Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999: SOR/2021-42

Canada Gazette, Part II, Volume 155, Number 7

Registration

SOR/2021-42 March 18, 2021

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2021-155 March 17, 2021

Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on June 8, 2019, a copy of the proposed Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999, substantially in the annexed form, 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;

Whereas, pursuant to subsection 93(3) of that Act, the National Advisory Committee has been given an opportunity to provide its advice under section 6 footnote c of that Act;

And whereas, in the opinion of the Administrator in Council, pursuant to subsection 93(4) of that Act, the proposed Regulations do not regulate an aspect of a substance that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Administrator in Council, sufficient protection to the environment and human health;

Therefore, His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 93(1) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999.

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:

Accredited laboratory

(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 the 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.

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 laboratories, 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 argued 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 in response to the above concerns resulted in the development of the policy document entitled “Standardized Provisions Related to the Accreditation of Laboratories for Use in Environment and Climate Change Canada Regulations,” which recommended the use of 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.

Objective

The objectives of the Regulations Amending Certain Regulations Made Under Subsection 93(1) of the Canadian Environmental Protection Act, 1999 (the 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 the regulatory text.

Description

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

The Amendments will 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 Amendments will require those parameters to be included in the scope of the laboratory's accreditation.

If no accredited method exists that can be used for a substance, the Amendments require that the analysis be conducted in accordance with generally accepted standards of scientific practice.

The Amendments will 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 Amendments will change “prescription drugs” to “a prescription drug” 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, the Amendments will 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, 2012.

Regulatory development

Consultation

Prior to the prepublication of the proposed Amendments in the Canada Gazette, Part I, on June 8, 2019, the Department undertook extensive consultations with the SCC and with the Canadian Association for Laboratory Accreditation for the amendments related to laboratory accreditation. Both organizations indicated their support for 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.

No comments were received during the formal consultation process following the 60-day prepublication comment period for the draft Amendments.

Modern treaty obligations and Indigenous engagement and consultation

Given that the Amendments are administrative in nature, no impacts to Indigenous peoples are anticipated as a result of the Amendments. Therefore, no specific engagement or consultation were undertaken with Indigenous peoples.

Instrument choice

In drafting the Amendments, the Department considered a range of regulatory and non-regulatory options. An amendment to the regulations was selected, as it is the only instrument that would allow for the lab accreditation provisions to be revised in the identified regulations.

Regulatory analysis

Benefits and costs

The impact of the Amendments on stakeholders is expected to be minimal, as the changes are minor and administrative 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. Overall, the impacts are expected to be positive due to the increased clarity and consistency of the regulatory text.

Small business lens

Two small businesses were identified as importers of products that are subject to laboratory testing requirements under the PCB Regulations. It was assumed that these businesses conduct duplicative testing in the baseline scenario of products that were already tested by laboratories that were accredited by accrediting bodies in other countries. These firms are expected to realize minor cost savings as a result of the Amendments.

One-for-one rule

The one-for-one rule does not apply, as there is no incremental change in administrative burden on businesses.

Regulatory cooperation and alignment

The Amendments will allow Canadian firms to recognize tests performed in appropriately accredited laboratories in other jurisdictions, including the United States, the United Kingdom, France, Germany, Korea, and Japan. The Amendments also provide for the alternate possibility that a laboratory be accredited under Quebec's Environment Quality Act, which is considered equivalent to that provided in ISO/IEC 17025.

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 Amendments do not alter the environmental objectives of the affected regulations.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the Amendments.

Implementation, compliance and enforcement, and service standards

Implementation

No new implementation, compliance and enforcement actions will be necessary as the existing enforcement regime will apply to the Amendments. The Amendments come into force upon registration.

Contacts

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

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