Pesticide Reregistration Facts
Current as of November 2011
The 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorized EPA to conduct the pesticide reregistration program – a comprehensive review of the human health and ecological effects of pesticides first registered before November 1, 1984, to ensure that they met current scientific and regulatory standards. Through the reregistration program, EPA called in and reviewed supporting scientific studies, completed human health and ecological risk assessments, and developed risk mitigation measures as needed using current science, transparency, and input from stakeholders and the public. The results of EPA’s reviews were summarized in Reregistration Eligibility Decisions (REDs). See http://www.epa.gov/pesticides/reregistration/status.htm.
Status of 613 Reregistration Cases
- 384 REDs completed (63%)
- 229 cases canceled (37%)
Scope and Status of Reregistration -– Approximately 1,150 pesticide active ingredients organized into 613 “cases” or related groups were subject to reregistration. 229 of these cases were canceled in the early years of the program. In September 2008, EPA completed the last of 384 REDs. About 20 of these REDs were voluntary cancellations completed later in the program.
Tolerance Reassessment -- The Food Quality Protection Act of 1996 (FQPA) amended the Federal Food, Drug and Cosmetic Act (FFDCA), requiring EPA to reassess within 10 years the 9,721 existing tolerances and tolerance exemptions to ensure that they met the new “reasonable certainty of no harm” safety standard. 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. See http://www.epa.gov/pesticides/tolerance/reassessment.htm.
EPA generally conducted reregistration in conjunction with tolerance reassessment. In developing decisions through these re-evaluation programs, 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, EPA accomplished significant improvements in health and safety and provided assurance that all registered pesticides could be used without unreasonable adverse effects on human health or the environment.
Product Reregistration -- Product reregistration is EPA’s program for implementing REDs by ensuring that required risk mitigation measures are reflected on pesticide product labels. After EPA completed a RED and found that 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. EPA plans to complete the last product reregistration decisions in 2014. See http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.
Public Participation -- – During reregistration and tolerance reassessment, EPA demonstrated a strong commitment to involving stakeholders and the public in reevaluating registered pesticides. The Agency’s public participation process for pesticide tolerance reassessment and reregistration provided a dynamic framework for public involvement and consultation during the conduct of these programs. 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 promoted robust public involvement while making timely pesticide regulatory decisions. See http://www.epa.gov/pesticides/reregistration/public.htm.
Cumulative Risk Assessment -- FQPA also directs EPA to assess the cumulative risks of pesticides that share common mechanisms of toxicity. In 2006 and 2007, the Agency completed cumulative risk assessments for the organophosphate (OP), N-methyl carbamate, triazine, and chloroacetanilide groups of pesticides. In October 2011, EPA completed the Pyrethrins/Pyrethroid Cumulative Risk Assessment. See http://www.epa.gov/oppsrrd1/cumulative/.
Registration Review -- Through the registration review program mandated by FQPA, EPA is reevaluating each registered pesticide at least every 15 years to determine whether it continues to meet the FIFRA standard for registration. See http://www.epa.gov/oppsrrd1/registration_review/.
FIFRA Reregistration Basics
Reregistration Lists -- The 1988 amended FIFRA directed EPA to divide the 600 cases undergoing reregistration into four lists: List A, B, C, and D.
- List A - List A, which contains most food use pesticides, consists of the 194 chemical cases (or 350 individual active ingredients) for which EPA had issued Registration Standards. Each Registration Standard document summarized the data available for a pesticide, called in any additional studies needed for reregistration, and required necessary product labeling changes. The safety of many food use pesticides was improved through this earlier program as EPA obtained updated studies and effected labeling improvements.
- Lists B, C, and D - The remaining pesticides subject to reregistration were divided into three lists based on their potential for human exposure and other factors, with List B containing pesticides of greater concern and List D pesticides of less concern. Some of the classification criteria included potential for residues in food or drinking water, significance of outstanding data requirements, potential for worker exposure, Special Review or restricted use status, and unintended adverse effects to animals and plants.
Reregistration Program Phases -- The reregistration program established by FIFRA '88 consisted of five phases which included deadlines and responsibilities for both EPA and pesticide registrants. The Agency completed the first four phases by the end of 1993, and completed phase 5 in 2008.
The List B, C, and D pesticides were required to go through all five phases. Because EPA had already substantially reviewed them under the Registration Standards program, the List A pesticides started reregistration in phase 5.
- Phase 1 - List Active Ingredients - As required, EPA published reregistration Lists A, B, C, and D within 10 months of FIFRA '88 (by October 24, 1989) and asked registrants of these pesticides whether they intended to seek reregistration.
- Phase 2 - Declare Intent and Identify Studies - In phase 2, registrants were required to notify EPA whether or not they intended to reregister their products; to identify and commit to providing necessary new studies; and to pay the first installment of the reregistration fee. During this phase, EPA issued guidance to registrants for preparing their phase 2 and 3 responses. Phase 2 activities were completed in 1990.
- Phase 3 - Summarize Studies - During phase 3, following EPA guidance, registrants were required to submit summaries and reformat acceptable studies, "flag" studies indicating adverse effects, re-commit to satisfying all applicable data requirements, and pay the final installment of the reregistration fee. Phase 3 ended in October 1990.
- Phase 4 - EPA Review and Data Call-In - During phase 4, EPA reviewed all phase 2 and 3 submissions and required registrants to meet any unfulfilled data requirements within four years. Phase 4 was completed in 1993.
- Phase 5 - Reregistration Decisions - In this final phase, EPA reviewed the studies submitted in support of reregistration and decided whether each case was eligible for reregistration - that is, whether the data base is substantially complete, and pesticides in the case could be used without unreasonable adverse effects on people or the environment. The Agency also considered whether pesticides met the new safety standard established by FQPA. Results of the Agency's reviews are presented in Reregistration Eligibility Decisions (REDs). Phase 5 was completed in September 2008 when EPA completed the last REDs. Even after REDs are completed, pesticides still must complete product reregistration, through which labeling changes and associated risk mitigation measures are implemented See http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.