[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Pesticides; Updated Draft Guidance for Pesticide Registrants on 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availability of and seeking public comment on an updated draft guidance 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 EPA updated the original draft 
guidance document in response to the public comments received on the 
original draft guidance document.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public comment on this updated draft guidance document, which is 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 This draft 
guidance document also contains a narrative discussion regarding 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 This draft guidance does not address or 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