Registration Review Process
Implementing Registration Review
EPA will review each registered pesticide at least every 15 years to determine whether it continues to meet the FIFRA standard for registration. Pesticides registered before 1984 have been reevaluated initially under the reregistration program. These pesticides also are subject to registration review.
We must complete registration review by October 1, 2022, for all pesticides registered as of October 1, 2007. We plan to open 70 or more new registration review public dockets annually through 2017. These docket openings are reflected in the agency’s Registration Review Schedules. New pesticide active ingredients will be added to the schedule so they will complete registration review within 15 years of their registration date.
Program Status
As of January 1, 2016, there are about 724 registration review “cases” that include approximately 1,140 pesticide active ingredients. Pesticide cases may be related by chemical class or structure, mode of action (or how the pesticide works), use, or for other reasons.
- Over 630 registration review cases are past the public docket opening stage.
- Over 550 registration review cases are in active review.
- 165 registration review interim and final decisions have been completed.
While each pesticide review is unique, all pesticides go through the basic registration review process described below. This process is also described in the Registration Review Procedures.
Registration Review Process Components:
Docket Opening
EPA initiates a registration review by establishing a public docket for a pesticide registration review case and opening the docket for public comment.
The docket contains a Preliminary Work Plan (PWP) summarizing information EPA has on the pesticide and the anticipated path forward. Among other things, the PWP includes:
- Facts about the pesticide and its current use and usage.
- Anticipated risk assessment and data needs.
- An estimated timeline for the review.
We publish a notice in the Federal Register announcing the availability of the docket and providing the public with a comment period of at least 60 days. Anyone may submit data or information to the public docket. We consider the information received during the comment period and develop a Final Work Plan.
EPA also announces when a pesticide is no longer subject to registration review because the pesticide does not have any pesticide product registrations.
The registration review docket for each case will remain publicly accessible throughout the registration review, until all actions required in the final decision have been completed.
Links to registration review case dockets that have opened are available in Chemical Search.
Focus Meetings
To enhance transparency and involvement, EPA holds focus meetings for many pesticides going through registration review. Typically involving registrants and others early in the process, focus meetings are intended to address any 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 public dockets. When 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.
Case Development
In conducting a pesticide's registration review, EPA will review available data and information. The Agency will:
Assess Changes since the Pesticide's Last Review
EPA will assess any changes that have occurred since the last registration decision to determine whether the pesticide still satisfies the statutory standard for registration. We consider any new data or information on the pesticide and decide whether a new risk assessment or a new risk/benefit assessment must be conducted.
Conduct New Assessments as Needed
If a new assessment of the pesticide is needed, we determine if we need new 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 to the registrant under the authority of FIFRA section 3(c)(2)(B).
Include the Public
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 risks of concern are identified, we may invite the public to submit suggestions for mitigating the risks.
Consult with our Regulatory Partners
In issuing draft ecological risk assessments for comment, EPA will consult informally with the National Marine Fisheries Service and the U.S Fish and Wildlife Service (the Services) about any potential risks from pesticide use to endangered species. Later, EPA will initiate formal consultation with the Services, as needed, when we complete final risk assessments and proposed registration review decisions.
Registration Review Decision
A registration review decision is EPA's determination whether a pesticide meets or does not meet the statutory standard for registration; that is, whether taking into account the labeling, composition and packaging of the product, 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 the public with a comment period of at least 60 days. The proposed decision and bases for the decision will be available in the pesticide's registration review docket.
In its proposed decision, among other things, EPA will:
- Present its proposed findings regarding the FIFRA standard, including the results of formal Endangered Species Act consultation, if needed, and the bases for these proposed findings;
- Propose modifications to the way the pesticide is used if risk concerns are identified;
- State whether we believe additional data are needed and, if so, describe the data (a Data Call-In may be issued to the registrant);
- Specify any proposed labeling changes;
- Identify deadlines for completing any required actions.
Final Decision
After considering any comments concerning 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. We 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 legal action.
Interim Decision
EPA may issue, when appropriate, an interim registration review decision before completing a registration review. The interim decision may, among other things,
- 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.
Resources
Understanding the Science behind EPA’s Pesticide Decisions