Canada Gazette, Part I, Volume 153, Number 23: Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999

June 8, 2019

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The laboratory accreditation provisions in four regulations made under the Canadian Environmental Protection Act, 1999 (CEPA) are problematic for varying reasons. Some of these regulations do not provide certainty as to which bodies can grant accreditation to labs, while others require retesting in Canada of products that were tested by appropriately accredited laboratories in other countries. Minor changes are also needed to correct inconsistencies, ambiguities and redundancies in some of the regulations.

Background

The Department of the Environment (the Department) administers a wide range of regulations under CEPA. To ensure that regulations continue to be administered efficiently and to provide clarity for regulated parties, regulations are reviewed and updated from time to time. The Department has identified the need for a number of changes to the regulatory text of several regulations made under CEPA. The analysis was undertaken in response to issues raised by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) and the Standards Council of Canada (SCC) with respect to the wording of laboratory accreditation requirements in a number of regulations.

In 2014, the SJCSR indicated that the requirement for laboratory analysis to be performed at a laboratory that is accredited by a recognized “Canadian accrediting body” does not provide certainty as to which bodies are actually able to grant this accreditation. To provide this certainty, the SJCSR indicated that more specificity is needed regarding what determines whether a particular body will be considered an accrediting body. In 2015, the SCC advised that the reference to a “Canadian accrediting body” excludes testing by appropriately accredited laboratories in other countries, resulting in unnecessary retesting of these products in Canada.

The analysis conducted by the Department concluded with a recommendation to use standardized regulatory text to provide clarity and establish consistency in the laboratory accreditation provisions across multiple regulations. This standardized text would also apply to new regulations with provisions related to laboratory accreditation.

Objectives

The objectives of the Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999 (the proposed amendments) are to provide certainty regarding which bodies can grant accreditation to labs, to remove the duplicative retesting that is required under some of the current regulations, and to improve the clarity and consistency of regulatory text.

Description

The proposed amendments would apply to the following regulations (collectively referred to as “the four regulations”) as part of an omnibus regulatory process:

The proposed amendments would clarify that any laboratory analysis for any of the four regulations must be performed by a laboratory that meets a set of criteria at the time that the analysis or determination is performed. The laboratory must either be accredited

Where a standard exists for the parameters that are being analyzed or determined, the proposed amendments would require those parameters to be included in the scope of the laboratory’s accreditation.

The proposed amendments would also amend the PCB Regulations to fix an inconsistency between the French and English versions of the regulatory text, by replacing the word “restoration” with “remediation” in section 22 of the English version. In the Microbeads in Toiletries Regulations, the proposed amendments would change “prescription drugs” to “a prescription drug” in the English version of the Regulations to promote consistency with the Food and Drug Regulations, and eliminate a redundancy in the definition of toiletries by removing the reference to non-prescription drugs and natural health products that are inherently included in the definition. Lastly, to eliminate redundancy and increase clarity, the proposed amendments would remove the word “quantity” from the reference to “any analysis performed to determine the concentration or quantity” in both the PCB Regulations and the Prohibition of Certain Toxic Substances Regulations, 2012.

“One-for-One” Rule

The “One-for-One” Rule does not apply, as there is no incremental change in administrative burden on business.

Small business lens

The small business lens does not apply to the proposed amendments, as there would be no increase in administrative or compliance costs for small businesses.

Consultation

For the amendments related to laboratory accreditation, the Department undertook extensive consultations with the SCC and with the Canadian Association for Laboratory Accreditation. Both organizations are supportive of the proposed changes to the laboratory accreditation provisions. The remaining amendments to improve clarity and consistency of regulatory texts are minor in nature and therefore no consultations were held with stakeholders.

Rationale

The proposed amendments would respond to the comments identified by the SJCSR and the SCC, and address numerous minor issues and inconsistencies in the current regulatory texts of the four regulations.

The impact of the proposed amendments on stakeholders is expected to be minimal, as the changes are relatively minor in nature. Some minor compliance cost savings are expected to be realized for regulatees who are required to perform duplicative testing in the baseline scenario. The proposed amendments would not add additional requirements nor impact level standards, timelines or reporting requirements. Overall, the impacts are expected to be positive considering the increased clarity and consistency of the regulatory text.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required, given that the proposed amendments do not alter the environmental objectives of the affected regulations.

Contacts

Astrid Télasco
Director
Regulatory Innovation and Management Systems
Department of the Environment
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Telephone: 819‑938‑4478
Fax: 819‑420‑7386
Email: ec.affairesreglementaires-regulatoryaffairs.ec@canada.ca

Matthew Watkinson
Director
Regulatory Analysis and Valuation Division
Department of the Environment
200 Sacré-Cœur Boulevard
Gatineau, Quebec
K1A 0H3
Telephone: 873‑469‑1452
Fax: 819‑938‑3374
Email: DARV.RAVD@canada.ca

PROPOSED REGULATORY TEXT

Notice is given, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, that the Governor in Council, pursuant to subsection 93(1) of that Act, proposes to make the annexed Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999.

Any person may, within 60 days after the date of 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 Astrid Télasco, Director, Regulatory Innovation and Management Systems, Legislative and Regulatory Affairs Directorate, Department of the Environment, 351 Saint-Joseph Boulevard, Gatineau, Quebec K1A 0H3 (fax: 819‑420‑7386; email: ec.affairesreglementaires-regulatoryaffairs.ec@canada.ca).

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, May 30, 2019

Julie Adair
Assistant Clerk of the Privy Council

Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999

Amendments

2-Butoxyethanol Regulations

1 Section 7 of the 2-Butoxyethanol Regulations footnote 1 is replaced by the following:

7 Any analysis performed to determine the concentration of 2-butoxyethanol for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis:

PCB Regulations

2 Subsection 1(3) of the PCB Regulations footnote 2 is replaced by the following:

Concentration

(3) Any analysis performed to determine the concentration of PCBs for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis:

3 Paragraphs 22(2)(a), (b) and (c) of the English version of the Regulations are amended by replacing “restoration” with “remediation”.

Prohibition of Certain Toxic Substances Regulations, 2012

4 Section 13 of the Prohibition of Certain Toxic Substances Regulations, 2012 footnote 3 is replaced by the following:

Accredited laboratory

13 (1) Any analysis performed to determine the concentration of a toxic substance for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis:

Standards of good practice

(2) If no method has been recognized by a standards development organization in respect of the analysis performed to determine the concentration of a toxic substance and the scope of the laboratory’s accreditation does not therefore include that analysis, the analysis must be performed in accordance with standards of good scientific practice that are generally accepted at the time that it is performed.

Microbeads in Toiletries Regulations

5 The definition toiletries in section 1 of the Microbeads in Toiletries Regulations footnote 4 is replaced by the following:

toiletries means any personal hair, skin, teeth or mouth care products for cleansing or hygiene, including exfoliants. (produit de toilette)

6 Section 2 of the English version of the Regulations is replaced by the following:

Non-application

2 These Regulations do not apply to a prescription drug within the meaning of section A.01.010 of the Food and Drug Regulations.

7 Section 5 of the Regulations is replaced by the following:

Accredited laboratory

5 (1) Any analysis performed to determine the presence of microbeads for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis:

Standards of good practice

(2) If no method has been recognized by a standards development organization in respect of the analysis performed to determine the presence of microbeads and the scope of the laboratory’s accreditation does not therefore include that analysis, the analysis must be performed in accordance with standards of good scientific practice that are generally accepted at the time that it is performed.

Coming into Force

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