Consultations on the CEPA New Substances Notification Regulations and New Substances Program - Final Report of the Multistakeholder Consultations

2. Background and Context of Multistakeholder Consultations on the NSN Regulations and NS Program

• 2.1 Introduction to the NSN Regulations
• 2.2 Focus of the Consultations on the NSN Regulations and NS Program
• 2.3 Guiding Principles of the NSN Table Deliberations

The NSN Regulations apply to chemicals, polymers and inanimate and animate products of biotechnology. These consultations did not address or make recommendations related to animate products of biotechnology because this was beyond their scope.

For the purposes of this report, the term "substances" will include only chemicals, polymers and inanimate products of biotechnology.

2.1 Introduction to the NSN Regulations

CEPA¹ was promulgated in 1988. Following a five-year review, it was replaced with a revised Act (CEPA'99) on March 31, 2000. Unless expressly stated to the contrary, all references to CEPA in this report are to CEPA'99. One of the objectives of CEPA is to ensure that no new substance is imported into or manufactured in Canada without a formal review, prior to market introduction, of its potential risks to human health and to the environment. The "Substances and Activities New to Canada" provisions in Part 5 of CEPA² are the authority under which the NS Program performs the risk assessments and manages chemicals and polymers when risks are identified. The NSN Regulations, which came into effect on July 1, 1994, are the principal means by which the authority is enacted.

The NSN Regulations require importers and manufacturers to notify Environment Canada of substances and activities new to Canada. The information that notifiers must submit to government is described in regulatory "schedules." The notification packages typically include test data relating to physicochemical properties, environmental fate and behaviour and/or toxicity. A detailed description of the NS Program, including the role of the Domestic Substances List (DSL) and the Non- Domestic Substances List (NDSL), is available on Environment Canada's NS Program web site.

Environment Canada is responsible for the administration of the NS Program, the assessment of potential risks to the environment, development and implementation of controls, compliance promotion and enforcement. Health Canada carries out the assessment of potential risks to human health. Notifiers are responsible for providing the information packages and any associated costs. NS Program costs are currently borne by Environment Canada and Health Canada; however, a cost recovery initiative is being pursued³ to recover some of the costs from notifiers. Table members agreed that, because of this other initiative, cost recovery would not be part of its deliberations. However, the Table recognizes that fees associated with cost recovery may need to be reexamined depending on the extent of the amendments to the NSN Regulations.

Multistakeholder consultations and review of the NS Program, procedures and practices have been, and continue to be, critical to the successful implementation of the NSN Regulations. The current NSN Regulations incorporate recommendations of the Environmental Contaminants Act Amendments Consultative Committee,⁴ a multistakeholder body. When the NSN Regulations were promulgated, a commitment was made on the part of Environment Canada and Health Canada to review the NSN Regulations following three years of their implementation. This exercise fulfils this promise.

2.2 Focus of the Consultations on the NSN Regulations and NS Program

In June 1999, Environment Canada and Health Canada established a multistakeholder consultative process to work towards common understanding of the NSN Regulations and NS Program and to provide consensus recommendations for their improvement. An independent facilitator and a Secretariat were contracted to design and implement the consultative process. Following discussions with several stakeholders, invitations to participate in the process (i.e., sit at the Table) were accepted by individuals representing Environment Canada (two seats), Health Canada (two seats) and Industry Canada (one seat), representatives of a broad range of industries affiliated with the NS Program (seven seats in total) and PAG representatives (three from the Canadian Environmental Network, two from Labour, one from the Consumers Association of Canada and one from the Canadian Public Health Association). A listing of individual participants and their affiliations is provided in Appendix 1. Several stakeholder groups declined a seat at the Table but requested that they be kept informed of the progress of the consultations (e.g., provinces, territories and Aboriginal associations).

The NSN Table held eight meetings and numerous subcommittee and other meetings between November 1999 and August 2001 to produce this report. At its first meeting, the Table agreed that the objective of this consultative process would be "to identify, discuss and develop consensus recommendations on ways to improve the NSN Regulations and the Program." The Table also agreed on a set of "procedural rules" to guide its deliberations (see Appendix 2). One of the rules states that each participant has an obligation to strive to consensus; however, where consensus cannot be reached on a particular issue despite best efforts, the differing views relating to that issue will be clearly articulated. This report recognizes this agreement.

The NSN Table acknowledges that consensus recommendations pertaining to amendments of the current NSN Regulations cannot bind the Parliamentary process (Cabinet is responsible for, and accountable for, making Regulations). Nevertheless, all Table members have agreed to support the consensus recommendations as a package. Government representatives in particular have undertaken to do their best to ensure that consensus recommendations will be reflected in any ensuing changes to the NSN Regulations and NS Program. Where this may not occur, Environment Canada and Health Canada representatives will report back to all Table participants any deviations from the consensus and the reasons therefor.

During its deliberations, the NSN Table considered information available in the public domain as well as information provided or generated by Table members, consultants or experts invited to attend specific sessions. Key documents used by the Table are referenced in the footnotes and in Appendix 3 of this report. A list of acronyms and definitions for technical and commercial terms used in this report are included in Appendix 4. The remaining appendices are as follows: 5- Description of the "New Substances" Industry Sector in Canada; 6- Proposed Requirements for Non-Good Laboratory Practice (GLP) Studies; 7- Additional Information on the Assessment of Degradation Products; and 8- Test Criteria for the Sunrise Approach.

2.3 Guiding Principles of the NSN Table Deliberations

The NSN Table members agreed that there are certain fundamental principles that the NSN Regulations and NS Program must incorporate and that, consequently, must always be weighed by the Table in developing its recommendations. The expectation of the Table members is that the NSN Regulations and NS Program will:

• promote high standards in the protection of human health and the environment;
• incorporate methodology and process improvements that allow better use of industry and government resources to achieve health and environmental objectives;
• enable government departments to provide a timely, predictable and transparent NS Program; and
• support the ability of Canadian industry to compete in a global marketplace.

The main focus of these consultations was on developing recommended amendments to the NSN Regulations and NS Program. However, it was necessary to set some boundaries on the scope of the consultations. These were discussed and agreed to at the first and second meetings. Table 2.1 describes the boundaries for the scope of the consultations on the NSN Regulations and NS Program set by the Table.

¹ Government of Canada, Canadian Environmental Protection Act (CEPA) Part 2 -- Toxic Substances: Substances New to Canada (1999); available at: http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=AB189605-1
² Government of Canada, New Substances Notification Regulations (July 1994); available at: http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=A2228809-1
³ Environment Canada, New Substances web site
⁴ Environment Canada and Health and Welfare Canada, Final Report of the Environmental Contaminants Act Amendments Consultative Committee (1986); available from the New Substances Notification Branch, Environment Canada.