[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Pesticides; Draft Guidance for Pesticide Registrants on Plant 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public comment on a draft guidance document entitled ``Guidance for 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This draft guidance document is intended to clarify that products with 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

[[Page 11539]]

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