EPA

1
EPAs Existing Chemicals Programs and
Initiatives Presented to the North and South
Carolina ChapterAmerican Industrial Hygiene
Association

• Charles Auer,
• Director, Chemical Control Division March 15,
  2002

2
Why is the HPV Challenge Needed?

• 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

3
HPV Challenge ProgramGoals and Approach

• 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
• Defined list of chemicals and battery of tests
  Screening Information Data Set (SIDS)
• Submit detailed summary information in a uniform
  database format (robust summaries)
• FR Notice issued December 26, 2000 (65 FR 81686)

4
HPV Challenge ProgramDesign Features

• 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

5
SIDS Data Elements

• Chemical Identity
• Chemical Name
• CAS Registry Number
• Physical/Chemical Properties
• Melting Point
• Boiling Point
• Vapor Pressure
• Partition Coefficient
• Water Solubility

6
SIDS Data Elements (cont.)

• Environmental Fate and Pathways
• Biodegradation
• Aerobic
• Abiotic Degradability
• Hydrolysis
• Photolysis
• Fate and Environmental Distribution Assessment

7
SIDS Data Elements (cont.)

• Ecotoxicity
• Acute Toxicity
• Fish
• Daphnia
• Algae
• Chronic Toxicity (when indicated)
• Daphnia

8
SIDS Data Elements (cont.)

• 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)

9
SIDS Data Elements (cont.)

• Mammalian Toxicity (Cont)
• 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)

10
SIDS Data Elements (cont.)

• 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.

11
HPV Challenge Program Success

• 423 companies and 131 consortia have pledged to
  voluntarily provide data on over 2100 chemicals
  by 2005!

12
HPV Challenge Program

• Companies now submitting test plans and robust
  summaries of existing data
• Data are publicly accessible through posting on
  Internet
• www.epa.gov/chemrtk

13
HPV Challenge Program

• 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.

14
Test Plan Performance

• 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 EPAs 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)

15
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.

16
Why is the Voluntary Childrens 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.

17

• 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 Childrens
  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.

18
Key Features of the VCCEP

• 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.

19
Key Features of the VCCEP (cont.)

• 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.

20
23 Pilot Chemicals

• Acetone Toluene
• Benzene Chlorobenzene
• Vinylidene chloride n-Dodecane
• Methyl ethyl ketone p-Dioxane
• Trichloroethylene Decane
• alpha-Pinene Tetrachloroethylene
• o-Xylene m-Dichlorobenzene
• Ethylbenzene Undecane
• p-Dichlorobenzene Decabromodiphenylether
• Ethylene dibromide Pentabromodiphenyl
  ether
• Ethylene dichloride Octabromodiphenyl ether
• m-Xylene
• unsponsored

21
1st Tier Toxicity Studies(HPV Challenge
Health-related Studies)

• Acute toxicity
• Repeated dose toxicity with reproductive and
  developmental toxicity screens
• Bacterial reverse mutation assay
• In vitro or in vivo chromosomal aberrations

22
2nd 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

23
3rd Tier Toxicity Studies

• Carcinogenicity
• Neurotoxicity screening battery
• Developmental neurotoxicity

24
Exposure Assessments

• 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

25
Peer Consultation

• Forum for scientists and experts from stakeholder
  groups to exchange scientific views on sponsors
  assessments.
• Hoping for participation by State experts.
• Not a consensus based approach.
• Managed by an independent third party that
  summarizes the consultations results and
  forwards them to EPA.
• Balanced science-based participation.
• First Peer Consultation for Tier 1 assessments
  anticipated mid-2002

26
Participation

• Tremendous support from chemical manufacturers
• 20 of 23 chemicals sponsored
• Over 35 sponsor companies
• 11 consortia (some sponsor multiple chemicals)

27
Why is VCCEP Important to Your Work?

• Complements HPV Challenge with detailed testing
  and assessment.
• Ability to develop key exposure data.
• Peer consultation may provide effective new way
  of working.

28
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

29
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 1950s for use in surface
  treatment, paper protection, and performance
  chemical (surfactant and insecticide) products.

30
PFOS Concerns

• Persistent
• Very stable chemical that does not break down or
  degrade in the environment once its there, it
  stays
• 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

31
PFOS Concerns

• 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

32
PFOS Concerns

• 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

33
PFOS Withdrawal Strategy

• 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.

34
PFOS Withdrawal Strategy

• 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

35
Follow Up Actions

• ? Final SNUR 67 FR 11008
• concerns 13 known discontinued PFOS chemicals
  making any new manufacture or importation a
  significant new use and
• 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

36
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?

37
Ongoing EPA Actions

• PFOS
• Complete action on proposed SNUR for 88 3M
  phaseout PFOS chemicals.
• Consider need/options for action on other
  200-plus PFOS chemicals.
• PFOA
• Preliminary hazard assessment released March 2002
• Assess new data as received.
• Identify needs/options for action.

38
Ongoing EPA Actions

• 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.

39
State, Tribal, and Local Challenges- Why PFOS
Issue is Important to You?

• 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?

40
For Further Information on PFAS

• Staff Technical Contact
• Mary F. Dominiak, 202-564-8104,
  dominiak.mary_at_epa.gov
• 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 1600 Eastern time
  oppt.ncic_at_epa.gov