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TIME
LINE
Usually
it takes seven to as much as ten years to go from Discovery, primary
screening, to the submission of a registration package to the EPA
for review and comment. In other words, to go through all three
phases. The following are the rough time line for major events along
the road to a product.
Phase
I - Discovery
Year
0-2: primary screening in the laboratory and greenhouse -- synthesis
of compounds or by-products, determination of activity type and
potential targets.
- Year
1-3: testing for mutagenicity, eye irritation, acute dermal
toxicity, and acute oral toxicity.
- Year
2-5: secondary screening in the greenhouse and field -- rates,
timings and methods of application, initial formulation development.
- Year
2-5: mode of action discovery, relation of activity to chemical
structure, efficacy on various crops and pests, use determination,
and patent development.
Phase
II - Development
- Year
2-4: short-term toxicity studies, 7 and 21-day tests, excretion
and elimination, and early metabolic trials.
- Year
3-4: decision to move from Discovery to Development.
- Year
3-4: chemical stability and fire hazard studies.
- Year
2-5: pilot plant manufacturing research.
- Year
3-7: large-scale, field trials with Universities and consultants
-- environmental assessment, interaction with soil microbes,
rain fastness, and solar radiation effects on activity.
- Year
3-7: residue studies -- plants, animals, soil, water.
- Year
3->: market analysis throughout the products lifetime.
Phase
III - Registration
- Year
3-7: metabolic studies in crops, target pests and non-target
organisms.
- Year
3-8: long-term residue studies on crops, pests and soils.
- Year
4-7: long-term toxicity studies -- 90-days to 2-years tests,
cancer research (carcinogenicity)
- Year
4-7: long-term environmental fate -- soil, water, air, bio-accumulation
through the food web.
- Year
5-8: processing-manufacturing research
- Year
7-8: submission to EPA, label development
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