Pesticides; Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis; Notice of Availability, 14625-14626 [2021-05535]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Notices Submit your comments to Docket ID No. EPA–HQ–ORD–2015–0611 by one of the following methods: • www.regulations.gov: Follow the online instructions for submitting comments. D Note: comments submitted to the www.regulations.gov website are anonymous unless identifying information is included in the body of the comment. • Email: Send comments by electronic mail (email) to: ORD.Docket@ epa.gov, Attention Docket ID No. EPA– HQ–ORD–2015–0611. D Note: comments submitted via email are not anonymous. The sender’s email will be included in the body of the comment and placed in the public docket which is made available on the internet. Instructions: All comments received, including any personal information provided, will be included in the public docket without change and may be made available online at www.regulations.gov. Information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute will not be included in the public docket, and should not be submitted through www.regulations.gov or email. For additional information about the EPA’s public docket visit the EPA Docket Center homepage at https:// www.epa.gov/dockets/. Public Docket: Publicly available docket materials may be accessed Online at www.regulations.gov. Copyrighted materials in the docket are only available via hard copy. The telephone number for the ORD Docket Center is (202) 566–1752. FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO), Tom Tracy, via phone/voicemail at: (202) 564–6518; or via email at: tracy.tom@ epa.gov. Any member of the public interested in receiving a draft agenda, attending the meeting, or making a presentation at the meeting should contact Tom Tracy no later than March 29, 2021. SUPPLEMENTARY INFORMATION: The Board of Scientific Counselors (BOSC) is a federal advisory committee that provides advice and recommendations to EPA’s Office of Research and Development on technical and management issues of its research programs. The meeting agenda and materials will be posted to https:// www.epa.gov/bosc. Proposed agenda items for the meeting include, but are not limited to, the following: Contaminated sites, including mine waste, solvent vapor VerDate Sep<11>2014 17:47 Mar 16, 2021 Jkt 253001 intrusion, underground storage tanks, and lead. Information on Services Available: For information on translation services, access, or services for individuals with disabilities, please contact Tom Tracy at (202) 564–6518 or tracy.tom@epa.gov. To request accommodation of a disability, please contact Tom Tracy at least ten days prior to the meeting to give the EPA adequate time to process your request. Authority: Pub. L. 92–463, 1, Oct. 6, 1972, 86 Stat. 770. Mary Ross, Director, Office of Science Advisor, Policy and Engagement. [FR Doc. 2021–05516 Filed 3–16–21; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2016–0093; FRL–10017–83] Pesticides; Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis; Notice of Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) is announcing the availability of the final guidance document entitled ‘‘Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis.’’ Guidance documents are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This final guidance document provides information to pesticide registrants concerning the Agency’s decision to expand the potential for data waivers for acute dermal studies to single technical active ingredients (technical AIs) used to formulate end use products. FOR FURTHER INFORMATION CONTACT: Tara Flint, Antimicrobial Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (703) 347–0398; email address: flint.tara@ epa.gov. SUMMARY: SUPPLEMENTARY INFORMATION: Frm 00055 Fmt 4703 I. Does this action apply to me? This action is directed to the public in general. Although this action may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also 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 regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. What action is the Agency taking? BILLING CODE 6560–50–P PO 00000 14625 Sfmt 4703 A. Authority This guidance is provided under the authority of FIFRA (7 U.S.C. 136 et seq.) and addresses the utility of the acute dermal toxicity study for single technical chemicals in pesticide labelling, such as the signal word and precautionary statements as described in 40 CFR 156.64 and 40 CFR 156.70. B. Background EPA’s OPP regularly receives acute lethality studies for oral, dermal and inhalation routes along with eye irritation, skin irritation, and skin sensitization—these data are required for both the registration of new and reregistration of existing pesticidal products. In 2016, OPP published the ‘‘Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis’’ to support the Agency’s goal to reduce unnecessary animal testing. The retrospective analysis supports the conclusion that the dermal acute toxicity study for formulations provides little to no added value in regulatory decision making. In 2017 Canada’s Pest Management Regulatory Agency (PMRA) released their Acute Dermal Toxicity Waiver. This policy includes both end use products and technical active ingredients. Stakeholders have requested that EPA expand its waiver guidance for technical active ingredients to support North American harmonization. In 2019 EPA Administrator Wheeler directed Agency leadership to prioritize animal testing reduction efforts. In 2020, the Agency published the draft guidance for public comment on October 8, 2020 (85 FR 63548), and received supportive comments from stakeholders. Therefore, the Agency is E:\FR\FM\17MRN1.SGM 17MRN1 14626 Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Notices finalizing the draft guidance as proposed. This final guidance document expands the potential for data waivers for acute dermal studies to single active ingredient technical chemicals (technical chemicals) used to formulate end use products. The reasoning and analysis in this dermal waiver guidance for technical chemicals is similar to what was presented in the 2016 guidance for end-use products. While more acute toxicity studies are submitted to OPP annually for formulated pesticide products than for technical chemicals, there is still the potential for animal and resource savings from waivers for technical chemical acute toxicity studies. Further, this guidance will allow EPA to harmonize with the PMRA. III. Do guidance documents contain binding requirements? As guidance, this document 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 document and any statute, regulation, or other legally binding document, the guidance document will not be controlling. IV. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. This unit addresses those requirements that apply to a guidance document. jbell on DSKJLSW7X2PROD with NOTICES A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review The Office of Management and Budget (OMB) determined that this is not a significant regulatory action under Executive Order 12866 (58 FR 51735, October 4, 1993). The guidance was not, therefore, submitted to OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). B. Paperwork Reduction Act (PRA) This guidance document does not create any new information collection burden that require additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR VerDate Sep<11>2014 17:47 Mar 16, 2021 Jkt 253001 1320.3(b). The information collection activities associated with pesticide registration are already approved by OMB under OMB Control No. 2070– 0060. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in Title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR, part 9, and included on the related collection instrument, or form, as applicable. Authority: 7 U.S.C. 136 et seq. Dated: March 10, 2021. Michal Freedhoff, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2021–05535 Filed 3–16–21; 8:45 am] BILLING CODE 6560–50–P EXPORT-IMPORT BANK Sunshine Act Meetings; Notice of Open Meeting of the Advisory Committee of the Export-Import Bank of the United States (EXIM) Tuesday, March 30, 2021 from 2:00–4:00 p.m. EDT. TIME AND DATE: The meeting will be held virtually. PLACE: Public Participation: The meeting will be open to public participation and time will be allotted for questions or comments submitted online. Members of the public may also file written statements before or after the meeting to external@exim.gov. Interested parties may register for the meeting at https:// register.gotowebinar.com/register/ 4784313056171425035. STATUS: Discussion of EXIM policies and programs to provide competitive financing to expand United States exports and comments for inclusion in EXIM’s Report to the U.S. Congress on Global Export Credit Competition. MATTERS TO BE CONSIDERED: CONTACT PERSON FOR MORE INFORMATION: For further information, contact Lee Stewart, Director of External Engagement, at 202–565–3773. Joyce B. Stone, Assistant Corporate Secretary. [FR Doc. 2021–05631 Filed 3–15–21; 4:15 pm] BILLING CODE 6690–01–P PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 FEDERAL COMMUNICATIONS COMMISSION [FRS 17569] Privacy Act of 1974; System of Records Federal Communications Commission. ACTION: Rescindment of two systems of records notices. AGENCY: The Federal Communications Commission (FCC) proposes to rescind two systems of records, FCC/OMD–20, Inter-office and Internet Email Systems, and FCC/OMD–22, Equipment Loan Records. The systems contained information concerning the names, email addresses, passwords, and badge numbers of FCC employees and contractors, as well as loaned electronic equipment, e.g., laptops, pagers, cellular telephones, and RSA Secure Tokens by the FCC to employees. DATES: This action will become effective on April 16, 2021. ADDRESSES: Send comments to the Privacy Team, Federal Communications Commission, 45 L Street NE, Washington, DC 20554, or Privacy@ fcc.gov. SUMMARY: FOR FURTHER INFORMATION CONTACT: Margaret Drake, Privacy Team, Federal Communications Commission, 45 L Street NE, Washington, DC 20554, 202– 418–1707, or Privacy@fcc.gov. SUPPLEMENTARY INFORMATION: The Privacy Act provides that an agency may only collect or maintain in its records information about individuals that is relevant and necessary to accomplish a purpose that is required by a statute or executive order. If a system of records is comprised of records that no longer meet this standard, the Privacy Act may require agencies to stop maintaining the system and expunge the records in accordance with the requirements in the SORN and the applicable records retention or disposition schedule approved by the National Archives and Records Administration. The System manager has deemed these systems obsolete and has declared that the records are no longer relevant to accomplish an agency mission/purpose identified. The categories of records in this system are no longer collectively maintained in a system of records. Therefore, consistent with the Privacy Act of 1974 (5 U.S.C. 552a) and the Office of Management and Budget (OMB) Circular No. A.108, the FCC proposes to rescind these two systems. E:\FR\FM\17MRN1.SGM 17MRN1

Agencies

[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Notices]
[Pages 14625-14626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05535]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0093; FRL-10017-83]


Pesticides; Final Guidance for Waiving Acute Dermal Toxicity 
Tests for Pesticide Technical Chemicals and Supporting Retrospective 
Analysis; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final guidance document entitled ``Guidance for 
Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & 
Supporting Retrospective Analysis.'' Guidance documents are issued by 
the Office of Pesticide Programs (OPP) to inform pesticide registrants 
and other interested persons about important policies, procedures, and 
registration related decisions, and serve to provide guidance to 
pesticide registrants and OPP personnel. This final guidance document 
provides information to pesticide registrants concerning the Agency's 
decision to expand the potential for data waivers for acute dermal 
studies to single technical active ingredients (technical AIs) used to 
formulate end use products.

FOR FURTHER INFORMATION CONTACT: Tara Flint, Antimicrobial Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 347-0398; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who are or may be 
required to conduct testing of chemical substances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also 
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 regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

II. What action is the Agency taking?

A. Authority

    This guidance is provided under the authority of FIFRA (7 U.S.C. 
136 et seq.) and addresses the utility of the acute dermal toxicity 
study for single technical chemicals in pesticide labelling, such as 
the signal word and precautionary statements as described in 40 CFR 
156.64 and 40 CFR 156.70.

B. Background

    EPA's OPP regularly receives acute lethality studies for oral, 
dermal and inhalation routes along with eye irritation, skin 
irritation, and skin sensitization--these data are required for both 
the registration of new and reregistration of existing pesticidal 
products.
    In 2016, OPP published the ``Guidance for Waiving Acute Dermal 
Toxicity Tests for Pesticide Formulations & Supporting Retrospective 
Analysis'' to support the Agency's goal to reduce unnecessary animal 
testing. The retrospective analysis supports the conclusion that the 
dermal acute toxicity study for formulations provides little to no 
added value in regulatory decision making.
    In 2017 Canada's Pest Management Regulatory Agency (PMRA) released 
their Acute Dermal Toxicity Waiver. This policy includes both end use 
products and technical active ingredients. Stakeholders have requested 
that EPA expand its waiver guidance for technical active ingredients to 
support North American harmonization.
    In 2019 EPA Administrator Wheeler directed Agency leadership to 
prioritize animal testing reduction efforts.
    In 2020, the Agency published the draft guidance for public comment 
on October 8, 2020 (85 FR 63548), and received supportive comments from 
stakeholders. Therefore, the Agency is

[[Page 14626]]

finalizing the draft guidance as proposed.
    This final guidance document expands the potential for data waivers 
for acute dermal studies to single active ingredient technical 
chemicals (technical chemicals) used to formulate end use products. The 
reasoning and analysis in this dermal waiver guidance for technical 
chemicals is similar to what was presented in the 2016 guidance for 
end-use products. While more acute toxicity studies are submitted to 
OPP annually for formulated pesticide products than for technical 
chemicals, there is still the potential for animal and resource savings 
from waivers for technical chemical acute toxicity studies. Further, 
this guidance will allow EPA to harmonize with the PMRA.

III. Do guidance documents contain binding requirements?

    As guidance, this document 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 document and any 
statute, regulation, or other legally binding document, the guidance 
document will not be controlling.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders. This unit addresses those requirements that apply to 
a guidance document.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) determined that this is 
not a significant regulatory action under Executive Order 12866 (58 FR 
51735, October 4, 1993). The guidance was not, therefore, submitted to 
OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, 
January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This guidance document does not create any new information 
collection burden that require additional approval by OMB under the 
PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). The 
information collection activities associated with pesticide 
registration are already approved by OMB under OMB Control No. 2070-
0060.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in Title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR, part 9, and included on the related 
collection instrument, or form, as applicable.

    Authority: 7 U.S.C. 136 et seq.

    Dated: March 10, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-05535 Filed 3-16-21; 8:45 am]
BILLING CODE 6560-50-P
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