[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Notices]
[Pages 11538-11540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05879]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2018-0258; FRL-9986-27]
RIN 2070-ZA21
Pesticides; Draft Guidance for Pesticide Registrants on Plant
Regulator Label Claims, Including Plant Biostimulants; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft guidance document entitled ``Guidance for
Plant Regulator Label Claims, Including Plant Biostimulants.'' 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This draft guidance document is intended to clarify that products with
label claims that are considered to be plant regulator claims are
subject to regulation as a pesticide.
DATES: Comments must be received on or before May 28, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0258, by one of the following methods:
Federal eRulemaking Portal: 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.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For general information contact: Prasad Chumble, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
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Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-8367;
email address: [email protected].
For technical information contact: Russell Jones, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (703) 308-5071; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA has developed a draft guidance document, entitled ``Guidance
for Plant Regulator Label Claims, Including Plant Biostimulants.'' 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 draft
guidance document.
B. What is the Agency's authority for taking this action?
This draft guidance document is issued under the Federal
Insecticide, Fungicide, and Rodenticide Act (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. EPA also
provides related non-binding guidance on its website at https://www.epa.gov/pesticides.
C. Does this action apply to me?
This draft guidance may be of particular interest to those who are
producers of 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.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. 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 may reduce confusion, 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 of bringing a
product to market; in some situations, uncertainty could deter firms
from developing products. To the extent this guidance clarifies what
products must be registered and what products do not need to be
registered, it will reduce the effort firms expend to determine the
appropriate regulatory path. However, these impacts are likely to be
small and intangible.
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 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 http://www.epa.gov/dockets/comments.html.
II. Overview
This draft guidance document provides guidance about plant
regulator label claims, including plant biostimulant claims. Plant
biostimulants (PBS) are a relatively new, but growing, category of
products containing naturally-occurring substances and microbes that
are used to stimulate plant growth, enhance resistance to plant pests,
and reduce 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
increasingly attractive for use in sustainable agriculture production
systems and integrated pest management (IPM) programs, which in turn
can reduce the use of irrigation water, as well as agrochemical
supplements and fertilizers.
Statutory definitions for PBS currently do not exist in the United
States or overseas and there is no applicable regulatory definition of
PBS under FIFRA. The draft guidance does not address or attempt to
provide a regulatory definition for ``plant biostimulant.'' The Agency
is seeking comment on this draft guidance. The Agency is also seeking
comment on whether EPA should develop a definition for plant
biostimulants, noting that the development of such a definition would
require rulemaking.
In developing the draft guidance, EPA considered whether a PBS
product, as understood by EPA, 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) includes plant regulators,
defoliants, desiccants, and nitrogen stabilizers in its definition of a
pesticide, so they are subject to federal registration as pesticides
under FIFRA. In addition, FIFRA section 2(v) both defines plant
regulator and explains which substances are excluded from the
definition. Based on the plant regulator definition contained in FIFRA
section 2(v), many PBS 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. Other PBS products will not
involve EPA oversight because they do not fit within the specific FIFRA
definition of how a plant regulator functions. A key consideration is
what claims are being made on product labels. This draft document is
intended to provide guidance on identifying product label claims that
are
[[Page 11540]]
considered to be plant regulator claims by the Agency, thereby
subjecting the products to regulation under FIFRA as pesticides.
Examples are provided of both claims that are considered plant
regulator claims and claims that are not considered plant regulator
claims.
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 draft 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 draft guidance document and
any statute, regulation, or other legally binding document, the draft
guidance document would not be controlling.
III. 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 Office of Management and Budget's (OMB) has determined that
this draft guidance document qualifies as a significant guidance
document under OMB's Final Bulletin for Agency Good Guidance Practices
(https://www.gpo.gov/fdsys/pkg/FR-2007-01-25/pdf/E7-1066.pdf). As such,
the draft document was submitted to OMB for review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes to the document made in response to OMB
recommendations have been documented in the docket for this action as
required by section 6(a)(3)(E) of Executive Order 12866.
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action 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 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.
Authority: 7 U.S.C. 136 et seq.
Dated: March 21, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2019-05879 Filed 3-26-19; 8:45 am]
BILLING CODE 6560-50-P