Vol. 137, No. 13 — June 18, 2003

Registration
SOR/2003-214 5 June, 2003

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Regulations Amending the New Substances Notification Regulations

P.C. 2003-871 5 June, 2003

Whereas, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 (see footnote a) , the Minister of the Environment published in the Canada Gazette, Part I, on November 2, 2002, a copy of the proposed Regulations Amending the New Substances Notification Regulations, substantially in the form set out in the annexed Regulations, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to paragraphs 89(1)(g) and (i.1) and 114(1)(c) of the Canadian Environmental Protection Act, 1999 (see footnote b) , hereby makes the annexed Regulations Amending the New Substances Notification Regulations.

REGULATIONS AMENDING THE NEW SUBSTANCES NOTIFICATION REGULATIONS

AMENDMENTS

1. The portion of subsection 12(1) of the New Substances Notification Regulations (see footnote 1)  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) 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) 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) 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 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 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 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 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 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 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 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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

The Regulations Amending the New Substances Notification Regulations (NSNR) set forth, for the industry, a streamlined and flexible mechanism which will now permit industry to propose to government, additions to the Domestic Substances List (DSL) more rapidly (e.g., chemicals, polymers, biochemicals, biopolymers and living organisms to be identified as a substance in Canadian commerce).

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

The former CEPA provided only one mechanism for adding new substances to the DSL. This means that once the most comprehensive information package has been assessed and the assessment conclusion results in no suspicion of toxic, notifiers of new substances are required to submit a notice indicating that they have exceeded certain volume triggers for manufacture or import before an addition to the DSL is considered.

Although this mechanism is still in place under CEPA 1999, these Regulations provide an alternative mechanism. Provided that the most comprehensive information package on the new substance was assessed and the assessment conclusion resulted in no suspicion of toxic, it is now permitted that notifiers be allowed to seek an addition to the DSL on submission of a notice that manufacturing or import has begun, in advance of exceeding volume triggers.

With respect to new living organisms, the former CEPA also established a listing mechanism based on volume triggers. Such a mechanism was inappropriate for new living organisms. The regulatory amendments provide a more appropriate mechanism for the addition of a new living organism to the DSL. The notifiers will now have to submit a notice, irrespective of volume triggers, specifying the starting date of manufacture or import of the living organism. Again, DSL listing will also be subject to the most comprehensive information package being assessed and the conclusion resulting in no suspicion of toxic.

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

Alternatives

These Regulations reflect administrative modifications to CEPA 1999. Using a voluntary approach would not satisfy the prescribed requirement specified in 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 or biopolymer industries, no additional costs will result from these 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 exceedance.

For living organisms, only minor administrative costs are expected for the regulatees comparable to a simple declaration similar to a Schedule I notification.

Government:

Only additional administrative costs (translation, proofreading, technical revision) associated with the publication of substances in the Canada Gazette.

Benefits

Regulatees:

For the chemical, biochemical, polymer, biopolymer industries, these Regulations provide the regulatees with an opportunity to submit prescribed information ahead of exceedance of maximal quantity prescribed by the regulations. The regulations may reduce the tracking requirements for the manufacture/import of chemicals, biochemicals, polymers and biopolymers. They also create a level playing field for industry for tracking requirements in the North American context.

These tracking requirements have been raised as a concern by the chemicals and polymers industries in previous consultations. It is estimated that these changes may result in a significant workload reduction.

Government:

The regulations ensure that the government is provided with the information with respect to 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 summer 2001, Environment Canada sent the proposed changes to the Industry Coordinating Group (ICG) that represents several chemical and industrial associations, as well as to the Biotechnology Group, the members of which are also subject to the NSNR. Responses from these groups were supportive of the initiative. Only minor changes to the proposed Regulations were made as a result of the few comments received.

These Regulations were pre-published in the Canada Gazette, Part I, on November 2, 2002. The mandatory 60-day comment period ended on January 8, 2003. Three comments were received during the comment period, from the ICG for CEPA, from the Chevron Oronite Company LLC, and from Procter & Gamble Inc. All of the comments were positive and supportive of the proposed Regulations without modifications.

Compliance and Enforcement

Since the regulations will be promulgated under CEPA 1999, CEPA 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 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 cost recovery.

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 of corrective action already 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
  Hull, Quebec
  K1A 0H3
  Telephone: (819) 997-4336
  E-mail: david.mcbain@ec.gc.ca

• Céline Labossière
  Regulatory and Economic Analysis Branch
  Economic and Regulatory Affairs Directorate
  Department of the Environment
  Hull, Quebec
  K1A 0H3
  Telephone: (819) 997-2377
  E-mail: celine.labossiere@ec.gc.ca

Footnote a 

S.C. 1999, c. 33

Footnote b 

S.C. 1999, c. 33

Footnote 1 

SOR/94-260

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