Canada | Use of "carbopolycycle, acid-treated, oxidized, silver-doped" in medical devices

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 21193

Ministerial condition

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance carbopolycycle, acid-treated, oxidized, silver-doped, Confidential Accession Number 19610-8;

And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance subject to the conditions of the following annex.

Marc D’lorio
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment

ANNEX

Conditions

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

“engineered hazardous waste landfill facility”

means a facility that is part of an overall integrated hazardous waste management system where wastes that do not require additional treatment or processing are sent and where hazardous materials are confined or controlled for the duration of their effective contaminating lifespan;

“notifier”

means the person who has, on April 4, 2022, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Canadian Environmental Protection Act, 1999;

“personal protective equipment”

means items that are worn to provide a barrier to help prevent potential exposure to infectious disease. These items include medical masks, medical examination gloves, surgical booties, caps, gowns, and respirators;

“substance”

means carbopolycycle, acid-treated, oxidized, silver-doped, Confidential Accession Number 19610-8;

“waste”

includes the effluents that result from manufacturing, formulating or coating fabric with the substance, effluents that result from rinsing equipment or vessels used for the substance, disposable vessels used for the substance, spillage that contains the substance, the process effluents that contain the substance and any residual quantity of the substance in any equipment or vessel.

2. The notifier may manufacture or import the substance subject to the present ministerial conditions.

Restrictions

3. The notifier shall manufacture the substance only for use in disposable or single-use personal protective equipment that is a medical device within the meaning of section 1 of the Medical Devices Regulations.

4. The notifier shall import the substance only for use in disposable or single-use personal protective equipment that is a medical device within the meaning of section 1 of the Medical Devices Regulations.

Handling and disposal of the substance

5. (1) The notifier shall not release the substance or waste to the environment.

(2) The notifier must collect any waste in their physical possession or under their control and destroy or dispose of it in the following manner:

• (a) incinerate it in accordance with the laws of the jurisdiction where the incineration facility is located; or
• (b) dispose of it in an engineered hazardous waste landfill facility, in accordance with the laws of the jurisdiction where the facility is located.

Environmental release

6. Where any release of the substance or waste to the environment occurs, the notifier shall immediately take all measures necessary to prevent any further release, and to limit the dispersion of any release. Furthermore, the notifier shall as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Canadian Environmental Protection Act, 1999.

Other requirements

7. (1) The notifier shall, prior to transferring the physical possession or control of the substance or waste to any person

• (a) inform the person, in writing, of the terms of the present ministerial conditions; and
• (b) obtain, prior to the first transfer of the substance or waste, written confirmation from the person that they were informed of the terms of the present ministerial conditions and agree to comply with the conditions specified in sections 3 to 6.

(2) Subsection (1) does not apply when the substance is contained in disposable or single-use personal protective equipment that is a medical device within the meaning of section 1 of the Medical Devices Regulations.

Record-keeping requirements

8. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

• (a) the specific use of the substance;
• (b) the quantity of the substance that the notifier manufactures, imports, purchases, distributes, sells and uses;
• (c) the name and address of each person in Canada who disposed of the substance or of waste for the notifier, the method used to do so and the quantities of the substance or waste shipped to that person;
• (d) the name and address of each person to whom the notifier transfers the physical possession or control of the substance or waste; and
• (e) the written confirmation referred to in paragraph 7(1)(b).

(2) The notifier shall maintain electronic or paper records mentioned in subsection (1) at their principal place of business in Canada, or at the principal place of business in Canada of their representative, for a period of at least five years after they are made.

Coming into force

9. The present ministerial conditions come into force on July 21, 2022.

Link to the Canada Gazette, Part I, Volume 156, Number 33: Index