Document ID: EPA-HQ-OPP-2016-0093-0182
Agency: epa
Document Type: Notice
Title: Guidance: Pesticides; Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis
Posted Date: 2021-03-17T04:00Z

[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.

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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: flint.tara@epa.gov.

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]
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