![[logo] US EPA](https://webarchive.library.unt.edu/eot2008/20090510034550im_/http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Pesticide Reregistration Facts
Current as of August 12, 2008
The 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorized EPA to conduct a comprehensive pesticide reregistration program - a complete review of the human health and environmental effects of pesticides first registered before November 1, 1984, to make decisions about these pesticides' future use. The goal of the reregistration program is to mitigate risks associated with the use of older pesticides while preserving their benefits. Pesticides that meet today's scientific and regulatory standards may be declared "eligible" for reregistration. The results of EPA's reviews are summarized in Reregistration Eligibility Decision (RED) documents.
In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). EPA must be able to conclude with "reasonable certainty" that "no harm" will come to infants, children, or other sensitive individuals exposed to pesticides. All non-occupational pesticide exposures - from food, drinking water, and home and garden use - must be considered in determining allowable levels of pesticides in food. The Agency also must consider the cumulative effects of pesticides and other compounds with common mechanisms of toxicity.
The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004. Among other things, PRIA directed EPA to complete REDs for pesticides with food uses/tolerances by August 3, 2006, and to complete REDs for all remaining non-food use pesticides by October 3, 2008.
Status of 613 Reregistration Cases
- 376 REDs completed (61.3%)
- 229 cases cancelled
(37.4 %) - 8 REDs to complete (1.3%)
Scope and Status of Reregistration - The reregistration program encompasses approximately 1,150 pesticide active ingredients organized into 613 "cases" or related groups. 229 of these cases were cancelled in the early years of the reregistration program. As of August 2008, EPA has completed 376 REDs and has 8 more REDs to complete. The Agency is on schedule to complete the remaining 8 REDs by October 3, 2008.
Tolerance Reassessment -- FFDCA as amended by FQPA required the reassessment of existing tolerances (maximum limits for pesticide residues in food) and tolerance exemptions within 10 years, to ensure that they meet the safety standard of the law. EPA was directed to give priority to the review of those pesticides that appear to post the greatest risk to public health, and to reassess:
- 33% of the 9,721 existing tolerances and tolerance exemptions within 3 years (by August 3, 1999).completed
- 66% within 6 years (by August 3, 2002).completed
- 100% within 10 years...over 99% completed by August 3, 2006; the remaining 84 decisions for N-methyl carbamate pesticides were completed in September 2007
Cumulative Risk Assessment -- EPA also must assess the cumulative risks of pesticides that share common mechanisms of toxicity. During 2006 and 2007, the Agency completed cumulative risk assessments for the triazine, chloroacetanilide, organophosphate (OP), and N-methyl carbamate groups of pesticides.
Public Participation -- EPA is strongly committed to involving stakeholders and the public in reevaluating registered pesticides. The Agency's public participation process for pesticide tolerance reassessment and reregistration has 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 provides options for conducting a full 6 phase process, modified 4 phase process, or streamlined low risk process. Using this tailored approach, EPA promotes robust public involvement while making timely pesticide regulatory decisions.
Risk Reduction through REDs -- The reregistration program is bringing about improvements in pesticide safety. Most REDs include at least some of the following risk reduction requirements:
- Voluntary cancellation;
- Some uses not eligible or not yet eligible;
- Limit amount, frequency or timing of applications;
- Other application restrictions;
- "Restricted Use Pesticide" classification;
- Personal Protective Equipment (PPE);
- Restricted Entry Intervals (REIs);
- User safety requirements and recommendations;
- Improved use directions and precautions;
- Special or tamper-resistant packaging;
- Engineering or production controls;
- Ground or surface water safeguards;
- Spray drift labeling;
- Ecological safeguards;
- Special programs to better protect young children.
Results -- EPA has required significant risk reduction in completing hundreds of individual pesticide reregistration and tolerance reassessment decisions, improving food safety and human health and environmental protection in the United States. Improved scientific methods have enabled the Agency to identify pesticide uses posing risk concerns and target mitigation actions to reduce or eliminate those risks.
Product Reregistration - After EPA has issued a RED and declared a pesticide eligible for reregistration, individual end-use products that contain the pesticide active ingredient still must be reregistered. Through this concluding part of the process, known as "product reregistration," the Agency makes sure that the risk reduction measures called for in REDs are reflected on individual pesticide product labels. In some cases, the Agency uses Memoranda of Agreement or other measures to include risk reduction measures on pesticide labels sooner, before product reregistration is completed. EPA plans to complete the last product reregistration decisions by 2014, several years after the last REDs are signed.
Registration Review - Even before the reregistration program was completed, EPA began implementing registration review starting in early 2007. This new program ensures that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides will continue to meet the statutory standard of no unreasonable adverse effects.
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 since then has been developing REDs as part of phase 5.
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 is reviewing the studies submitted in support of reregistration and deciding whether each case is eligible for reregistration - that is, whether the data base is substantially complete, and pesticides in the case can be used without unreasonable adverse effects on people or the environment. The Agency also is considering whether pesticides meet the new safety standard established by FQPA. Results of the Agency's reviews are presented in Reregistration Eligibility Decisions (REDs). Even after REDs are completed, pesticides still must complete product reregistration, through which labeling changes and associated risk mitigation measures are implemented.