Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices 73841 

Contact: Lance J Rakovan 301–415– 

2589. 

Revision to FR Notice Published 09/ 

08/2023; Extending the Comment Period 

from 10/23/2023 to 11/07/2023. 

EIS No. 20230116, Draft Supplement, 

BLM, USFWS, AK, Coastal Plain Oil 

and Gas Leasing Program, Comment 

Period Ends: 11/07/2023, Contact: 

Serena Sweet 907–271–4543. 

Revision to FR Notice Published 09/ 

08/2023; Extending the Comment Period 

from 10/23/2023 to 11/07/2023. 

Dated: October 23, 2023. 

Nancy Abrams, 

Associate Director, Office of Federal 

Activities. 

[FR Doc. 2023–23759 Filed 10–26–23; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 nearterm 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 longerterm 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: (202) 566– 

1030; email address: 

pesticidequestions@epa.gov. 

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 


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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 nearterm 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 nearterm 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 chemicalspecific 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 


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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-epadockets. 

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

FFDCA 

provision Mandatory obligation Status of obligation EPA discretionary commitment and status 

408(p)(1) ......... Must create estrogen screening program Completed when EPA created the 

EDSP in 1998.

In 1998, expanded screening program to 

include androgen, thyroid, and wildlife. 

408(p)(2) ......... Must implement screening program by 

Aug. 1999.

Completed the deadline obligation, but 

ongoing implementation.

Ongoing (currently implementing expanded screening). 

408(p)(3) ......... Must provide for testing of all pesticide 

chemicals and may provide for testing 

of other substance with cumulative effect to a pesticide chemical.

Ongoing (currently obtaining data 

through FIFRA regulations and processes).

Ongoing (currently obtaining data 

through FIFRA regulations and processes). 

408(p)(4) ......... None, but EPA may exempt chemical 

from 408(p).

Ongoing (established the Endocrine 

Disruptor Science Policy Council 

(EDSPOC) to make recommendations 

on exemptions).

Ongoing (established the EDSPOC to 

make recommendations on exemptions). 

408(p)(5) ......... Must issue test orders ............................ Ongoing (currently implementing for 

pesticide active ingredients through 

FIFRA regulations and processes).

Ongoing (currently implementing for 

pesticide active ingredients through 

FIFRA regulations and processes). 


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TABLE 1—SUMMARY OF FFDCA SECTION 408(p) MANDATORY OBLIGATIONS AND DISCRETIONARY COMMITMENTS FOR

PESTICIDE ACTIVE INGREDIENTS—Continued 

FFDCA 

provision Mandatory obligation Status of obligation EPA discretionary commitment and status 

408(p)(6) ......... Must take action to protect public health 

against a substance with endocrine 

effect.

Ongoing (working to address protections 

for pesticide active ingredients in 

FIFRA decisions).

Through this notice, EPA will begin 

issuing determinations for pesticide 

active ingredients when 408(p)(6) is 

met for human estrogen, androgen, 

and thyroid. 

408(p)(7) ......... Must report to Congress by August 2000 Completed ............................................... N/A. 

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 highthroughput 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 


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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 onegeneration 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 


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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 twogeneration 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 nonmammalian species that are covered by 

the EDSP (e.g., birds, fish, amphibians). 

Second, EPA is already taking 

unprecedented steps to reduce pesticide 


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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 twogeneration 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 twogeneration reproductive study is 

ambiguous or inconclusive for one or 

more endocrine endpoints, EPA may 

consider whether OSRI addresses the 


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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 


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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 thyroidrelated 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 twogeneration 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. 


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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 


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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

Assay name Estrogen 

pathway 

Androgen 

pathway 

Thyroid 

pathway 

In vitro Assays 

OCSPP 890.1550—Steroidogenesis (Human Cell Line—H295R) ......................................................... D D 

OCSPP 890.1200—Aromatase (Human Recombinant) .......................................................................... D 

In vivo Assays 

OCSPP 890.1400—Hershberger (Rat) ................................................................................................... D 

OCSPP 890.1450—Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats ............................................................................................................................................. D D 

OCSPP 890.1500—Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male 

Rats ...................................................................................................................................................... D D 

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 


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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 wellconducted 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/EPAHQ-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-screeningprogram-has-made-limited-progressassessing. 

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/EPAHQ-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=F8B12F13B2F19A27

31C51FA392B78716. 

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/EPAHQ-OPP-2011-0448-0076. 

9. US EPA. EPA’s Workplan and Progress 

Toward Better Protections for 

Endangered Species. EPA website. 

https://www.epa.gov/endangeredspecies/epas-workplan-and-progresstoward-better-protections-endangeredspecies. 

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. 


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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=

B2CCC35058D14B0

3AFA5C29EBB5D1CE5. 

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=19E7679541E3927AE

5066BBB8CFA0F54. 

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] 

BILLING CODE 6560–50–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Meetings 

TIME AND DATE: Wednesday, November 

1, 2023 at 10:30 a.m. and its 

continuation at the conclusion of the 

open meeting on November 2, 2023. 

PLACE: 1050 First Street NE, 

Washington, DC and virtual (This 

meeting will be a hybrid meeting). 

STATUS: This meeting will be closed to 

the public. 

MATTERS TO BE CONSIDERED: 

Compliance matters pursuant to 52 

U.S.C. 30109. 

Matters relating to internal personnel 

decisions or internal rules and practices. 

Information for which disclosure would 

constitute an unwarranted invasion of 

privacy. Investigatory records compiled 

for law enforcement purposes and 

production would disclose investigative 

techniques. 

Information the premature disclosure 

of which would be likely to have a 

considerable adverse effect on the 

implementation of a proposed 

Commission action. 

Matters concerning participation in 

civil actions or proceedings or 

arbitration. 

* * * * * 

CONTACT PERSON FOR MORE INFORMATION: 

Judith Ingram, Press Officer, Telephone: 

(202) 694–1220. 

(Authority: Government in the Sunshine Act, 

5 U.S.C. 552b) 

Dated: October 25, 2023. 

Laura E. Sinram, 

Secretary and Clerk of the Commission. 

[FR Doc. 2023–23907 Filed 10–25–23; 4:15 pm] 

BILLING CODE 6715–01–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Meetings 

TIME AND DATE: Thursday, November 2, 

2023 at 10:30 a.m. 

PLACE: Hybrid meeting: 1050 First Street 

NE Washington, DC (12th floor) and 

virtual. Note: For those attending the 

meeting in person, current COVID–19 

safety protocols for visitors, which are 

based on the CDC COVID–19 hospital 

admission level in Washington, DC, will 

be updated on the Commission’s contact 

page by the Monday before the meeting. 

See the contact page at https:// 

www.fec.gov/contact/. If you would like 

to virtually access the meeting, see the 

instructions below. 

STATUS: This meeting will be open to the 

public, subject to the above-referenced 

guidance regarding the COVID–19 

hospital admission level and 

corresponding health and safety 

procedures. To access the meeting 

virtually, go to the Commission’s 

website www.fec.gov and click on the 

banner to be taken to the meeting page. 

MATTERS TO BE CONSIDERED: 

Proposed Directive Regarding 

Investigations Conducted by the 

Office of General Counsel 

Proposed Final Audit Report on Steve 

Daines for Montana (A21–04) 

Draft Advisory Opinion 2023–06: Texas 

Majority PAC 

Management and Administrative 

Matters 

CONTACT PERSON FOR MORE INFORMATION: 

Judith Ingram, Press Officer, Telephone: 

(202) 694–1220. 

Individuals who plan to attend in 

person and who require special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should contact Laura 

E. Sinram, Secretary and Clerk, at (202) 

694–1040 or secretary@fec.gov, at least 

72 hours prior to the meeting date. 

(Authority: Government in the Sunshine Act, 

5 U.S.C. 552b) 

Laura E. Sinram, 

Secretary and Clerk of the Commission. 

[FR Doc. 2023–23930 Filed 10–25–23; 4:15 pm] 

BILLING CODE 6715–01–P 

GENERAL SERVICES 

ADMINISTRATION 

[Notice–PBS–2023–06; Docket No. 2023– 

0002; Sequence No. 26] 

Notice of Availability for a Draft 

Supplemental Environmental Impact 

Statement and Floodplain Assessment 

and Statement of Findings for the 

International Falls Land Port of Entry 

Modernization and Expansion Project 

in International Falls, Minnesota 

AGENCY: Public Buildings Service (PBS), 

General Services Administration (GSA). 

ACTION: Notice of Availability (NOA); 

Announcement of public hearing. 

SUMMARY: This notice announces the 

availability of the Draft Supplemental 

Environmental Impact Statement (SEIS), 

which examines potential 

environmental impacts from the 

modernization and expansion of the 

International Falls Land Port of Entry 

(LPOE) in International Falls, 

Minnesota. The existing International 

Falls LPOE is owned and managed by 

GSA and is operated by the U.S. 

Department of Homeland Security’s 

Customs and Border Protection (CBP). 

The Draft SEIS describes the purpose 

and need for the project; alternatives 

considered; the existing environment 

that could be affected; the potential 

impacts resulting from each of the 

alternatives; and proposed best 

management practices and/or mitigation 

measures. The Draft SEIS also includes 

the Draft Finding of No Practicable 

Alternative (FONPA), which provides a 

floodplain assessment and statement of 

findings as a result of construction in a 

floodplain at the International Falls 

LPOE. 

DATES: 

Public Comment Period—Interested 

parties are invited to provide comments 

on the Draft SEIS and Floodplain 

Assessment and Statement of Findings. 

The Public Comment Period begins with 


ddrumheller on DSK120RN23PROD with NOTICES1