LAB TO LABEL TIMELINE
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
- 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
Lab to Label: