Chemical Screening Programs Ted Smith Dale Phenicie
Slide 2
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
Slide 3
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
Slide 4
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
Slide 5
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
Slide 6
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
Slide 7
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
Slide 8
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
Slide 9
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
Slide 10
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
Slide 11
TRI PBT Reporting Lowered reporting thresholds for PBTs Lowered
reporting thresholds for PBTs PBTs identified plus doixin PBTs
identified plus doixin
Slide 12
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
Slide 13
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
Slide 14
FDA Approvals New drugs and food additives New drugs and food
additives Benefits must outweigh the risks Benefits must outweigh
the risks
Slide 15
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
Slide 16
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
Slide 17
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
Slide 18
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
Slide 19
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
Slide 20
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
Slide 21
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
Slide 22
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
Slide 23
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
Slide 24
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
Slide 25
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
Slide 26
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
Slide 27
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