Transcript EPA’s Existing Chemicals Programs and Initiatives

EPA’s
Existing Chemicals Programs and Initiatives
Presented to the North and South Carolina Chapter
American Industrial Hygiene Association
Charles Auer,
Director, Chemical Control Division
March 15, 2002
Why is the HPV Challenge
Needed?
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43% of the U.S. HPV chemicals have
no publicly available studies for any
of the 6 basic endpoints
Only 7% of the U.S. HPV chemicals
have a full set of publicly available
studies for the 6 basic endpoints
HPV Challenge Program
Goals and Approach
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HPV Challenge goal is public availability of a baseline
set of health and environmental effects data on
approximately 2800 HPV chemicals; goal is not testing
chemicals
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Defined list of chemicals and battery of tests – Screening
Information Data Set (SIDS)
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Submit detailed summary information in a uniform
database format (“robust summaries”)
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FR Notice issued December 26, 2000 (65 FR 81686)
HPV Challenge Program
Design Features
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Voluntary program for companies to make basic
hazard data on their HPV chemicals publicly
available by 2005
Strongly encourage greater international testing
efforts under OECD HPV/SIDS, ICCA
Public involvement at every step
Incorporate animal welfare considerations and
encourage use of SAR/category approach
SIDS Data Elements
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Chemical Identity
Chemical Name
CAS Registry Number
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Physical/Chemical Properties
Melting Point
Boiling Point
Vapor Pressure
Partition Coefficient
Water Solubility
SIDS Data Elements (cont.)
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Environmental Fate and Pathways
Biodegradation
Aerobic
Abiotic Degradability
Hydrolysis
Photolysis
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Fate and Environmental Distribution Assessment
SIDS Data Elements (cont.)
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Ecotoxicity
Acute Toxicity
Fish
Daphnia
Algae
Chronic Toxicity (when indicated)
Daphnia
SIDS Data Elements (cont.)
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Mammalian Toxicity
Acute Toxicity
Oral preferred if not available (except for
gases)
Repeated Dose Toxicity
Combined Repeat Dose and Reprotox Screen
(OECD 422) OR
28-day study (OECD 407)
SIDS Data Elements (cont.)
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Mammalian Toxicity (Con’t)
Genotoxicity
Gene mutation
Chromosomal aberrations
Reproductive/Developmental Toxicity
Combined Reproductive and Developmental
Toxicity Screen (OECD 420) OR
Combined Repeat Dose and Reprotox Screen
(OECD 422)
SIDS Data Elements (cont.)
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Report Other Available Hazard/Exposure Data - the
OECD SIDS “Dossier” includes reporting for:
Irritation
Sensitization
Carcinogenicity
Other physical/chemical properties
Human Experience
Exposure/Use Information
Etc.
HPV Challenge Program
Success
423 companies and 131
consortia have pledged to
voluntarily provide data on
over 2100 chemicals by 2005!
HPV Challenge Program
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Companies now submitting test plans and
robust summaries of existing data
Data are publicly accessible through
posting on Internet:
– www.epa.gov/chemrtk
HPV Challenge Program
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Companies exploring voluntary
submission of exposure data to provide
context for hazard data.
Companies should delay start of new
testing for 120 days after posting of test
plan to allow public comment.
Test Plan Performance
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121 Test Plans covering 776 chemicals have
been received by EPA. Test Plans cover 65
chemical categories and 56 single chemicals
116 Test Plans have been posted on EPA’s
web site for public comment
Test Plans are generally being sent to EPA
on the schedule committed to by the
sponsors.
Test rule to ensure equity ( 65 FR 81658)
Why the HPV Challenge Program
is Important to Your Work?
By 2005 :
 basic information available to
industry, government and the public
on all HPVchemicals.
 fully searchable database.
 as data are assessed, priority
chemicals are identified for additional
testing, assessment, or management.
Why is the Voluntary Children’s
Chemical Evaluation Program
(VCCEP) Needed?
“... review and report on what new testing may be
needed to address the special impact industrial
chemicals may have on children.”
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VCCEP developed via a public stakeholder
process.
VCCEP is not a testing program – hazards,
exposures, and risks of chemicals to children are
evaluated and if necessary information gaps are
to be filled.
FR Notice announcing the “Voluntary Children’s
Chemical Evaluation Program” issued December
26, 2000 (65 FR 81699).
The Pilot attempts to define a workable common
ground that meets the needs of diverse
stakeholders.
Key Features of the VCCEP
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Goal is publicly available data.
Strong chemical selection criteria –
biomonitoring data.
Tiered testing scheme.
Implementation process builds on and models
the HPV Challenge when ever possible.
Commitments made tier by tier in the Pilot.
Key Features of the VCCEP
(cont.)
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Role for exposure information gathering
and assessment.
Additional data development decisions
(such as testing) based on whether
chemical is adequately characterized given
the available data.
Peer Consultation promotes joint
stewardship of the program and a strong
science foundation.
23 Pilot Chemicals
Acetone
Benzene
Vinylidene chloride
Methyl ethyl ketone
Trichloroethylene
alpha-Pinene
o-Xylene
Ethylbenzene
p-Dichlorobenzene
[Ethylene dibromide]
Ethylene dichloride
m-Xylene
[ ] = unsponsored
Toluene
[Chlorobenzene]
n-Dodecane
p-Dioxane
Decane
Tetrachloroethylene
[m-Dichlorobenzene]
Undecane
Decabromodiphenylether
Pentabromodiphenyl ether
Octabromodiphenyl ether
1st Tier Toxicity Studies
(HPV Challenge Health-related Studies)
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Acute toxicity
Repeated dose toxicity with
reproductive and developmental
toxicity screens
Bacterial reverse mutation assay
In vitro or in vivo chromosomal
aberrations
nd
2
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Tier Toxicity Studies
Sub chronic (90 day) toxicity
Prenatal developmental toxicity
Reproductive and fertility effects
Metabolism and pharmacokinetics
Immunotoxicity
In vivo chromosomal aberrations or in
vivo micronucleus test
3rd Tier Toxicity Studies
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Carcinogenicity
Neurotoxicity screening battery
Developmental neurotoxicity
Exposure Assessments
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Biomonitoring data used for chemical selection contribute
to an overall assessment.
Depth of exposure information increases with each tier:
– Tier 1: screening level data
– Tiers 2 and 3: advanced assessments using exposure
studies, monitoring data, and modeling
Transparency
Exposure assessments need to address standard issues:
– Populations
– Routes of exposure
– Extent, duration and frequency of exposures
Peer Consultation
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Forum for scientists and experts from
stakeholder groups to exchange scientific
views on sponsor’s assessments.
Hoping for participation by State experts.
Not a consensus based approach.
Managed by an independent third party that
summarizes the consultation’s results and
forwards them to EPA.
Balanced science-based participation.
First Peer Consultation for Tier 1 assessments
anticipated mid-2002
Participation
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Tremendous support from chemical
manufacturers
20 of 23 chemicals sponsored
Over 35 sponsor companies
11 consortia (some sponsor multiple
chemicals)
Why is VCCEP Important to
Your Work?
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Complements HPV Challenge with
detailed testing and assessment.
Ability to develop key exposure data.
Peer consultation may provide
effective new way of working.
Information Access
For more information about HPV and
VCCEP and its pilot (including past Federal
Register Notices, HPV Test Plan Review
information, VCCEP Peer Consultation
information, guidance materials and other
technical materials) see:
www.epa.gov/chemrtk
PerFluoroOctyl Sulfonates (PFOS)
and Related Chemicals
PerFluoroOctyl Sulfonates; acids, salts,
halides,etc.
 Over 300 chemicals, including polymers.
 Man-made: do not occur in nature.
 Produced since 1950’s for use in surface
treatment, paper protection, and
performance chemical (surfactant and
insecticide) products.
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PFOS Concerns
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Persistent:
– Very stable chemical that does not break down or
degrade in the environment; once it’s there, it stays
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Bioaccumulative:
– PFOS can build up over time; its half-life in human
blood may be from 1 to 4 years
– Organisms higher-up in the food chain are
exposed to the full dose of what has built up in
their food
PFOS Concerns
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Toxic:
- In repeat dose systemic and reproductive
toxicity studies, serious effects seen
» Post-natal deaths in rats at 3.2 and 1.6 mg/kg/day
» In repeat-dose treated Rhesus monkeys, death
within 3 weeks at 10 mg/kg/day; within 7 weeks at
4.5 mg/kg/day. Adverse effects in cynomolgus
monkeys at 0.75 mg/kg/day
PFOS Concerns
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Exposure:
Detected in blood not only in workers
handling the chemical, but in the general US
population and in wildlife worldwide
– High as 12.83 ppm in manufacturing workers
– In pooled serum from general population, 30-40 ppb;
small sample of children, mean 54 ppb
– In birds, wild mammals, and fish, in ppb range
PFOS Withdrawal Strategy
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3M Corporation conducted studies, shared
results with EPA, and discussed concerns.
In May, 3M publicly announced voluntary
phase-out of perfluorooctanyl chemistries,
most by end of 2000, others by end of 2002.
3M continues aggressive research program.
EPA followed up voluntary action with
regulation.
PFOS Withdrawal Strategy
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EPA proposed and took public comment on a
Significant New Use Rule (SNUR) to manage 90
PFOS chemicals discontinued by 3M
Public meeting on March 27, 2001, raised
clarification questions, more information provided
from several industry sectors through October 2001
Follow-up actions published in the Federal
Register Monday, March 11, 2002
Follow Up Actions
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Final SNUR 67 FR 11008
concerns 13 known discontinued PFOS chemicals
making any new manufacture or importation a
significant new use; and
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Supplemental Proposed Rule 67 FR 11014
includes 75 additional chemicals,
proposing to exclude from the definition of
“significant new use” specifically defined, low
volume, controlled exposure uses in:
semiconductor manufacture;
aviation hydraulics;
photography;
Related Chemistry Concerns
 PFOA and related substitutes, such as fluorinated
“telomers”, may present
similar concerns:
– Known persistence.
– Evidence of toxicity data in public literature.
– PFOA also found in human blood, although at lower levels
than PFOS
EPA working with industry to answer key questions and
develop comprehensive database
– PFOA: similar bioaccumulative potential? fate and
transport?
– similar widespread exposure? Toxicity?
– Telomers: fate and transport? similar widespread exposure?
Toxicity? what degradates are formed from the telomers?
What is the degradates bioaccumulation potential?
Ongoing EPA Actions
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PFOS:
– Complete action on proposed SNUR for 88
3M phaseout PFOS chemicals.
– Consider need/options for action on other
200-plus PFOS chemicals.
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PFOA:
– Preliminary hazard assessment released
March 2002
– Assess new data as received.
– Identify needs/options for action.
Ongoing EPA Actions
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Telomers:
– Begin EPA review of existing data.
– Review submissions from voluntary
industry testing program in 2001-2002.
– Address existing, as yet unsubstantiated
market claims that telomerization products
are safer than fluorochemicals produced
through other processes.
State, Tribal, and Local Challenges- Why
PFOS Issue is Important to You?
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Hazard assessment outcomes on fluorochemicals
may influence future discharge and permitting
decisions at manufacturing plants and facilities.
Changes in fire fighting foam formulations over the
next 10 years may affect municipal, tribal, and
volunteer fire departments using synthetic foams
(different foam types require different equipment).
Alternatives will be developed to meet the many
other uses of PFOS: What is their safety and
effectiveness?
For Further Information on PFAS
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Staff Technical Contact:
Mary F. Dominiak, 202-564-8104,
[email protected]
For data CDs from PFOS/PFOA/telomer
file (AR-226), or for copies of comments
on SNUR (OPPTS-50639): TSCA NCIC,
202-260-7099, Monday-Friday, noon to
16:00 Eastern time; [email protected]