Registration Review Process
Current as of December 2012
While each pesticide review is unique, all pesticides go through the following basic registration review process. This process is also discussed in the Registration Review Rule. See Schedule for Beginning Reviews - 2012 to 2015 for information on the planned schedule for opening registration review cases over the next four years.
Note that whenever EPA determines there are urgent human and environmental risks from pesticide exposures that require prompt attention, the Agency will take appropriate regulatory action, regardless of the registration review status of that pesticide.
- Focus Meetings
- Docket Opening
To enhance transparency and involvement, EPA has instituted Focus Meetings for many pesticides going through registration review. Typically involving registrants and others, Focus Meetings are intended to address areas of uncertainty such as unclear labels or missing studies that could affect EPA’s pesticide risk assessments and risk management decisions. By obtaining better information early in the process, EPA can narrow the scope of pesticide reevaluations to areas that pose real concerns, based on current data and use patterns.
To ensure transparency, materials associated with Focus Meetings are available in the pesticide-specific registration review dockets. For circumstances in which a Focus Meeting is held prior to the opening of a chemical-specific docket, materials are available in a special Focus Meetings docket, EPA-HQ-OPP-2012-0778 at www.regulations.gov.More information on Focus Meetings.
EPA initiates a registration review by establishing a docket for a pesticide registration review case and opening the docket for public review and comment. The Agency publishes a Federal Register notice that announces the availability of the docket and provides a comment period of at least 60 days. Anyone may submit data or information in response. EPA will consider information received during the comment period in conducting a pesticide's registration review.
Each docket contains a Summary Document that explains what information EPA has on the pesticide and the anticipated path forward. The Summary Document includes:
- A Preliminary Work Plan highlighting anticipated risk assessment and data needs, providing an anticipated timeline for completing the pesticide's review, and identifying the types of information that would be especially useful to the Agency in conducting the review;
- A fact sheet providing general background information and summarizing the current status of the pesticide;
- Ecological risk assessment problem formulation and human health scoping sections describing the data and scientific analyses expected to be necessary to complete the pesticide's registration review.
The Summary Document explains what EPA's Office of Pesticide Programs knows about the pesticide and our thought process for determining the anticipated data and assessment needs. By sharing this information in the docket, EPA anticipates that the public will be better able to see what types of new or available data or other information would be helpful as the Agency moves toward a decision.
EPA also will announce when pesticides are no longer subject to registration review because they do not have active federal pesticide product registrations.
The registration review docket for each case will remain publicly accessible throughout the registration review process; that is, until all actions required in the final decision on a case have been completed.
Information on registration review dockets that have opened is available in Chemical Search.
In conducting a pesticide's registration review, EPA will review the data and information that it believes should be considered in the review. The Agency will then:
- Assess changes since the pesticide's last review - EPA will assess any changes that have occurred since the Agency's last registration decision, to determine the significance of those changes and whether the pesticide still satisfies the FIFRA standard for registration. The Agency will consider whether any new data or information on the pesticide warrant conducting a new risk assessment or a new risk/benefit assessment.
- Conduct new assessments as needed - If EPA finds that a new assessment of the pesticide is needed, the Agency will determine whether the assessment can be based on available data or information.
- If sufficient data or information are available, EPA will conduct the new risk assessment or risk/benefit assessment.
- If additional data or information are needed to conduct the review, EPA will issue a Data-Call In (DCI) notice under FIFRA section 3(c)(2)(B).
- Include the public, as appropriate - EPA will generally make available for public review and comment a draft risk assessment for a pesticide if a new risk assessment has been conducted. The Agency also will announce the availability of a revised risk assessment. If the revised assessment indicates risks of concern, the Agency may invite the public to submit suggestions for mitigating the risks identified.
A registration review decision is EPA's determination whether a pesticide meets or does not meet the standard for registration in FIFRA; that is, whether the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.
Proposed Decision - EPA will publish a Federal Register notice announcing the availability of a proposed registration review decision and will provide a comment period of at least 60 days. The proposed decision and bases for the decision will be placed in the pesticide's registration review docket.
In its proposed decision, EPA will:
- Present its proposed findings regarding the FIFRA standard and the bases for these proposed findings;
- Identify proposed risk mitigation measures or other proposed requirements;
- State whether the Agency believes additional data are needed and, if so, describe the data (a DCI may be issued);
- Specify proposed labeling changes;
- Identify deadlines for completing any required actions.
Final Decision - After considering any comments on the proposed decision, EPA will issue a registration review decision, including an explanation of any changes to the proposed decision and a response to significant comments. The Agency will publish a Federal Register notice announcing the availability of this decision.
If a registrant fails to take action required in a registration review decision, EPA may take appropriate action under FIFRA.
Interim Decision - EPA may issue, when appropriate, an interim registration review decision before completing a registration review. The interim decision may
- require new or impose interim risk mitigation measures;
- identify data or information needed to complete the review (a DCI may be issued); and
- include schedules for submitting the required data, conducting the new risk assessment, and completing the registration review.
The Agency will follow the procedures for a proposed and final decision discussed above when issuing a proposed or final interim registration review decision.