[Federal Register Volume 88, Number 207 (Friday, October 27, 2023)]
[Notices]
[Pages 73841-73853]
[FR Doc No: 2023-23721]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0474; FRL-11384-01-OCSPP]

Endocrine Disruptor Screening Program (EDSP); Near-Term
Strategies for Implementation; Notice of Availability and Request for
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting comment on the near-term strategies
described in this document to help the Agency meet its obligations and
commitments under the Federal Food, Drug, and Cosmetic Act (FFDCA),
which requires, among other things, that EPA screen for and protect
against endocrine disrupting effects in humans. An important part of
these obligations and commitments is the Endocrine Disruptor Screening
Program (EDSP), which EPA established in 1998 as a two-tier endocrine
screening and testing process for pesticides and other chemicals. After
over two decades of implementing the EDSP and other aspects of the
mandate in FFDCA, EPA has developed near-term strategies to begin
addressing the challenges it has encountered and to rebuild the EDSP.
This document covers only the initial strategies that EPA is taking
over the next several years to generate momentum toward its longer-term
goal of timely addressing all its endocrine screening data needs and
decisions. Through this notice and to help implement its strategies,
EPA is also seeking additional endocrine data on two groups of active
ingredients currently undergoing registration review, or explanations
of why the additional data are unnecessary for EPA to make its FIFRA
and FFDCA decisions.

DATES: Comments must be received on or before December 26, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0474, using the Federal eRulemaking Portal
at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: Catherine Aubee, Endocrine Disruptor
Screening Program (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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:
     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 (NAICS code 5417).

B. What is the Agency's authority for taking this action?

    FFDCA section 408(p)(1) requires, among other things, that EPA
``develop a screening program, using appropriate validated test systems
and other scientifically relevant information to determine whether
certain substances may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen, or such other
effects as [EPA] may designate.'' (21 U.S.C. 346a(p)). FFDCA sections
408(p)(2) and (p)(7) require EPA to implement the EDSP by August 1999
and report to Congress on the program's progress by August 2000,
respectively.
    FFDCA section 408(p)(3) 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.'' (21 U.S.C. 231(q)(1)). However, FFDCA section 408(p)(4)
authorizes EPA to, by order, exempt a substance from the EDSP if the
EPA ``determines that the substance is anticipated not to produce any
effect in humans similar to an effect produced by a naturally occurring
estrogen.'' FFDCA section 408(p)(5) identifies the requirements and
processes for issuing test orders, requiring testing under the EDSP,
and submitting information obtained from the testing to EPA. (21 U.S.C.
346a(p)(5)). Finally, FFDCA section 408(p)(6) requires EPA to ``as
appropriate, take action under such statutory authority as is available
to the Administrator, including consideration under other sections of
this chapter, as is necessary to ensure the protection of public
health'' for ``any substance that is found, as a result of testing and
evaluation under this section, to have an endocrine effect on humans.''
    The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
precludes the distribution and sale of any pesticide that is not
registered under FIFRA. (7 U.S.C. 136a(a)). Applications for
registration of a pesticide may be submitted to EPA but must meet the
requirements in FIFRA sections 3(c) and 33, which include providing
complete data in support of that registration request. (7 U.S.C. 136a
and 136w-8). The data required to support these applications are
identified in EPA regulations at 40 CFR part 158. EPA may issue Data
Call-In (DCI) notices under FIFRA section 3(c)(2)(B) to require
additional data during the registration process to address a risk or
after registration to maintain a registered pesticide. (7 U.S.C.
136a(c)(2)(B)). To grant a pesticide registration, FIFRA requires EPA
to consider whether the pesticide has ``unreasonable adverse effects''
to human health and the environment. (7 U.S.C. 136a(c)(5)). FIFRA
section 2(bb) defines ``unreasonable adverse effects on the

environment'' to mean, among other things, ``any unreasonable risk to
man or the environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide.'' (7
U.S.C. 136(bb)). EPA is required to review each pesticide registration
every 15 years to determine whether the pesticide continues to satisfy
this FIFRA standard for registration. (7 U.S.C. 136a(g)). EPA
regulations at 40 CFR part 155, subpart C apply to the conduct of this
registration review process.

C. What action is the Agency taking?

    This document describes three near-term strategies the Agency is
taking to further implement its obligations and commitments under FFDCA
section 408(p) relating to the EDSP, which EPA established in 1998 as a
two-tier endocrine screening and testing process for pesticides and
other chemicals. EPA is pursuing these strategies to generate momentum
toward its longer-term goal of timely addressing all its endocrine data
needs and decisions.
    Under strategy one, EPA will prioritize addressing potential human
estrogen, androgen, and thyroid effects for conventional pesticide
active ingredients. Although the Agency will continue to address
wildlife endocrine effects and endocrine effects from other pesticide
chemicals (e.g., inert ingredients and active ingredients intended
solely for biological or antimicrobial uses), updates and activities
relating to that work are on a longer-term timeline for the reasons
discussed in the strategy. Under strategy two, EPA will use existing
data, routinely obtained through FIFRA registration and registration
review, to determine whether additional human health-related endocrine
data are needed and to make endocrine decisions under FIFRA and FFDCA
section 408(p). This strategy also describes the endocrine data that
EPA considers sufficient to register a new conventional active
ingredient and how EPA will address endocrine data deficiencies for
those registration submissions and for registration review cases. Under
strategy three, EPA will phase into its registration review processes
any new data requirements to address potential human estrogen,
androgen, and thyroid effects for conventional pesticide active
ingredients, starting with 30 registration review cases (``Group 1''
cases) that EPA has identified using a new framework for prioritizing
estrogen and androgen data needs. In this notice, EPA is requesting
comments and the voluntary submittal of existing information on these
30 cases and, during the comment period, plans to begin preparing DCIs
with the goal of issuing those them in spring of 2024 for specified
EDSP Tier 1 data for these cases.
    To support the strategies described in this document, EPA has
posted the following three reference documents in the docket:
    1. Use of Existing Mammalian Data to Address Data Needs and
Decisions for Endocrine Disruptor Screening Program (EDSP) for Humans
under FFDCA Section 408(p) (Ref. 1). This endocrine science paper
explains when and how EPA will rely on data it has already received
under FIFRA to address the data needs and decisions under FFDCA section
408(p), providing the scientific support for strategies two and three.
    2. List of Conventional Registration Review Chemicals for Which an
FFDCA Section 408(p)(6) Determination is Needed (Ref. 2). This paper
lists each currently registered conventional pesticide active
ingredient, and how the types of data EPA has for each active
ingredient inform where it fits within EPA's priorities for obtaining
any additional endocrine data for those pesticides in registration
review. Commenters should use this list to identify the active
ingredients for which EPA is seeking information through this document.
    3. Status of Endocrine Disruptor Screening Program (EDSP) List 1
Screening Conclusions (Ref. 3). This paper explaining EPA's decisions
under FFDCA section 408(p) relating to the human endocrine system
(estrogen, androgen, and thyroid endpoints) for all 52 EDSP List 1
chemicals. In 2009, EPA published the List 1 chemicals and issued test
orders for them (the original List 1 had 67 chemicals). The Agency
later revised the list to 52 chemicals because 15 were canceled or
discontinued. The actions to address the remaining List 1 chemicals are
unrelated to the development of Group 1 chemicals in this document.
    Many aspects of this document overlap with policies described in a
notice issued in the Federal Register of August 11, 1998 (63 FR 42852)
(FRL-6021-3) (hereinafter referred to as the ``1998 Notice''), that
established the basic components of the EDSP. EPA views this document
as consistent with the policies in the 1998 Notice and thus is not
rescinding or modifying those policies. Rather, this document augments
the notice with complementary strategies and priorities that reflect
advances in science, EPA's experience administering the EDSP, and the
Agency's recent efforts to more quickly meet its FFDCA section 408(p)
obligations and commitments.

D. Why is the Agency taking this action?

    After over two decades of implementing FFDCA section 408(p), EPA
has developed the near-term strategies in this document to begin to
transparently address the challenges it has encountered and rebuild the
EDSP. This document explains how the Agency currently obtains and will
obtain data needed to assess a conventional pesticide active
ingredient's interaction with the human estrogen, androgen, and thyroid
pathways, and when and how EPA intends to make the requisite FFDCA
section 408(p)(6) finding that the pesticide use adequately protects
human health. This document also addresses the confusion about when and
how EPA obtains data in the registration and registration review
processes to assess the potential for effects to the endocrine system
from use of a conventional pesticide active ingredient. These near-term
strategies also help EPA respond to specific recommendations in a 2021
EPA Office of Inspector General (OIG) Report to develop a strategic
plan for the EDSP and to a legal complaint filed in the Federal
District Court for the Northern District of California raising similar
issues.

E. Does this document contain binding requirements?

    This document describes EPA's near-term strategies over the next
several years to accelerate how the Agency meets its FFDCA section
408(p) obligations and commitments. The requirements in the statutes
and any future FIFRA DCIs or FFDCA test orders are binding on EPA and
the order recipients, respectively, but this document does not impose
any binding requirements on EPA or outside parties. The strategies
outlined in this document further the general goals of the program, and
EPA may depart from the strategies where circumstances warrant and
without prior notice. In general, however, EPA will continue to offer
notice and comment on chemical-specific proposed decisions that
implement these strategies.

F. What should I consider as I prepare my comments for EPA?

1. Scope of Request for Comments
    As discussed further in strategy three of this document, EPA
encourages the public to submit any relevant estrogen, androgen, and
thyroid data for the Group 1 and Group 2 cases of pesticide

active ingredients currently in registration review. The public may
also submit any explanations for why additional endocrine data are
unnecessary to inform the Agency's findings under FIFRA and FFDCA
section 408(p) for potential endocrine effects in humans.
    Please submit any relevant endocrine data, Other Scientifically
Relevant Information (OSRI), or explanations of why the additional data
are unnecessary for EPA to make its FIFRA and FFDCA section 408(p)
decisions to the ``Registration Review'' section of EPA's Pesticide
Submission Portal (PSP). The PSP can be accessed through EPA's Central
Data Exchange (CDX) using the link https://cdx.epa.gov/.
2. Submitting CBI
    Do not submit CBI to EPA through https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that
you claim to be CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
3. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov//commenting-epa-dockets.

II. Background

A. What is the endocrine system?

    Endocrine systems, also referred to as hormone systems, are found
in all mammals, birds, fish, and many other living organisms. These
systems are made up of glands located throughout the body, the hormones
synthesized by these glands and released into the bloodstream or the
fluid surrounding cells, and the receptors in various organs and
tissues that recognize and respond to the hormones.

B. What is the relevant history of the EDSP?

    In 1996, Congress amended the FFDCA with the Food Quality
Protection Act, 21 U.S.C. 346a(p), requiring 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 effects as [EPA] may designate.'' In
response, EPA established the EDSP, the basic components of which were
described in the 1998 Notice (63 FR 42852). Further, when carrying out
the EDSP, EPA ``shall provide for the testing of all pesticide
chemicals,'' which includes active and inert ingredients, and ``may
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.'' The FFDCA required EPA to implement the EDSP by
August 1999 and report to Congress on the program's progress by August
2000. EPA met both requirements on time, as the Agency began
implementing the EDSP after issuing the 1998 Federal Register Notice
(the statute does not specify when implementation ends nor steps for
implementing the EDSP, and thus EPA views implementation as an ongoing
activity) and the Agency issued its report to Congress in August 2000.
    FFDCA section 408(p) requires EPA to screen only for estrogen
effects in humans that are similar to an effect produced by a naturally
occurring estrogen. Through the 1998 Federal Register Notice, however,
EPA permissibly expanded the scope of the EDSP in two important ways.
One is to include screening for androgen and thyroid effects, based on
the recommendations of the Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC), which EPA formed to advise on designing a
screening and testing program for chemicals. EPA had explained that it
will focus on estrogen, androgen, and thyroid because they are among
the most studied of the approximately 50 known vertebrate hormones,
with a relatively large body of relevant data and screening tests. EPA
also explained that including these three hormone systems will help the
Agency understand effects on reproduction, development, and growth.
Further, EPA adopted the EDSTAC recommendation to screen for effects in
the same endocrine systems in wildlife because adverse effects on
wildlife can forewarn of potential risks to humans and because strong
evidence existed for endocrine disruption from pesticides in natural
wildlife and fish populations. Throughout this document, when EPA
refers to section 408(p) ``obligations and commitments,'' the Agency is
describing both the mandatory aspects of this section (obligations) and
the discretionary aspects (commitments), as summarized in Table 1.

   Table 1--Summary of FFDCA Section 408(p) Mandatory Obligations and
       Discretionary Commitments for Pesticide Active Ingredients
------------------------------------------------------------------------
                                                               EPA
                         Mandatory         Status of      discretionary
  FFDCA provision       obligation        obligation      commitment and
                                                              status
------------------------------------------------------------------------
408(p)(1)..........  Must create       Completed when    In 1998,
                      estrogen          EPA created the   expanded
                      screening         EDSP in 1998.     screening
                      program.                            program to
                                                          include
                                                          androgen,
                                                          thyroid, and
                                                          wildlife.
408(p)(2)..........  Must implement    Completed the     Ongoing
                      screening         deadline          (currently
                      program by Aug.   obligation, but   implementing
                      1999.             ongoing           expanded
                                        implementation.   screening).
408(p)(3)..........  Must provide for  Ongoing           Ongoing
                      testing of all    (currently        (currently
                      pesticide         obtaining data    obtaining data
                      chemicals and     through FIFRA     through FIFRA
                      may provide for   regulations and   regulations
                      testing of        processes).       and
                      other substance                     processes).
                      with cumulative
                      effect to a
                      pesticide
                      chemical.
408(p)(4)..........  None, but EPA     Ongoing           Ongoing
                      may exempt        (established      (established
                      chemical from     the Endocrine     the EDSPOC to
                      408(p).           Disruptor         make
                                        Science Policy    recommendation
                                        Council           s on
                                        (EDSPOC) to       exemptions).
                                        make
                                        recommendations
                                        on exemptions).
408(p)(5)..........  Must issue test   Ongoing           Ongoing
                      orders.           (currently        (currently
                                        implementing      implementing
                                        for pesticide     for pesticide
                                        active            active
                                        ingredients       ingredients
                                        through FIFRA     through FIFRA
                                        regulations and   regulations
                                        processes).       and
                                                          processes).

408(p)(6)..........  Must take action  Ongoing (working  Through this
                      to protect        to address        notice, EPA
                      public health     protections for   will begin
                      against a         pesticide         issuing
                      substance with    active            determinations
                      endocrine         ingredients in    for pesticide
                      effect.           FIFRA             active
                                        decisions).       ingredients
                                                          when 408(p)(6)
                                                          is met for
                                                          human
                                                          estrogen,
                                                          androgen, and
                                                          thyroid.
408(p)(7)..........  Must report to    Completed.......  N/A.
                      Congress by
                      August 2000.
------------------------------------------------------------------------

C. What is the screening and testing process under the EDSP?

    Through the 1998 Notice, EPA also adopted the EDSTAC recommendation
to create a two-tier EDSP screening and testing process. The purpose of
the first tier of testing (Tier 1) is to screen chemicals for the
potential to interact with the estrogen, androgen, or thyroid systems
and inform the need for any additional data (e.g., Tier 2) to evaluate
possible adverse effects in humans or wildlife. The purpose of Tier 2
testing is to identify, characterize, and quantify those adverse
effects for risk assessment. The Tier 1 screening battery consists of
11 assays, six of which are in vivo (performed with living organisms)
and five of which are in vitro (performed outside of living organisms,
with biological material such as cells or tissues).
    As described in its January 2023 white paper on new approach
methodologies (NAMs; Ref. 4), EPA has now validated two computational
models that integrate bioactivity data from multiple in vitro assays,
referred to as the ToxCast Pathway Models for estrogen and androgen
receptors, which can serve as alternatives to four of the 11 assays.
Specifically, the validated estrogen receptor ToxCast Pathway Model can
serve as an alternative for three of the Tier 1 assays that detect
estrogen activity and the validated androgen receptor ToxCast Pathway
Model can serve as an alternative for one of the Tier 1 assays that
detect androgen activity. Research is ongoing to develop validated
models as alternatives for other Tier 1 and Tier 2 assays.
    Under the EDSP two-tier process, analysis of Tier 1 screening data,
in conjunction with OSRI on the endocrine system, results in one of two
outcomes: a recommendation for additional data (e.g., through Tier 2
testing of the chemical) to establish a dose-response relationship for
any adverse effects that may result from interactions with the
endocrine system, or an explanation for why no further testing is
needed to assess the chemical for potential impacts to the estrogen,
androgen, and thyroid hormone pathways. If more testing is recommended,
the Tier 1 analysis also informs which tests may be performed.

D. How is FIFRA involved in EPA's implementation of the EDSP?

    FFDCA section 408(p) is not limited to EDSP screening and testing,
as paragraph (p)(6) also requires EPA to ``as appropriate, take action
under such statutory authority as is available to the Administrator,
including consideration under other sections of this chapter, as is
necessary to ensure the protection of public health'' for ``any
substance that is found, as a result of testing and evaluation under
this section, to have an endocrine effect on humans.'' Because FFDCA
section 408(p) does not itself provide legal authority to ``ensure the
protection of public health,'' EPA must rely on authorities in other
sections of FFDCA and other laws, such as FIFRA, to satisfy FFDCA
section 408(p)(6). In this respect, EPA's implementation of FFDCA
section 408(p) and FIFRA are closely linked.
    The two are closely linked in another important manner. To meet the
FIFRA requirement of ensuring that a pesticide will not cause
``unreasonable adverse effects on the environment,'' EPA reviews
numerous studies to assess potential adverse outcomes from exposure to
chemicals. These studies include acute, sub-chronic, and chronic
toxicity, including assessments of a wide range of potential toxic
effects for carcinogenicity, neurotoxicity, developmental,
reproductive, and general or systemic toxicity, and other effects.
These studies include endpoints that may be susceptible to endocrine
influence, including effects on endocrine target organ weights and
histopathology, estrus cyclicity, sexual maturation, fertility,
pregnancy rates, reproductive loss, and sex ratios in offspring.
    In the past, however, EPA's Office of Pesticide Programs (OPP) has
generally focused on endocrine-related activities under FIFRA separate
from the EDSP testing strategy. Thus, OPP's FIFRA decisions have not
been explicit about how its review of required and submitted data for
FIFRA informs EPA's obligations and commitments under FFDCA section
408(p). For instance, OPP amended its FIFRA data requirements at 40 CFR
part 158 to incorporate an updated reproductive study, which is the
same study identified in EDSP Tier 2 and which allows the Agency to
fully evaluate the potential for a conventional pesticide active
ingredient to interact with the estrogen and androgen pathways.
However, EPA did not explain how that effort informs the obligations
and commitments under FFDCA section 408(p).
    In addition, while prior FIFRA decisions often referred to the
FFDCA section 408(p) screening program, those decisions have not
expressly discussed whether or how the data EPA reviews for its FIFRA
decisions address FFDCA section 408(p) obligations or commitments. For
example, FIFRA actions protect for the most sensitive endpoints in
humans, which in many cases are not endocrine endpoints. In these
situations, EPA did not take the final step of explaining whether or
how the FIFRA decision fully addresses the data needs and decisions
under FFDCA section 408(p) and protects the public from potential
endocrine effects.
    One reason EPA has not completed these FFDCA section 408(p) actions
is that it had focused on developing the science and technology to
rapidly screen for chemicals that may have the potential to disrupt the
estrogen, androgen, and thyroid systems of humans and wildlife. In
recent years, for example, the Agency has focused on NAMs, particularly
with high-throughput testing approaches, because of their central role
in supporting the screening of the thousands of chemicals covered by
the EDSP. This includes EPA testing of over 1,800 chemicals using the
estrogen receptor and androgen receptor ToxCast Pathway Models, which,
as explained in a separate white paper previously released, fulfill the
data

needs for four separate EDSP Tier 1 assays for those chemicals. Through
the strategies in this document, EPA is planning to expand the scope of
its EDSP work to emphasize obtaining any additional human endocrine
data as part of the Agency's FIFRA decisions and to issue FFDCA section
408(p)(6) decisions where possible.

E. What concerns have been raised about EPA's implementation of the
EDSP?

    The issues discussed earlier have led to confusion and criticism
about the extent to which EPA has implemented FFDCA section 408(p) for
pesticides. These criticisms have included concerns that EPA has been
failing to obtain data and assess whether a pesticide active ingredient
may cause adverse endocrine effects at the regulated levels and failing
to make decisions under FFDCA section 408(p)(6) that consider those
data and effects. In addition, EPA understands that some stakeholders
have heard different messages over the years about whether EPA would
require Tier 1 data when it has adequate Tier 2 data to make FIFRA
determinations and FFDCA section 408(p) findings. Through this notice,
EPA seeks to transparently address some of these criticisms and
concerns.
    In July 2021, EPA's OIG issued a report concluding that the Agency
has made limited progress in implementing the EDSP (Ref. 5). The report
identified several reasons for this limited progress, including delays
in testing pesticides for endocrine disruption, and lack of strategic
guidance, performance measures, and other actions needed to implement
the EDSP. The report offered ten recommendations for OCSPP, which the
office generally agreed with and proposed to address. This document
represents the Agency's strategic plan for rebuilding the EDSP that
OCSPP will augment in the future. OCSPP has also begun implementing
several other OIG recommendations, including publishing an EDSP white
paper on NAMs, conducting an annual internal program review, and
periodically updating the program website.
    In December 2022, EPA received a complaint in Alianza Nacional de
Campesinas et al. v. EPA, alleging that EPA has violated the FFDCA and
Administrative Procedures Act by not implementing the EDSP and not
testing all pesticide chemicals for possible endocrine effects. (Ref.
6).

III. Strategies To Further Implement FFDCA Section 408(p)

    EPA recognizes that its past practice has created questions about
whether and how the Agency has been implementing FFDCA section 408(p),
and now seeks to address these questions and accelerate progress in
further implementing the EDSP, beginning with the three strategies
described in this section. Before discussing the strategies, EPA is
identifying the two overall approaches for expediting its ability to
meet its FFDCA section 408(p) obligations and commitments.

A. Obtain Needed Endocrine Data During FIFRA Registration or
Registration Review

    EPA will use the FIFRA registration and registration review
processes to obtain data as needed to assess potential human estrogen,
androgen, and thyroid effects for its FIFRA and FFDCA section 408(p)
decisions. In general, EPA is already receiving some endocrine data
through these processes as part of its standard FIFRA processes and
regulatory data requirements. For example, for over a decade, EPA has
routinely received data on mammalian estrogen and androgen effects for
new conventional pesticide registrations through either a two-
generation reproductive study (typically performed in the rat (Ref. 7))
or an extended one-generation reproductive toxicity (EOGRT) study (also
normally performed in the rat) (Organization for Economic Cooperation
and Development (OECD) TG443) (Ref. 8). In these situations, EPA will
generally not need to obtain additional data for these endpoints,
including Tier 1 data, as explained in strategy three. Further, EPA
understands that some registrants may have generated endocrine data to
meet registration requirements in other countries but never submitted
those data to EPA. EPA will consider those data, if submitted, to
assess the need for additional endocrine data and to make the relevant
FIFRA and FFDCA section 408(p) decisions, while avoiding unnecessary
duplicative testing.
    Where EPA has identified outstanding endocrine data needs for a
pesticide active ingredient, it will generally obtain the data through
the FIFRA registration or registration review process, rather than
through the FFDCA section 408(p)(5) process for issuing FFDCA test
orders, as EPA already has a well-established process of seeking data
through FIFRA. Further, EPA will generally obtain the data based on
prioritized lists of pesticide active ingredients that it has begun
developing and describes in strategy three.

B. Integrate FFDCA Data and Decisions into FIFRA Decisions

    For conventional pesticide active ingredients, EPA will integrate
its FFDCA section 408(p) endocrine data and decisions into its FIFRA
decisions, so that the Agency can efficiently use its FIFRA process and
timelines to also address its FFDCA obligations and commitments for
those chemicals. This approach will significantly increase EPA's
consistency and transparency about how and when the Agency is meeting
its FFDCA section 408(p) obligations and commitments as part of FIFRA
decisions.
    Moving forward, when EPA has addressed those obligations and
commitments for a pesticide active ingredient, it will clearly indicate
that it has sufficient endocrine data and completed taking action under
FFDCA section 408(p)(6) to ``ensure the protection of public health.''
This can occur in one of three scenarios. In scenario one, the most
sensitive human endpoint identified in the pesticide's database is not
an endocrine endpoint and is protective of endocrine effects at higher
doses, if any are present. In scenario two, EPA exempts a pesticide
active ingredient from the requirements of FFDCA section 408(p) because
the Agency determines that the chemical meets the section 408(p)(4)
statutory standard that it ``is anticipated not to produce any effect
in humans similar to an effect produced by a naturally occurring
estrogen.'' In its 2023 decision for citric acid, for instance, EPA
concluded the acid is not anticipated to produce in humans or other
organisms any effect similar to an effect produced by naturally
occurring estrogen, androgen, or thyroid hormones, because it has no
endocrine activity and no toxic effects at levels that people consume
(Ref. 9).
    In both scenarios, EPA will issue a determination as part of a
FIFRA decision for a pesticide that the Agency has completed taking
action under FFDCA section 408(p)(6) to ``ensure the protection of
public health'' by regulating exposure based on the most sensitive
endpoint. Although FFDCA section 408(p)(6) does not obligate EPA to
issue this determination and explanation, EPA is committing to do so
because the Agency recognizes the benefits of more clarity and
transparency about how it implements FFDCA section 408(p). This is
another example where EPA distinguishes between mandatory obligations
and

discretionary commitments, as summarized in Table 1.
    In scenario three, an endocrine effect is the most sensitive
endpoint, so EPA would directly regulate to protect against that effect
and issue a determination that it has completed taking action under
FFDCA section 408(p)(6) through its FIFRA decision that uses the
endocrine endpoint to regulate exposure to that pesticide. For example,
the thyroid is a target organ for the insecticide fipronil, and thyroid
effects were used as the basis for deriving most of the risk assessment
endpoints and points of departure in the most recent human health risk
assessment for this chemical (Ref. 10).
    Throughout this document, when EPA refers to a FFDCA section
408(p)(6) ``decision,'' it is referring to one of these three
scenarios. Strategies two and three explain when and how EPA will
integrate these FFDCA section 408(p) data and decisions into its FIFRA
registration and registration review decisions for conventional
pesticide active ingredients.
    In implementing these strategies, EPA recognizes that it cannot
address all past and present challenges simultaneously. For example,
EPA is concerned about overwhelming the capacity of testing
laboratories if it were to immediately impose testing for the hundreds
of pesticide active ingredients in registration review. In addition,
EPA does not have the resources to immediately assess each active
ingredient case to identify all endocrine data gaps and to begin
obtaining all outstanding data immediately. Thus, EPA developed this
document to help prioritize how the Agency will implement these
strategies. To summarize, the three strategies discussed are as
follows:
     EPA will prioritize addressing potential human estrogen,
androgen, and thyroid effects for conventional pesticide active
ingredients (see strategy one), starting with the use of existing data
routinely obtained through FIFRA registration and registration review
activities, to determine whether additional endocrine data are needed
(see strategy two).
     If existing data are adequate to inform the FFDCA section
408(p)(6) and FIFRA decisions for any of the three endocrine pathways,
EPA will make those decisions without obtaining additional endocrine
data for that pathway (e.g., Tier 1), because any additional data would
be duplicative and would not alter those decisions (see strategy
three).
     EPA will continue to require that all applications for
conventional new active ingredient registrations include adequate data
to assess potential interaction with the human estrogen, androgen, and
thyroid pathways. Those data will inform the FIFRA registration
decision, which will include whether or how it addresses FFDCA section
408(p) endocrine data and decisions (see strategy two).
    Similarly, to ensure all existing registrations for conventional
pesticide active ingredients are supported by adequate human health-
related endocrine data, EPA will phase into the registration review
process, using the framework discussed in this document (see strategy
three), any additional data needs for evaluating potential interaction
with human estrogen, androgen, and thyroid pathways. For 30 high
priority conventional pesticide active ingredients, however, EPA is
seeking any comments, existing endocrine data, and explanations on the
need for additional endocrine data for any chemical on this list.
During the public comment period, EPA will initiate the process for
issuing DCIs in spring 2024 to require specified data for each of these
active ingredients to address gaps in the data. EPA expects to include
in the DCIs for these chemicals the requirement for the following EDSP
Tier 1 studies or equivalent data: steroidogenesis, aromatase,
Hershberger, female rat pubertal, and male rat pubertal studies. EPA
also expects to include in the DCIs the potential for requiring
submission of Tier 2 studies, based on the results of the Tier 1
studies submitted and any OSRI that may inform the weight-of-evidence
analyses on those data. In the alternative, EPA expects to accept Tier
2 data in response to the DCIs to assess for potential effects to the
estrogen and androgen pathways. Thus, if EPA receives an acceptable
two-generation reproductive or EOGRT study, the study would fully
satisfy the EDSP Tier 1 DCI for estrogen and androgen endpoints. As
discussed in strategy three, EPA has prioritized the 30 chemicals
because it lacks sufficient Tier 2 data for the chemicals but does have
screening-level data indicating potential activity in the mammalian
estrogen and/or androgen system. Further, as with new conventional
active ingredient applications, EPA will explain in registration review
documents for conventional active ingredients whether or how EPA's
assessment or decision addresses FFDCA section 408(p) data and
decisions.
1. Scope
    EPA's resources for the EDSP are limited, so the Agency must
prioritize which aspects of the EDSP to address first. For these near-
term strategies, EPA has prioritized the registration of new
conventional active ingredients and the registration review of
conventional active ingredients, because they comprise the majority of
registered active ingredients. The strategies are not intended to apply
at this time to pesticide active ingredients that are solely intended
for biological and antimicrobial uses or inert ingredients. Those
ingredients span a wider range of uses and modes of action and can
often present very different chemistries than conventional pesticides.
EPA is still evaluating how best to prioritize human endocrine
assessments for those active and inert ingredients and to develop
strategies for the chemicals.
2. Strategy One: Prioritize Human Endocrine Effects
    The FFDCA section 408(p)(1) mandate is limited to developing a
screening program to identify potential estrogen effects in humans, but
EPA in 1998 expanded the scope of the program to include potential
androgen and thyroid effects in humans and potential wildlife estrogen,
androgen, and thyroid effects. Because of limited resources, however,
EPA will initially focus on ensuring that the potential for human
endocrine effects is transparently and sufficiently addressed for
conventional pesticide active ingredients.
    Meanwhile, EPA will maintain its current approach in its FIFRA
decisions of addressing wildlife endocrine effects if it already has
adequate endocrine data for a species or group of species, supported by
multiple lines of scientific evidence, as part of a new conventional
registration or registration review action. EPA will also prioritize
resources for research and risk assessment methods development to
better understand endocrine effects in wildlife.
    There are several reasons for this decision to first address EPA's
statutory requirement to more fully assess human endocrine effects
before assessing discretionary wildlife effects. First, EPA's
scientific understanding of the impacts of chemical interactions on the
human endocrine system is generally more developed than for most
wildlife. Thus, the data and science currently available to EPA enable
the Agency to make progress in evaluating effects on humans using the
approaches presented in this document. This is especially true
considering the large number of non-mammalian species that are covered
by the EDSP (e.g., birds, fish, amphibians). Second, EPA is already
taking unprecedented steps to reduce pesticide

exposure to wildlife through its work under FIFRA and the Endangered
Species Act (ESA) (16 U.S.C. 1531 et seq.). Through its ESA-FIFRA
Workplan released in April 2022 and subsequent updates, EPA has
prioritized mitigating pesticide effects on endangered species earlier
in the FIFRA registration and registration review processes (Ref. 11).
In addition, EPA has developed and will be implementing FIFRA Interim
Ecological Mitigation measures for agricultural crop uses of
conventional pesticide active ingredients in registration review. EPA
expects that these mitigation measures will reduce pesticide exposures
for ESA-listed species. EPA is also pursuing several pilot projects to
expedite mitigation for listed species (e.g., herbicide strategy,
Hawaiian species initiative) and continuing to implement the mitigation
measures from ESA biological opinions for individual pesticide active
ingredients, such as certain organophosphates (Ref. 11). These
mitigation measures are also expected to reduce pesticide exposure to
wildlife, which will also reduce the potential for endocrine
disruption.
    EPA will continue to advance the science and develop strategies to
consider the potential for endocrine effects on wildlife under the
EDSP. For example, as outlined in the EDSP NAMs white paper, EPA is
continuing to refine and apply species extrapolation processes and
tools, which will help EPA understand how test results on laboratory
animals extrapolate to effects on wildlife (Ref. 4). EPA is also
involved in international efforts to assess the addition of thyroid
endpoints to fish assays and tests that are commonly submitted to
support pesticide registrations. Lastly, EPA is building datasets to
support the development and validation of models that would allow in
vitro to in vivo extrapolation for Tier 1 ecological studies. EPA will
further discuss its approach to wildlife under the EDSP in future
strategy documents. For the remainder of this document, all discussions
are limited to the human endocrine system.
3. Strategy Two: Use Existing Data To Determine Whether Additional
Endocrine Data Are Needed and To Inform FIFRA and FFDCA Endocrine
Findings
    As a key part of rebuilding the EDSP, EPA is committing to
transparency when assessing the adequacy of data on whether a
conventional pesticide active ingredient has the potential to interact
with the estrogen, androgen, and thyroid pathways. EPA is also
committing to ensure that when it authorizes a new pesticide through
registration and reauthorizes its use through registration review,
those decisions adequately protect human health, as required by FFDCA
section 408(p)(6). EPA can make these determinations more promptly when
they are based on existing data, supplemented by targeted requests for
additional data and explanations to address any potential data gaps. In
most cases, the existing data will already have been submitted through
registration or registration review to inform the FIFRA unreasonable
adverse effects finding.
    In this strategy, EPA explains the overall status of what data are
already typically available to the Agency on conventional pesticide
active ingredients as part of its registration and registration review
program. If EPA determines that available Tier 2 or other data are
sufficient to fully inform the FIFRA registration/registration review
and FFDCA section 408(p)(6) decisions for estrogen, androgen, and
thyroid pathways, EPA will make the decisions without seeking
additional EDSP Tier 1 data. In contrast, if EPA determines that
additional data are needed to make the decisions, EPA will base the
next steps and timing for those steps on the priority group in which
the chemical belongs, as further discussed subsequently in this
document.
    To inform when and how EPA will use existing FIFRA data or OSRI to
determine whether a pesticide has a potential endocrine effect under
FFDCA section 408(p), EPA has prepared a science support paper (Ref.
1), which is available in the docket and briefly summarized in this
strategy. That paper explains the data typically submitted to EPA that
will meet EPA's needs for evaluating potential interaction with human
estrogen, androgen, and thyroid pathways. EPA is separating its
discussion of estrogen and androgen data from thyroid data because the
data on estrogen and androgen are often generated together and separate
from thyroid data. As discussed further subsequently in this document,
EPA plans to reevaluate its approach to assessing any additional
thyroid data needs in the coming years.
a. Human Estrogen and Androgen Data
    EPA created the two-tier EDSP system in 1998 as one way to screen
and prioritize testing for the thousands of chemicals that required
screening. The goal was to limit the more expensive and lengthier Tier
2 testing by using Tier 1 screening to eliminate Tier 2 testing
requirements for chemicals that had no potential to affect the human
endocrine system. Since 1998, however, EPA has obtained additional data
for many pesticide active ingredients through registration or
registration review, because those data are also important to evaluate
whether a pesticide meets the FIFRA registration standard.
Specifically, in 1998, EPA updated its guidelines for the two-
generation reproductive study (OCSPP 850.3800). Soon after this update,
EPA required the updated study to be submitted for all new
registrations of conventional pesticide active ingredients. In
addition, in some cases EPA may have also received the updated study
for pesticides registered before the guideline update. The updated
reproductive study is the same as what EPA would have required through
Tier 2 testing to determine effects on human estrogen and androgen
pathways, as explained in the science support paper (Ref. 1).
Similarly, for some newer pesticide active ingredients, EPA has
received a rodent EOGRT study instead of an updated two-generation
reproductive study. The EOGRT study provides the same estrogen and
androgen data as the updated reproductive study, and thus EPA also
considers the EOGRT study as a validated alternative to satisfy the
Tier 2 and FIFRA data needs (Ref. 1). There may also be OSRI (such as a
study submitted to meet other countries' regulatory requirements) that
might meet the data needs that the Tier 2 mammalian study is designed
to fulfill.
    Further, if EPA has adequate Tier 2 data, it does not expect that
Tier 1 data are needed to inform FFDCA section 408(p)(6) decisions for
human estrogen and androgen effects and FIFRA unreasonable adverse
effects determinations. EPA recognized this relationship between EDSP
Tier 1 and Tier 2 data in the 1998 Federal Register Notice (Ref. 12)
with the conceptual framework for the EDSP, which states that ``the
outcome of Tier 2 is designed to be conclusive in relation to the
outcome of Tier 1 and any other prior information. Thus, a negative
outcome in Tier 2 will supersede a positive outcome in Tier 1.''
Consistent with this statement, when EPA has either an updated two-
generation reproductive or EOGRT study, only in exceptional situations
would the Agency need to consider OSRI or require more data (e.g., Tier
1 data) to assess for interaction with the estrogen or androgen
pathway. For example, if the outcome of a two-generation reproductive
study is ambiguous or inconclusive for one or more endocrine endpoints,
EPA may consider whether OSRI addresses the

ambiguity or inconclusiveness. This strategy clarifies that when EPA
concludes that the two-generation reproductive study, EOGRT study, or
OSRI are adequate to assess a conventional pesticide active ingredient
for interaction with the estrogen or androgen pathway, it will
explicitly make that determination as part of a FIFRA assessment and
the accompanying registration or registration review decision. In those
situations, EPA will not need or require EDSP Tier 1 data under FIFRA
or FFDCA section 408(p)(5).
    Based on this analysis, for new pesticide active ingredient
registrations, EPA will continue to require the updated two-generation
reproductive study, the alternative EOGRT study, or equivalent data.
Applications for new conventional pesticide active ingredients that are
not accompanied by either study or equivalent data will be deemed
incomplete and unacceptable for further review.
    For conventional active ingredients in registration review, EPA
will first determine whether an updated reproductive or EOGRT study is
available and adequate to assess for interaction with the estrogen and
androgen pathways. Among the approximately 460 conventional active
ingredient cases currently in registration review, EPA has received
acceptable updated two-generation reproductive or EOGRT studies for
approximately 90 (20%) cases. This is only an estimate based on EPA's
initial analysis and will change over time.
    For the remaining conventional registration review cases without
the updated two-generation reproductive or EOGRT study, EPA's approach
will depend on which of three groups the chemical belongs to, as
discussed in strategy three. To help implement these next steps, EPA
will use its Endocrine Disruptor Science Policy Council (EDSPOC),
established in 2022 to review hazard and exposure data and to recommend
whether to exempt a pesticide under FFDCA section 408(p)(4). The EDSPOC
will recommend whether additional Tier 2 data are needed based on its
review of comments and data submitted in response to this document,
future DCIs for endocrine data, and all existing data for pesticides
for which the Agency lacks either an updated two-generation
reproductive or EOGRT study. This issue is discussed in the science
support paper (Ref. 1).
b. Human Thyroid Data
    Unlike the estrogen and androgen pathways, a Tier 2 assay for
thyroid was not established at the time of the EDSP's creation in 1998.
At the time, only the Tier 1 rat pubertal assays provided thyroid
evaluation in the EDSP battery. In 2005, EPA released its ``Guidance
for Thyroid Assays in Pregnant Animals, Fetuses and Postnatal Animals,
and Adult Animals'' (Ref. 13), which was used to develop studies to
evaluate lifestage sensitivity to thyroid effects. This includes the
EOGRT study that the OECD adopted in 2011 and the comparative thyroid
assay (CTA). Both studies evaluate the same endpoints as the Tier 1 rat
pubertal assays for adult animals, while providing additional
information on thyroid toxicity at various stages of an animal's life.
If a registrant has submitted an acceptable EOGRT study with a thyroid
evaluation or a CTA, EPA does not expect to need Tier 1 or other data
to inform its FFDCA section 408(p)(6) decision for thyroid effects,
unless the Agency identifies an issue that warrants additional
lifestage information.
    EPA recognizes that studies such as the EOGRT and CTA are animal
and resource intensive, and certain endpoint data may be difficult to
obtain (e.g., advanced techniques necessary for small blood volumes
particularly in young animals, limited number of laboratories capable
of properly conducting studies). As a result, EPA does not require
either of these studies for all pesticide active ingredients unless
data indicate such a need. Currently, EPA evaluates all available
thyroid data during registration or registration review to assess
whether evidence exists that a chemical may cause adverse thyroid
effects and determine whether additional thyroid information is needed.
This includes data from several studies required under FIFRA (e.g.,
subchronic, chronic, and carcinogenicity) for conventional pesticide
active ingredients that evaluate potential thyroid toxicity.
Measurements in these studies typically include thyroid organ weights
and histopathology (e.g., colloid amount, follicular cell height and
shape) that can detect changes associated with thyroid hormone
perturbations. For some of these conventional pesticide active
ingredients, registrants also submit optional thyroid hormone data to
EPA to provide additional characterization of potential thyroid
toxicity. Additionally, EPA may also consider data from EDSP Tier 1 rat
pubertal assays or OSRI that provide thyroid evaluation. These data are
predominantly obtained from guideline studies in rats, which are
recognized as a sensitive animal model for humans, as discussed in the
science support paper (Ref. 9). Thus, a lack of thyroid toxicity in
these rat studies provides a strong basis for concluding a lack of
concern for thyroid toxicity in humans and thus a sufficient basis for
FIFRA and FFDCA section 408(p)(6) findings. This strategy clarifies
that if EPA finds no evidence of thyroid toxicity, then it will
conclude that no further data are needed at that time under FIFRA and
FFDCA section 408(p) to assess the conventional pesticide active
ingredient for thyroid toxicity. The registration and registration
review documents will explain that conclusion.
    In contrast, if EPA determines that there is evidence of thyroid
toxicity, EPA will refer the case to the Hazard and Science Policy
Council (HASPOC), an internal peer review council that addresses
whether additional data may be necessary to evaluate the potential of
an active ingredient to interact with the thyroid pathway. HASPOC takes
a weight-of-evidence approach to determine whether additional thyroid
information is needed considering data from multiple lines of evidence,
such as physical-chemical properties, toxicity of the chemical and any
structurally related chemicals, exposure from the registered use
pattern, and estimated risks. HASPOC has predominantly considered the
need for a CTA to obtain lifestage specific thyroid measurements,
including thyroid hormones. Depending on the available data, however,
EPA may seek additional thyroid data for screening the chemical before
requiring lifestage information. If the HASPOC concludes that no
further data are needed at that time under FIFRA and FFDCA section
408(p) to assess the conventional pesticide active ingredient for
thyroid effects, the EPA registration or registration review documents
will explain that conclusion. If substantial new information is raised
in the future calling into question these FIFRA and FFDCA findings, EPA
can address the issue at that time, as appropriate to the
circumstances.
    EPA believes that there may be existing studies with thyroid
measurements, such as EDSP Tier 1 rat pubertal assays or EOGRT studies,
that EPA had not yet specifically requested. Additionally, although
thyroid hormone and organ weight measures are not required as part of
the EPA rat subchronic toxicity test guidelines (OCSPP 870.3050,
870.3100), registrants may submit existing or future studies that
follow the OECD guidelines to support pesticide registrations. In 2018,
the OECD updated its guidelines for the 28-day and 90-day rat
subchronic studies (TGs 407 and 408 (Refs. 14 and 15, respectively)) to
measure thyroid hormones and organ weight, in addition

to the previously required thyroid histopathology evaluations in those
guidelines, to detect perturbations to the thyroid pathway. EPA
anticipates that as more pesticide applications are submitted
consistent with the OECD guidelines, EPA will receive additional
thyroid-related data, which will be consistent with the data obtained
from the Tier 1 rat pubertal assays.
    As of 2023, most new conventional pesticide active ingredient
registration submissions that EPA receives have not followed the
voluntary 2018 OECD guidelines for the subchronic rodent oral toxicity
studies. One reason is that EPA regulations allow registrants,
consistent with the OECD agreement on Mutual Acceptance of Data, to
decide whether to follow the EPA or the OECD guidelines for the
subchronic rodent oral toxicity studies. A second reason is that
registrants typically perform these types of studies many years before
they submit a registration application package to EPA. The Agency
expects within the next few years to begin receiving more FIFRA new
pesticide active ingredient applications with studies that follow the
2018 OECD guidelines for subchronic rodent oral toxicity studies that
will contain these additional thyroid-related measures.
    EPA is actively considering potential revisions to its current
framework for thyroid data needs, including scientific advancements and
potential to require additional thyroid measures. As described in the
EDSP white paper on NAMs (Ref. 4), EPA has ongoing research to develop
high-throughput screening assays for thyroid-relevant targets, and
models to predict thyroid-related apical outcomes (e.g., growth,
reproduction). Further, EPA is collaborating in international efforts
to advance NAMs for thyroid effects. EPA needs additional research and
peer review before it can include these NAMs in the EDSP. Thus, EPA
expects to convene a FIFRA Scientific Advisory Panel (SAP) (anticipated
in 2025) to obtain external peer review on potential revisions to the
thyroid framework and may alter its approach after the FIFRA SAP
review.
c. Where Endocrine Data Are Inadequate or Absent
    Strategy two pertains to situations where EPA can clearly use
existing endocrine data, but in some situations further analysis of
available data will lead EPA to determine that data gaps exist. For
example, EPA estimates approximately 317 conventional pesticide cases
in registration review that lack an updated, post-1998 two-generation
reproductive or EOGRT study. Compared to the updated guideline
reproductive study that provides Tier 2 test data (Ref. 7), the pre-
1998 study likely did not evaluate all the endocrine-related endpoints
that were added to the test guideline in 1998. As a result, for these
pesticides, EPA will need to assess the results of the pre-1998 study
along with any OSRI to determine the need for additional data on the
potential for estrogen and androgen effects. What constitutes
additional data will depend on the extent of missing information as
described in more detail in strategy three. In general, EPA will seek
Tier 1 data or OSRI to augment the data obtained from the pre-1998
reproductive study. Although both FIFRA section 3(c) and FFDCA section
408(p) provide authority for EPA to obtain any additional needed
endocrine data, EPA already has an established FIFRA process under
section 3(c) to obtain data, so the Agency will generally use this
process rather than the FFDCA process.
d. Other Potential Uses of Tier 1 Data Unrelated to the EDSP
    Thus far, the discussion of Tier 1 data has been limited to whether
EPA needs those data when it has adequate Tier 2 data or OSRI to assess
potential effects on the human endocrine system. This is a result of
the structure of the two-tier EDSP that EPA developed in 1998. More
generally, however, the data listed in EDSP Tier 1 may be developed
independently of the EDSP and, thus, may also inform aspects of risk
assessment unrelated to FFDCA section 408(p). One potential role is to
inform the required FFDCA cumulative effects analysis of whether a
substance ``may have an effect that is cumulative to the effect of a
pesticide chemical.'' To the extent such Tier 1 data has already been
submitted (or is submitted) to EPA for purposes of the EDSP, EPA may
find that data useful for informing other aspects of risk assessment.
If EPA needs similar data in those or other situations, it can obtain
them under FIFRA or provisions of the FFDCA unrelated to the EDSP,
although it would not be called ``Tier 1 data'' per se. Because this
document covers only the initial rebuilding of the EDSP, it does not
address potential uses of that type of data for non-EDSP uses.
    To summarize, the key parts of strategy two are as follows:
     For human estrogen and androgen effects, if EPA has an
adequate updated two-generation or EOGRT study to support a new
conventional pesticide active ingredient application or a currently
registered conventional pesticide active ingredient in registration
review, then it will likely conclude that it has sufficient data to
inform its FIFRA and its FFDCA section 408(p)(6) decisions for
potential human estrogen and androgen effects. In those case, EPA will
not seek Tier 1 data to complete those decisions.
     Consistent with current practice, new conventional
pesticide active ingredient applications will be deemed incomplete if
EPA has neither an adequate updated two-generation or EOGRT study, or
equivalent data. Those applications will not proceed through the
registration process.
     For currently registered conventional pesticide active
ingredients, strategy three explains how EPA will prioritize these
pesticides to determine whether and what additional data it needs. In
general, EPA will prioritize an active ingredient that lacks an
adequate updated two-generation or EOGRT study (which will likely be
the case for pesticides registered before 1998), if EPA determines
available data are inadequate or insufficient to address interaction on
the estrogen and androgen pathway.
     For human thyroid effects, if EPA has an acceptable CTA or
EOGRT study with thyroid evaluations, then it will likely have
sufficient thyroid toxicity data to inform its FIFRA and FFDCA
408(p)(6) decisions for potential human thyroid effects, and EPA will
not seek Tier 1 data to support those decisions. When neither of these
studies are available, EPA will continue with its current approach of
evaluating the available data for each pesticide active ingredient. If
no evidence exists of thyroid-related toxicity or if HASPOC has not
recommended requiring additional data (e.g., CTA) based on the weight-
of-the evidence evaluation, then EPA will include in its FIFRA
assessments and accompanying registration or registration review
decision an explanation for why the available data are sufficient to
inform its FIFRA and its FFDCA section 408(p)(6) decisions for thyroid.
In these cases, EPA will not need Tier 1 data for thyroid. If HASPOC
recommends additional thyroid data, OPP's regulatory divisions will
review the recommendation during the registration or registration
review process for the pesticide to determine whether or when to issue
a DCI for the additional needed thyroid data. EPA may alter its
approach to determining additional thyroid data needs following the
FIFRA SAP review (anticipated in 2025) of potential revisions to its
thyroid framework.

4. Strategy Three: Through Registration Review, Phase in Any New Data
Requirements To Address Potential Human Estrogen, Androgen, and Thyroid
Effects for Registered Conventional Pesticide Active Ingredients,
Starting with Priority Chemicals
    EPA's longstanding goal is for its registration review final
decisions to include decisions under FFDCA section 408(p) for potential
human estrogen, androgen, and thyroid effects. To continue fulfilling
this goal, EPA has created a framework for conventional pesticides
awaiting human endocrine decisions that prioritizes obtaining new data
based on whether EPA already has data for the pesticide and, if so,
whether the data indicate a potential for endocrine disruption.
Depending on the answers to these questions, EPA has assigned each
conventional active ingredient in registration review into one of three
groups. For example, Group 1, which consists of 30 cases, is the
highest priority for potential data collection.
    Where possible, EPA's goal is to incorporate any data requirements
for additional estrogen, androgen, and thyroid data into the start of
registration review cases, as EPA does for other potential human health
effects. Where the current registration review case is farther along in
registration review, EPA will address any additional endocrine data
needs by issuing a DCI, as appropriate, in later stages of registration
review for a chemical.
    The number of registration review cases presented in this section
is an approximation and subject to change. Readers should not focus on
the number of cases for exactness and instead use them to gain a
general understanding of the number of cases currently in registration
review that are priorities for further human endocrine screening and
decisions. In the future, EPA plans to revise the registration review
website to include updates of the number of cases presented in this
section.
a. How EPA Prioritized Conventional Active Ingredients Undergoing
Registration Review for Obtaining Additional Estrogen-Androgen Data
    EPA has developed the framework that EPA will be using to determine
which conventional pesticides in registration review require additional
estrogen and androgen data for human health effects and how the Agency
will prioritize obtaining additional data through DCIs (as discussed in
strategy two, EPA will continue its current approach for thyroid). The
framework represents EPA's initial approach to organize and prioritize
the large number of registration review pesticides for any additional
estrogen and androgen data and regulatory decisions, and may evolve as
EPA gains experience implementing it. See Figure 1. in Ref. 2 for a
diagram of the framework used for prioritizing the 403 conventional
pesticide cases currently in registration review for which an FFDCA
section 406(p)(6) determination is needed.
    EPA has 459 conventional pesticide cases currently in registration
review that have neither a registration review final decision nor an
FFDCA section 408(p)(6) decision. These cases cover pesticides
registered before October 2007 (with a current registration review
deadline of October 2026) and some pesticides registered after this
date. There are seven cases for which EPA has exempted the pesticide
active ingredient from testing under FFDCA section 408(p)(4), and 49
cases from List 1 that EPA is addressing separate from this framework
(see List 1 decision memo (Ref. 3)). That leaves 403 cases currently in
registration review for further consideration of whether and when to
require additional endocrine data. A pesticide registration review case
is comprised of one or multiple pesticide active ingredients depending
on the case. Many conventional pesticide cases have only one active
ingredient.
    Table 2 includes estimates of the number of conventional pesticide
cases currently in registration review for which an FFDCA section
406(p)(6) determination is needed. EPA is addressing List 1 pesticides
separately in the List 1 decision memo (Ref. 3).

     Table 2--Categorization of the 403 Conventional Pesticide Cases
  Currently in Registration Review for Which an FFDCA Section 406(p)(6)
                         Determination is Needed
------------------------------------------------------------------------
                     Description                       Number of cases *
------------------------------------------------------------------------
No further testing for estrogen or androgen.........                  86
    Cases with updated 2-gen. repro. study..........                  82
    Cases with EOGRT study..........................                   4
May need further estrogen or androgen data:.........                 317
    Group 1 cases...................................                  30
    Group 2 cases...................................                 126
    Group 3 cases...................................                 161
------------------------------------------------------------------------
* Numbers as of 8/25/2023.

    As previously stated and further explained in the science support
paper, either an updated two-generation reproductive or EOGRT study
will generally provide sufficient data on potential estrogen and
androgen effects in humans. The Agency has data from at least one of
these studies for 86 of the 403 cases (82 cases with the updated
reproductive study and 4 cases with the EOGRT study) (Ref. 2).
    , and EPA expects to make FFDCA section 408(p)(6) decisions for
these human endocrine effects as part of registration review for these
pesticides without seeking further estrogen or androgen data.
    For the remaining 317 cases without either study, EPA then
determined whether it has data on the estrogen receptor and androgen
receptor from the ToxCast Pathway Models. The ToxCast program, which
generates high throughput data for chemicals of interest to EPA, has
produced endocrine screening data for over 1,800 chemicals to inform
the estrogen receptor and androgen receptor ToxCast Pathway Models. For
191 of the 317 cases, EPA has ToxCast Pathway Model scores for the
estrogen receptor, androgen receptor, or both. The ToxCast Pathway
Model scores for 30 of these 191 cases show bioactivity that may
provide evidence for a potential effect on estrogen, androgen, or both,
indicating the need for additional data to evaluate the potential to
interact with the estrogen, androgen, or both pathways (the remaining
161 of the 317 cases without positive ToxCast data are discussed later
in this section). EPA is seeking through this notice any Tier 1 data,
OSRI, or explanation of how existing data address the ToxCast

Pathway Model scores, in order to determine whether there is actually a
potential for an estrogen-androgen effect for these 30 cases. During
the public comment period, EPA will initiate the process for issuing
DCIs for these cases by spring 2024. Because the cases show the
potential for endocrine activity, EPA considers them the highest
priority for obtaining additional data and will refer to them as
``Group 1'' cases.
    For the remaining 126 of 317 cases, ToxCast Pathway Model scores
were not available for the estrogen receptor or androgen receptor.
These chemicals are also high priorities for obtaining data, but not as
high as Group 1 cases because data currently exist that demonstrate
potential activity in the ToxCast models for the Group 1 cases. EPA
considers these 126 cases ``Group 2'' for assessment and potential data
collection. While the Agency prioritizes Group 1 cases, it will refine
the Group 2 cases as follows. First, EPA will determine whether any of
the active ingredients for those cases are exempt from further testing
under FFDCA section 408(p)(4) because the Agency has determined that an
active ingredient ``is anticipated not to produce any effect in humans
similar to an effect produced by a naturally occurring estrogen.'' If
so, EPA will exempt the active ingredient and explain its decision.
Second, for the remaining cases, EPA will search for any existing
estrogen or androgen data and evaluate its potential as OSRI. EPA will
then determine whether further testing is needed for each of the
remaining cases to make an FFDCA section 408(p) determination.
    Among the 191 cases with ToxCast data, there are 161 cases that
show no activity for either estrogen or androgen receptors. EPA has
assigned these pesticides a lower priority for obtaining additional
data, given current data suggest no potential for estrogen or androgen
activity, and is referring to these 161 cases as ``Group 3.'' In the
docket is a document titled, ``List of Conventional Registration Review
Chemicals for Which an FFDCA Section 408(p)(6) Determination is
Needed,'' that lists the pesticide cases that fall within each group,
accounting for all 403 registration review cases discussed in this
strategy (Ref. 2).
b. How EPA Will Obtain Additional Data and Integrate the New Data Into
Registration Review
i. For Group 1 Cases: 30 Cases Without an Updated Two-Generation
Reproductive or EOGRT Study but for Which ToxCast Data Show Activity
for Estrogen, Androgen, or Both
    For the 30 Group 1 cases, EPA will seek additional data to better
understand the positive findings in the ToxCast data for estrogen,
androgen, or both. Specifically, for each pesticide, EPA is seeking
through this notice any Tier 1 data, OSRI, or explanation of how
existing data address the existing ToxCast Pathway Model scores. During
this public comment period, EPA will begin the process for issuing DCIs
for these 30 cases with the goal to begin issuing them in spring 2024.
The DCIs will cover all the Tier 1 data relevant to mammals, except the
assays for which the ToxCast Pathway Model scores may serve as
alternatives (i.e., estrogen receptor binding in vitro assay, estrogen
receptor transcriptional activation in vitro assay, in vivo
uterotrophic assay, and androgen receptor binding in vitro assay).
Thus, as part of a DCI, EPA will require data from the following five
Tier 1 assays to complete screening for estrogen and androgen effects
in humans: Steroidogenesis, aromatase, Hershberger, female rat
pubertal, and male rat pubertal (see Table 3). In lieu of all five Tier
1 assays, EPA expects to allow a registrant, in response to a DCI, to
submit an updated two-generation reproductive or EOGRT study, or
equivalent data, which will generally provide conclusive data for
potential estrogen and androgen effects in humans. The DCIs will be
based on the Pesticide Data Call-Ins Information Collection Request
(EPA No. 2288.04).

       Table 3--Additional EDSP Tier 1 Data EPA Expects To Request
------------------------------------------------------------------------
                                  Estrogen      Androgen       Thyroid
          Assay name               pathway       pathway       pathway
------------------------------------------------------------------------
                             In vitro Assays
------------------------------------------------------------------------
OCSPP 890.1550--                    [ssquf]       [ssquf]
 Steroidogenesis (Human Cell
 Line--H295R).................
OCSPP 890.1200--Aromatase           [ssquf]
 (Human Recombinant)..........
------------------------------------------------------------------------
                             In vivo Assays
------------------------------------------------------------------------
OCSPP 890.1400--Hershberger                       [ssquf]
 (Rat)........................
OCSPP 890.1450--Pubertal            [ssquf]                     [ssquf]
 Development and Thyroid
 Function in Intact Juvenile/
 Peripubertal Female Rats.....
OCSPP 890.1500--Pubertal                          [ssquf]       [ssquf]
 Development and Thyroid
 Function in Intact Juvenile/
 Peripubertal Male Rats.......
------------------------------------------------------------------------

    As EPA receives data for the Group 1 cases through public comments
and any DCIs, it will determine the most efficient way to review the
data and integrate them into the registration review process so that
the Agency can issue its FIFRA and FFDCA section 408(p) findings for
potential human estrogen, androgen, and thyroid effects. EPA must
consider multiple factors when developing this timeline, including
efficiencies in batching similar chemicals, the timing of when the
Agency will receive and review data for other EDSP priority pesticides,
the length of time needed to generate the data, the deadlines to
complete other aspects of registration review for a pesticide, and the
timeframe for amending pesticide labels to reflect any needed updated
mitigation measures. EPA expects to release a more detailed timeline in
2024.
ii. For Group 2 Cases: 126 Cases Without Updated Two-Generation
Reproductive or EOGRT Study, and No ToxCast Pathway Model Scores
    EPA is not initiating the process for issuing DCIs for Group 2
cases at this time because the Agency's resources are currently limited
to obtaining and reviewing additional data for the Group 1 cases. The
more immediate focus on Group 1 cases will also allow EPA to apply any
lessons learned in collecting and reviewing data for Group 1 to Group 2
cases. Although EPA does not yet have

a precise timeframe for issuing FIFRA DCIs for these cases, it expects
to begin drafting them in 2025.
    In the meantime, the Agency will make some progress on Group 2
cases in two ways. One is to consider any endocrine data or OSRI that
registrants of these pesticides submit to EPA. As with Group 1 cases,
EPA is particularly interested in any existing Tier 1 or Tier 2 data
that the Agency is unaware of, endocrine data submitted to support
distribution and use of the pesticide in other countries, or data from
well-conducted studies addressing the pesticide active ingredient's
endocrine effects. Although EPA cannot yet commit to reviewing these
data within a specific timeframe, the Agency believes it may be useful
to, at a minimum, gain a better understanding of the breadth and depth
of available data for these pesticides before issuing DCIs. Thus, as
with the Group 1 cases, EPA encourages registrants of Group 2
pesticides to identify and submit any relevant endocrine data that have
not been submitted to EPA or any explanations for why further testing
should not be required.
    Second, given the large number of pesticides in the Group 2 list,
EPA will identify the pesticides within this group that are higher
priorities for endocrine testing. EPA will use comments, data, and
explanations submitted, as well as the tools for prioritization
described in its January 2023 EDSP NAMs white paper (Ref. 4), to
determine which Group 2 pesticides will receive DCIs first. EPA will
also use these same data and tools to determine whether to exempt any
pesticides on the list from further testing under FFDCA section
408(p)(4) using its current approach to exemptions. In 2024, EPA will
provide more information on its timeline for Group 2 chemicals.
iii. For Group 3: All Remaining Conventional Registration Review Cases
Not in Group 1 or Group 2
    As explained earlier, a main goal of rebuilding the EDSP is to
incorporate the FFDCA section 408(p) obligations and commitments into
the FIFRA process, including the registration review of existing
pesticides. EPA will thus begin phasing into registration review those
obligations and commitments for the 161 Group 3 cases. By phasing Group
3 cases into the existing registration review schedule, EPA may also
need to shift where a case currently stands in registration review.
    Most Group 3 cases (approximately 154 out of 161 cases) have active
ingredients that were registered before October 2007 and have a current
registration review deadline of October 2026. Typically, EPA issues
DCIs before the draft risk assessment (DRA) phase of registration
review. The pre-2007 cases, however, are generally past the DRA phase,
often by several years. EPA will thus likely address its endocrine data
needs as part of its continuous work plan (CWP) for these cases. Like a
preliminary work plan (PWP), a CWP will provide an overview of the
registration review case status, list registrations, and provide other
pertinent data or information. As a continuation of an existing
registration review case, the CWP will explain any new developments
that EPA knows about a case, including any newly identified data or
other information needed for a final registration review decision.
Thus, EPA currently plans to prioritize the Group 3 cases and use the
CWP to notify the public of when additional endocrine data are needed
for each case and then issue a DCI to obtain the necessary data before
completing a final decision for registration review. Consistent with
existing EPA policy, a final decision will include an FFDCA section
406(p)(6) decision for human estrogen, androgen, and thyroid.
    For the approximately seven other Group 3 cases with active
ingredients registered after October 2007, EPA will determine whether
to address its endocrine data needs through a CWP or a PWP. EPA will
use the latter approach when it can integrate endocrine data needs into
the registration review process from the outset, such as for cases
without a PWP yet. Thus, for these cases, EPA will likely address the
endocrine data needs before it does so for many Group 2 case, because
the Group 3 case happens to be at an early enough stage of registration
review where EPA can incorporate those data needs into the normal
review process.

V. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. US EPA. Use of Existing Mammalian Data to Address Data Needs and
Decisions for Endocrine Disruptor Screening Program (EDSP) for
Humans under FFDC Section 408(p). October 2023.
2. US EPA. List of Conventional Registration Review Chemicals for
Which an FFDCA Section 408(p)(6) Determination is Needed. October
2023.
3. US EPA. Status of Endocrine Disruptor Screening Program (EDSP)
List 1 Screening Conclusions. October 2023.
4. US EPA. Availability of New Approach Methodologies (NAMs) in the
Endocrine Disruptor Screening Program (EDSP). December 12, 2022.
https://www.regulations.gov/document/EPA-HQ-OPP-2021-0756-0002.
4. US EPA Office of Inspector General (OIG). EPA's Endocrine
Disruptor Screening Program Has Made Limited Progress in Assessing
Pesticides. Report No. 21-E-0186. Report Type: Audit. July 28, 2021.
https://www.epaoig.gov/reports/audit/epas-endocrine-disruptor-screening-program-has-made-limited-progress-assessing.
5. The United States District Court for the Northern District of
California. Case No. 22-cv-9030. Filed December 20, 2022.
6. US EPA. Health Effects Test Guidelines: OPPTS 870.3800
Reproduction and Fertility Effects [EPA 712-C-98-208]. August 1,
1998. https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0156-0018.
6. Organisation for Economic Co-operation and Development (OECD).
OECD Guideline for the Testing of Chemicals, Extended One-Generation
Reproductive Toxicity Study. OECD/OCDE 443. Adopted: June 25, 2018.
https://www.oecd-ilibrary.org/docserver/9789264185371-en.pdf?expires=1695671098&id=id&accname=guest&checksum=F8B12F13B2F19A2731C51FA392B78716.
7. US EPA. Exemption of Citric Acid from the Requirements of the
Endocrine Disruptor Screening Program. January 19, 2023. https://www.regulations.gov/document/EPA-HQ-OPP-2020-0558-0008.
8. US EPA. Fipronil: Draft Human Health Risk Assessment for
Registration Review. March 20, 2020. https://www.regulations.gov/document/EPA-HQ-OPP-2011-0448-0076.
9. US EPA. EPA's Workplan and Progress Toward Better Protections for
Endangered Species. EPA website. https://www.epa.gov/endangered-species/epas-workplan-and-progress-toward-better-protections-endangered-species.
10. US EPA. Endocrine Disruptor Screening Program; Proposed
Statement of Policy. Federal Register. 63 FR 71542, December 28,
1998 (FRL-6052-9). https://www.epa.gov/sites/default/files/2015-08/documents/122898frnotice.pdf.
11. US EPA. Guidance for Thyroid Assays in Pregnant Animals, Fetuses
and Postnatal Animals, and Adult Animals. October 24, 2005. https://www.epa.gov/sites/default/files/2015-06/documents/thyroid_guidance_assay.pdf.

12. OECD. OECD Guidelines for the Testing of Chemicals, Repeated
Dose 28-Day Oral Toxicity Study in Rodents. OECD/OCDE 407. Adopted:
October 3, 2008. https://www.oecd-ilibrary.org/docserver/9789264070684-en.pdf?expires=1695669052&id=id&accname=guest&checksum=B2CCC35058D14B03AFA5C29EBB5D1CE5.
13. OECD. OECD Guideline for the Testing of Chemicals, Repeated Dose
90-Day Oral Toxicity Study In Rodents. OECD/OCDE 408 Adopted: June
25, 2018. https://www.oecd-ilibrary.org/docserver/9789264070707-en.pdf?expires=1695668998&id=id&accname=guest&checksum=19E7679541E3927AE5066BBB8CFA0F54.

VI. Paperwork Reduction Act (PRA)

    The strategies outlined in this document describe information
collection activities that do not create any new paperwork burdens that
require additional approval by OMB under the PRA, 44 U.S.C. 3501 et
seq. The information collection activities associated with pesticide
registration are already approved by OMB under OMB Control No. 2070-
0226, entitled ``Consolidated Pesticide Registration Submission
Portal'' (EPA ICR No. 2624.01). Information collection activities
associated with data call-in activities, including the generation of
data for registration review, are approved under OMB Control No. 2070-
0174, entitled ``Pesticides Data Call-In Program Information Collection
Request'' (EPA ICR No. 2288.06).
    Authority: 7 U.S.C. 136 et seq. and 21 U.S.C. 346a.

    Dated: October 20, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-23721 Filed 10-26-23; 8:45 am]
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1E. g., where the effective date of designation to nonattainment for an area for the 8 hour ozone NAAQS is after June 1, 2007 but before June 1, 2010, the baseline inventory will be for calendar year 2005. 8/ 126/ 05 From RFP / baseline issue section b. Summary of Final Rule As set forth in our proposed rule, for areas designated nonattainment for the 8 hour ozone NAAQS with an effective date of June 15, 2004, we are requiring States to use the 2002 inventory as the baseline inventory for the RFP requirement. As noted in the proposal, the inventory for the 2002 calendar year would be the most recently available inventory at the time of designation in 2004. However, in response to several comments, we are allowing States the option of justifying the use of an alternative baseline inventory year for RFP. To justify an alternative, the State would have to demonstrate how the alternative year meets the CAA's provisions for RFP and whyprovide a rationale for the use of the 2002alternative baseline year is impracticable. We believe that for multi state nonattainment areas, the several States must agree on a single baseline. The baseline emissions inventory is calculated as of the effective date of an area's nonattainment designation using the most recent calendar year for which a complete inventory is required to be submitted to EPA under subpart A of this part. Under subpart A, States are required to submit a comprehensive inventory on 3 year cycles within 17 months after the close of the reporting period. Thus, the 2002 inventory was due 17 months after the December 31, 2002 close of the reporting period, i. e., was due by June 1, 2004. For those areas designated nonattainment for the 8 hour ozone NAAQS effective June 15, 2004 ( 69 FR 23858, April 30, 2004), the baseline emissions inventory shall be based on the calendar year 2002 because the 2002 inventory was due under subpart A of this part prior to the time of designation. For areas with an effective nonattainment designation in the future, the baseline inventory will be for the calendar year of the most recent triennial inventory as of the date of designation. 1


[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Proposed Rules]
[Page 23678-23679]
[DOCID:fr20my09-28]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2005-0161; FRL-8906-9]
RIN 2060-A081

Public Hearing for the RFS2 Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of public hearing.

-----------------------------------------------------------------------

SUMMARY: The EPA is announcing a public hearing to be held for the
proposed rule ``Regulation of Fuels and Fuel Additives: Changes to
Renewable Fuel Standard Program'' (the proposed rule is hereinafter
referred to as ``RFS2''), which will be published separately in the
Federal Register. The hearing will be held in Washington, DC on June 9,
2009.
    In a separate notice of proposed rulemaking, EPA is proposing a
regulation to implement changes to the Renewable Fuel Standard program
as mandated by the Clean Air Act (as amended by Sections 201, 202, and
210 of the Energy Independence and Security Act of 2007). The revised
statutory requirements specify the volumes of cellulosic biofuel,
biomass-based diesel, advanced biofuel, and total renewable fuel that
must be used in transportation fuel each year, with the volumes
increasing over time. The rule proposes regulations designed to ensure
that refiners, blenders, and importers of gasoline and diesel would use
enough renewable fuel each year so that the four volume requirements of
the Energy Independence and Security Act would be met with renewable
fuels that also meet the required lifecycle greenhouse gas emissions
performance standards. The RFS2 proposed rule describes the standards
that would apply to these parties and the renewable fuels that would
qualify for compliance, and the proposed regulations make a number of
changes to the current Renewable Fuel Standard program while retaining
many elements of the compliance and trading system already in place.
The signed notice of proposed rulemaking was posted on the EPA Web site
prior to publication in the Federal Register, and contained the same
public hearing date presented in this announcement.

DATES: The public hearing will be held on June 9, 2009 in Washington,
DC. To register to testify at the hearing, notify the contact person
listed under FOR FURTHER INFORMATION CONTACT by June 1, 2009.
Information regarding time of the hearing, as well as the Lifecycle
Greenhouse Gas (GHG) workshop, is also listed below in SUPPLEMENTARY
INFORMATION.

ADDRESSES: The hearing will be held at the following location: Dupont
Hotel, 1500 New Hampshire Avenue, NW., Washington, DC 20036. Written
comments on the proposed rule may also be submitted to EPA
electronically, by mail, by facsimile, or through hand delivery/
courier. Please refer to the notice of proposed rulemaking for the
addresses and detailed instructions for submitting written comments.
    When the proposed rule is published in the Federal Register, a
complete set

of documents related to the proposal will be available for public
inspection at the EPA Docket Center, located at 1301 Constitution
Avenue, NW., Room 3334, Washington, DC between 8:30 a.m. and 4:30 p.m.,
Monday through Friday, excluding legal holidays. A reasonable fee may
be charged for copying. Documents are also available through the
electronic docket system at http://www.regulations.gov. The EPA Web
site for the rulemaking, which includes information about the public
hearings and a copy of the signed proposal (which is essentially the
same as the proposal that will be published) can be found at: http://
www.epa.gov/otaq/renewablefuels/index.htm.

FOR FURTHER INFORMATION CONTACT: Julia MacAllister, Office of
Transportation and Air Quality, Assessment and Standards Division,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>or Assessment and Standards
Division Hotline; telephone number<PHONE_NUMBER>; E-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The proposal for which EPA is holding the
public hearing will be published separately in the Federal Register. A
copy of the signed notice of proposed rulemaking, which is essentially
the same as the proposal that will be published in the Federal
Register, has been available since May 5, 2009, on the following Web
site: http://www.epa.gov/otaq/renewablefuels/index.htm. The notice on
the Web site contains the same public hearing date, addresses, and
registration information presented in this announcement of public
hearing.
    Public Hearing: The public hearing will provide interested parties
the opportunity to present data, views, or arguments concerning the
proposed rule. The EPA may ask clarifying questions during the oral
presentations but will not respond to the presentations at that time.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as any oral
comments and supporting information presented at the public hearing.
Written comments must be received by the last day of the comment
period, as specified in the proposal of the RFS2 rule.
    The public hearing will be held on June 9 in Washington, DC and
will begin at 10 a.m. and end at 5 p.m., local time. To testify at the
public hearing, please notify the contact person listed under FOR
FURTHER INFORMATION CONTACT by June 1, 2009.
    Verbatim transcripts of the hearings and written statements will be
included in the rulemaking docket.
    Workshop: We will also hold a workshop on June 10-11, 2009 at the
Dupont Hotel in Washington, DC to present details of our lifecycle GHG
analysis. During this workshop, we intend to go through the lifecycle
GHG analysis included in this proposal. The intent of this workshop is
to help ensure a full understanding of our lifecycle analysis, the
major issues identified and the options discussed. We expect that this
workshop will help ensure that we receive submission of the most
thoughtful and useful comments to this proposal and that the best
methodology and assumptions are used for calculating GHG emissions
impacts of fuels for the final rule. While this workshop will be held
during the comment period, it is not intended to replace either the
formal public hearing or the need to submit comments to the docket.

How Can I Get Copies of This Document, the Proposed Rule, and Other
Related Information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2005-0161. The EPA has also developed a Web site for the
proposed RFS2 rule, including the notice of proposed rulemaking, at the
address given above. Please refer to the notice of proposed rulemaking
for detailed information on accessing information related to the
proposal.

    Dated: May 13, 2009.
Margo T. Oge,
Director, Office of Transportation and Air Quality.
[FR Doc. E9-11644 Filed 5-19-09; 8:45 am]

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