[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76562-76563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26299]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2018-0258; FRL-10015-32]
Pesticides; Updated Draft Guidance for Pesticide Registrants on
Plant Regulator Products and Claims, Including Plant Biostimulants;
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availability of and seeking public comment on an updated draft guidance
document entitled ``Guidance for Plant Regulator Products and Claims,
including Plant Biostimulants,'' which was originally issued for public
review and comment in March 2019. 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. EPA updated the original draft
guidance document in response to the public comments received on the
original draft guidance document. EPA is seeking an additional round of
public comment on this updated draft guidance document, which is
intended to provide guidance on identifying product claims that are
considered to be plant regulator claims by the Agency, thereby
subjecting the products to regulation as pesticides under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Examples are
provided of both claims that are considered plant regulator claims and
claims that are not considered plant regulator claims. This draft
guidance document also contains a narrative discussion regarding
current and previously registered plant regulator active ingredients
and their modes of action. This draft guidance does not address or
attempt to provide a regulatory definition for ``plant biostimulant''
or for ``nutritional chemical'' or to change any existing regulatory
definitions. After considering the comments received on this draft
updated guidance, EPA intends to issue a final guidance document.
DATES: Comments must be received on or before December 30, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0258, 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: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (703) 347-8920; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing the availability of and seeking public comment on
the updated draft guidance document, entitled ``Guidance for Plant
Regulator Label Claims, Including Plant Biostimulants,'' which was
originally issued for public review and comment in the Federal Register
issue of March 27, 2019 (84 FR 11538, FRL-9986-27). This document is
intended to provide guidance to EPA personnel and decisionmakers, and
to pesticide registrants. EPA invites comment from prospective guidance
users and other stakeholders concerning this updated draft guidance
document.
B. What is the Agency's authority for taking this action?
This updated draft guidance document is issued under FIFRA, 7
U.S.C. 136-136y. EPA regulations regarding pesticide registration and
exemptions from registration are contained in 40 CFR parts 150 through
189.
C. Does this action apply to me?
This action is directed to the public in general. However, this
action may be of particular interest to those persons who are producers
or registrants of pesticide products making labeling claims that are
considered to be plant regulator claims by the Agency, thereby
subjecting the products to regulation under FIFRA as pesticides. The
North American Industrial Classification System (NAICS) codes are
provided to assist you and others in determining if this action might
apply to certain entities. Potentially affected entities may include,
but are not limited to:
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS 32532), e.g., pesticide manufacturers or formulators of
pesticide products, pesticide importers or any person or company who
seeks to register a pesticide.
Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturing (NAICS 325300), e.g., establishments primarily engaged in
manufacturing agricultural chemicals, including nitrogenous and
phosphoric fertilizer materials, mixed fertilizers, and agricultural
and household pest control chemicals.
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.
D. What are the potential incremental economic impacts of taking this
action?
The Agency anticipates that this guidance will reduce uncertainty,
in both the regulated community and regulatory agencies, as to whether
specific products are or are not subject to registration as a pesticide
under FIFRA. Reducing uncertainty may reduce costs, not necessarily
monetary costs, but in the effort to bring a product to market; in some
situations, uncertainty could deter firms from developing products. To
the extent this guidance improves the understanding as to what products
must be registered and what products do not need to be registered, the
effort firms expend to determine the appropriate regulatory path is
reduced.
E. 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
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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.
II. Overview
A. Intended Purpose of the Guidance
EPA intends to provide guidance to the pesticide registrant
concerning plant regulator label claims, including plant biostimulant
claims. Plant biostimulants (PBS) are a growing category of products
containing naturally-occurring substances and microbes that are used to
stimulate plant growth by enhancing water and nutrient use efficiency,
and reducing abiotic stress. The increasing popularity of PBS arises
from their ability to enhance agricultural productivity by stimulating
natural processes in the plant and in soil using substances and
microbes already present in the environment. PBS can promote greater
water and nutrient use efficiency, but do not provide any
nutritionally-relevant fertilizer benefit to the plant. PBS products
are becoming attractive for use in sustainable agriculture production
systems and integrated pest management programs, which in turn can
reduce the use of irrigation water, as well as agrochemical supplements
and fertilizers.
One question to consider is whether a product physiologically
influences the growth and development of plants in such a way as to be
considered plant regulators by the Agency and thereby triggering
regulation under FIFRA as a pesticide. FIFRA section 2(u) defines plant
regulators as pesticides, so they are subject to federal registration
as pesticides under FIFRA, and FIFRA section 2(v) provides a definition
of a plant regulator, as well as for those substances that may be
excluded from the definition. Based on the plant regulator definition
contained in FIFRA section 2(v), many plant biostimulant products and
substances may be excluded or exempt from regulation under FIFRA
depending upon their intended uses as plant nutrients (e.g.,
fertilizers), plant inoculants, soil amendments, and vitamin-hormone
products. A key consideration is what claims are being made on product
labels. This document is intended to provide guidance on identifying
products and product claims that are considered to be plant regulator
claims by the Agency, thereby subjecting the products to regulation
under FIFRA as pesticides. Examples are provided of claims that are
considered plant regulator claims and claims that are not considered
plant regulator claims.
B. The March 2019 Draft Guidance
In recognition of the growing categories of products generally
known as plant biostimulants, EPA identified the need to provide
guidance on identifying products and product claims that are considered
to be plant regulator products and plant regulator claims by the
Agency, thereby subjecting the products to regulation as pesticides
under FIFRA. EPA discussed its approach with stakeholders, including
the Association of American Plant Food Control Officials (AAPFCO), the
Biological Products Industry Alliance (BPIA), the United States
Biostimulants Coalition (USBC), and the State FIFRA Issues Research and
Evaluation Group (SFIREG). In the Federal Register of March 27, 2019
(84 FR 11538, FRL-9986-27), EPA announced the availability of and
sought public comment on a draft guidance document that was developed
based on those discussions. The Agency extended the comment period
twice and received 161 comments, of which 18 were requests for an
extension of the comment period. The Agency has considered the public
comments received and has prepared a response to comment document that
is available in the docket under Docket ID No. EPA-HQ-OPP-2018-0258.
B. The Updated Draft Guidance
Given the diversity of public comments on the original draft
guidance document, EPA has developed responses to comments received and
updated the draft guidance accordingly. Although much of the guidance
remains the same, examples of some targeted changes involve the
incorporation of suggested edits to the product claims tables and the
replacement of Table 4 with a narrative. EPA believes that allowing for
additional public feedback will be useful in determining whether added
clarification addresses the comments received on the original draft
guidance document.
III. Do guidance documents contain binding requirements?
While the requirements in the statutes and Agency regulations are
binding on EPA and the applicants, guidance documents are not binding
on either EPA or pesticide registrants, and EPA may depart from the
guidance where circumstances warrant and without prior notice.
Likewise, pesticide registrants may assert that the guidance is not
appropriate generally or not applicable to a specific pesticide or
situation.
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.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
The updated draft guidance was determined to be significant due to
interagency equities and interests. As such, the updated draft guidance
was submitted to the Office of Management and Budget (OMB) for review
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket.
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This updated draft guidance document is not subject to the
requirements for regulatory actions specified in Executive Order 13771
(82 FR 9339, February 3, 2017).
C. Paperwork Reduction Act (PRA)
This updated draft guidance does not create paperwork burdens that
require additional approval by OMB under the PRA, 44 U.S.C. 3501 et
seq. The information collection activities associated with pesticide
registration are already approved by OMB under OMB Control No. 2070-
0060. The corresponding information collection request (ICR) document
is entitled ``Application for New and Amended Pesticide Registration''
(EPA ICR No. 0277.16). Clarifying which products are subject to
pesticide regulations is not expected to have more than a de minimis
impact on the number of products regulated annually and is not,
therefore, expected to impact the estimated burdens. In addition, since
EPA provides the language for and approves pesticide labeling, OMB has
determined that pesticide labeling requirements generally qualify for
the labeling exception.
Authority: 7 U.S.C. 136 et seq.
Dated: November 19, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2020-26299 Filed 11-27-20; 8:45 am]
BILLING CODE 6560-50-P