1. Regulatory Controls PBT Strategy Team Great Lakes Regional Collaboration February 22, 2005

2. Clean Air Act 1977-1990 State Implementation Plans State Implementation Plans Enforcement and Permitting Enforcement and Permitting Ozone Protection Ozone Protection Prevention of Significant Deterioration Prevention of Significant Deterioration NAAQS for NO 2, CO, O 3, PM-10, SO 2, & Pb NAAQS for NO 2, CO, O 3, PM-10, SO 2, & Pb Visibility Protection Visibility Protection Emission Standards for Mobil Sources Emission Standards for Mobil Sources Air Quality Monitoring and Modeling Air Quality Monitoring and Modeling

3. Clean Air Act 1990 to Now Hazardous Air Pollutants (HAP) & MACT Hazardous Air Pollutants (HAP) & MACT National Emission Standards for HAPs National Emission Standards for HAPs New Source New Source Stationary Sources Stationary Sources Major sources Major sources > 10 tons per year of 1 HAP > 10 tons per year of 1 HAP 25 tons of >1 HAP 25 tons of >1 HAP Area sources -- non-major, same industrial group, common control, potential for accidental release, contiguous Area sources -- non-major, same industrial group, common control, potential for accidental release, contiguous Residual risk eight years after NESHAPs Residual risk eight years after NESHAPs

4. Clean Air Act “Toxic” EPA Administrator may add HAP by rule, after Review of pollutant’s presence, route of exposure, threat of adverse human health effects or adverse environmental effects Review of pollutant’s presence, route of exposure, threat of adverse human health effects or adverse environmental effects Human Health Effects including but not limited to: substances which are known to be, or may reasonably be anticipated to be, carcinogenic, mutagenic, teratogenic, neurotoxic, which may cause reproductive dysfunction, or which are acutely or chronically toxic) Human Health Effects including but not limited to: substances which are known to be, or may reasonably be anticipated to be, carcinogenic, mutagenic, teratogenic, neurotoxic, which may cause reproductive dysfunction, or which are acutely or chronically toxic) Adverse Environmental Effects through ambient concentrations, bioaccumulation, deposition, or otherwise Adverse Environmental Effects through ambient concentrations, bioaccumulation, deposition, or otherwise

5. Clean Water Act Wastewater Standards for Industry Wastewater Standards for Industry Scientific Water Quality Criteria Scientific Water Quality Criteria State Water Quality Standards for 64 toxic pollutants State Water Quality Standards for 64 toxic pollutants All Contaminants in Surface Water All Contaminants in Surface Water Aquatic Life, Human Health (fishable, swimmable, drinkable) Aquatic Life, Human Health (fishable, swimmable, drinkable) Numeric, Narrative (“free from toxicity”), Biological Criteria, Nutrient Criteria, Sediment Criteria Numeric, Narrative (“free from toxicity”), Biological Criteria, Nutrient Criteria, Sediment Criteria Construction Grants/SRF for Sewage Treatment Plants Construction Grants/SRF for Sewage Treatment Plants Great Lakes Critical Programs Act of 1990 Great Lakes Critical Programs Act of 1990 LaMPs/RAPs, GLI, schedule for States, monitoring LaMPs/RAPs, GLI, schedule for States, monitoring

6. Cleanup Enforcement Authority Comprehensive Environmental Response, Compensation, and Liability Act (Superfund) Comprehensive Environmental Response, Compensation, and Liability Act (Superfund) “Hazardous Substance” “Hazardous Substance” Resource Conservation and Recovery Act Resource Conservation and Recovery Act 500 specific hazardous wastes; wastes containing 40 toxic chemicals above regulatory threshold; ignitable, corrosive, or reactive wastes; and used oil 500 specific hazardous wastes; wastes containing 40 toxic chemicals above regulatory threshold; ignitable, corrosive, or reactive wastes; and used oil Oil Pollution Act Oil Pollution Act Oil (animal, vegetable, mineral) spills Oil (animal, vegetable, mineral) spills

7. ESA, EPCRA, & SDWA Endangered Species Act Endangered Species Act Prohibits any action that results in the “taking” of an endangered or threatened (listed) species or adversely impacts habitat Prohibits any action that results in the “taking” of an endangered or threatened (listed) species or adversely impacts habitat Emergency Planning and Community RTK Act Emergency Planning and Community RTK Act To protect public health, safety, and the environment from chemical hazards To protect public health, safety, and the environment from chemical hazards “Extremely hazardous substance” “Extremely hazardous substance” Safe Drinking Water Act Safe Drinking Water Act Screen & test for chemicals & pesticides for ED effects Screen & test for chemicals & pesticides for ED effects

8. Pesticide Programs FIFRA FIFRA Registering pesticide products for use based on a detailed assessment of the potential effects of a product on HH&E when used according to label instructions Registering pesticide products for use based on a detailed assessment of the potential effects of a product on HH&E when used according to label instructions Reevaluate older pesticides to ensure they meet more recent safety standards Reevaluate older pesticides to ensure they meet more recent safety standards Worker safety, applicator training & certification Worker safety, applicator training & certification FFDCA pesticide tolerances for food & feed FFDCA pesticide tolerances for food & feed

9. More Pesticide Programs Food Quality Protection Act Food Quality Protection Act Tolerances for pesticide residues in food Tolerances for pesticide residues in food Develop and implement an estrogenic effects screening program for all pesticides using validated test methods. Develop and implement an estrogenic effects screening program for all pesticides using validated test methods. EPA may require testing of other chemicals that may have an effect that is cumulative to a pesticide effect; data may be obtained via FIFRA, TSCA, or an order. EPA may require testing of other chemicals that may have an effect that is cumulative to a pesticide effect; data may be obtained via FIFRA, TSCA, or an order. Federal Advisory Committee Act: Federal Advisory Committee Act: TRAC, FSAC, EDSTAC, PPDC, SAP/SAB, SFIREG TRAC, FSAC, EDSTAC, PPDC, SAP/SAB, SFIREG

10. Toxic Substances Control Act Authority to track (and ban) industrial chemicals currently produced or imported Authority to track (and ban) industrial chemicals currently produced or imported Regulations to gather health/safety and exposure information, require testing, & control exposure Regulations to gather health/safety and exposure information, require testing, & control exposure Pre-Manufacture Notice (PMN) Pre-Manufacture Notice (PMN) Significant New Use Rule (SNUR) Significant New Use Rule (SNUR) Testing after reviewing volumes, release or exposure, or significant human exposure Testing after reviewing volumes, release or exposure, or significant human exposure Recordkeeping and reporting Recordkeeping and reporting Any person who learns that a chemical presents a substantial risk of injury to HH&E shall inform the EPA Administrator Any person who learns that a chemical presents a substantial risk of injury to HH&E shall inform the EPA Administrator

11. OSHA, VSTA, PPA Occupational Safety and Health Act Occupational Safety and Health Act Implemented by Department of Labor Implemented by Department of Labor Material Safety and Data Sheets required Material Safety and Data Sheets required Virus-Serum-Toxin Act and Plant Protection Act Virus-Serum-Toxin Act and Plant Protection Act Implemented by Department of Agriculture Implemented by Department of Agriculture Under VSTA, the Center for Veterinary Biologics ensures that veterinary biologics are pure, safe, potent, and effective Under VSTA, the Center for Veterinary Biologics ensures that veterinary biologics are pure, safe, potent, and effective Under PPA, the Animal and Plant Health Inspection Service has regulatory oversight over products of modern biotechnology Under PPA, the Animal and Plant Health Inspection Service has regulatory oversight over products of modern biotechnology

12. National Environmental Protection Act Federal agencies perform environmental impact statements or find no significant impact for major federal actions Federal agencies perform environmental impact statements or find no significant impact for major federal actions Actions include projects and programs Actions include projects and programs Use all practicable legal means to restore and enhance human environment Use all practicable legal means to restore and enhance human environment Avoid or minimize any possible adverse effects Avoid or minimize any possible adverse effects