A short history of pesticide registration and review in the US

1. A short history of pesticide registration and review in the US HORT 5009, S 2009 Vera Krischik Department of Entomology University of Minnesota

2. History of pesticide regulation Silent Spring by Dr. Rachael Carson was published in 1962. She wrote it at home in Silver Spring MD. She was a researcher at the US Fish and Wildlife Service in MD. Rachael Carson died in April 1964. In 1970 Silent Spring was first published in serial form in the New Yorker Magazine. This exhaustively researched, carefully reasoned, and beautifully written attack on the indiscriminate use of pesticides attracted immediate attention and wound up causing a revolution in public opinion. The EPA was created on December 2, 1970.

3. History of pesticide regulation The U.S. Food and Drug Administration (FDA) is an agency of the US Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, medical devices, blood products, drugs, vacines, radiation emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to blood.

4. History of pesticide regulation The U.S. Department of Agriculture (USDA) is an agency concerned with: Agriculture Programs Forestry Programs CSREES Food and Nutrition Laws and regulation Marketing and Trade Natural resources, Forest Service, Parks, Pesticide Training ARS, Agriculture Research Service APHIS Animal Plant Health Inspection Service

5. History of pesticide regulation The U.S. Environmental Protection Agency (EPA) is an agency concerned with: Ecosystems Water, Air, Climate Waste Pesticides Pollution 1996 Food Quality Protection Act reforms the nation's food safety laws. Signed into law by President Clinton on August 3, 1996, the act amends the two major laws involving pesticides: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, in EPA) and the Federal Food, Drug, and Cosmetic Act (FFDCA in FDA). FQPA revises the FFDCA so that the 1958 Delaney Clause no longer affects pesticides. FQPA is part of the EPA.

6. History of pesticide regulation USDA, FDA, and EPA 1839 Agricultural Division in US Patent Office 1849 Patent Office transferred to Department of Interior and Agricultural Division was created 1862 Pres. Lincoln created USDA 1887 Hatch Act for Agricultural Funding 1906 FDA or Division of Chemistry in USDA created with the passage of the Federal Food and Drugs Act 1914 Smith-Lever Act founded Cooperative Extension Service

7. History of pesticide regulation USDA, FDA, and EPA 1910 FIA, Federal Insecticide Act, by Congress to protect farmers from fraud 1947 FIFRA, Federal Insecticide, Fungicide, and Rodenticide Act regulated pesticides in USDA 1970 EPA created. 1972 FIFRA transferred to EPA 1980 Department of Health and Human Services created and FDA is part of it. 1987 Methyl bromide banned by the Montreal Protocol. Bromomethane is on the list of banned ozone depleting substances, which included Chlorofluorocarbons (CFCs), used in aeresol cans. Bromine is 60 times more destructive to ozone than chlorine, even small amounts of bromomethane cause considerable damage to the Ozone layer. 1996 Food Quality Protection Act (FQPA) amends FIFRA and FFDCA

8. History of pesticide regulation USDA 1987 Methyl bromide banned by the Montreal Protocol. Bromomethane is on the list of banned ozone depleting substances, which included Chlorofluorocarbons (CFCs), used in aeresol cans. Bromine is 60 times more destructive to ozone than chlorine, even small amounts of bromomethane cause considerable damage to the Ozone layer. 2000 President Bill Clinton (1993-2000) All USDA programs need to use IPM and 75% of all acreage in US needs to be under IPM by the 2000. 2005 and 2006 Methyl bromine was granted a critical use exemption under the Montreal Protocol for use in soil fumigation, quarantine fumigation, and grain product fumigation.

9. History of pesticide regulation 1996 Food Quality Protection Act in EPA reforms the nation's food safety laws. Signed into law by President Clinton on August 3, 1996, the act amends the two major laws involving pesticides: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA in EPA) and the Federal Food, Drug, and Cosmetic Act (FFDCA in FDA).

10. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA 1958 Delaney Clause no longer affects pesticides. 1. The Delaney Clause established a zero cancer risk standard for pesticide residues on some processed foods as compared to a negligible risk standard for raw commodities.A cancer risk standard for pesticide residues in some processed foods and with a single "safe" standard of a reasonable certainty of no harm to consumers for pesticide residues in raw and processed foods. The Delaney Clause attempted to address the possible link between some pesticides and human cancer. However, the law soon produced problems, the Delaney Paradox, a pesticide that could legally not be found in any amount in processed foods could be used on the raw commodity. The detection of pesticides improved over the years, making a zero tolerance standard difficult to meet.

11. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA 2. Provides Protection for Infants and Children Requires explicitly that pesticide residues be safe for infants and children and includes an additional safety factor of 100-fold, if necessary, to allow for uncertainty in data collected on children's diets. Also takes into account children's special sensitivity to pesticides.

12. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA 3. Toxicity & aggregate exposure: When setting a tolerance, the EPA now must consider aggregate exposure to compounds with a common mechanism of toxicity. Aggregate exposure includes not only dietary (food) sources of residues, but also exposure to non-food residues through water, gardens, lawns, golf courses, pets, homes, businesses, etc. Compounds with a common mechanism of toxicity would be such groups as OPs, pyrethroids, or Bts, and would also include pesticides with food and non-food uses. The "risk cup" is filled with the risk from aggregate exposure to pesticides with a common mechanisim of toxicity. When the risk cup is full, registrants must reduce risk prior to adding pesticides to the cup or eliminate uses.

13. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA 4. Review of tolerances: All existing tolerances will be reviewed over the next 10 years - 33% within 3 years, 66% within 6 years, and 100% within 10 years. The first reviews will focus on the "Worst First":1997: B2 ("probable human") carcinogens - pesticides which cause cancer in lab animals, but human evidence is lacking. Includes EBDC fungicides. 1998: Organophosphates (OPs) - pesticides which are toxic to humans due to their effect on acetylcholinesterase function. Includes such insecticides as Diazinon, Dursban, Guthion, Lorsban, Malathion, and Orthene. 1999: Carbamates - pesticides with a similar mode of action as OPs, but are often not as long-lasting in their effect. Includes Benlate, Furadan, and Sevin.

14. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA Endocrine disrupters: The endocrine system is a group of organs in the body, for example the thyroid, pituitary, thymus, ovaries, and testes, that secrete hormones directly into the blood stream. These hormones move to target cells in the body and influence development, reproduction, and metabolism. An endocrine disrupter is a compound that mimics or blocks a hormone, or disturbs its target. Endocrine disrupters therefore can disrupt normal body processes. Examples would include DDT, a pesticide which impacted bird reproduction, and thalidimide, a drug taken by pregnant women that caused birth defects. The EPA must test all pesticides (food or non-food use) and inert ingredients for endocrine disrupting effects. A blueprint for the screening program must be developed within two years, and the program itself must start within three years. No protocol is currently available for detecting and evaluating compounds as endocrine disrupters, but it is expected that the emphasis will be on estrogenic effects, and that the testing will use both cell culture and lab animals.

15. History of pesticide regulation 1996 Food Quality Protection Act FQPA revises the FFDCA 5. Sets National Uniformity Prohibits state and local governments from setting pesticide tolerances more rigid than those established by the EPA, unless states petition EPA for exception. 6. Gives Consumers Right To Know Requires EPA to prepare for produce retailers a brochure discussing the risks and benefits of pesticides, how to avoid risks including recommending substitute foods, and identifying foods that have tolerances for pesticide residues that were granted under the benefits provisions of FQPA. Recognizes states' rights to require warning or labels on food treated with pesticides, such as California's Proposition 65.

16. History of pesticide regulation FQPA Changes the Federal Insecticide, Fungicide and Rodenticide Act Pesticide (FIFRA in EPA) Reregistration Program: 1. Reauthorizes and increases user fees from $14 million to $16 million each year; the fees cover review of older pesticides to ensure they meet current standards. Makes reassessment of tolerances part of reregistration. 2. Pesticide Registration Renewal: Requires EPA periodic review of pesticide registrations to establish a 15-year cycle to ensure that all pesticides meet new safety standards. 3. Registration of Reduced-Risk Pesticides: Provides for quick review of reduced-risk pesticides to enable them to reach the market sooner to replace older, potentially more risky chemicals. 4. Minor-Use Pesticides: Establishes minor-use programs in EPA and USDA to coordinate use issues and policy and provides a revolving grant fund to develop data necessary to register minor- use pesticides.

17. History of pesticide regulation Impacts of FQPA 1. Loss of certain pesticide classes: A. triazine herbicides due to concerns about groundwater contamination and endocrine disruptionB. organophosphates C. carbamates due to toxicity concerns D. EBDC fungicides, which are targeted as B2 carcinogens. 2. Loss of minor uses: In order to meet the new standard of noharm resulting from aggregate exposure, registrants may choose to drop minor uses of a pesticide in favor of more profitable registrations. 3. Changes in labeling and usage: Rather than eliminate a use, a registrant could make changes in its product labeling, such increasing the reentry or preharvest intervals, changing protective equipment requirements, reducing rate, or lower AI formulation. 4. Lowering of tolerances: This is due to accounting for alleged sensitivity children, plus the combined effects of considering aggregate exposure and pesticides with common mechanisms of action.