New Industrial Chemicals Notification and Assessment in the United States

• Name of the scheme: TSCA New Chemicals Program
• Language(s) which can be used for notification/registration: English
• Year when the scheme was established: 1979
• Year when the scheme was last modified: 1995

2-1 Contact in the government

• Rebecca S. Cool
  Office of Pollution Prevention and Toxics, Chemical Control Division
  U.S. Environmental Protection Agency
  EPA-East Building - Mail Code 7405M 1200 Pennsylvania Ave, NW, Washington DC 20460
  Telephone: 202-564-9138
  Fax: 202-564-9490
  E-mail: cool.rebecca@epamail.epa.gov
  Type of enquiry that can be handled: All

2-2 Contact in chemical industry associations

• Mike Walls or Steve Russell
  Product Stewardship
  American Chemistry Council
  1300 Wilson Blvd, Arlington, VA 22209, USA
  Telephone: 703-741-5167 (Mike Walls) or 703-741-5178 (Steve Russell)
  Fax: 703-741-6098
  E-mail: Mike_Walls@americanchemistry.com and Steven_Russell@americanchemistry.com
  Type of enquiry that can be handled: All

3-1 Legislation, its explanatory note and guidance for putting together a notification

• Name: TSCA, Federal Register/Code of Federal Regulations, Chemistry Assistance Manual for Premanufacture Notification Submitters and Instructions for Completing the Premanufacture Notice Form,
  Regulatory Information (http://)
  (1) OPPT Home Page ( www.epa.gov/opptintr)
  (2) TSCA New Chemicals Program Home Page ( www.epa.gov/opptintr/newchems)
  (3) TSCA Statute ( www.law.cornell.edu/uscode/15/ch53.html)
  (4)TSCA Inventory (searchable database) ( www.pdc.cornell.edu/issearch/tscasrch.htm)
  (5) TSCA Inventory (NTIS ordering information) ( www.ntis.gov/yellowbk/1nty268.htm)
  (6) 40 CFR Sections 700-799 ( www.epa.gov/docs/epacfr40/chapt-I.info/subch-R)
  (7) TSCA Federal Registers (10/94- present) ( www.epa.gov/fedrgstr/EPA-TOX)
  (8) CORR List ( www.epa.gov/opptintr/CORR)
  (9) Biotechnology Home Page ( www.epa.gov/opptintr/biotech)
  (10) Chemical Abstracts Service (CAS) ( www.cas.org)
  (11) Harmonized Testing Guidelines ( www.epa.gov/docs/OPPTS_Harmonized/)
  (12) TSCA PBT Policy ( www.epa.gov/fedrgstr/EPA-TOX/1999/November/Day-04/t28888.htm)
  (Note: Some of the above Internet documents may be available through the TSCA Hotline as well)
  
• Publications
  (1) 8(e) Triage ( www.epa.gov/opptintr/8e_triag)
  (2) Aqueous and Semi-Aqueous Solvent Guide ( www.epa.gov/opptintr/solvents)
  (3) Chemistry Assistance Manual for PMN Submitters ( www.epa.gov/opptintr/chem-pmn)
  (4) Consumer Labeling Initiative ( www.epa.gov/opptintr/labeling/index.html)
  (5) Chemical Right-to-Know Initiative (including the High Production Volume Challenge Program) ( www.epa.gov/chemrtk)
  (6) Lighting Waste Disposal (PCBs) ( www.epa.gov/GCDOAR/waste.html)
  (7) Master Testing List, 12/96 ( www.epa.gov/opptintr/main/mtl.htm)
  (8) National Center for Environmental Publications & Information ( www.epa.gov/ncepihom)
  (9) NCP Chemical Categories Report ( www.epa.gov/opptintr/newchems/chemcat.htm)
  (10) OECA Self Policing Policy (es.epa.gov/oeca/ore/tped/gendocs.html)
  (11) Points to Consider for Biotech Submissions ( www.epa.gov/opptintr/biotech/biorule.htm)
  (12) TSCA Enforcement Response Policies (es.epa.gov/oeca/ore/tped/toxpest.html)
  
• Resources Available from TSCA Hotline
  email: tsca-hotline@epa.gov (202) 554-1404 (phone), (202) 554-5603 (fax)- TSCA PMN Rule Amendments (60 FR 16298-16351, 3/29/95)
  - Revised PMN Form (EPA #7710-25)
  - Notice of Commencement Form (EPA #7710-56)
  - PMN Instruction Manual (Instructions for Completing the PMN Form)
  - Fact Sheet on 1995 PMN Rule Amendments
  - Draft Q&A on 1995 TSCA PMN Rule Amendments
  - 5/4/95 Public Meeting Agenda and Materials
  
• Inventory Background Papers
  - Information on CAS Resources and CAS Registry Services Inventory Expert Service
  - Polymer Exemption Guidance Manual (June, 1997)
  - Fact Sheet on the Low Volume Exemption
  -Draft LoREX Guidance
  - Exemptions for Research and Development and Test Marketing (1986-1, November 1986, Office of Toxic Substances).
• Purpose:TSCA gives general statutory background, FR/CFR gives rulemaking.
  Above cited manuals provide information for completing premanufacture notifications (PMNs).
• Intended audience: PMN Submitters
• Content: These are support and guidance documents for prospective PMN submitters. The New Chemicals Program also expects to have an extensive web site with many of these materials on it up: www.epa.gov/opptintr/newchms.htm
• Language(s): English
• Publication: In paper & electronic forms
• Date of publication: Various
• Charge for the information: Free of charge
• Contact for obtaining copy of information:
  TSCA Hotline
  c/o Office of Pollution Prevention and Toxics, Environmental Assistance Division
  401 M St., SW (mailcode 7408), Washington, DC 20460, USA
  Telephone: (202) 554-1404
  Fax: (202) 554-5603
  E-mail: tsca-hotline@epamail.epa.gov

4-1 Government gazette notices and inventory

• Name: Significant New Use Rules (SNURs)
  Notices of Commencement (NOCs) of Manufacture
  List of Pre-manufacture notifications (PMNs)
  TSCA Chemicals Substances Inventory
• Purpose: Record of activity for notified chemicals
• Intended audience: Chemical Industry
• Content: Self-explanatory.
• Type of chemicals included: Notified and/or assessed new chemicals
• No. of chemicals included: Over 35,000
• Language(s): English
• Publication: In electronic form
• Charge for the information:Free of charge
• Name/Division: TSCA Hotline
  c/o Office of Pollution Prevention and Toxics, Environmental Assistance Division
  401 M St., SW (mailcode 7408), Washington, DC 20460, USA
  Telephone: (202) 554-1404
  Fax: (202) 554-5603
  E-mail: tsca-hotline@epa.gov