Registration Review Process
- Registration Review Overview
- Registration Review Process
EPA reviews each registered pesticide at least every 15 years to ensure that each pesticide can carry out its intended function(s) without creating unreasonable adverse effects to human health and the environment.
EPA always strives to base its decisions on the best available and sound science. However, science is constantly evolving, and new scientific information can come to light at any time and change our understanding of potential risks from pesticides. As part of registration review, EPA may identify data that may be useful for assessing a pesticide. Data that are not submitted in a timely fashion may affect EPA’s registration review timeline.
You can find the EPA’s planned registration review actions—including work plans, draft risk assessments, and decision documents—in the Registration Review Schedules.
While each pesticide review is unique, all pesticides go through the same basic registration review process.
*After publication EPA generally holds a 60-day public comment period.
Learn more about each step below, or see EPA’s Registration Review Procedures.
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.
EPA publishes 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. EPA considers 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.
Narrowing the Scope: 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.
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.
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. The Agency considers 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, EPA will determine if the Agency needs 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, EPA 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 the Agency completes final risk assessments and proposed registration review decisions.
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.
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 ESA 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 DCI may be issued to the registrant);
- Specify any proposed labeling changes;
- Identify deadlines for completing any required actions.
EPA will issue a proposed interim decision when the Agency needs to conduct additional assessments such as an endangered species assessment or endocrine screening.
EPA may issue, when appropriate, an interim registration review decision before completing a registration review. After considering any comments concerning the proposed interim decision, EPA will issue an interim registration review decision, including an explanation of any changes to the proposed interim decision and a response to significant comments. The Agency will publish a Federal Register notice announcing the availability of this decision.
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
- Require the submission of updated labels.
If a registrant fails to take action required in an interim registration review decision, EPA may take appropriate legal action.
For pesticide interim decisions, EPA will issue a final decision once a listed-species assessment has been completed and any necessary ESA Section 7 consultation with U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) as appropriate. The Agency is working with the Services to improve the consultation process for national threatened and endangered species for pesticides under ESA. In addition, EPA’s registration review final decisions will take into account the Endocrine Disruptor Screening Program screening consistent with the Federal Food, Drug, and Cosmetic Act § 408(p).
If a registrant fails to take action required in a registration review decision, EPA may take appropriate legal action.