Regulations Amending the New Substances Notification Regulations

Statutory Authority

Canadian Environmental Protection Act, 1999

Sponsoring Department

Department of the Environment

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The proposed Regulations Amending the New Substances Notification Regulations set forth for the industry a streamlined and flexible tracking requirement, which will permit industry to propose to Government additions to the Domestic Substances List (DSL) [e.g. for chemicals, polymers, biochemicals, biopolymers, and living organisms to be identified as a substance in Canadian commerce.]

These proposed Regulations amend the New Substances Notification Regulations (NSNR) to address new elements established in subsections 87(5) and 112(1) of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

The existing NSNR require notifiers to submit a notice of exceedence for manufacture or import, in order to have chemical, biochemical, polymer, or biopolymer substances listed on the DSL, provided that all other listing requirements are met.

These proposed Regulations provide notifiers with an alternative mechanism for adding a new chemical, biochemical, polymer or biopolymer to the DSL, by submitting a notice specifying that the person has started manufacturing or importing the chemical, biochemical, polymer or biopolymer, provided that all other listing requirements are met.

A notice for the manufacture or import of living organisms is not required by the existing NSNR.

In addition, these proposed Regulations provide the notifiers with a mechanism for the adding of a new living organism to the DSL, by requiring the submission of a notice specifying the starting date of manufacture or import of the living organism, provided that all other listing requirements are met.

These proposed Regulations will come into effect at the date of their registration.

Alternatives

These proposed Regulations reflect administrative modifications to the CEPA 1999. Using a voluntary approach would not satisfy the prescribed requirement specified in the CEPA 1999, and would not be appropriate, as these practices have been regulated since 1994 and have proven effective.

Benefits and Costs

Costs

Regulatees

For the chemical, biochemical, polymer, and biopolymer industries, no additional costs will result from these proposed Regulations, as the regulatees' effort to submit a notice specifying that the person has manufactured or imported the substance will be equivalent to and would replace the effort to file a notice of exceedence.

For living organisms, regulatees can expect only minor administrative costs such as a simple declaration similar to a Schedule 1 notification.

Government

Additional administrative costs (translation, proof reading, technical revision) associated with the publication of substances in the Canada Gazette.

Benefits

Regulatees

For the chemical, biochemical, polymer, biopolymer industries, these proposed Regulations will provide the regulatees with an opportunity to submit prescribed information before the maximum limit prescribed by the proposed Regulations has been exceeded. The proposed Regulations may reduce the tracking requirements for the manufacture/importation of chemicals, biochemicals, polymers, and biopolymers. They would also create for the industry a level playing field for tracking requirements in the North-American context.

These tracking requirements had previously been raised as a concern by the chemical and polymer industries in previous consultations. It is estimated that these changes may result in a significant workload reduction.

Government

The proposed Regulations will ensure that the Government is provided with the necessary information concerning chemicals, biochemicals, polymers, biopolymers, and living organisms, to determine whether or not a substance meets the criteria set forth in CEPA 1999, in order to be listed on the DSL (i.e. notice of commercial activity in Canada).

Consultation

In the summer of 2001, Environment Canada sent the proposed changes to the Industry Coordinating Groups that represent several chemical and industrial associations, and to the Biotechnology Group, whose members are also subject to the NSNR. The response from these groups was supportive of the initiative. Only minor changes were made to the proposed Regulations, as a result of the few comments received.

Upon publication of the proposed Regulations in Part I of the Canada Gazette, the private sector and the public will have 60 days to provide the Ministers with comments. These comments will be taken into consideration by the Ministers prior to the proposed Regulations being published in Part II of the Canada Gazette.

Compliance and Enforcement

Since the proposed Regulations will be promulgated under the CEPA 1999, enforcement officers will apply the Compliance and Enforcement Policy implemented under the Act. Their compliance promotion activities are limited to the distribution of the Act, the Regulations, and the CEPA 1999 Compliance and Enforcement Policy. The Policy outlines measures to be implemented by Environment Canada scientists and engineers to promote compliance, including education, information, and consultation on the development of proposed regulations.

This Policy sets out the range of possible responses to alleged violations: warnings, directions and environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court prosecution after the laying of charges for a CEPA 1999 violation). In addition, the policy explains when Environment Canada will resort to civil suits by the Crown for recovery of costs.

When, following an inspection or an investigation, a CEPA enforcement officer discovers an alleged violation, the officer will choose the appropriate enforcement action, based on the following criteria:

-- Nature of the alleged violation: This includes consideration of the seriousness of the harm or potential harm to the environment, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of the Act.

-- Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance with the Act within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator's history of compliance with the Act, willingness to cooperate with enforcement officers, and evidence that corrective action has already been taken.

-- Consistency in enforcement: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce the Act.

Contacts

David McBain, New Substances Branch, Toxic Pollution Prevention Directorate, Department of the Environment, Ottawa, Ontario K1A 0H3, (819) 997-4336 (Telephone), david.mcbain@ ec.gc.ca (Internet address) or Céline Labossière, Regulatory and Economic Analysis Branch, Economic and Regulatory Affairs Directorate, Department of the Environment, Ottawa, Ontario K1A 0H3, (819) 997-2377 (Telephone), celine.labossiere@ ec.gc.ca (Internet address).

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 ( S.C. 1999, c. 33), that the Governor in Council proposes, pursuant to paragraphs 89(1)(g) and (i.1) and 114(1)(c) of that Act, to make the annexed Regulations Amending the New Substances Notification Regulations.

Any person may, within 60 days after the publication of this notice, file with the Minister of the Environment comments with respect to the proposed Regulations or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Director, New Substances Branch, Toxic Pollution Prevention Directorate, Environmental Protection Service, Department of the Environment, Ottawa, Ontario K1A 0H3.

A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.

Ottawa, October 31, 2002

EILEEN BOYD

Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE NEW SUBSTANCES NOTIFICATION REGULATIONS

AMENDMENTS

1. The portion of subsection 12(1) ( SOR/97-119) of the New Substances Notification Regulations ( SOR/94-260) before paragraph (a) is replaced by the following:

12. (1) The periods within which the Ministers shall assess the information specified in a schedule referred to in section 6, 8, 10 or 16.1 are as follows:

2. The Regulations are amended by adding the following after section 16:

16.1 (1) The information that is prescribed with respect to a substance for the purpose of paragraph 87(5)(a) of the Act is the following:

(a) a notice from the person who provides the information, stating that the person has manufactured or imported the substance; and

(b) the information specified in

(i) Schedule II, if the substance is specified on the NDSL or if that information has been provided in accordance with subsection 6(6), or

(ii) Schedule III, in any other case.

(2) If the substance is a biotechnology product that is not derived from whole animals or whole plants, the person must provide, in addition to the information described in subsection (1), the information described in paragraph 10.1(1)(b).

3. The portion of subsection 25(1) ( SOR/97-119) of the Regulations before paragraph (a) is replaced by the following:

25. (1) The periods within which the Ministers shall assess the information specified in a schedule referred to in section 18, 19, 21, 23 or 28.2 are as follows:

4. The Regulations are amended by adding the following after section 29:

29.01 (1) The information that is prescribed with respect to a polymer for the purpose of paragraph 87(5)(a) of the Act is the following:

(a) a notice from the person who provides the information, stating that the person has manufactured or imported the polymer;

(b) for a polymer, other than a polymer described in subsection 19(1), the information set out in

(i) Schedule VII, except the information specified in subitem 2(2) of that Schedule, if the polymer is specified on the NDSL or if that information has been provided in accordance with subsection 18(4),

(ii) Schedule VII, if the polymer is not specified on the NDSL and if the polymer is manufactured solely from reactants that are substances specified on the DSL, or if that information has been provided in accordance with subsection 18(4), or

(iii) Schedule VIII, in any other case; and

(c) for a polymer described in subsection 19(1), the information specified in

(i) Schedule VI, if the polymer is specified on the NDSL or is manufactured solely from reactants that are substances specified on the DSL or the NDSL or if that information has been provided in accordance with paragraph 26(2)(a), or

(ii) Schedule VII, in any other case.

(2) If the polymer is a biotechnology product not derived from whole animals or whole plants, the person must provide, in addition to the information described in subsection (1), the information described in subsection 23.1(1) that is required in respect of that polymer.

5. Subsection 29.11(1) ( SOR/97-119) of the Regulations is replaced by the following:

29.11 (1) A person who manufactures or imports a micro-organism shall provide

(a) a notice indicating the date on which the person started to manufacture or import the micro-organism; and

(b) subject to subsections (2) to (6), the information specified in Schedule XV.

6. Subparagraph 29.12(a)(i) ( SOR/97-119) of the Regulations is replaced by the following:

(i) referred to in subsection 29.11(1)

(A) no later than 30 days after the start date of the manufacture or importation of the micro-organism, or within 120 days after this subparagraph comes into force, whichever is later, in the case of information referred to in paragraph 29.11(1)(a), or

(B) at least 120 days before the day on which the person manufactures or imports the micro-organism, in the case of information referred to in paragraph 29.11(1)(b);

7. Section 29.16 ( SOR/97-119) of the Regulations is renumbered as subsection 29.16(1) and is amended by adding the following:

(2) The person referred to in subsection (1) must also provide a notice indicating the date on which the person started to manufacture or import the organism.

8. Section 29.17 ( SOR/97-119) of the Regulations is replaced by the following:

29.17 (1) The information referred to in subsection 29.16(1) shall be provided at least 120 days before the day on which the person manufactures or imports the organism.

(2) The notice referred to in subsection 29.16(2) shall be provided no later than 30 days after the start date of the manufacture or importation of the organism, or within 120 days after this subsection comes into force, whichever is later.

9. The section references ( SOR/97-119) after the heading "SCHEDULE II" in Schedule II to the Regulations are replaced by the following:

(Paragraphs 6(1)(b) and (2)(b), subsection 6(3), paragraph 6(4)(a), subsections 6(5) and (6), paragraphs 8(1)(a) and (2)(b) and 10.1(1)(b), subsections 11(3), 12(2) and 13(1), paragraph 14.1(1)(b), section 15.1 and subparagraph 16.1(1)(b)(i))

10. The section references ( SOR/97-119) after the heading "SCHEDULE III" in Schedule III to the Regulations are replaced by the following:

(Paragraphs 6(1)(c) and (4)(b), subsection 6(6), paragraphs 8(1)(b) and 10.1(1)(b), subsections 11(3) and 12(2) and subparagraph 16.1(1)(b)(ii))

11. The section references ( SOR/97-119) after the heading "SCHEDULE VI" in Schedule VI to the Regulations are replaced by the following:

(Subparagraphs 18(1)(a)(i) and 19(2)(a)(i), paragraph 19(2)(b), subsections 19(3) and 23(1), paragraphs 23(3)(b) and 23.1(1)(a), subsections 24(3) and 25(2), clause 26(1)(a)(i)(A), paragraph 26(2)(a), subparagraph 26(2)(b)(ii), paragraphs 27(1)(b) and 27.1(1)(a), section 28.1 and subparagraph 28.2(1)(c)(i))

12. The section references ( SOR/97-119) after the heading "SCHEDULE VII" in Schedule VII to the Regulations are replaced by the following:

(Paragraph 18(1)(b), subsections 18(2) and (3), clause 19(2)(b)(ii)(B), paragraphs 23(3)(a) and 23.1(1)(b), subsections 24(3) and 25(2), clause 26(1)(a)(i)(B), paragraphs 26(1)(b), 27(1)(a) and 27.1(1)(b), section 28.1 and subparagraphs 28.2(1)(b)(i) and (ii) and (c)(ii))

13. The section references ( SOR/97-119) after the heading "SCHEDULE VIII" in Schedule VIII to the Regulations are replaced by the following:

(Clauses 18(1)(b)(ii)(B) and (2)(b)(ii)(B), paragraph 23.1(1)(b), subsections 24(3) and 25(2) and subparagraph 28.2(1)(b)(iii))

COMING INTO FORCE

14. These Regulations come into force on the day on which they are registered.

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