Availability of New Approach Methodologies in the Endocrine Disruptor Screening Program; Notice of Availability and Opportunity for Comment, 3406-3408 [2023-00940]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 3406 Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Chris Moore, AO/OP/NCEE, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202–566– 2348; fax number: 202–566–2448; email address: moore.chris@epa.gov. SUPPLEMENTARY INFORMATION: This is a request for approval of a new collection. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Public comments were previously requested via the Federal Register on September 29, 2021, during a 60-day comment period (86 FR 53960). This notice allows for an additional 30 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202–566–1744. For additional information about EPA’s public docket, visit https://www.epa.gov/dockets. Abstract: Researchers and analysts in EPA’s Office of Research and Development (ORD), Office of Water (OW), and National Center for Environmental Economics (NCEE) are collaborating to improve EPA’s ability to perform benefit cost analysis on changes in surface water quality (lakes, rivers, and streams). We are requesting approval to conduct a survey that will provide data critical to that effort. A number of non-market valuation methods can be used to estimate the economic benefits of improving environmental quality, but they often require more time and resources than federal agencies have to complete the regulatory impact analysis. Benefit transfer can provide reasonably accurate estimates of economic benefits under certain conditions with fewer resources and far less time. Federal agencies rely on benefit transfer often when analyzing the economic impacts of environmental regulation. In conducting benefit cost analyses of surface water regulations, however, it has become apparent that there is a lack of data on some features of policy analysis that have forced analysts to make assumptions about the relationships between a number of factors. This information collection is VerDate Sep<11>2014 17:49 Jan 18, 2023 Jkt 259001 necessary to provide insight on those relationships and improve the EPA’s and other federal agencies’ ability to perform benefit transfer in regulatory analysis. Analysts in the Office of Policy, the Office of Water, and the Office of Research and Development have begun work on an integrated hydrological and economic model that will be capable of estimating benefits for a wide range of surface water regulations. The data collected with this survey will inform that effort. Analysts elsewhere in the EPA and other federal agencies may also be able to use the results of this study to improve benefit transfer in other applications. The survey will be administered electronically to a probability-based internet panel. An internet-based survey mode provides several advantages in efficiency and accuracy over other collection modes. It is also necessary to meet several of our research objectives described in the ICR Supporting Statement. Participation in the survey will be voluntary and the identity of the participants will be kept confidential. Form numbers: EPA Form 5800–078, A Survey on Water Quality in Rivers, Lakes, and Streams. Respondents/affected entities: Eligible respondents for this survey will be U.S. civilian, non-institutionalized individuals, age 18 years and older. Respondent’s obligation to respond: Voluntary. Estimated number of respondents: 6120 (total). Frequency of response: One-time collection. Total estimated burden: 2,040 hours. Total estimated cost: $637,122. There are no capital or operation and maintenance costs associated with this collection. Changes in the estimates: This is a new collection. The survey is a one-time data collection activity. ACTION: Notice of availability. The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on a draft White Paper entitled ‘‘Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).’’ This draft White Paper was developed pursuant to the Federal, Food, Drug and Cosmetic Act (FFDCA), which requires 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 other endocrine effects. This draft White Paper announces that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain EDSP Tier 1 assays while others are useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight of evidence evaluations. SUMMARY: Courtney Kerwin, Director, Regulatory Support Division. Comments must be received on or before March 20, 2023. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2021–0756, through 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/dockets. FOR FURTHER INFORMATION CONTACT: Natalie Bray, Pesticide Reregistration Division (7508M), Office of Pesticide Programs, Environmental Protection Agency; telephone number: (202) 566– 2222; email address: bray.natalie@ epa.gov. [FR Doc. 2023–00972 Filed 1–18–23; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–P I. General Information ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2021–0756; FRL–10116–01– OCSPP] Availability of New Approach Methodologies in the Endocrine Disruptor Screening Program; Notice of Availability and Opportunity for Comment Environmental Protection Agency (EPA). AGENCY: PO 00000 Frm 00031 Fmt 4703 DATES: Sfmt 4703 A. Does this action apply to me? This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions E:\FR\FM\19JAN1.SGM 19JAN1 Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices regarding the applicability of this action to a particular entity, contact the person listed under FOR FURTHER INFORMATION CONTACT. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit CBI information to EPA through regulations.gov or email. 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. 2. Multimedia submissions. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). 3. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/ comments.html. Please note that once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. II. Executive Summary A. What is the Agency’s authority for taking this action? Section 408(p)(1) of the Federal, Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 408, requires EPA to ‘‘develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effects as [EPA] may designate.’’ khammond on DSKJM1Z7X2PROD with NOTICES B. What action is the Agency taking? The Agency is releasing the draft document entitled ‘‘Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP)’’ [herein called the draft ‘‘White Paper’’]. This draft White Paper announces that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain EDSP VerDate Sep<11>2014 17:49 Jan 18, 2023 Jkt 259001 Tier 1 assays while others are useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight of evidence evaluations. The draft White Paper provides further details concerning when specified NAMs may be used. In 1998, pursuant to FFDCA section 408(p)(1), EPA introduced the EDSP including the use of a two-tiered screening framework consisting of a battery of in vitro and in vivo assays (63 FR 42852, August 11, 1998 (FRL–6021– 3) and 63 FR 71542, December 28, 1998 (FRL–6052–9)). The purpose of Tier 1 screening is to identify chemicals that have potential biological activity (‘‘bioactivity’’) in the estrogen, androgen or thyroid hormone pathways using a battery of assays. For more than a decade at the EPA, research efforts have focused on the development and evaluation of high-throughput in vitro assays and in silico methods as NAMs, including databases and computational models, for use as alternatives to the current suite of assays in the EDSP Tier 1 battery to accelerate the pace of screening, add efficiencies, decrease costs, and reduce animal testing. EPA has determined that the Estrogen Receptor (ER) pathway model based on the full 18-assay ToxCast/Tox21 battery may be used as an alternative to performing certain EDSP Tier 1 screening assays: ER binding in vitro assay (OCSPP 890.1250), ER transcriptional activation in vitro assay (ERTA; OCSPP 890.1300), and the in vivo Uterotrophic assay (rat) (OCSPP 890.1600). EPA has further determined that the Androgen Receptor (AR) pathway model based on the full 11assay ToxCast/Tox21 battery may be used as an alternative for the AR binding in vitro assay (OCSPP 890.1150). The data from these NAMs will be evaluated on a chemical-bychemical basis (each assay evaluated independently). The following models and assays are not yet accepted by the EDSP as alternatives per se for Tier 1 screening assays, but may be used for priority setting for EDSP Tier 1 screening or for consideration for use as other scientifically relevant information, where appropriate in weight of evidence evaluations: (1) ER and AR pathway models using assay subsets (also referred to as reduced or minimal assay data sets); (2) In Silico Qualitative Structure Activity Relationship Consensus Models for ER and AR (https://ntp.niehs.nih.gov/ whatwestudy/niceatm/comptox/ctopera/opera.html); (3) Integration of Bioactivity and Exposure (Integrated PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 3407 Bioactivity Exposure Ratio), which compares an estimated external dose threshold for a biological effect, based on an internal dose (i.e., plasma concentration) derived from bioactivity data (e.g., ER and AR pathway model outputs), with estimates of exposure; and, (4) The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) tool for interspecies extrapolation. EPA requests the public provide comment on the clarity and completeness of the draft document. Given the strengths and uncertainties of these methods, EPA also requests the public provide comment on the draft conclusions that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain EDSP Tier 1 assays while others are useful for prioritization purposes and for consideration for use as other scientifically relevant information. Included in the docket for this action are two documents that respond to comments on related subject matter. One document responds to comments received in response to a notice issued in the Federal Register of June 19, 2015 (80 FR 35350 (FRL–9928–69), see also docket ID No. EPA–HQ–OPPT–2015– 0305) requesting comment on EPA’s document titled ‘‘Endocrine Disruptor Screening Program: Use of High Throughput Assays and Computational Tools.’’ The other document contains EPA’s responses to comments regarding the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) Meeting from November 28–30, 2017 (82 FR 26097, June 6, 2017 (FRL–9962–79) and 82 FR 36137, August 3, 2017 (FRL–9965–61), see also docket ID No. EPA–HQ–OPP– 2017–0214). EPA is including these documents in the docket for this action because they provide useful context on past public input on the EDSP which EPA considered when developing the draft White Paper. EPA is not requesting public comment on these response to comments documents. III. Do guidance documents contain binding requirements? As guidance, the draft White Paper is not binding on the Agency or any outside parties, and the Agency may depart from it where circumstances warrant and without prior notice. While EPA has made every effort to ensure the accuracy of the discussion in the guidance, the obligations of EPA and the regulated community are determined by statutes, regulations, or other legally binding documents. In the event of a conflict between the discussion in the guidance documents and any statute, E:\FR\FM\19JAN1.SGM 19JAN1 3408 Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices regulation, or other legally binding document, the guidance documents will not be controlling. Authority: 21 U.S.C. 408. Dated: January 13, 2023. Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2023–00940 Filed 1–18–23; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OAR–2007–1196; FRL–10485–01– OAR] Recent Postings of Broadly Applicable Alternative Test Methods Environmental Protection Agency (EPA). AGENCY: ACTION: Notice of availability. This notice announces the broadly applicable alternative test method approval decisions that the Environmental Protection Agency (EPA) made under and in support of New Source Performance Standards (NSPS) and the National Emission Standards for Hazardous Air Pollutants (NESHAP) between January 1, 2022, and December 31, 2022. SUMMARY: An electronic copy of each alternative test method approval document is available at https://www.epa.gov/emc/broadlyapplicable-approved-alternative-testmethods. For questions about this notice, contact Mrs. Lula H. Melton, Air Quality Assessment Division, Office of Air Quality Planning and Standards (E143–02), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541– 2910; fax number: (919) 541–0516; email address: melton.lula@epa.gov. For technical questions about individual alternative test method decisions, refer to the contact person identified in the individual approval document(s). FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. General Information khammond on DSKJM1Z7X2PROD with NOTICES A. Does this notice apply to me? This notice will be of interest to entities regulated under 40 Code of Federal Regulations (CFR) parts 59, 60, 61, 63 and 65; state, local, and tribal agencies; and the EPA Regional offices responsible for implementation and enforcement of regulations under 40 CFR parts 59, 60, 61, 63, and 65. VerDate Sep<11>2014 17:49 Jan 18, 2023 Jkt 259001 B. How can I get copies of this information? You may access copies of the broadly applicable alternative test method approval documents at https:// www.epa.gov/emc/broadly-applicableapproved-alternative-test-methods. II. Background This notice identifies broadly applicable alternative test methods that the EPA approved in 2022 under the NSPS, 40 CFR part 60 and the NESHAP, and 40 CFR part 63 programs. See Table 1 of this notice for the summary of these test methods. Source owners and operators may voluntarily use these broadly applicable alternative test methods in lieu of otherwise required test methods or related testing procedures. Use of these broadly applicable alternative test methods are not intended to and should not change the applicable emission standards. The Administrator has the authority to approve the use of alternative test methods for compliance with requirements under 40 CFR parts 59, 60, 61, 63, and 65. This authority is found in 40 CFR 60.8(b)(3), 61.13(h)(1)(ii), and 63.7(e)(2)(ii). Additional and similar authority can be found in 40 CFR 59.104(f) and 65.158(a)(2). The criteria for approval and procedures for submission and review of broadly applicable alternative test methods are explained in a previous Federal Register notice published at 72 FR 4257 (January 30, 2007) and located at https://www.epa.gov/emc/broadlyapplicable-approved-alternative-testmethods. As explained in this notice, we will announce approvals for broadly applicable alternative test methods at https://www.epa.gov/emc/broadlyapplicable-approved-alternative-testmethods as they are issued and publish an annual notice that summarizes approvals for broadly applicable alternative test methods during the preceding year. As also explained in the January 30, 2007 notice, our approval decisions involve thorough technical reviews of numerous source-specific requests for alternatives and modifications to test methods and procedures. Based on these reviews, we have often found that these modifications or alternatives would be equally valid and appropriate to apply to other sources within a particular class, category, or subcategory. Consequently, we have concluded that where either a method modification or an alternative method is clearly broadly applicable to a class, category, or subcategory of sources, it is both equitable and efficient to PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 simultaneously approve its use for all appropriate sources and situations. Use of approved alternative test methods is not mandatory but rather permissive. Sources are not required to employ such a method but may choose to do so in appropriate circumstances. As specified in 40 CFR 63.7(f)(5), however, a source owner or operator electing to use an alternative method for 40 CFR part 63 standards must continue to use the alternative method until otherwise authorized. Source owners or operators should, therefore, review the specific broadly applicable alternative method approval decision at https:// www.epa.gov/emc/broadly-applicableapproved-alternative-test-methods before electing to employ any alternative method. Source owners or operators choosing to use a broadly applicable alternative should also notify their regulatory agency prior to using the alternative. III. Approved Alternative Test Methods and Modifications to Test Methods This notice specifies five broadly applicable alternative test methods that the EPA approved between January 1, 2022, and December 31, 2022. The alternative method decision letter/ memo designation numbers, test methods affected, sources allowed to use this alternative, and method modifications or alternative methods allowed are summarized in Table 1 of this notice. A summary of approval documents was previously made available on our Technology Transfer Network between January 1, 2022, and December 31, 2022. For more detailed information, please refer to the complete copies of these approval documents available at https://www.epa.gov/emc/ broadly-applicable-approvedalternative-test-methods. As also explained in our January 30, 2007 notice, we will revisit approvals of alternative test methods in response to written requests or objections indicating that a particular approved alternative test method either should not be broadly applicable or that its use is not appropriate or should be limited in some way. Any objection to a broadly applicable alternative test method, as well as the resolution of that objection, will be announced at https:// www.epa.gov/emc/broadly-applicableapproved-alternative-test-methods and in a subsequent Federal Register notice. If we decide to retract a broadly applicable test method, we will likely consider the need for an appropriate E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3406-3408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00940]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0756; FRL-10116-01-OCSPP]


Availability of New Approach Methodologies in the Endocrine 
Disruptor Screening Program; Notice of Availability and Opportunity for 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting public comment on a draft White Paper 
entitled ``Availability of New Approach Methodologies (NAMs) in the 
Endocrine Disruptor Screening Program (EDSP).'' This draft White Paper 
was developed pursuant to the Federal, Food, Drug and Cosmetic Act 
(FFDCA), which requires 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 
other endocrine effects. This draft White Paper announces that certain 
NAMs have been validated and may now be accepted by the EPA as 
alternatives for certain EDSP Tier 1 assays while others are useful for 
prioritization purposes and for use as other scientifically relevant 
information, where appropriate, in weight of evidence evaluations.

DATES: Comments must be received on or before March 20, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2021-0756, through 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/dockets.

FOR FURTHER INFORMATION CONTACT: Natalie Bray, Pesticide Reregistration 
Division (7508M), Office of Pesticide Programs, Environmental 
Protection Agency; telephone number: (202) 566-2222; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to a wide range of stakeholders including environmental, human 
health, farm worker, and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the sale, 
distribution, or use of pesticides. Since others also may be 
interested, the agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions

[[Page 3407]]

regarding the applicability of this action to a particular entity, 
contact the person listed under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. 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.
    2. Multimedia submissions. Multimedia submissions (audio, video, 
etc.) must be accompanied by a written comment. The written comment is 
considered the official comment and should include discussion of all 
points you wish to make. The EPA will generally not consider comments 
or comment contents located outside of the primary submission (i.e., on 
the web, cloud, or other file sharing system).
    3. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html. Please note that once submitted, comments cannot be 
edited or removed from the docket. The EPA may publish any comment 
received to its public docket.

II. Executive Summary

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

    Section 408(p)(1) of the Federal, Food, Drug and Cosmetic Act 
(FFDCA), 21 U.S.C. 408, requires EPA to ``develop a screening program, 
using appropriate validated test systems and other scientifically 
relevant information, to determine whether certain substances may have 
an effect in humans that is similar to an effect produced by a 
naturally occurring estrogen, or such other endocrine effects as [EPA] 
may designate.''

B. What action is the Agency taking?

    The Agency is releasing the draft document entitled ``Availability 
of New Approach Methodologies (NAMs) in the Endocrine Disruptor 
Screening Program (EDSP)'' [herein called the draft ``White Paper'']. 
This draft White Paper announces that certain NAMs have been validated 
and may now be accepted by the EPA as alternatives for certain EDSP 
Tier 1 assays while others are useful for prioritization purposes and 
for use as other scientifically relevant information, where 
appropriate, in weight of evidence evaluations. The draft White Paper 
provides further details concerning when specified NAMs may be used.
    In 1998, pursuant to FFDCA section 408(p)(1), EPA introduced the 
EDSP including the use of a two-tiered screening framework consisting 
of a battery of in vitro and in vivo assays (63 FR 42852, August 11, 
1998 (FRL-6021-3) and 63 FR 71542, December 28, 1998 (FRL-6052-9)). The 
purpose of Tier 1 screening is to identify chemicals that have 
potential biological activity (``bioactivity'') in the estrogen, 
androgen or thyroid hormone pathways using a battery of assays. For 
more than a decade at the EPA, research efforts have focused on the 
development and evaluation of high-throughput in vitro assays and in 
silico methods as NAMs, including databases and computational models, 
for use as alternatives to the current suite of assays in the EDSP Tier 
1 battery to accelerate the pace of screening, add efficiencies, 
decrease costs, and reduce animal testing.
    EPA has determined that the Estrogen Receptor (ER) pathway model 
based on the full 18-assay ToxCast/Tox21 battery may be used as an 
alternative to performing certain EDSP Tier 1 screening assays: ER 
binding in vitro assay (OCSPP 890.1250), ER transcriptional activation 
in vitro assay (ERTA; OCSPP 890.1300), and the in vivo Uterotrophic 
assay (rat) (OCSPP 890.1600). EPA has further determined that the 
Androgen Receptor (AR) pathway model based on the full 11-assay 
ToxCast/Tox21 battery may be used as an alternative for the AR binding 
in vitro assay (OCSPP 890.1150). The data from these NAMs will be 
evaluated on a chemical-by-chemical basis (each assay evaluated 
independently).
    The following models and assays are not yet accepted by the EDSP as 
alternatives per se for Tier 1 screening assays, but may be used for 
priority setting for EDSP Tier 1 screening or for consideration for use 
as other scientifically relevant information, where appropriate in 
weight of evidence evaluations:
    (1) ER and AR pathway models using assay subsets (also referred to 
as reduced or minimal assay data sets); (2) In Silico Qualitative 
Structure Activity Relationship Consensus Models for ER and AR (https://ntp.niehs.nih.gov/whatwestudy/niceatm/comptox/ct-opera/opera.html); 
(3) Integration of Bioactivity and Exposure (Integrated Bioactivity 
Exposure Ratio), which compares an estimated external dose threshold 
for a biological effect, based on an internal dose (i.e., plasma 
concentration) derived from bioactivity data (e.g., ER and AR pathway 
model outputs), with estimates of exposure; and, (4) The Sequence 
Alignment to Predict Across Species Susceptibility (SeqAPASS) tool for 
interspecies extrapolation.
    EPA requests the public provide comment on the clarity and 
completeness of the draft document. Given the strengths and 
uncertainties of these methods, EPA also requests the public provide 
comment on the draft conclusions that certain NAMs have been validated 
and may now be accepted by the EPA as alternatives for certain EDSP 
Tier 1 assays while others are useful for prioritization purposes and 
for consideration for use as other scientifically relevant information.
    Included in the docket for this action are two documents that 
respond to comments on related subject matter. One document responds to 
comments received in response to a notice issued in the Federal 
Register of June 19, 2015 (80 FR 35350 (FRL-9928-69), see also docket 
ID No. EPA-HQ-OPPT-2015-0305) requesting comment on EPA's document 
titled ``Endocrine Disruptor Screening Program: Use of High Throughput 
Assays and Computational Tools.'' The other document contains EPA's 
responses to comments regarding the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) Meeting from 
November 28-30, 2017 (82 FR 26097, June 6, 2017 (FRL-9962-79) and 82 FR 
36137, August 3, 2017 (FRL-9965-61), see also docket ID No. EPA-HQ-OPP-
2017-0214). EPA is including these documents in the docket for this 
action because they provide useful context on past public input on the 
EDSP which EPA considered when developing the draft White Paper. EPA is 
not requesting public comment on these response to comments documents.

III. Do guidance documents contain binding requirements?

    As guidance, the draft White Paper is not binding on the Agency or 
any outside parties, and the Agency may depart from it where 
circumstances warrant and without prior notice. While EPA has made 
every effort to ensure the accuracy of the discussion in the guidance, 
the obligations of EPA and the regulated community are determined by 
statutes, regulations, or other legally binding documents. In the event 
of a conflict between the discussion in the guidance documents and any 
statute,

[[Page 3408]]

regulation, or other legally binding document, the guidance documents 
will not be controlling.
    Authority: 21 U.S.C. 408.

    Dated: January 13, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-00940 Filed 1-18-23; 8:45 am]
BILLING CODE 6560-50-P
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