Reregistration and Other Review Programs Predating Pesticide Registration Review
Before EPA launched the registration review program, EPA reevaluated existing registered pesticides through programs including:
In 2008, EPA completed a review of older pesticides – those initially registered before November 1, 1984 – to ensure that they met current scientific and regulatory standards. Through this reregistration process, authorized by the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA called in and reviewed missing scientific studies and assessed human health and ecological effects, using up-to-date science, and input from stakeholders and the public. The agency developed mitigation measures as needed to reduce risks of concern, such as limiting or eliminating certain uses of the pesticide, requiring buffer zones around areas to be treated, or requiring protective clothing for pesticide workers. The results of EPA’s reviews were summarized in Reregistration Eligibility Decisions (REDs). The agency is continuing to implement some of these decisions.
Approximately 1,150 pesticide active ingredients organized into 613 “cases” or related groups were subject to reregistration. In September 2008, EPA completed the last REDs for 384 of these cases. The remaining cases were cancelled.
Final Status of 613 Reregistration Cases
- 384 cases completed (63%)
- 229 cases canceled (37%)
- Cases were canceled if all the pesticide registrations were canceled before the reregistration decision was completed.
EPA also reassessed existing tolerances (pesticide residue limits in food) to ensure that they met the safety standard established by the Food Quality Protection Act (FQPA) of 1996. FQPA amended the Federal Food, Drug and Cosmetic Act (FFDCA), requiring EPA to reassess within 10 years the existing 9,721 tolerances and tolerance exemptions to ensure that they met the new “reasonable certainty of no harm” safety standard.
The law required EPA to give priority to the review of those pesticides that appeared to pose the greatest risk to public health. EPA completed over 99 percent of the tolerance reassessment decisions by August 3, 2006. The remaining 84 tolerance reassessment decisions for five pesticides were completed in September 2007 when the agency concluded the cumulative risk assessment for the N-methyl carbamate pesticides.
EPA integrated reregistration and tolerance reassessment to most effectively accomplish the goals of both programs. In developing decisions, to mitigate risks of concern, EPA canceled pesticide registrations, terminated uses, or imposed new use restrictions, as needed, while preserving important social and economic benefits. As a result, significant improvements in health and safety were made. Through these early reevaluation programs, by holding all registered pesticides to the same updated standards, EPA provided assurance that pesticides on the market could be used without unreasonable risks to human health or the environment.
EPA demonstrated a strong commitment to involving stakeholders and the public in these early pesticide reevaluation programs. The agency’s public participation process for tolerance reassessment and reregistration provided a dynamic framework for public involvement and consultation.
Because pesticides do not all present the same degree of risk or complexity of issues, the public participation process provided options for conducting a full 6-phase process, modified 4-phase process, or streamlined low risk process. Using this tailored approach, EPA supported robust public involvement while making timely pesticide regulatory decisions.
Pesticide Reregistration Performance Measures and Goals
As required by FIFRA as amended by FQPA, EPA has published annually a report describing the agency’s progress in meeting goals for reregistration and tolerance reassessment.
- 2012 Federal Register Notice and Report
- 2011 FRN and Report
- 2009 & 2010 Correction
- 2009 & 2010
- Additional years (1997-2008)
Product reregistration is EPA’s program for implementing Reregistration Eligibility Decisions (REDs) by ensuring that required risk mitigation measures are reflected on pesticide product labels.
After EPA completed a RED and found that pesticide uses were eligible for reregistration, the agency called in product-specific data and revised labeling for each individual product covered by the RED. After reviewing the data and updated labeling, the Agency may reregister products that meet current standards.
Several outcomes are possible for a pesticide product completing this final phase of the reregistration process:
If the required product-specific data and revised labeling are acceptable, EPA may reregister the pesticide product.
If the product contains multiple pesticide active ingredients, the agency issues an amendment to the product’s registration, incorporating the labeling changes specified in the RED. A product with multiple active ingredients cannot be fully reregistered until the last active ingredient in its formulation is eligible for reregistration.
The agency may temporarily suspend a product’s registration if the registrant has not submitted required product-specific studies within the time frame specified. Read more about suspension of registrations.
The agency may cancel a product’s registration because the registrant did not pay the required registration maintenance fee. Alternatively, the registrant may request a voluntary cancellation of its end-use product registration.
- Complete over 600 product reregistration actions each year
- Complete the last product reregistration decisions for conventional pesticides in 2018
Status of the Product Reregistration Universe
A total of 24,975 products were subject to product reregistration as of the end of fiscal year (FY) 2016. The following information is a snapshot in time, showing the current status of these products.
- Products reregistered = 5,121
- Products amended = 3,491
- Products canceled = 11,702
- Products suspended = 40
- TOTAL products completed = 20,354
- Products pending actions = 4,621
Product Reregistration Actions
EPA completed a total of 483 product reregistration actions during FY 2016.
- Product reregistration actions = 14
- Product amendment actions = 65
- Product cancellation actions = 404
- Product suspension actions = 0
REDs with Product Reregistration Decisions Completed
Product reregistration has been completed for 284 cases (out of a total of 384 cases). The 284 cases that have completed product reregistration include 30 organophosphate (OP) pesticides (out of 31 OPs). See list of cases that have completed product reregistration.
EPA may initiate the Pesticide Special Review process when it has reason to believe that the use of a registered pesticide may result in unreasonable adverse effects on people or the environment. Special Review usually involves intensive review of only one or a few potential risks. 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, the ultimate goal of the Special Review process has been to reduce the risks posed by a pesticide. This includes considering to the extent permissible under law both the risks and benefits provided by the use of the pesticide. Special Review has provided a mechanism for public input into EPA’s deliberations before the agency issued a Notice of Final Determination describing its selected regulatory action.
Pesticides in Special Review
Since the 1970s, EPA has reviewed more than 100 pesticides under the Special Review process and completed reviews of most of the pesticides. The agency now has only a few pending Special Review decisions to complete, including:
- Atrazine, Propazine, and Simazine (Triazines)
- Ethylene Oxide (ETO)
Completing the full Special Review process can take many years because of the extensive amount of data that must be collected and reviewed. EPA plans to complete the remaining Special Reviews through the registration review program.
Criteria for Initiating Special Review
- 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.