EPA issues white paper exploring the adoption of structured content and digital pesticide labels

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The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label. Both labels would provide the framework for the consistent placement and order of the regulated portions of pesticide label information, with the digital label organizing the contents as data. EPA asserts the adoption of these labels will streamline the submission and review processes thereby saving time and resources.

BY PATRICIA ISCARO, ESQ. | NOV 16, 2023 10:57 PM CST

Regulatory background

  • The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) governs the registration, distribution, sale, and use of pesticides in the U.S. A pesticide is any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, or any nitrogen stabilizer.
  • All pesticides sold or distributed in the U.S. must be registered by the Environmental Protection Agency (EPA) and show, based on scientific data, that they will not cause unreasonable adverse effects to human health or the environment when used as directed on product labeling.
  • FIFRA’s registration review program is intended to ensure that all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. The registration review program requires the EPA to re-evaluate registered pesticides every 15 years to ensure the product can continue to be used safely. The review of a pesticide can take as little as four years or as long as 12 years. This means that the EPA’s obligations to review registered pesticides will extend at least through 2050.
  • EPA’s Office of Pesticide Programs (OPP) has four electronic label registration programs. Introduced in 2002, the Central Database Exchange (CDX) is currently the primary way stakeholders electronically submit studies and label registration in a pdf format. However, although submissions have minimum placement requirements and must include certain elements, there is no standardized format. Submitters may arrange certain elements as they wish, which causes variability in labels resulting in extended review times. Additional redundancies in multiple iterations of label submissions, marketing claims, and additional languages also create review lag time.
  • EPA also has an online tool, Electronic Confidential Statement of Formula Application (e-CSF), which applicants can use to create and submit confidential statements of formula on CDX. The tool provides self-validation checks to ensure key fields are populated before submission.
  • Finally, the “ Office of Pesticide Program Electronic Label” (OPPEL) was a pilot program that involved the development of a standardized digital label format by nine stakeholders. The program allowed for the label to be customized for specific application instructions while other sections were structured and standardized. However, the two separate sections created duplicative work for both registrants and reviewers. Consequently, the agency is not proposing the program’s adoption.

The White Paper explores challenges with current label submission and review processes

  • The EPA’s OPP released a White Paper (paper) on November 15, 2023, asserting the benefits of adopting structured content for label submissions and digital pesticide labels. The paper reviews the current submission system and challenges, and then explains the structured and digital labels and related challenges and benefits to adoption.
  • As described above, stakeholders use the CDX to submit studies and label registration in a pdf format. However, since there is no standardized format, submitters may move certain elements to different locations. Risk-associated information such as personal protective equipment (PPE), application rates, and efficacy are presented throughout the label and can be difficult to locate, resulting in additional reviewing time.
  • The increase in the number of new registration and label updates for existing registrations, combined with a decrease in staffing levels, only makes the inefficiencies and redundancies more difficult to manage. Registration actions may involve the review of language related to the Endangered Species Act (ESA) and non-Pesticide Registration Improvement Act (PRIA) label updates. The paper asserts the current variability of pesticide labels on the market hinders states and NGOs when providing training and certification programs due to the difficulty in determining required information.

Benefits of Structured Labels and Structured Digital Labels

  • A structured label (SL) is a template for all required pesticide product label information. It allows for the consistent placement and order of this information for all registered pesticide uses. It would be used for both the registration and review processes and would be a static file.
  • The EPA explains that a structured digital label (SDL) is a digital framework that organizes the contents of labels as data (including metadata) which can be reorganized, searched, and displayed in multiple outputs according to the needs of any user, including regulators, registrants, NGOs, enforcement officials, end users, and the public.
  • SLs would require the same information currently required, such as active ingredient, product name, company name, and use sites. According to the EPA, the labels would utilize “more direct language and tables for application rates.” The required fields OPP determines to be essential have been incorporated from the Organisation for Economic Cooperation and Development’s (OECD) Report on OECD Surveys on Pesticide Product Label Data Elements to Support the Sharing of Pesticide Label Data on March of 2023. The report lists the key fields that were shared by Canada, Australia, United Kingdom, the European Food Safety Authority (EFSA), New Zealand and Germany.
  • The paper elaborates on the benefits of SLs for regulators, users, the regulated community, and the public. It lists label accuracy, quality, review efficiency, and consistency as some of the benefits. Reviewers would have a consistent format to review which would save time when checking for compliance with the required sections and language. SLs could also be prepopulated with consistent label language and marketing claims for a particular ingredient. Additionally, a comparison tool would allow reviewers to electronically compare previous submissions to updates. This would allow both federal and state regulators to compare only changes to substantive content.
  • Finally, the paper contends that a SL would facilitate harmonization across multiple markets within the U.S. and internationally. Regulators in different jurisdictions could share standards and guidelines, saving time and resources. Standardized vocabulary would also enable label translation in international markets.
  • SDLs could contain self-certified fields such as contact numbers, incident reporting information, links, QR codes, and language translations which could be reviewed and approved without requiring a manual review. Suggested language would also be included which, once chosen, would not require additional review. An example is the suggested label language for the ESA Workplan Update for ESA mitigation. Standardized pre-approved statements would improve consistency and review time. The EPA anticipates that standardized structure and vocabulary would reduce the registration of labels with unclear or unenforceable language.
  • The authors of the paper contend that digitized labels would allow the OPP to build a registration database that could be used to check new registration decisions, ensure mitigation measures, and marketing claims. Notifications of required label updates could be automatically emailed to registrants which would save time and result in increased worker protection. In addition, notifications could also be used to address human or environmental risk mitigations.
  • The paper refers to EPA’s online database for active pesticide product registration information ( APPRIL) as a tool that could be utilized to validate digital labels, resulting in more rapid compliance for labels required for production, transport, and sale of pesticides. Additionally, EPA’s Pesticide Product and Label System ( PPLS) provides a searchable collection of pesticide product labels accepted by the EPA. EPA also hosts another website that allows users to search by need for various insect repellents. If the EPA adopted SDL, these sites could be replaced or expanded to allow users to search for products by numerous key fields and associated metadata. The new tool could be used by the public and could be augmented by additional guidance on product efficacy, and resistance management by agricultural extension programs or NGOs.
  • Safety and stewardship elements of structured digital labels are also discussed as benefits to reduce misuse and incidents. Third parties would be able to interface with the SDLs with the applications (apps) to access and download label information when the user is on-site in the field. SDLs would also be able to embed spatial data which would allow buffers around listed species or sensitive habitats to be programmed. This label information could be incorporated into GPS-enabled spraying equipment, which would minimize the chance of harm to these species or areas.

Transitions and next steps

  • The paper provides that the adoption of a SDL could promote the development and adoption of emerging agricultural technology which could potentially reduce overall pesticide application tonnage, resulting in increased effectiveness and protection of ecologically sensitive areas. EPA’s Pesticide Program Dialogue Committee provides recommendations for actions the agency should take concerning these emerging technologies.
  • Since one of the challenges to the conversion to the SL and SDL is the transition of existing labels from the current format to the structured one, EPA states that a tool to translate and add this information to the system is needed. The EPA has looked at using artificial intelligence (AI) to expedite this process, but “is not confident” current AI tools are reliable enough at this time.
  • Regulators in other jurisdictions are dealing with similar issues, and EPA has reached out to various stakeholders and international groups to coordinate efforts and harmonize labels.
  • Requiring mandatory submission of SDLs would require OPP to revise regulations through rulemaking, which the agency does not foresee in the near future. Although CDX digital submissions are not mandatory, CDX is the only way labels have been submitted since 2020. EPA expects that stakeholders will recognize the benefits of SDLs over unstructured labels and that this will ultimately drive adoption.
  • The paper sets out proposed phases of adoption of SLs and SDLs. EPA is seeking feedback on all aspects of the paper as well as the proposed phases. Appendix 1 contains the proposed required fields for a Use Rate Summary Table and anticipated fields for the SDL. Stakeholders may submit comments on or before March 14, 2024.

To contact the author of this analysis, please email Patricia Iscaro.

To contact the editor of this analysis, please email Scott Stephens.

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