2023-25140. 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.

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 https://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. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

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: [e-mail].

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:

• 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.

• Agricultural Establishments (Crop Production) (NAICS code 111).
• Nursery and Tree Production (NAICS code 111421).
• Agricultural Pest Control and Pesticide Handling on Farms (NAICS code 115112).
• Crop Advisors (NAICS codes 115112, 541690, 541712).
• Agricultural (Animal) Pest Control (Livestock Spraying) (NAICS code 115210).
• Forestry Pest Control (NAICS code 115310).
• Wood Preservation Pest Control (NAICS code 321114).
• Pesticide Registrants (NAICS code 325320).
• Pesticide Dealers (NAICS codes 424690, 424910, 444220).
• Research & Demonstration Pest Control, Crop Advisor (NAICS code 541710).
• Industrial, Institutional, Structural & Health Related Pest Control (NAICS code 561710).
• Ornamental & Turf, Rights-of-Way Pest Control (NAICS code 561730).
• Environmental Protection Program Administrators (NAICS code 924110).
• 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. 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 https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/​dockets/​commenting-epa-dockets#rules 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.

• Can any of anticipated phases be done concurrently?
• Is there a different order to the phases?
• 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.