Notice2023-25140
Pesticides; White Paper Describing Benefits of Structured and Digital Content Labels for Pesticide Products; Notice of Availability and Request for Comment
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Published
November 15, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on a white paper describing the benefits of the creation, submission, review, approval, and distribution of structured content and digital pesticide labels. Structured labels are information or content that is organized in a predictable way, and digital content is those categorized fields with metadata. The current process for submitting, reviewing, and approving labels is time-consuming for both registrants and regulators. The increasing complexity of pesticide labels, inconsistent label language across products, and inconsistent placement of information on the labels often creates significant challenges for pesticide users and the public seeking information about how to use the products. Structured content and digital labels could streamline and standardize the submission, review, and access to label content, providing benefits across the spectrum of stakeholders. In addition to developing a framework for structured content and digital labels, EPA intends to identify the key information needed for the structured digital label.
Full Text
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<title>Federal Register, Volume 88 Issue 219 (Wednesday, November 15, 2023)</title>
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[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78357-78358]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25140]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0562; FRL-11546-01-OCSPP]
Pesticides; White Paper Describing Benefits of Structured and
Digital Content Labels for Pesticide Products; 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 soliciting public comment on a white paper
describing the benefits of the creation, submission, review, approval,
and distribution of structured content and digital pesticide labels.
Structured labels are information or content that is organized in a
predictable way, and digital content is those categorized fields with
metadata. The current process for submitting, reviewing, and approving
labels is time-consuming for both registrants and regulators. The
increasing complexity of pesticide labels, inconsistent label language
across products, and inconsistent placement of information on the
labels often creates significant challenges for pesticide users and the
public seeking information about how to use the products. Structured
content and digital labels could streamline and standardize the
submission, review, and access to label content, providing benefits
across the spectrum of stakeholders. In addition to developing a
framework for structured content and digital labels, EPA intends to
identify the key information needed for the structured digital label.
DATES: Submit your comments on or before March 14, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0562, through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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. Additional instructions on commenting and visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Christian Bongard, Information
Technology and Resources Management Division (7602M), Office of Program
Support, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (706) 566-2238; email
address: <a href="/cdn-cgi/l/email-protection#573538393036253379343f253e24233e36391732273679303821"><span class="__cf_email__" data-cfemail="73111c1d141201175d101b011a00071a121d331603125d141c05">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you are a
producer, registrant, or user of pesticide products. The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
<bullet> Chemical Producers (NAICS 32532), e.g., pesticide
manufacturers or formulators of pesticide products, pesticide importers
or any person or company who seeks to register a pesticide.
<bullet> Agricultural Establishments (Crop Production) (NAICS code
111).
<bullet> Nursery and Tree Production (NAICS code 111421).
<bullet> Agricultural Pest Control and Pesticide Handling on Farms
(NAICS code 115112).
<bullet> Crop Advisors (NAICS codes 115112, 541690, 541712).
<bullet> Agricultural (Animal) Pest Control (Livestock Spraying)
(NAICS code 115210).
<bullet> Forestry Pest Control (NAICS code 115310).
<bullet> Wood Preservation Pest Control (NAICS code 321114).
<bullet> Pesticide Registrants (NAICS code 325320).
<bullet> Pesticide Dealers (NAICS codes 424690, 424910, 444220).
<bullet> Research & Demonstration Pest Control, Crop Advisor (NAICS
code 541710).
<bullet> Industrial, Institutional, Structural & Health Related
Pest Control (NAICS code 561710).
<bullet> Ornamental & Turf, Rights-of-Way Pest Control (NAICS code
561730).
<bullet> Environmental Protection Program Administrators (NAICS
code 924110).
<bullet> Governmental Pest Control Programs (NAICS code 926140),
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be interested
in 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.
B. What is the Agency's authority for taking this action?
This action is being taken under the authority of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et
seq.).
C. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the document entitled ``White Paper: Benefits of the Adoption of
Structured Content and Digital Pesticide Labels'' (also referred to as
the White Paper), a copy of which is available in the docket. The White
Paper describes a framework for the creation, submission, review,
approval, and distribution of structured content and digital pesticide
labels.
[[Page 78358]]
Structured content is information or content that is organized in a
predictable way, and digital labels are typically classified with
metadata. Currently, the pesticide labels are reviewed and approved
during the registration process, which can involve time consuming
manual reviews, approval of labeling language focused on each product,
without considering consistency across products, and a non-digital
label that can increase the transaction cost to both registrants and
regulators. The increasing complexity of pesticide labels, inconsistent
label language across products, and inconsistent placement of
information on the labels, often creates significant challenges for
pesticide users and the public seeking information about how to use the
products. Structured content and digital labels could streamline and
standardize the submission, review, and access to label content,
providing benefits across the spectrum of stakeholders. In addition to
developing a framework for structured content and digital labels, EPA
intends to also identify the key information needed for the structured
digital label during the registration process.
EPA is requesting public comment on all aspects of the Structured
Label Content, including but not limited to the anticipated benefits,
risks, challenges, key fields, and proposed phases of adoption. In
addition, the Agency is seeking specific feedback on several topics
discussed in Unit II.
D. Why is the Agency taking this action?
Historically, the pesticide registration process often leads to
time consuming reviews, potential approval of inconsistent label
language, and high cost to both registrants and regulators. The
increasing complexity of pesticide labels and inconsistency across
label language and placement of information on labeling are challenges
for pesticide users and the public seeking information about how to use
the products. Structured content digital labels would streamline and
standardize the submission, review, and access to label content,
providing benefits across the spectrum of stakeholders.
E. Does this document contain binding requirements?
This document describes EPA's proposed framework for developing
structured labels and structured digital labels. The requirements in
the statutes are binding on EPA and registrants, respectively, but this
document does not impose any binding requirements on EPA or outside
parties. The strategies outlined in this document further the general
goals of the program, and EPA may depart from the strategies where
circumstances warrant and without prior notice. In general, however,
EPA will continue to offer notice and comment on proposed decisions
that implement these strategies.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the
part or all of the information that you claim to be 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. hen preparing and submitting
your comments, see the commenting tips and instructions at https://
www.epa.gov/dockets/commenting-epa-dockets.
II. Request for Comments
EPA is seeking comment on all aspects of the White Paper and is
particularly interested in public comment on the following questions
related to previous digitalization efforts referenced in the White
Paper.
1. Are there additional benefits to the adoption of structured
labeling or structured digital labeling that have not been captured? If
so, please describe.
2. Are there additional challenges associated with the adoption of
structured labeling or structured digital labeling that have not been
captured? If so, please describe.
3. Please provide feedback on the anticipated phases the Office of
Pesticide Program's work towards structured labeling and structured
digital labeling.
<bullet> Can any of anticipated phases be done concurrently?
<bullet> Is there a different order to the phases?
<bullet> Are any activities necessary in the development of
structured labels and structured digital labels not accounted for in
the anticipated phases? If so, please describe.
4. Are there additional efforts underway around development of
structured labels or structured digital labels that EPA should be aware
of? If so, please provide information for EPA's consideration.
5. Are there elements of the current ``narrative'' labels that
could not be translated into structured labeling or structured digital
labeling? If so, what are the elements and what are the barriers to
their adoption?
6. Please comment on the key fields listed in Appendix 1 in this
document.
III. Paperwork Reduction Act (PRA)
The strategies outlined in the White Paper describe information
collection activities that do not create any new 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-
0226, entitled ``Consolidated Pesticide Registration Submission
Portal'' (EPA ICR No. 2624.01).
Authority: 7 U.S.C. 136 et seq.
Dated: November 8, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-25140 Filed 11-14-23; 8:45 am]
BILLING CODE 6560-50-P
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