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

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

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

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  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 ITC’s 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).

  8. 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 Member’s 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.

  11. 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

  12. What does the ITC do? (continued) Develops strategies to identify chemicals with U.S. Government data needs, Suspicions of Toxicity, but FEW DATA

  13. What does the ITC do? (continued) Recommends or designates chemicals with U.S. Government data needs for testing or information reporting

  14. 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

  15. 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

  16. 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 rule’s Federal Register publication date. They are automatic final rules that are only promulgated for the ITC.

  17. 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

  18. 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

  19. 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

  20. 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 rule’s Federal Register publication date. They are automatic final rules that are only promulgated for the ITC.

  21. 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/what-we-do/databaseforms.aspx?id=384). Some newer records may be available at http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm

  23. 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

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