[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Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity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.
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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availability of and seeking public comment on a draft guidance document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This draft guidance document provides information to pesticide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 http://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