Chemical Screening Programs Ted Smith Dale Phenicie

U.S. Programs TSCA TSCA Inventory Inventory PMN PMN Inventory update Inventory update Significant adverse reaction reports (Sec. 8e) Significant adverse reaction reports (Sec. 8e) Additional data requests Additional data requests FIFRA FIFRA EPA OPPTS Harmonization of test guidelines EPA OPPTS Harmonization of test guidelines

U.S. Programs - Continued HPV Challenge HPV Challenge Voluntary Children's Chemical Evaluation Progam Voluntary Children's Chemical Evaluation Progam TRI PBT reporting thresholds TRI PBT reporting thresholds PBT profiler PBT profiler EPA endocrine screening program EPA endocrine screening program FDA regulated products screening FDA regulated products screening USDA food safety inspection program USDA food safety inspection program

U.S. Programs - Continued Federal hazardous substance act/CPSC hazard identification/labeling program Federal hazardous substance act/CPSC hazard identification/labeling program National toxicology program National toxicology program NIEHS NIEHS ATSDR ATSDR NIOSH NIOSH

International Programs CEPA-DSL CEPA-DSL EU REACH proposal EU REACH proposal EU interim PBT strategy EU interim PBT strategy UNECE convention on LRT POPs protocol UNECE convention on LRT POPs protocol Stockholm convention on POPs Stockholm convention on POPs UNEP Rotterdam convention UNEP Rotterdam convention UN Economic Social convention UN Economic Social convention CEC SMOC CEC SMOC International HPV program International HPV program

TSCA Inventory listing Inventory listing 1979 initial – 61,000 substances 1979 initial – 61,000 substances PMN Screening – 36,600 substances screened since 1976 PMN Screening – 36,600 substances screened since 1976 Inventory update – every 4 years, 1080 companies reported on 9,000 chemicals in ’02 Inventory update – every 4 years, 1080 companies reported on 9,000 chemicals in ’02 Sec 8(e) Sig. Adverse Reaction Reports – 15,000 reports Sec 8(e) Sig. Adverse Reaction Reports – 15,000 reports Sec 5 Additional Data Requests – 300 in ‘03 Sec 5 Additional Data Requests – 300 in ‘03

FIFRA Products registered – no unreasonable risk to public health and environment Products registered – no unreasonable risk to public health and environment Data submitted pursuant to EPA protocol Data submitted pursuant to EPA protocol Toxicology, physical properties, mobility, hazards to humans, animals, non-target organisms, potential to contaminate surface water or groundwater from leaching, runoff, and spray drift Toxicology, physical properties, mobility, hazards to humans, animals, non-target organisms, potential to contaminate surface water or groundwater from leaching, runoff, and spray drift

EPA OPPTS Harmonization Test protocols for substances subject to TCSA and FIFRA Test protocols for substances subject to TCSA and FIFRA Product performance, properties, fate transport and transformation, spray drift, ecological effects, residue chemistry, health effects, occupational and residential exposure, biochemicals, and microbial pesticides Product performance, properties, fate transport and transformation, spray drift, ecological effects, residue chemistry, health effects, occupational and residential exposure, biochemicals, and microbial pesticides

EPA HPV Challenge Human health and environment effects testing on high volume chemicals Human health and environment effects testing on high volume chemicals 2,800 chemicals produced or imported in quantities > 1 million lbs. per year 2,800 chemicals produced or imported in quantities > 1 million lbs. per year Physical properties, environmental fate, environmental toxicity, repeat dose toxicity, reproductive/developmental toxicity Physical properties, environmental fate, environmental toxicity, repeat dose toxicity, reproductive/developmental toxicity Does not include developmental neurotoxicity Does not include developmental neurotoxicity Chems. not subject to Challenge are subject to TSCA Sec. 4 follow-up testing requests Chems. not subject to Challenge are subject to TSCA Sec. 4 follow-up testing requests

VCCEP Identify potential risks to children associated with certain chemical exposures Identify potential risks to children associated with certain chemical exposures 23 specific chemicals found in human blood, breast milk, exhaled breath, indoor air, drinking water 23 specific chemicals found in human blood, breast milk, exhaled breath, indoor air, drinking water Manufacturers asked to volunteer to test Manufacturers asked to volunteer to test Chems not tested subject to TSCA Sec. 4 follow-up testing requests Chems not tested subject to TSCA Sec. 4 follow-up testing requests

TRI PBT Reporting Lowered reporting thresholds for PBTs Lowered reporting thresholds for PBTs PBTs identified plus doixin PBTs identified plus doixin

PBT Profiler Predicts PBT characteristics of compounds Predicts PBT characteristics of compounds Developed jointly by EPA, ACC, CCC, SOCMA and supported by Environmental Defense Developed jointly by EPA, ACC, CCC, SOCMA and supported by Environmental Defense Predicts on basis of chemical structure using data base containing over 100,000 discrete chemical substances Predicts on basis of chemical structure using data base containing over 100,000 discrete chemical substances

EPA Endocrine Disruptor Screening Program Identify potential EDCs Identify potential EDCs Also determine adverse effects, dose- response relationships, risk assessment and management needs – using existing laws Also determine adverse effects, dose- response relationships, risk assessment and management needs – using existing laws Protocols now under development Protocols now under development

FDA Approvals New drugs and food additives New drugs and food additives Benefits must outweigh the risks Benefits must outweigh the risks

USDA Food Safety Inspections Food supply contamination screening program Food supply contamination screening program Presence of agricultural chemicals, animal drugs, environmental contaminants Presence of agricultural chemicals, animal drugs, environmental contaminants

Federal Hazardous Substances Act Consumer Product Safety Commission Product hazard determination Product hazard determination Labels to warn of risk Labels to warn of risk Bans if labeling inadequate to protect public Bans if labeling inadequate to protect public

National Toxicology Program Substance evaluation using toxicology and molecular biology Substance evaluation using toxicology and molecular biology Best science employed to prioritize, design, conduct, and interpret studies Best science employed to prioritize, design, conduct, and interpret studies NIEHS/NIH, NIOSH/CDC, NCTR/FDA primary collaborators NIEHS/NIH, NIOSH/CDC, NCTR/FDA primary collaborators

NIEHS Evaluating if exposure to certain chemicals contributes to the development of cancer or reproductive disorders Evaluating if exposure to certain chemicals contributes to the development of cancer or reproductive disorders

ATSDR Toxicological profiles of substances Toxicological profiles of substances Profiles (or draft profiles) produced for 275 priority substances found at hazardous waste sites, or requested by Department of Defense or Energy Profiles (or draft profiles) produced for 275 priority substances found at hazardous waste sites, or requested by Department of Defense or Energy

NIOSH Hazardous chemical information guide (NIOSH Pocket Guide) Hazardous chemical information guide (NIOSH Pocket Guide) Hazard data provided for 677 compounds Hazard data provided for 677 compounds

International Programs CEPA DSL CEPA DSL List/categorize substances List/categorize substances Screen for toxicity Screen for toxicity Separate process for new chemicals Separate process for new chemicals 20,000 substances listed so far 20,000 substances listed so far Screening is underway Screening is underway

International Programs - Continued EU Reach Proposal EU Reach Proposal Collect data on, test, authorize new and existing chemicals Collect data on, test, authorize new and existing chemicals Industry submit data on hazards, exposure, risk associated with 30,000 substances Industry submit data on hazards, exposure, risk associated with 30,000 substances Authorization process that could restrict or ban substances deemed to pose significant risk to public health or environment Authorization process that could restrict or ban substances deemed to pose significant risk to public health or environment EC considering major changes to proposal EC considering major changes to proposal

International Programs - Continued EU Interim PBT Strategy EU Interim PBT Strategy Screening program establishes chemicals that are PBT and vPvB substances Screening program establishes chemicals that are PBT and vPvB substances 25 substances identified 25 substances identified 25 additional substances selected for reveiw 25 additional substances selected for reveiw

International Programs - Continued UNECE Convention on LRT POPs Protocol UNECE Convention on LRT POPs Protocol Risk criteria used to select Ops for ban and/or restrictions on use and/or release Risk criteria used to select Ops for ban and/or restrictions on use and/or release 16 substances selected 16 substances selected 8 banned 8 banned 4 to be eliminated at later date 4 to be eliminated at later date 4 releases restricted 4 releases restricted

International Programs - Continued Stockholm POPs Convention Stockholm POPs Convention Controls production, use, and/or emission of 12 POPs of “historical concern” Controls production, use, and/or emission of 12 POPs of “historical concern” Included mechanism for considering additions to the list of POPs Included mechanism for considering additions to the list of POPs National implementation plans due May 2006 National implementation plans due May 2006

International Programs - Continued UNEP Rotterdam Convention UNEP Rotterdam Convention Importers/exporters must exchange chemical hazard information regarding potentially hazardous chemicals Importers/exporters must exchange chemical hazard information regarding potentially hazardous chemicals UN Economic and Social Council UN Economic and Social Council Harmonizes chemical hazard communication information throughout the world Harmonizes chemical hazard communication information throughout the world

International Programs - Continued CEC SMOC CEC SMOC Chemical selection process for identifying priority chemical pollution issues of Regional concern. Chemical selection process for identifying priority chemical pollution issues of Regional concern. International HPV Program International HPV Program Internationally harmonized hazard assessment data for 1000 HPV chemicals – more than 90 percent of global chemical production Internationally harmonized hazard assessment data for 1000 HPV chemicals – more than 90 percent of global chemical production