76562 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

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Pesticides; Updated Draft Guidance for 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. 

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comment on an updated draft guidance 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original draft guidance document in 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received on the original draft guidance 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updated draft guidance document, 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draft guidance document also contains a 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 This draft guidance 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: kausch.jeannine@

epa.gov. 

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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Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76563 

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/lawsregulations/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 


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