2. Background
The NS (Notification, Assessment and Management) Program ensures that no new substance is imported into, or manufactured in, Canada without a formal review of its potential risks to human health and to the environment. The NSN Regulations, which came into effect on July 1, 1994, apply to chemicals and polymers. While a subsequent amendment to the NSN Regulations included animate products of biotechnology, the consultations did not address or make recommendations related to these other substances. However, it is inevitable that many recommendations of a program nature will lead to concurrent actions relating to the products of biotechnology component of the program (e.g., increasing transparency, service delivery).
The consultation recommendations do not address the specific requirements of Schedule XIV (Information required in respect of biotechnology products not derived from whole animals or whole plants); however, biochemicals and biopolymers will be affected by changes made to the new Regulations, since they are subject to the same regulatory structure.
There are no immediate plans to examine, via a multistakeholder process, the regulations pertaining to animate products of biotechnology (in effect since September 1, 1997), although some changes may be made to certain sections (e.g., research and development, or R&D).
The objectives laid out for the NSN Multistakeholder Consultations were "to identify, discuss and develop consensus recommendations on ways to improve the NSN Regulations and the Program." More specifically, the consultations were to:
- ascertain whether changes to the NSN Regulations are warranted based on five years of experience and on developments in similar programs in other countries, and make specific recommendations within the statutory framework of CEPA;
- ensure that the environment and human health continue to be protected from new toxic substances and substances that are capable of becoming toxic;
- make the NSN Regulations, policies and processes more efficient and more effective; and
- update the NSN Regulations with respect to CEPA 1999, recent government-wide policies and strategies, and future issues.
At the outset, stakeholders agreed that there were certain fundamental principles that the NSN Regulations and NS Program must incorporate and that the consultation must take into consideration. They were as follows:
- to promote high standards in the protection of human health and the environment;
- to incorporate methodology and process improvements that allow better use of industry and government resources to achieve health and environmental objectives;
- to enable government departments to provide a timely, predictable and transparent NS Program; and
- to support the ability of Canadian industry to compete in a global marketplace.
The final recommendations resulting from the NSN Multistakeholder Consultations, presented in Appendix 3, involve amendments to the Regulations and revisions to the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (hereafter referred to as "the Guidelines"), changes in program procedures, increased transparency, further collaboration with industry on various issues and intensifying international collaboration. Many of the recommendations touch on program policy, regulatory approach and resource allocations.
Some of the key changes resulting from the implementation of the recommendations include:
- a reduction in the number of notification schedules and, in some cases, an increase in the volume that triggers the need for a notification;
- a removal of cumulative volume tracking and "in-possession" tracking;
- simplified notification requirements for substances for R&D and "site-limited" substances, as well as no volume limit;
- a reduction of the time lag for addition to the Non-Domestic Substances List (NDSL) of substances added to the U.S. Toxic Substances Control Act (TSCA) inventory to one year from five years;
- the inventory status of monomers will no longer affect regulatory requirements for polymers of low concern (PLCs);
- increased testing for high-exposure NDSL substances;
- exemptions from mammalian toxicity testing requirements for certain classes of polymers to be specified in the new schedules;
- further opportunities for class waivers or exemptions for groups of substances;
- a requirement for full Good Laboratory Practice (GLP) documentation for toxicity and ecotoxicity studies; and
- improved guidelines to provide more extensive assistance to notifiers.
The Environment Canada/Health Canada response describes the manner in which Environment Canada and Health Canada will pursue the implementation of the recommendations and provides a general timeframe for implementation. The iterative process that was used for the development of the Environment Canada/Health Canada response is outlined in Figure 1.
A two-day response team workshop for approximately 20 government participants was held on December 12 and 13, 2001, to obtain an objective perspective from staff outside of the NS Program on consultation recommendations and considerations for their implementation. Participants included representatives from Environment Canada and Health Canada programs, regions and common support services who did not participate directly in the consultations. Participants provided their views, based on their experience and involvement in other departmental programs, on specific recommendations and their role in addressing the themes; technical, practical and policy considerations for their implementation; and relative priority and time required for implementation.
The departments then engaged in dialogue with the NSN Multistakeholder Table and other federal government departments, based on a first draft of the response document. Constructive comments were received and addressed appropriately in the finalization of this document.
The departments' overall approach for pursuing the implementation of the recommendations is based on relative priority, timing and ease of implementation.
Amendments to the NSN Regulations and revisions to the Guidelines will be made in parallel and initiated in 2002.
Figure 1: Process/Path Forward for Developing the Environment Canada/Health Canada Response
The Multistakeholder consultations on amending the New Substances Notification Regulations and the New Substances Program concluded in August 2001. A Response Team Workshop was held in December 2001. The Environment Canada/Health Canada Response Document was drafted from January to March 2002. Environment Canada and Health Canada participated in discussions regarding the draft response and the draft was circulated to consultation Table members and to the Response Team for their input. Other government departments were then consulted on the draft document in April 2002. The Final Report of the Consultations was published in May 2002. From May to June 2002, the Final Report and the draft Response document will be used to develop a detailed Action Plan for pursuing the implementation of the consultation recommendations. The Response document is expected to be published in Fall 2002. Revised Regulations will be available by 2004-2005. Amendments to the Program and publicly reporting on the progress of implementation of the recommendations are ongoing.
1 This Environment Canada/Health Canada response document was developed by Environment Canada and Health Canada. The following federal government departments were briefed via the ADM Committee on Toxics Management on the process related to implementing the consultation recommendations and were subsequently given an opportunity to provide input to the draft Environment Canada/Health Canada response: Industry Canada, Department of Fisheries and Oceans, the Pest Management Regulatory Agency, Natural Resources Canada, Agriculture and Agri-Food Canada, Privy Council Office, the Canadian Food Inspection Agency and the Department of National Defence.
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