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Dr. Neil TolsonHead, In Commerce Substances Unit 1New Substances Assessment and Control Bureau The In Commerce List EnviroPharm 2009 O1 October 2009
Introduction • Background • Revision Process • Communications Strategy for Revision Process • Next Steps • Contact Information and Website Address
Background: What is the In Commerce List • The In Commerce List (ICL) consists of approximately 9,000 substances in products subject to the regulations of the Food and Drugs Act that were in commerce between 01 Jan. 1987 and 13 Sept. 2001. • The current list was created in 2001 from records in HC commodity groups. • Each entry has a maximum of three pieces of information: CAS Name, CAS Number and alternate name. • Substances on the ICL are defined as “new” substances under CEPA, i.e., they are not on the DSL, however, under the current policy NSNR requests will not be made for ICL substances
Background: The Need to Revise the ICL The current list has a number of deficiencies, including: • incorrect information, e.g., CAS numbers do not match CAS names; • omissions: substances in commerce that were not in HC records; duplications: the same substance may be present under a different name; • substances on the DSL; • lack of information: most substances do not have a CAS Number and CAS Name; the list does not contain structures, use patterns, or annual volumes
Background: Management of ICL Substances • Revision of the current ICL • 2. Categorization/prioritization substances on the revised ICL • 3. Assessment of risks of ICL substances to humans (indirect exposure) and to the environment • 4. Proposal of risk mitigation measures, where required
Revision Process: Multi-stakeholder Consultations • The ICL technical subcommittee was established in 2007 under the multi-stakeholder Environmental Assessment Working Group (EAWG). • The ICL subcommittee’s work has focused on what substances should be nominated to the revised ICL, what substances should be excluded, and the process on how to submit nominations to a revised ICL.
Revision Process: Nomination Process • The revision of the ICL will be based on a two-phase nomination process • Industry will submit information to HC to enable the identification of each substance • For substances on the current ICL, no proof of in commerce required. Substances not on the current ICL will require proof of in commerce
Revision Process: Additions to the Current ICL • Health Canada is accepting requests for additions to the ICL until the nomination process for revision of the ICL is initiated. • To date approximately 300 substances have been added to the ICL following receipt requests and assessment of the supporting information from manufactures and importers. • Enquiries on the process for submitting a request for additions to the ICL should be addressed to the In Commerce Substances Unit 1 (see slide on contact information).
Revision Process: Verification of Substance Identity To Date • The identity of 2200 substances on the current ICL, approximately 25% of the List, has been verified through a contract with Chemical Abstract Services (CAS). These substances will be added directly to the revised ICL.
Communications Strategy: Components • A communications strategy for stakeholders and the public has been prepared. The strategy includes: distribution of the Guidance Document; presentations to industry; HC website for the ICL; and, an e-mail address and telephone line for enquiries
Communications Strategy:Guidance Document For Nomination Process • Acomprehensive Guidance Document on the nomination process will be available on line. It will contain information on what to nominate, how to nominate and nomination forms.
Communications Strategy: HC Website • An updated ICL website has been activated, effective June 2009. A subscribers option is being be added for stakeholders and the subscribers will be notified automatically by e-mail of updates to the website.
Next Steps: Nomination Process • Conclude consultations • Initiate the communications strategy, including production of the Guidance Document • Launch the first phase of the nomination process
Next Steps: Prioritization Process • Preliminary work is being conducted by Health Canada on approaches to prioritize substances on the ICL.
Contact Information • Neil Tolson • Head, In Commerce Substances Unit 1 • New Substances Assessment and Control Bureau • 123 Slater Street, 5th Floor • Ottawa Ontario K1A 0K9 • PL 3505A • neil_ tolson @hc-sc-gc.ca • Tel. 613-941-0144
Website Address • Information on the ICL, including substances on the current list, can be obtained from the following website: • http://www.hc-sc.gc.ca/ewh-emt/contaminants/person/impact/list/index-eng.php