Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis; Notice of Availability and Request for Comment, 63548-63549 [2020-22325]

Download as PDF 63548 Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices Dated: October 2, 2020. Kimberly D. Bose, Secretary. [FR Doc. 2020–22296 Filed 10–7–20; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98–1–000] Records Governing Off-the-Record Communications; Public Notice This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications. Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication. Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable Docket No. File date Prohibited: NONE. Exempt: CP16–9–000 ........................................................................ Dated: October 2, 2020. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2020–22329 Filed 10–7–20; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2016–0093; FRL–10015–11] Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis; Notice of Availability and Request for Comment Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) is announcing the availability of and seeking public comment on a draft 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:48 Oct 07, 2020 Jkt 253001 10–2–2020 proceeding in accordance with Rule 2010, 18 CFR 385.2010. Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v). The following is a list of off-therecord communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission’s website at https:// www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ ferc.gov or toll free at (866) 208–3676, or for TTY, contact (202) 502–8659. Presenter or requester U.S. Representative Stephen F. Lynch. 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 draft guidance document provides information to pesticide registrants concerning the Agency’s consideration to expand the potential for data waivers for acute dermal studies to single technical active ingredients (technical AIs) used to formulate end use products. The reasoning and analysis in this dermal waiver guidance for technical active ingredients is similar to what was presented in the 2016 guidance for enduse products. While more acute toxicity studies are submitted to OPP annually for formulated pesticide products than for technical AIS, there is still the potential for animal and resource savings from waivers for acute toxicity studies. 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. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. 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. Comments must be received on or before November 9, 2020. SUPPLEMENTARY INFORMATION: DATES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2016–0093, though the Federal eRulemaking Portal at https://www.regulations.gov. Follow ADDRESSES: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 I. General Information A. 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 E:\FR\FM\08OCN1.SGM 08OCN1 Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices 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. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as 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. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/ commenting-epa-dockets. C. How can I get copies of this document and other related information? A copy of the draft guidance document is available in the docket under docket ID number EPA–HQ– OPP–2016–0093. III. Do guidance documents contain binding requirements? khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:48 Oct 07, 2020 Jkt 253001 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. This draft guidance document will expand 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 would allow EPA to harmonize with the PMRA. 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 would not be controlling. Authority: 7 U.S.C. 136 et seq. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 63549 Dated: October 2, 2020. Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2020–22325 Filed 10–7–20; 8:45 am] BILLING CODE 6560–50–P FARM CREDIT ADMINISTRATION Privacy Act of 1974; System of Records Farm Credit Administration. Notice of a modified system of AGENCY: ACTION: records. Pursuant to the provisions of the Privacy Act of 1974, notice is hereby given that the Farm Credit Administration (FCA or Agency) is amending an existing system of records, FCA–7—Inspector General Investigative Files—FCA. DATES: You may send written comments on or before November 9, 2020. FCA filed an amended System Report with Congress and the Office of Management and Budget on July 20, 2020. This notice will become effective without further publication on November 18, 2020 unless modified by a subsequent notice to incorporate comments received from the public. ADDRESSES: We offer a variety of methods for you to submit your comments. For accuracy and efficiency, commenters are encouraged to submit comments by email or through the FCA’s website. As facsimiles (fax) are difficult for us to process and achieve compliance with section 508 of the Rehabilitation Act, we are no longer accepting comments submitted by fax. Regardless of the method you use, please do not submit your comment multiple times via different methods. You may submit comments by any of the following methods: • Email: Send us an email at regcomm@fca.gov. • FCA website: https://www.fca.gov. Click inside the ‘‘I want to . . .’’ field, near the top of the page; select ‘‘comment on a pending regulation’’ from the dropdown menu; and click ‘‘Go.’’ This takes you to an electronic public comment form. • Mail: David Grahn, Director, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA 22102–5090. You may review copies of comments we receive at our office in McLean, Virginia, or from our website at https:// www.fca.gov. Once you are in the website, click inside the ‘‘I want to . . .’’ field, near the top of the page; select ‘‘find comments on a pending SUMMARY: E:\FR\FM\08OCN1.SGM 08OCN1

Agencies

[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63548-63549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22325]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0093; FRL-10015-11]


Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity 
Tests for Pesticide Technical Chemicals and Supporting Retrospective 
Analysis; 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 seeking public comment on a draft 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 draft guidance document provides information to pesticide 
registrants concerning the Agency's consideration to expand the 
potential for data waivers for acute dermal studies to single technical 
active ingredients (technical AIs) used to formulate end use products. 
The reasoning and analysis in this dermal waiver guidance for technical 
active ingredients 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 AIS, there is still the potential for animal and resource 
savings from waivers for acute toxicity studies.

DATES: Comments must be received on or before November 9, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2016-0093, though 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

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. General Information

A. 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

[[Page 63549]]

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.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as 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. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

C. How can I get copies of this document and other related information?

    A copy of the draft guidance document is available in the docket 
under docket ID number EPA-HQ-OPP-2016-0093.

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.
    This draft guidance document will expand 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 would 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 would not be controlling.

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

    Dated: October 2, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2020-22325 Filed 10-7-20; 8:45 am]
BILLING CODE 6560-50-P
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