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FIFRA-88, GLP, and QA: pesticide registration
1USDA/APHIS/WS, National Wildlife Research Center, Ft. Collins, Colorado 80524-2719, USA.
Quality Assurance (San Diego, Calif.)
|July 1, 1997
Summary
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) and EPA Good Laboratory Practice (GLP) standards increased pesticide registration costs. This study illustrates these challenges using a specific avicide registration process.
Area of Science:
- Environmental Science
- Toxicology
- Regulatory Affairs
Background:
- The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has led to fewer pesticide registrations.
- Implementation of U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased the costs associated with maintaining pesticide registrations.
- The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) manages vertebrate pesticide registrations for its Wildlife Services (WS) program.
Purpose of the Study:
- To examine the impact of FIFRA-88 and EPA GLP/QA standards on pesticide registration and maintenance costs.
- To illustrate the complexities of pesticide registration using the avicide DRC-1339 (Starlicide) as a case study.
- To provide perspectives on future career paths for QA professionals in light of trends in pesticide and veterinary drug development.
Main Methods:
- Summarized, performed, and submitted or gained waivers for over 500 studies requested by the U.S. EPA.
- Utilized milestones for the registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient in DRC-1339, to detail the GLP/QA/animal welfare process.
- Compared trends in new pesticide and veterinary drug development.
Main Results:
- FIFRA-88 and subsequent GLP/QA standards have significantly increased the operational costs and complexity for maintaining pesticide registrations.
- The registration process for the avicide DRC-1339 highlights challenges related to study submission, waivers, and adherence to stringent GLP/QA and animal welfare guidelines.
- The analysis provides insights into the evolving landscape for QA professionals in the agrochemical and veterinary sectors.
Conclusions:
- Navigating FIFRA-88 and EPA GLP/QA requirements presents substantial financial and procedural hurdles for maintaining pesticide registrations.
- The case of DRC-1339 underscores the intricate nature of regulatory compliance, including data generation, quality control, and ethical considerations.
- Future career development for QA professionals should consider the increasing regulatory demands and scientific advancements in pesticide and veterinary drug development.