Public Participation Process for Registration Actions
March 31, 2010
Federal pesticide law only requires limited public participation in the pesticide registration process. In response to President Obama’s directive on transparency and open government, EPA’s Pesticide Program explored opportunities for expanding the openness of the process, and accordingly in October of 2009 began implementing a public participation process for certain registration actions.
By establishing this process, the Agency has increased opportunities for the public to comment on risk assessments and proposed registration actions. Both EPA and the public will benefit from a public participation process because the public will help to inform the risk assessment and risk management processes associated with registration. Such input can aid in understanding potential risks and benefits, contribute to meaningful protective measures, and improve the public dialogue on pesticide registration decisions.
Public Participation Process
The public participation process for registration actions provides a meaningful opportunity for the public to comment on major registration decisions at a point in the registration process when comprehensive information and analysis are available. The Agency intends to use the outlined public participation process for the following types of applications:
- new active ingredients;
- first food use;
- first outdoor use;
- first residential use; and
- other actions of significant interest.
The new process was announced on October 1, 2009. The public participation process for registration consists of the steps identified below.
- Publish in the Federal Register a Notice of Receipt and, where applicable, a Notice of Filing when an application and/or tolerance petition is received. Basic information will be presented, 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.
This notice will open a public docket for the active ingredient, provide an initial 30-day comment period, and state that the public will be provided another 30-day comment period when the risk assessments and proposed decision have been completed and added to the docket. The start of this initial 30-day comment period will be announced on the Agency's Web site (http://iaspub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:30) in addition to the Federal Register.
- Once risk assessments are completed and a proposed decision is drafted, the documents will be added to the public docket (http://www.regulations.gov) with a notice on the Web site that they are available for a second 30-day comment period. For actions related to biopesticide active ingredients, the comment period may be reduced or conducted concurrently with registration, except in cases where the EPA determines that a 30-day comment period is appropriate.
- After the comment period closes, analyze the comments received, prepare a response-to-comment document and revise assessments and related decision documents, as needed.
- Make a final decision on the registration. Supporting documents will be placed in the public docket.
- Publish a Notice of Issuance in the Federal Register for the final decision.
- If a petition for a tolerance or tolerance exemption is associated with the application, a final rule will be promulgated as appropriate.
As this new process evolves, it is possible that some circumstances will require a departure from the typical process, but the Agency expects that any revisions to the process will result in improvements while continuing to allow for meaningful stakeholder involvement.
Confidential Business Information Concerns
Historically, much of the information submitted with pesticide applications was either claimed as Confidential Business Information (CBI), or its confidentiality status was unclear. The 2007 revision of 40 CFR 158.33 required 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, the risk manager will send a letter or e-mail 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. The documents are reviewed for CBI before posting to the public docket.