Special Review Process
EPA uses the Pesticide Special Review process when it has reason to believe that the use of a pesticide may result in unreasonable adverse effects on people or the environment. The Special Review process usually involves intensive review of only a few or just one potential risk. The review involves evaluating existing data, acquiring new information and/or studies, assessing the identified risk and determining appropriate risk reduction measures.
Known formerly as the Rebuttable Presumption Against Registration (RPAR) process, Special Review provides a mechanism for public input into EPA’s deliberations before the Agency issues a Notice of Final Determination describing its selected regulatory action. The Special Review process determines whether some or all registrations of a particular active ingredient or ingredients meet the federal standard for registration, or whether amendment or cancellation of portions or all of the registrations is appropriate. Since the 1970s, EPA has reviewed more than 100 pesticides under the Special Review process.
On this page:
- Actions Regarding Chemicals in Special Review
- Criteria for Initiating Special Review
- Possible Outcomes of the Special Review Process
- Faster Alternatives to the Full Special Review Process
- Related Information
Since the inception of the Special Review process, EPA has conducted and concluded Special Review on many pesticides (PDF) (65 pp, 111 MB, About PDF). The Agency now has only a few pending Special Review decisions to complete.
- Ethylene Oxide; Preliminary Determination to Terminate Special Review [October 29, 2008]
- Dichlorvos (DDVP); Final Determination to Terminate Special Review [December 21, 2007]
- November 16, 2007 - Oxydemeton-Methyl; Final Determination to Terminate Special Review
- November 16, 2007 - Ethyl Parathion; Final Determination Not to Initiate Special Review and Tributyltin Antifoulants; Final Determination to Terminate Special Review
- September 26, 2007 - Dichlorvos (DDVP); Proposed Determination to Terminate Special Review
- August 8, 2007 - Final Decision Not to Initiate a Special Review of 2,4-D, 2,4-DB and 2,4-DP
- August 8, 2007 - Proposal to Terminate Special Review of Oxydemeton-methyl (ODM)
- August 8, 2007 - Proposal Not to Initiate Special Review of Ethyl parathion, and Terminate the Special Review of Tributyltin (TBT)
- Acute toxicity to humans or domestic animals.
- Potential chronic or delayed toxic effects in humans.
- Potential hazards to non-target organisms.
- Risk to the continued existence of any threatened or endangered species.
- Risk of destruction or other adverse modification of a critical habitat of any threatened or endangered species.
- Any other adverse effect to humans or the environment that may outweigh the benefits that justify initial or continued registration.
The decision to begin Special Review does not necessarily mean that the pesticide poses unreasonable risks and will be canceled. Special Reviews may end with a determination that the pesticide does not pose such risks, or that it may require other risk reduction measures such as labeling changes or removal of certain uses.
The ultimate goal of the Special Review process is to reduce the risks posed by a pesticide. This includes considering both the risks and benefits provided by the use of the pesticide to the extent permissible under law. Completing the full Special Review process can take many years because of the extensive amount of data that must be collected and reviewed.
Where appropriate, EPA employs alternative approaches to develop timely decisions and risk reduction measures. For example, EPA has conducted the Special Review program along with tolerance reassessment and reregistration for older pesticides. EPA is planning to complete Special Reviews for many of the chemicals currently in the process in conjunction with reregistration, and EPA is consolidating its reviews to expedite decision-making.
Possible alternatives to using the full Special Review process include:
- Combining Steps of the Special Review Process – If the Agency’s risk assessment is refined at the time it makes a decision to initiate a Special Review, EPA may elect to initiate a Special Review and propose risk reduction measures concurrently.
- Negotiated Settlements - At any time, a registrant may reach an agreement with the Agency to modify the terms and conditions of a pesticide registration in order to reduce risk to an acceptable level. The modifications may include, but are not limited to, canceling uses, changing use patterns, changing application methods and/or rates, and imposing protective measures.
- Notice of Intent to Suspend (NOIS) - Under FIFRA section 6(b), the Agency may also issue a Notice of Intent to Suspend or emergency suspension order to remove a pesticide from the market quickly when it poses an imminent hazard.
- Notice of Intent to Cancel (NOIC) - Under FIFRA section 6(b), the Agency may issue a Notice of Intent to Cancel when it has been determined that a pesticide poses unreasonable adverse effects. Uses or registrations posing the risks are canceled and removed from the market.
These alternatives are not intended to replace the conventional, intensive Special Review process. EPA may use some of the alternatives concurrently with the conventional process to achieve timely risk reduction of critical concerns while the overall review continues. In other cases, the alternative steps are used to quickly reduce risk concerns associated with the use of a pesticide before it is placed in the formal Special Review process.
March 2000 Status of Chemicals in Special Review (PDF) (65 pp, 111 MB, About PDF) Describes the status of pesticides which are currently undergoing or have completed the Special Review program. March 2000 Report: EPA-738-R-00-001