supporting data in an

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electronic format whether submitting
one or several studies. OPP has
established Adobe Portable Document
Format (PDF) as the standard file format
for the electronic submission of required
studies, using compact disks as the
transport medium. In addition, OPP
recently announced an e-Submission
initiative to help EPA move toward a
more paperless environment. The
information exchange from industry to
EPA is based on a harmonized
eXtensible Markup Language (XML)
schema used by Canada’s PMRA, which
has been adapted by EPA. This
harmonization assures industry that a
documentation package submitted to
one participating regulatory agency can
likewise be submitted to the other
participating agency, thus increasing
standardization and decreasing the
burden on industry. EPA also believes
that information submitted to EPA in
the XML schema format is intended to
improve data quality and allow for a
more efficient pesticide registration
process. To assist pesticide registrants
with the creation of the e-Submission
XML packages, EPA has established an
e-Submission XML help desk. For more
information about electronic
submissions, go to http://www.epa.gov/
pesticides/regulating/registering/
submissions/index.htm.
b. Transmittal document. In order for
EPA to effectively track the compliance
of each order recipient, each submission
in satisfaction of a FFDCA section
408(p) test order would need to be
accompanied by a transmittal document
that includes the following information:
• Identity of the submitter.
• The date on which the submission
package was prepared for transmittal to
EPA.
• The FFDCA section 408(p) test
order number.
• Summary of the response
commitment for each assay.
• A list of the individual documents
included in the submission, with
relationship to assay specified.
c. Individual study or test result
documents. Unless otherwise specified
by the Agency, and varying based on the
order recipient’s initial response, EPA
would generally expect each submission
package to be in the form of individual
documents or studies to address each
assay specified in the order. As
indicated previously, EPA does not
anticipate the resubmission of
previously submitted documents absent
a specific Agency request. Instead it
would be sufficient for previously
submitted documents to be cited with
adequate information to identify the
previously submitted document. EPA

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would typically expect each study or
document to include the following:
i. A title page including the following
information:
• The FFDCA section 408(p) test
order number.
• The title of the study, including
identification of the substance(s) tested
and the test name or data requirement
addressed.
• The author(s) of the study.
• The date the study was completed.
• If the study was performed in a
laboratory, the name and address of the
laboratory, project numbers or other
identifying codes.
• If the study is a commentary on or
supplement to another previously
submitted study, full identification of
the other study with which it would 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, any data
confidentiality claims must be
accompanied by a signed and dated
document containing the appropriate
statement(s) as described in the FFDCA
section 408(p) test order, which EPA
expects would reference PR Notice 86–
5 or other available Agency guidance, as
appropriate.
iii. A statement of compliance or noncompliance with respect to GLP
standards as described in 40 CFR part
160, as applicable.
iv. A complete and accurate English
translation for any information that is
not in English.
5. Submit a written request for an
extension. The FFDCA section 408(p)
test order would identify a due date for
submitting the data specified to EPA. If
an order recipient determines that they
will not be able to submit the data
specified in the order to EPA by the due
date, the recipient can submit a written
request for a time extension that
provides a clear rationale for the need
for an extension, along with any
supporting documentation, in order to
allow the Agency to properly and timely
assess the request. EPA intends to
review all such requests and send a
written response to the requester in a
timely fashion. In most cases the
original deadline would remain while
EPA considers the request. The Agency
intends to only grant extensions that
were requested in writing. Ordinarily,
extensions would only be available in
cases of extraordinary testing problems
beyond the expectation or control of the
order recipient. Extensions would not
be considered if the request for
extension is not made in a timely

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fashion; or if it is submitted at or after
the deadline. EPA intends to only grant
extension requests in writing.
6. Maintain records. EPA generally
intends for the FFDCA section 408(p)
test order to identify the following
records that the recipient would
maintain as part of compliance with the
order. Typically, the Agency expects
recipients to retain copies of the data
and other information submitted to the
Agency in response to an order.
Under FIFRA section 8, all producers
of pesticides, devices, or active
ingredients used in producing
pesticides subject to FIFRA, including
pesticides produced pursuant to an
experimental use permit and pesticides,
devices, and pesticide active ingredients
produced for export, are required to
maintain certain records. As such, any
recipients who are pesticide registrants
or who otherwise submit their data in
support of a pesticide registration will
be held to the recordkeeping standards
in 40 CFR part 169. Consistent with 40
CFR 169.2(k), this includes all test
reports submitted to the Agency in
support of a registration or in support of
a tolerance petition, all underlying raw
data, and interpretations and
evaluations thereof. Under part 169, the
registrant must retain these records as
long as the ingredient is contained in a
pesticide product with a valid
registration and the producer is in
business, and such records must be
made available to EPA or its agent for
inspection upon request.
Recipients who are not a registrant
would also be asked to retain records
related to the generation of the data and
copies of other information submitted to
the Agency in response to the order. In
general, EPA would typically expect
recipients who are not a registrant to
also retain such records for the same
length of time as a registrant, and to also
make the records available to EPA or its
agent for inspection upon request.
G. What are the Consequences for a
Recipient Who Fails to Respond or
Comply with the Test Order?
For pesticide active ingredients,
FFDCA section 408(p)(5)(C)(i) requires
EPA to issue to any registrant that fails
to comply with a FFDCA section 408(p)
test order ‘‘a notice of intent to suspend
the sale or distribution of the substance
by the registrant.’’ The proposed
suspension ‘‘shall become final at the
end of the 30–day period beginning on
the date that the registrant receives the
notice of intent to suspend, unless
during that period a person adversely
affected by the notice requests a hearing
or the Administrator determines that the
registrant has complied’’ with the

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FFDCA section 408(p) test order. As
specified by FFDCA section
408(p)(5)(C)(iii), the Administrator shall
terminate a suspension if the
Administrator determines that the
registrant has complied fully.
For all pesticide inert ingredient
manufacturers/importers, FFDCA
section 408(p)(5)(D) provides for EPA to
apply the penalties and sanctions
provided under section 16 of TSCA (15
U.S.C. 2615) ‘‘to any person (other than
a registrant) who fails to comply with an
[FFDCA section 408(p)] order.’’
H. Process for Contesting a Test Order/
Pre-enforcement Review
FFDCA section 408(p) does not
explicitly address the process for
challenging a test order (e.g., if the test
order recipient disagrees that a
particular study is appropriate or valid).
The statute only specifies the rights and
procedures available to test order
recipients who have failed to comply
with a test order. Further, the issue is
somewhat complicated by the fact that
the statute establishes different
procedures for enforcing the test orders
against pesticide registrants and against
chemical manufacturers or importers.
(Compare 21 U.S.C. 346a(p)(3)(C) and
(D)). Nor is this issue resolved by
FFDCA section 408’s general judicial
review provision; that provision is
applicably solely to the enumerated
actions, which do not include FFDCA
section 408(p) test orders. (21 U.S.C.
346a(h)). Consequently, FFDCA section
408(p) is ambiguous on a number of
issues, such as the availability of preenforcement review, and the issues that
may be raised in an enforcement
hearing.
For pesticide registrants, FFDCA
section 408(p)(5)(C) directs EPA to
initiate proceedings to suspend the
registration when a registrant fails to
comply with a test order. (21 U.S.C.
346a(p)(3)(C)(i)). Prior to the
suspension, a registrant may request a
hearing, but the statute restricts the
issues in the hearing solely to whether
the registrant has complied with the test
order. (21 U.S.C. 346a(p)(3)(C)(ii)). The
substance of the test order may not be
challenged during this hearing. Thus,
for example, to challenge whether EPA
should have required a particular study,
the registrant would need to challenge
the test order itself in the appropriate
district court. (See, e.g., Atochem v.
EPA, 759 F.Supp. 861, 869-872 (D.D.C.
1991)). The basis for the statutory
restriction is that the FFDCA section
408(p) test order constitutes final agency
action, and as such, is subject to review
upon issuance. (See, Atochem, supra).
In addition, as discussed above, EPA

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currently intends to issue the test orders
for testing of active ingredients jointly
under FFDCA section 408(p) and FIFRA
section 3(c)(2)(B). The procedures
discussed above for challenging an
FFDCA section 408(p) test order are
wholly consistent with the procedures
applicable to FIFRA section 3(c)(2)(B),
which similarly limits the issues for
resolution in any suspension hearing
held for failure to comply with the
order. (See 7 U.S.C. 136a(c)(2)(B)(iv)).
Accordingly, EPA believes that for
pesticide registrants, pre-enforcement
review of the test order would be
available directly in federal district
courts under any approach, and based
on the plain meaning of the statute,
would be the only means to obtain
judicial review of the validity of the test
order itself.
By contrast, FFDCA section
408(p)(5)(D) provides that nonregistrants (manufacturers or importers
of pesticide inert ingredients) are
subject to monetary penalties through
an enforcement proceeding, using the
process established by TSCA section 16.
Under TSCA section 16, civil penalties
of up to $25,000 per day may be
assessed, after an administrative hearing
is 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 the recipient 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 CFR 22.13–22.14). TSCA
section 16 also specifies that the
following issues shall be taken into
account in determining the amount of a
civil penalty: The nature,
circumstances, extent and gravity of the
violation(s); the violator’s ability to pay;
the effect on the violator’s ability to
continue to do business; any history of
prior violations; the degree of
culpability; and such other matters as
justice may require. (15 U.S.C.
2615(a)(2)(B)).
Although neither FFDCA section
408(p) nor TSCA section 16 expressly
imposes the same restriction on the
issues that a non-registrant may raise in
the penalty hearing, EPA’s
interpretation of the statutes and
existing regulations is to impose a
similar restriction. In large measure this
interpretation turns on the fact that, at
least for pesticide registrants, FFDCA
section 408(p) test orders constitute
final agency action, and consequently,
would be subject to review in the
appropriate district court. Logically, it

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makes sense to interpret the test order
to be final for all parties, as the
provisions of FFDCA section
408(p)(5)(A) that describe the test order
do not distinguish between registrants
and other test order recipients.
Accordingly, pre-enforcement judicial
review of the test order will be
available, and would be the means by
which any test order recipient would
challenge the validity of the test order.
As a consequence of that interpretation,
EPA interprets TSCA section 16 to
restrict the issues that may be raised in
any enforcement hearing to whether the
test order recipient had violated the test
order, as well as the appropriate amount
of any penalty. This interpretation is
consistent with the issues listed in
TSCA section 16(a)(2)(B), which do not
expressly relate to the validity of the
underlying requirement.
I. Informal Administrative Review
Procedure
EPA generally intends to include a
provision in the FFDCA section 408(p)
test order by which order recipients
would raise any questions or challenges
concerning the issuance of the test order
to the Agency in response to the order.
In addition, because the mere filing of
the objection (or indeed, the filing of a
judicial challenge) would not
necessarily extend the deadline for
submission of the studies, in order for
this process to be completed in a timely
fashion, EPA expects order recipients to
present their objections with sufficient
specificity and detail to allow the
Agency to adequately and fairly
evaluate the issue(s) presented. EPA
intends to review the issues presented
and provide a written response within
a reasonable amount of time. The
Agency understands that it will need to
respond within sufficient time for the
order recipient to either comply with
the order or determine whether to
pursue its concerns through judicial
review.
J. How Would EPA Handle Responses
from Recipients of Test Orders?
Just as there are many different,
acceptable responses that recipients
may provide to a test order, so too are
there many actions that EPA may take.
In some cases, a recipient’s response
would affect only the recipient. This
would be the case for a response from
a test order recipient:
• Who claims that it is not subject to
the order (see Unit IV.F.1.d.); or
• Who voluntarily cancels its
registration (see Unit IV.F.1.e.); or
• Who reformulates its registered
products (see Unit IV.F.1.f.); or

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• Who claims that it qualifies for the
formulator’s exemption (see Unit
IV.F.1.g.); or
• Who claims that it does not or no
longer manufacture(s) or import(s) the
chemical (see Unit IV.F.1.h.).
Each of these responses would only
affect the specific recipient’s obligation
under the order. If EPA agreed with the
response, the recipient would not be
required to generate the EDSP data (not
subject to the order or qualified for the
formulator’s exemption) or EPA would
cancel the recipient’s registration as
requested. EPA actions on these kinds of
responses would not affect other order
recipients; they would still be required
to respond to the order by generating the
data or making one of the other
acceptable responses.
In some cases, however, another
recipient’s response may have
consequences for other recipients. This
would be the case for a response from
a test order recipient:
• Who intends to generate the data
(see Unit IV.F.1.a.); or
• Who cites or submits existing data
(see Unit IV.F.1.b.); or
• Who enter (or offer to enter) a joint
agreement to generate the data (see Unit
IV.F.1.c.); or
• Who commits to not sell their
chemical for use in the pesticide market
(see Unit IV.F.1.i.).
The following discussion summarizes
how EPA expects to handle responses to
test orders that may have consequences
for other recipients.
1. Publication order recipients,
responses, and order status. As noted
earlier, EPA intends to publish the list
of all order recipients in the Federal
Register and post the list on the
Agency’s website. The Agency intends
to also post the status of the testing
orders, including recipients’ responses,
on the Agency website so that both
order recipients and the public can
check on the status of responses to the
orders. This information is intended to
enable recipients of test orders to
identify and join other order recipients
to develop the data in response to the
order, which in turn would help achieve
EPA’s goals of minimizing duplicative
testing and promoting fair and equitable
sharing of test costs. For example, if
more than one recipient has agreed to
perform the required studies (see Unit
IV.F.1.a.), it will be reflected on the list
and having this information will help
them explore the possibility of
generating the data jointly. In addition,
a recipient who has agreed to generate
required EDSP data can see all other
recipients who have informed the
Agency that they would be willing to
share the cost of performing the

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required studies (see Unit IV.F.1.b.).
This information will aid in their
sorting of offers to share the cost of
generating the required data from any
recipient whom EPA indicates has
promised to make an offer to share test
costs, but has not yet contacted the
recipient.
2. Publication of EPA decisions
regarding reliance on existing data or
requests for an exemption under section
408(p)(4), and decisions challenging the
issuance of the test orders. The EPA
website would also contain information
on decisions about whether a test
recipient may rely on existing data (see
Unit IV.F.1.c.). If so, the Agency intends
to regard the existing data as meeting
the requirement for all test order
recipients. Similarly, if EPA determines
that a recipient has demonstrated that
the Agency should exempt the chemical
from testing under section 408(p)(4) (see
Unit IV.F.1.h.), that decision would
apply equally to all test order recipients.
Finally, a recipient’s challenge to the
legal basis for a test order (see Unit
IV.F.1.i.) might be resolved in a way that
affects the validity of the order for other
recipients. Publishing these decisions
may also be considered by others with
similar questions.
3. Generation of data, tracking
compensability of submitted data, and
enforcing compensation obligations.
When EDSP data on an active ingredient
are submitted, EPA intends to handle
the submission in the same manner
used under FIFRA. The name of the data
submitter would be added to the Data
Submitters List and all future applicants
for registration of a pesticide containing
the active ingredient would be required
to cite and offer to pay compensation in
order to rely on the data for the 15–year
period following submission of such
data.
In the case of EDSP data on pesticide
inert ingredients, as explained in Unit
IV.C.2.c., EPA intends to establish a list
(i.e., the PIIDSSL) to identify any person
who has submitted compensable data on
a pesticide inert ingredient in response
to a test order issued under FFDCA
section 408(p). Assuming at least one
recipient of a test order submits the
required EDSP data, EPA would add the
name of the submitter to the PIIDSSL
under the name of the ingredient as an
‘‘original data submitter.’’ The PIIDSSL
would also include any other test order
recipient who has made an offer to share
the cost of testing as an ‘‘approved
source,’’ i.e., a source from whom an
applicant or registrant may obtain the
pesticide inert and not have to offer to
pay compensation to the original data
submitter. Since it is important to have
as complete a list of approved sources

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as possible, EPA encourages original
data submitters to identify additional
companies as approved sources, for
example, because they have a contract
to buy from the data submitter. Then,
pursuant to FIFRA section 3(c)(1)(F),
when an applicant’s product contains a
pesticide inert ingredient on the
PIIDSSL, the applicant would identify
the source of the pesticide inert
ingredient. If the applicant’s source does
not appear on the PIIDSSL, the
applicant would either switch to a
source on the PIIDSSL, offer to pay
compensation to the original data
submitter(s) on the PIIDSSL, or generate
their own data.
EPA intends to also take a number of
measures to ensure that pesticide
registrants are not obtaining the
pesticide inert ingredient from an
‘‘unapproved’’ source. Shortly after the
receipt of test order responses, EPA
intends to make public the
commitments made by recipients of test
orders–the names of the companies that
have agreed to generate (or share in the
cost of generating) test data (‘‘data
generators’’) and the names of the
companies that have committed to
discontinue selling into the pesticide
market. If at least one order recipient
has agreed to generate the required data,
EPA intends to inform registrants that in
the future they will need to obtain the
pesticide inert ingredient only from a
data submitter or approved source, offer
to pay compensation to the data
submitter for the right to rely on existing
data, or generate new data.
The Agency thinks these procedures
will result in a system that effectively
provides data use protections to
generators of EDSP data on pesticide
active and inert ingredients. Through
this system all manufacturers and
importers of pesticide inert ingredients
will understand whether or not they are
allowed to sell into the pesticide
market. If a manufacturer or importer
takes the necessary steps that allow it to
sell into the pesticide market, such a
company would be listed on the
PIIDSSL. Those manufacturers and
importers whose products reached the
pesticide market through other
suppliers could add the names of the
suppliers to the PIIDSSL. Similarly,
through this system, applicants for new
products and registrants of existing
products will understand from which
sources they may purchase a pesticide
inert ingredient without having to offer
to pay compensation, or without
running the risk of needing to generate
their own data.
The Agency recognizes that these
safeguards do not automatically ensure
compliance with the data use

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protections. But the Agency expects that
manufacturers and importers who
commit not to sell their chemical into
the pesticide market will adhere to this
promise and will work with their
customers to ensure they also observe
this market constraint.
EPA also intends to take steps to try
to prevent companies from
inadvertently subverting the
commitment made by order recipients.
For example, the Agency’s Federal
Register document that announces the
issuance of the FFDCA section 408(p)
order(s), would also inform those
companies who sell a chemical that is
used as a pesticide inert ingredient
(other than test order recipients) that
they may receive and become subject to
an FFDCA section 408(p) order if they
obtain the pesticide inert ingredient
(either directly or indirectly) from a
source who has not committed to
generate the EDSP data but then sell the
pesticide inert ingredient into the
pesticide market. EPA intends to inform
manufacturers who agree to generate the
data that EPA intends to rely on them
to bring to EPA’s attention information
indicating that a pesticide registrant
appears to be obtaining the pesticide
inert ingredient from an ‘‘unapproved’’
source. As indicated previously, EPA
intends to issue ‘‘catch-up’’ orders to
any manufacturer or importer of a
pesticide inert ingredient who enters the
market place after EPA has issued a test
order for that ingredient.
4. All test order recipients for a
pesticide inert ingredient ‘‘opt out’’ of
the pesticide market. If no test order
recipient has agreed to generate the
required data, the Agency intends to
issue a Federal Register notice
informing registrants that the pesticide
inert ingredient will no longer be
available for use in formulating
pesticide products unless someone
commits to generate the required data.
EPA intends to ask for a commitment to
generate the required data within 6
months of publication. After that date,
EPA would take steps to remove the
pesticide inert ingredient from its list of
cleared pesticide inerts and to revoke
any tolerances or tolerance exemptions
for the pesticide inert ingredient. EPA
would also remind registrants that
under existing regulations, they must
apply to amend their registrations before
they may sell a pesticide product that
has a composition that differs from the
approved Confidential Statement of
Formula for the product. On a case-bycase basis, EPA may issue a DCI notice
and/or a section 408(p) test order for the
required data to registrants whose
products contain the pesticide inert
ingredient.

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K. Adverse Effects Reporting
Requirements

V. Statutory and Executive Order
Reviews

Under FIFRA section 6(a)(2), pesticide
product registrants are required to
submit adverse effects information
about their products to the EPA. Among
other things, the implementing
regulations in 40 CFR part 159, subpart
D provide registrants with detailed
instructions on whether, when, and how
to report information in the possession
of the registrant or its agents.
In addition, under TSCA section 8(c),
companies can be required to record,
retain and in some cases report
‘‘allegations of significant adverse
reactions’’ to any substance/mixture that
they produce, import, process, or
distribute. EPA’s TSCA section 8(c) rule
requires producers, importers, and
certain processors of chemical
substances and mixtures to keep records
concerning significant adverse reaction
allegations and report those records to
EPA upon notice in the Federal Register
or upon notice by letter. The TSCA
section 8(c) rule also provides a
mechanism to identify previously
unknown chemical hazards in that it
may reveal patterns of adverse effects
which otherwise may not be otherwise
noticed or detected. Further information
is available under 40 CFR part 717.
Under TSCA section 8(e), U.S.
chemical manufacturers, importers,
processors, and distributors are required
to notify EPA within 30 calendar days
of new, unpublished information on
their chemicals that may lead to a
conclusion of substantial risk to human
health or to the environment. The term
‘‘substantial risk’’ information refers to
that information which offers reasonable
support for a conclusion that the subject
chemical or mixture poses a substantial
risk of injury to health or the
environment and need not, and
typically does not, establish
conclusively that a substantial risk
exists. For additional information about
TSCA section 8(e), please go to http://
www.epa.gov/oppt/chemtest/pubs/
sect8e.htm.
EPA does not require duplicate
submission of EDSP results under
FIFRA section 6(a)(2) or TSCA section
8(c) or (e). Any information submitted
under FIFRA section 6(a)(2) or TSCA
section 8(c) or 8(e) procedures does not
need to be submitted again to satisfy the
FFDCA section 408(p) test order. The
test order recipient would instead
submit the necessary information to cite
to the previously submitted information
as described earlier in this document.

A. Regulatory Planning and Review
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
EPA submitted this document to the
Office of Management and Budget
(OMB) for review. Any changes made in
response to OMB recommendations
have been documented in the docket for
this action as required by section
6(a)(3)(E) of the Executive Order.

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B. Paperwork Reduction Act (PRA)
The information collection
requirements associated with issuing
orders for Tier 1 screening under the
EDSP have been submitted for review
and approval by OMB under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq. An agency may not
conduct or sponsor, and a person is not
required to respond to a collection of
information unless it displays a
currently valid OMB control number. As
a new ICR, the Agency does not yet have
an OMB control number for this
information collection activity. Once
assigned, EPA will announce the OMB
control number for this information
collection in the Federal Register, and
will add it to any related collection
instruments or forms used, and include
it in the orders issued.
A copy of the final ICR package
submitted to OMB for review and
approval under the PRA (identified
under EPA ICR No. 2249.01) has been
placed in the docket for this policy. A
draft of the ICR package was issued for
public comment pursuant to the PRA
and 5 CFR 1320.8(d) on December 13,
2007 (72 FR 70839) (FRL–8155–8). The
ICR has been revised to address
comments received, and the following is
a brief summary of the final ICR package
that was submitted to OMB for approval
under the PRA and which describes the
information collection activities
discussed in the final policy and
procedures document, along with EPA’s
estimated burden in more detail.
Under the PRA, ‘‘burden’’ is defined
at 5 CFR 1320.3(b). For the purposes of
this ICR, the information collection
activities include reviewing the order,
providing the initial response,
participating in a consortia, generating
the data, preparing and submitting a
progress report, submitting the data,
requesting an extension, and
maintaining records. As described in
more detail in the ICR, the total
estimated per chemical/per respondent
paperwork burden is 3,008 hours, with
an estimated cost of $212,369.
Annualized over 3 years, the per

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respondent burden is 1,003 hours, and
the cost is $70,790. The total annualized
estimated paperwork burden for this
ICR is 108,364 hours, with an estimated
total annual cost of $7,478,116 million.
Although individual respondent burden
varies based on their individual
activities, this estimate assumes that the
respondent actively participates in all
potential activities, including
developing consortia, generating all of
the potential data, submitting a progress
report, requesting an extension, and
submitting the data.
Pursuant to 5 CFR 1320.12, the
submission of the ICR to OMB, along
with a solicitation of comments on that
ICR, is addressed in a separate
document published elsewhere in
today’s Federal Register. Please follow
the instructions in that document to
view the ICR and submit comments on
the revised ICR.
VI. References
The following is a list of the
documents that are specifically
referenced in this document and placed
in the docket that was established under
Docket ID number EPA–HQ–OPPT–
2007–1080. For information on
accessing the docket, refer to the
ADDRESSES unit at the beginning of this
document.
1. EPA. Endocrine Disruptor
Screening and Testing Advisory
Committee (EDSTAC) Final Report.
August 1998. http://www.epa.gov/
scipoly/oscpendo/pubs/edspoverview/
finalrpt.htm.
2. Organization for Economic
Cooperation and Development (OECD).
Final Report of the OECD Workshop on
Harmonization of Validation and
Acceptance Criteria for Alternative
Toxicological Test Methods. August
1996.
3. EPA. Response to Comments on the
Endocrine Disruptor Screening Program:
Draft Policies and Procedures for Initial
Screening and Testing. March 2009.
4. EPA. EPA’s Approach for
Considering Other Scientifically
Relevant Information (OSRI) under the
Endocrine Disruptor Screening Program.
March 17, 2009.
List of Subjects

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Environmental protection, Chemicals,
Endocrine disruptors, Pesticides and
pests, Reporting and recordkeeping.
Dated: April 3, 2009.
James Jones,
Acting Assistant Administrator for
Prevention, Pesticides and Toxic Substances.
[FR Doc. E9–8706 Filed 4–14–09; 8:45 am]
BILLING CODE 6560–50–S

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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2004–0109; FRL–8399–7]

Final List of Initial Pesticide Active
Ingredients and Pesticide Inert
Ingredients to be Screened Under the
Federal Food, Drug, and Cosmetic Act
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:

SUMMARY: Section 408(p) of the Federal
Food, Drug, and Cosmetic Act (FFDCA)
directs EPA to develop a chemical
screening program using appropriate
validated test systems and other
scientifically relevant information to
determine whether certain substances
may have hormonal effects. In
September 2005, EPA published its
approach for selecting the initial list of
chemicals for which testing will be
required under the Endocrine Disruptor
Screening Program (EDSP) and in June
2007, EPA published the draft list of the
first group of chemicals proposed for
screening in the Agency’s EDSP. This
document presents the final list of the
first group of chemicals that will be
screened in the Agency’s EDSP. The list
was produced using the approach
described in the September 2005 notice
and considers comments received in
response to the June 2007 draft list. The
list includes chemicals that the Agency,
in its discretion, has decided should be
tested first, based upon exposure
potential. The Agency deleted 6
chemicals from the original list of 73
based upon recent information showing
that the chemicals are no longer
expected to be found in 3 exposure
pathways. The first group of 67
chemicals identified for testing includes
pesticide active ingredients and High
Production Volume (HPV) chemicals
used as pesticide inert ingredients (also
known as other ingredients). This list
should not be construed as a list of
known or likely endocrine disruptors.
Nothing in the approach for generating
the initial list provides a basis to infer
that by simply being on this list these
chemicals are suspected to interfere
with the endocrine systems of humans
or other species, and it would be
inappropriate to do so. This document
does not describe other aspects of the
EDSP such as the administrative
procedures EPA will use to require
testing, which is addressed in a separate
notice published in today’s Federal
Register.
FOR FURTHER INFORMATION CONTACT:

Linda Phillips, Office of Science
Coordination and Policy (7203M),

PO 00000

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Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(202) 564–1264; e-mail address:
phillips.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. You may be potentially
affected by this action if you produce,
manufacture, use, consume, work with,
or import pesticide chemicals. To
determine whether you or your business
may be affected by this action, you
should carefully examine section 408(p)
of FFDCA, 21 U.S.C. 346a(p). Potentially
affected entities, using the North
American Industrial Classification
System (NAICS) codes to assist you and
others in determining whether this
action might apply to certain entities,
may include, but are not limited to:
• Chemical manufacturers, importers
and processors (NAICS code 325), e.g.,
persons who manufacture, import or
process chemical substances.
• Pesticide, fertilizer, and other
agricultural chemical manufacturers
(NAICS code 3253), e.g., persons who
manufacture, import or process
pesticide, fertilizer and agricultural
chemicals.
• Scientific research and
development services (NAICS code
5417), e.g., persons who conduct testing
of chemical substances for endocrine
effects.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2004–0109. All documents in the
docket are listed in the docket index
available in regulations.gov. To access
the electronic docket, go to http://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is

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