Key Steps in the Special Review Process

This page describes the steps that EPA considers when initiating Special Review. EPA uses the Special Review process when it has a reason to believe that the use of a pesticide may result in unreasonable adverse effects on people or the environment. Read more about Special Review.

On this page:

• Notice to the Manufacturers
• Notice of Special Review (Position Document 1)
• Notice of Proposal to Terminate Special Review (Position Document 2)
• Notice of Preliminary Determination (Position Document 2/3)
• Notice of Final Determination (Position Document 4)

Notice to the Manufacturers

As required by federal regulations, EPA sends the producers of a pesticide (the registrants) a private notification that the Agency is considering a Notice of Special Review. Issuing this private notification begins the pre-Special Review phase of the process. The registrant is allowed a short period of time to dispute the validity of the Agency's concerns.

If, after notifying the registrants and receiving their response, the Agency tentatively determines that use of the pesticide does not pose a significant risk, EPA issues a Federal Register (FR) notice that explains the reasons for its decision. This notice also announces the availability of the public docket, which includes the pre-Special Review notification and all written information received in response to the notification. The FR notice also solicits public comment, after which the Agency makes a final decision on whether or not to initiate a Special Review. The final decision will be published in an FR notice, either as a Position Document 1 (PD1) announcing the initiation of a Special Review, or as a final determination not to initiate a Special Review.

If EPA initiates Special Review, the Agency will propose its determination in either a Position Document 2 (PD2) or Position Document 2/3 (PD2/3) for comment, and announce its final decision in a Position Document 4 (PD 4).

Notice of Special Review (Position Document 1)

EPA will publish a Notice of Special Review (Position Document 1) in the FR if the Agency determines that a significant risk may be associated with a pesticide. This notice describes the following:

• Special Review criterion of concern.
• Assumptions and data used in the analysis.
• Strength of the conclusions.

The notice will also announce the availability of the pre-Special Review public docket, solicit public comment, and request additional information on the pesticide.

Consultation with Key Stakeholders - After issuance of the Notice of Special Review, the Agency may meet with interested parties, provided minutes are publicly available, to discuss the risk concerns and available options to reduce the potential risks to health or the environment.

Risk/Benefit Analysis - With the commencement of a Special Review, the Agency begins gathering data and information to conduct comprehensive risk and benefit analyses (as appropriate under law) of each use of the pesticide subject to Special Review. Potential risks are evaluated by considering factors such as:

• Adverse effects to health or the environment.
• Magnitude of exposure of humans and other non-target organisms.
• Size of the population at risk.

Benefits of use are evaluated by assessing the availability, efficacy, and cost of alternative control methods, and impact on users, consumers, and other parties (not registrants) if the pesticide is canceled.

Notice of Proposal to Terminate Special Review (Position Document 2)

If, after issuing Position Document 1, the risks are determined to be lower than originally believed and are acceptable, the Agency may decide that continuing the Special Review is not warranted. This new risk determination may result from further analysis of the risks and/or benefits or from risk reduction actions taken on behalf of the registrants.

After EPA initiates Special Review, interested parties often provide new data or information to the Agency. Such data or information can change the Agency's understanding of either the risks or benefits of the pesticide and support a decision for continued registration. Alternatively, the registrants may voluntarily amend their registrations in a manner that would reduce the risks of the pesticide use. In these instances, the Agency ends the Special Review by publishing a Notice of Proposal to Terminate the Special Review (Position Document 2) in the FR.

Notice of Preliminary Determination (Position Document 2/3)

EPA will publish a Notice of Preliminary Determination (Position Document 2/3) for public comment if the Special Review is not concluded by publishing a Position Document 2. This notice includes the regulatory measures the Agency will undertake to reduce risks of the pesticide use(s). The notice also includes a Draft Notice of Intent to Cancel (NOIC), deny, or reclassify any registrations that do not comply with these measures.

EPA then submits the Draft NOIC to the FIFRA Scientific Advisory Panel (SAP) for comment on the Agency's scientific rationale. Concurrently, EPA submits the Draft NOIC to the United States Department of Agriculture (USDA) for comment, especially on the benefits issues and agricultural impacts.

Notice of Final Determination (Position Document 4)

After evaluating all comments received from the public, USDA, and the SAP on the proposed action, the Agency will modify the proposal where appropriate prior to issuing it as a final action. EPA publishes a Notice of Final Determination (Position Document 4) in the FR, along with a Notice of Intent to Cancel, Deny, or Reclassify Registration, if required to implement the determination. Any such notice becomes effective by operation of law unless the registrant makes the necessary corrections or a person adversely affected by the notice requests a hearing in a timely manner.