Summary of Week 12
Pesticides
Background
- old Federal Insecticide Fungicide and Rodenticide Act (FIFRA) + amendments + Federal Environmental Pesticide Control Act of '72 + subsequent amendments
- collectively the above is generally referred to as FIFRA
- pre-EPA (under USDA) focus on efficacy (protect farmers from "snake oil salesmen")
- earlier regs required pesticide registration but law had "no teeth"
- new focus is on health / environmental effects
Pesticide Registration
- the "heart" of FIFRA/FEPCA
- manufacturers, distributers, importers must register
- provide detailed information
- formula,labelling,test descriptions, test results
- crop specific and insect specific data required
- costly & lengthy process to gather needed info
- "conditional registration"
- for identical or similar pesticides in use already
- new uses for registered pesticides
- new active ingredients (unregistered)
- no unreasonable adverse health or environmental effects
- use is in the public interest
- grant conditional registration unless a Rebuttable Presumption Against Registration (RPAR) issued
re-registration required every 5 years ('88 Amendments)
up to 4 yrs. allotted to complete data gathering
anti-featherbedding
- provisions for compensating R&D investment of company making original registration
- requires the follow on filer or government to compensate for loss of this property right in data
registration of biotechnology products still a "work in progress" but same risk/benefit analysis should control
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