Pesticide Legislation and Registration

1. Pesticide Legislation and Registration Plant Science 280 Mr. Gomes

2. The Principles of Pesticide Registration • Most of the worlds nations have some sort of procedure • Less developed countries, procedural and data requirements are few to nonexistent • Fiscal constraints • Unawareness of need • Some countries are not implemented

3. Regulatory Control • Use Control • Performance Claims • Label directions and precautions • Packaging • Advertising • Proper use of environmental/human safety • In general, process covers public interests and manufacturers rights

4. History of/for Regulatory • Have been in place in developed countries for nearly 100 years • Fear Driven by media often times (DDT) • 1960’s first public debate over pesticide use became real. Why??? • 1984 a cloud of methyl isocyanate killed 14,000 in India and injured 30,000 more • Glyphosate resistance and that drive for GMO’s. Public awareness • Roughly 20,000 people die annually from pesticide poisoning • Developing countries 25% use, 99% of fatalities • Debate over pro’s and cons to GM crops. Has raised legitimate social, economic, and biological concern • Concern for weed science is the widespread adoption of herbicide resistant technology

6. Federal Laws • Insecticide Act of 1910 • Restriction of ineffective and adulterated insecticides/fungicides • US Federal Food, Drug, and Cosmetic Act in 1938 • Gained more control of integrity of food moving interstate • Department of Health, Education, and Welfare 1953 • Safe levels of residues • EPA in 1970 • Tolerance levels for all pesticides • The Food and Drug Act 2006

7. Federal Insecticide, Fungicide, and Rodenticide Act • Became law in 1947, essentially replacing the Insecticide Act of 1910 • First to require that pesticide formulation should meet proper standards • Introduced two new ideas • All pesticides for shipment needed to be registered with US Sec. of Ag • USDA given control over all precautions on labels • Required labels to contain new items • Protection from physical injury or economic loss • Protection for the public from injury. Previously only user • Manufacturer has to prove efficacy for use

8. Environmental Protection Agency • Created in 1970 • The entire pesticide regulations divisions transferred to EPA OPP • Includes registration and enforcement divisions • Maintain 5 sections • Efficacy • Chemistry • Human safety • Fish and wildlife safety • registration • Pledged in 1993 to greatly reduce pesticide use in US • Also handle inspection and imports, case review and development, control office, prosecutions, field enforcement staff

9. Federal Environmental Pesticide Control Act • Enacted in 1972 by Nixon • Designed to protect humans and the environment and federal regulation to all pesticides in state • Responsibility now shifted to the applicator with this act • Ultimate responsibility still on the manufacturer • Labels had to now consider public interest, including benefits from pesticide use • Restricted or General Use

11. Tolerance Classes • All pesticides are in one of four tolerance classes • Exempt • Zero • Finite • Nonfood Crop Registration

12. Exempt • Occur when there is no known human or animal health concern • These are generally categorized as safe • Have a long list of products including; • Castor oil, cinnamon, corn gluten meal, cottonseed oil, mint oil, etc

13. Zero • Means none of the chemical is permitted in any crop • EPA decides it is not in the public interest to accept any detectable residue • Used to mean no traceable residue, but more sensitive testing eradicated the concept. Parts per/??? • What’s the most commonly known zero tolerance pesticide???

14. Finite • Used when chemical residues are known to exist but pose know known threat • Most every pesticide falls into this category • Requires a two year feed study on at least two mammals after the efficacy studies conclude

15. Nonfood Crop Registration • Pesticide used in soil well in advance of planting • Proves to decompose or metabolize so as to dissipate well before harvest • Use in parking lots, dormant crops, seed treatment

17. Procedures for Pesticide Registration • A. A statement of active and inert ingredients, chemical and physical properties of formulation, complete formula, environmental stability, known impurities • B. Five Copies of the proposed label • 1. Brand Name • 2. Complete chemical name and physical/chemical properties • 3. Ingredients • 4.Directions for use, specifying crops or intended sites • 5. Rate • 6. timing of application • 7.Any precautions or limitations on use • 8. Warning Statement of protection on nontarget species • 9. Antidote in case of human consumption • 10. Warning to keep away from children • 11. Manufacturing details • 12. Net Weight • 13. Restricted versus general use

18. Procedures Cont. • C. Full description including scientific data proving efficacy and safety • D. Complete Toxicity report including; • 1. two year rate feeding study to determine repo and cancer effects • 2. 18 month mouse feeding study to represent the same • 3. two year dog feeding study • 4. mutagenic possibilities in mice • 5. teratogenic study in rabbits • 6. three generation rat repro study and repro studies in chickens • 7. meat residue in cows, chickens, swine; milk and eggs • 8. 90 feed study to determine mammalian metabolites • 9. 21 day subacute toxicity in bunnies, oral and dermal LD50 in rats • 10. eye and skin irritation • 11. tests to determine effects on two species of fish and quail

19. Procedures Cont. • E. Results of tests on the amounts of residue including testing methods • F. Practical methods of removing methods exceeding tolerance • G. Proposed tolerance for the pesticide and reasons for request • H. Reasonable grounds for the support of the petition • If all of this is met, then tit goes to the Fish and Wildlife Service of the Department of the Interior AND the Hazard Evaluation Division of the EPA, either can concur or deny the petition.