The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC)

1
The Toxic Substances Control Act (TSCA)
Interagency Testing Committee (ITC)
2
What is the ITC?

• An Independent Advisory Committee to the
  Administrator of the U.S. Environmental
  Protection Agency (U.S. EPA) that was created in
  1976 under section 4(e) of TSCA

3
What are the 8 TSCA section 4(e) chemical
screening factors that the ITC must consider
before recommending a chemical for testing?

• 1. Quantities of chemicals manufactured
• 2. Quantities of chemicals released to the
  environment
• 3. Numbers of individuals exposed and duration of
  exposure
• 4. Extent of human exposure
• 5. Structure activity relationships to known
  toxic substances
• 6. Available toxicity data
• 7. Reliability of test data to predict hazard
• 8. Availability of testing facilities

4
What other statutory mandates are authorized by
TSCA section 4(e) ?

• 1. ITC must give high priority to chemicals that
  cause birth defects, cancer and gene mutations
• 2. ITC must designate chemicals for which the
  U.S. EPA Administrator should promulgate testing
  rules within 12 months of the designation
• 3. ITC must not add more than 50 designated
  chemicals to the Priority Testing List
• 4. At least every 6 months, the ITC must send a
  Report to the U.S. EPA Administrator announcing
  revisions to the Priority Testing List

5
What other statutory mandates are authorized by
TSCA section 4(e) ?

• 5. Upon receipt of ITC Reports, the U.S. EPA
  Administrator must publish them in the Federal
  Register
• 6. The U.S. EPA Administrator must provide
  opportunity for public comment on the ITCs
  Reports
• 7. Within 12 months of receiving an ITC Report,
  the U.S. EPA Administrator must publish in the
  Federal Register either a rule requiring testing
  of a designated chemical or a notice explaining
  why a test rule is not being published
• 8. The U.S. EPA Administrator must provide
  support to allow the ITC to implement TSCA
  section 4(e)

6
Which U.S. Government organizations are Statutory
Members ?

• The President's Council on Environmental Quality
  (CEQ),
• Department of Commerce (DOC),
• U.S. Environmental Protection Agency (EPA),
• National Cancer Institute (NCI),
• National Institute of Environmental Health
  Sciences (NIEHS),
• National Institute for Occupational Safety and
  Health (NIOSH),
• National Science Foundation (NSF) and
• Occupational Safety and Health Administration
  (OSHA).

7
Which U.S. Government organizations are Liaison
Members ?

• Agency for Toxic Substances and Disease Registry
  (ATSDR),
• Consumer Product Safety Commission (CPSC),
• Department of Defense (DoD),
• Department of the Interior (DoI),
• Food and Drug Administration (FDA),
• U.S. Department of Agriculture (USDA).

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What are the TSCA section 4(e) requirements for
Statutory Members?

• Serve 4-year terms,
• Cannot accept employment or compensation from a
  company subject to TSCA section 4 until 12 months
  after leaving the ITC
• Cannot own stocks or bonds or have any pecuniary
  interest in any company subject to TSCA section 4

9
What support does the U.S. EPA provide to the ITC?

• The U.S. EPA provides support for 2 ITC staff
  members, travel and training funds, an extramural
  contractor and resources to
• 1) prepare and publish ITC Reports in the Federal
  Register,
• 2) prepare and publish Federal Register rules
  that require submission of TSCA 8(a) and 8(d)
  data for ITC recommended chemicals and
• 3) prepare and publish Federal Register notices
  to implement testing of ITC recommended chemicals.

10
What support do Statutory and Liaison Members
provide to the ITC?

• Statutory and Liaison Members provide resources
  and travel funds to participate in ITC meetings
  and to
• 1) develop nominations of chemicals for
  recommendation by reviewing data and meeting with
  others in their organizations,
• 2) review unpublished data submitted for
  recommended chemicals,
• 3) work with the U.S. EPA to implement the
  recommended testing and to utilize the data
  resulting from the recommended testing.

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What does the ITC do?

• Meets at least every 6 months to prioritize and
  select chemicals for information reporting and
  testing to meet the coordinated data needs of its
  member U.S. Government organizations

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What does the ITC do? (continued)

• Develops strategies to identify chemicals with
  U.S. Government data needs, Suspicions of
  Toxicity, but FEW DATA

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What does the ITC do? (continued)

• Recommends or designates chemicals with U.S.
  Government data needs for testing or information
  reporting

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What does the ITC do? (continued)

• Every May November,
• adds or removes chemicals with
• U.S. Government data needs to or
• from the Priority Testing List in
• Reports to the U.S. EPA
• Administrator

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What does the ITC do? (continued)

• Asks the U.S. EPA to add Priority Testing List
  chemicals to TSCA section 8(a) Preliminary
  Assessment Information Reporting (PAIR) rules

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What do PAIR rules require?

• PAIR rules require manufacturers and importers of
  Priority Testing List chemicals to submit
  production and worker exposure data within 90
  days of the rules Federal Register publication
  date. They are automatic final rules that are
  only promulgated for the ITC.

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What data must be reported under a PAIR rule?

• Quantity of chemicals manufactured or imported
• Quantity of chemicals lost to the environment
• Quantity of chemicals manufactured in open,
  controlled release or closed systems
• Number of workers and worker hours associated
  with chemical manufacture

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Are PAIR data publicly available?

• PAIR data are not publicly available, because
  they contain TSCA Confidential Business
  Information (CBI).
• PAIR data can only be reviewed by Federal
  employees who have clearance to review TSCA CBI

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What does the ITC do? (continued)

• Asks the U.S. EPA to add Priority Testing List
  chemicals to TSCA section 8(d) Health and Safety
  Data Reporting (HaSDR) rules

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What do HaSDR rules require?

• HaSDR rules require importers, manufacturers and
  processors of Priority Testing List chemicals to
  submit unpublished Health and Safety studies
  within 90 days of the rules Federal Register
  publication date. They are automatic final rules
  that are only promulgated for the ITC.

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What types of studies must be reported under a
HaSDR rule?

• Health effects
• Ecological effects
• Environmental fate
• Bioaccumulation
• Metabolism
• Monitoring and exposure

22
Are studies reported under a HaSDR rule publicly
available?

• Studies reported under a HaSDR rule are publicly
  available from the U.S. EPA TSCA docket, the NTIS
  and Syracuse Research Corporation. Studies
  reported under a HaSDR rule that were indexed
  prior to 12/08/2004 are in the TSCA Test
  Submissions (TSCATS) database (http//srcinc.com/w
  hat-we-do/databaseforms.aspx?id384). Some newer
  records may be available at http//yosemite.epa.go
  v/oppts/epatscat8.nsf/ReportSearch?OpenForm

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Where can I learn more about the ITC?

• http//www.epa.gov/oppt/itc
• Member Organizations
• Reports
• Chemicals
• TSCA section 8(a) 8(d) rules
• Frequently Asked Questions