Public Participation Process for Registration Actions
Legally Required Public Participation Process
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA) require EPA to engage the public at specific times during the registration process, including when:
- EPA receives an application for registration of a new pesticide active ingredient or one that would entail a changed use pattern (FIFRA section 3(c)(4));
- EPA is establishing, modifying, suspending, or revoking a tolerance or exemption from the requirement of a tolerance on the Administrator’s own initiative (FFDCA section 408(e));
- EPA is establishing a tolerance at a level different from a maximum residue level for the same pesticide chemical established by the Codex Alimentarius Commission (FFDCA section 408(b)(4)); and
- EPA is issuing a notice of intent to cancel under FIFRA section 6(b) or a notice of request for voluntary cancellation under section 6(f).
In each scenario, the Agency opens a public docket, which is announced in the Federal Register. The Agency publishes a Notice of Receipt and, where applicable, a Notice of Filing (when an application and/or tolerance petition has been received) for each action, initiating a separate 30-day comment period for each. Each Notice of Receipt includes information, such as the EPA file symbol, applicant name and address, product name, product type, active ingredient name and concentration, proposed classification/use, and target pests. Each Notice of Filing includes the petition number, applicant name and address, active ingredient name, product type, and proposed tolerances. These are the mandatory comment periods.
Additional Public Participation Process
While not mandated by law, to enhance transparency, EPA offers additional opportunities for public engagement beyond those initial, mandatory comment periods required by FIFRA and FFDCA. This means that for some actions, there will be multiple opportunities for the public to provide comment. Both EPA and the public benefit from this practice because public input helps inform risk assessment and risk management. Such input improves understanding of risks and benefits, contributes to meaningful protective measures, and expands the public dialogue on pesticide registration decisions. This added opportunity for public input does not affect the statutory opportunities for public engagement in regulatory decision-making.
Depending on the circumstances, EPA offers either a 30-day or 15-day comment period for these actions. The shorter, 15-day, period may be applied to regulatory actions that involve low- or reduced-risk actions. The 15-day comment period also may be appropriate where a previous comment period on a related or similar regulatory action did not yield substantive comments. This creates more flexibility for achieving timely regulatory decisions while maintaining EPA’s robust public engagement for regulatory actions.
EPA uses the process outlined below for applications for new or amended registrations that involve:
- new active ingredients,
- first food use,
- first outdoor use,
- first residential use or
- other actions of significant interest.
The additional public participation process for registration actions for new active ingredients, first food use, first outdoor use, first residential use and other actions of significant interest includes the following steps:
- Once risk assessments are completed and a proposed decision is drafted, the Agency adds documents to the public docket and announces on the website that they are available for comment (this is in addition to the mandatory comment period required by law). See current open comment listings.
- For actions related to biopesticide active ingredients, EPA offers a 15-day comment period, unless the Agency determines that a 30-day comment period is appropriate. For most conventional pesticides, EPA announces a 30-day comment period. However, the Agency may offer a 15-day comment period (which can be extended upon request) for actions when one or more of the following conditions are met:
- The active ingredient is generally low risk, with no substantial risk mitigation being proposed.
- The application has been granted reduced risk status or fits the profile for reduced risk.
- The active ingredient is proposed to be registered for IR-4-supported minor uses.
- The active ingredient or similar active ingredients have a history of not receiving substantive comments during other comment periods.
- After the comment period closes, EPA analyzes and responds to substantive comments and revises assessments and related decision documents, as needed.
- The Agency reaches a final decision on the registration and makes supporting documents available in the public docket.
- EPA posts approved labels on its searchable web-based data base, the Pesticide Product and Label System (PPLS).
- If a petition for a tolerance or tolerance exemption is associated with the application, the Agency will promulgate a final rule as appropriate.
Confidential Business Information (CBI) Concerns
EPA reviews all documents for CBI before posting to the public docket. The 2007 revision of 40 CFR 158.33 requires all information submitted under part 158 (Data Requirements for Pesticides) to be clearly marked as confidential or be subject to public disclosure. For any information in the risk assessment or final decision that is not submitted under part 158 and for which there is no indication whether the applicant claims the information as CBI, EPA will send a letter or email to the registrant requesting a written response that clarifies what is being claimed as CBI. If the information was filed under part 158 but not claimed as CBI, then the information may be included in the risk assessment or decision document without further consultation with the applicant.