Canada Overhauls CEPA NSN Scheme

Date: Oct 20, 2005

On September 21, 2005, revised Canadian Environmental Protection Act (CEPA) New Substance Notification (NSN) regulations were published in the Canada Gazette (Canada Gazette Part II, Vol. 139, No. 19 at 1,863).

  • Regulations repealing the current NSN regulations appear on p. 1,863 of the Gazette.
  • Regulations applying to Chemicals and Polymers appear on pp. 1,864-1,928 of the Gazette.
  • Regulations applying to Organisms appear on pp. 1,929-1,948 of the Gazette.
  • Amendments to the NSN fees regulations appear on pp. 2,198-2,203 of the Gazette.

The amended regulations and NSN scheme will become effective October 31, 2005. Notifiers and prospective notifiers will be subject to the former or revised scheme depending on whether certain notifications are received by Environment Canada before or after this date.

The amendments generally streamline and reduce requirements for chemicals and polymers. Under the amendments:

  • The CEPA Non-Domestic Substances List (NDSL) will no longer be based upon substances that have appeared on the U.S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory (TSCA Inventory) for five years, but will be updated semi-annually based on substances that have appeared on the TSCA Inventory for at least one year.
  • Notifiers will no longer be required to track their cumulative and in-possession quantities of substances.
  • The categories of "research and development" (R&D) and "product development" (PD) substances have been simplified into a single category.
  • Notifiers of special category (e.g., R&D, PD, site-limited intermediate, and export-only) substances are only required to submit test data that are already available.
  • Information requirements and the production quantities that trigger information submission have been optimized for each category of substance; depending on the type of substance, test requirements have been added, removed, and/or requested at a different quantity trigger.
  • New notification requirements have been added for high-volume chemicals and polymers that appear on the NDSL and that meet specific criteria indicative of significant release to the environment and/or human exposure.
  • Test data that must comply with the practices set out in the Organization for Economic Cooperation and Development (OECD) "Principles of Good Laboratory Practice" (GLP) have been specifically identified in the regulations.
  • Assessment periods have been optimized to better reflect the complexity of the assessment required.
  • Regulatees are required to keep a copy of the information and any supporting data at the person's principal place of business in Canada or at the principal place of business in Canada of a representative of that person, which must be retained for a period of five years after the year in which the information is provided.

The revised regulations are the culmination of an extensive stakeholder consultation by Environment Canada and Health Canada. In 1994, when the chemicals and polymers portion of the NSN regulations came into force, Environment Canada and Health Canada committed to conduct a formal review of the first three years of their implementation. A multistakeholder consultative process was initiated in 1999, which resulted in 76 consensus recommendations, many of which are reflected in the revised regulations.

If you would like additional information on the NSN amendments, please contact Tom Berger at berger@khlaw.com or (202) 434-4285.