Temporary certificate TU 0886.2: Monkeypox samples

Temporary certificate pursuant to Subsection 31(2.1) of the Transportation of Dangerous Goods Act, 1992

Certificate Number: TU 0886 (Ren. 2)

Pursuant to subsection 31(2.1) of the Transportation of Dangerous Goods Act, 1992 (TDG Act) the Minister may, in the public interest, issue a temporary certificate authorizing any activity to be carried on in a manner that does not comply with the TDG Act.

Following an outbreak of the Monkeypox virus, in April 2022, Canadian healthcare workers have been tasked with conducting testing for Monkeypox.

To ensure that healthcare professionals respond to suspected cases of Monkeypox as rapidly as possible, it is important that patient specimens be transported to laboratories for analysis without delay. The patient specimens are dangerous goods and as such, they must be handled, offered for transport, and transported in accordance with the Transportation of Dangerous Goods Regulations (TDG Regulations). The TDG Regulations require that patient specimens be packed in P620 packaging. Furthermore, since the patient specimens are dangerous goods, appropriate TDG training is required for the handling, offering for transport, or transport of the patient specimens. As patient specimens are being collected at facilities not accustomed to Category A infectious substances, it is challenging to ensure that patient specimens are transported in a timely manner in P620 packaging since many facilities may not have a sufficient supply of P620 packaging.

Following an assessment carried out by the Public Health Agency of Canada, it was requested that patient specimens and waste generated from the collection or testing of patient specimens which may contain Monkeypox virus be authorized to be reclassified as Category B infectious substances.

Furthermore, remote access locations face particular challenges, especially related to access to trained road carriers in accordance with Part 6 (Training) of the TDG Regulations.

To assist medical professionals to respond to this unexpected situation, the Minister authorizes the handling, offering for transport, or transporting of dangerous goods that are patient specimens or waste generated from the collection or testing of patient specimens, which may contain Monkeypox virus by issuing a temporary certificate under subsection 31(2.1) of the TDG Act. This certificate takes into account existing safety requirements of the TDG Regulations and recommendations from the Public Health Agency of Canada.

In my opinion, the issuance of a temporary certificate is in the public interest, and I hereby authorize the handling, offering for transport, or transport of dangerous goods in a road vehicle, railway vehicle, vessel, or aircraft between two points in Canada, in a manner that does not comply with:

• part 2 (Classification) of the TDG Regulations,
• Part 6 (Training) of the TDG Regulations, but only as it relates to road carriers in limited access locations,
• Subparagraph 12.1(1)(b)(ii) of Part 12 (Air) of the TDG Regulations,
• Part 2;6.3.2 of the Technical Instructions for the Safe Transport of Dangerous Goods by Air of the International Civil Aviation Organization (ICAO Technical Instructions).

This temporary certificate is subject to the following terms and conditions:

PART A - PATIENT SPECIMENS

1) General

1. The dangerous goods are patient specimens;
2. The patient specimens are in transport for the purposes of screening or testing.
3. Home test kits for Monkeypox are not covered under this temporary certificate

2) Classification

1. Despite 2.36(3) of the TDG Regulations and Table 2-10 of Part 2, Chapter 6 of the ICAO Technical Instructions, patient specimens that may contain Monkeypox virus may be reclassified as:

   UN Number	Shipping Name and Description	Class	Packing Group
   UN3373	BIOLOGICAL SUBSTANCE, CATEGORY B	6.2	Category B

2. The patient specimens may not contain any Category A infectious substances covered by 2.36(3) of the TDG Regulations and Table 2-10 of Part 2, Chapter 6 of the ICAO Technical Instructions, other than the Monkeypox virus.

3) Modal particularities

1. For road, rail or marine transport, the patient specimens covered under this temporary certificate may be transported in accordance with section 1.39 of the TDG Regulations;
2. For air transport, the patient specimens covered under this temporary certificate must be transported in accordance with Packing Instruction 650 of the ICAO Technical Instructions.

4) Marking

1. The outer packaging shall be marked, on a contrasting background, with one of the following:
   1. “TU 0886”,
   2. “Temporary Certificate - TU 0886”, or
   3. “Certificat Temporaire - TU 0886”.

5) Training

1. Despite subsection 6.1(1) of the TDG Regulations, the person handling, offering for transport or transporting the dangerous goods may be assisted, by videoconference, by a person who is adequately trained and holds a valid training certificate as per Part 6 of the TDG Regulations. The contact information of the person providing assistance must be given to an inspector immediately upon request;
2. Despite subsection 6.1(1) of the TDG Regulations, for limited access locations or resource-limited locations, the road carrier is not required to hold a training certificate in accordance with Part 6 of the TDG Regulations, if they have received a verbal briefing and an information sheet on the hazards of the dangerous goods and their responsibilities in case of a spill or damage to the package.  The consignor is responsible for providing the verbal briefing and information sheet to the road carrier;

3. Any person handling, offering for transport or transporting the dangerous goods covered by this temporary certificate must be knowledgeable and understand the conditions of this temporary certificate, except for road carriers in limited access locations.

PART B - WASTE GENERATED FROM THE COLLECTION OR TESTING OF PATIENT SPECIMENS

1) General

1. The dangerous goods are waste generated from:
   1. patient care, or
   2. the collection or testing of patient specimens.

2) Classification

1. Despite 2.36(3) of the TDG Regulations and Table 2-10 of Part 2, Chapter 6 of the ICAO Technical Instructions, waste generated from the collection or testing of patient specimens that may contain Monkeypox virus may be reclassified as:

   UN Number	Shipping Name and Description	Class	Packing Group
   UN3291	CLINICAL WASTE, UNSPECIFIED, N.O.S.; (BIO) MEDICAL WASTE, N.O.S.; or REGULATED MEDICAL WASTE, N.O.S	6.2	II

2. The waste may not contain any Category A infectious substances covered by 2.36(3) of the TDG Regulations and Table 2-10 of Part 2, Chapter 6 of the ICAO Technical Instructions, other than the Monkeypox virus.

3) Modal particularities

1. For road, rail or marine transport, the waste covered under this temporary certificate may be transported in accordance with section 1.42.3 of the TDG Regulations.
2. For air transport, the waste covered under this temporary certificate must be transported in accordance with Part 12 of the TDG Regulations and the ICAO Technical Instructions.

4) Marking

1. The outer packaging shall be marked, on a contrasting background, with one of the following:
   1. “TU 0886”,
   2. “Temporary Certificate - TU 0886”, or
   3. “Certificat Temporaire - TU 0886”.

5) Training

1. When the dangerous goods are transported by road, rail, or marine mode, under Section 1.42.3 of the TDG Regulations, training in accordance with Part 6 of the TDG Regulations is not required;
2. When the dangerous goods are transported by air, training in accordance with Part 6 of the TDG Regulations is required. However, despite subsection 6.1(1) of the TDG Regulations, the person handling or offering for transport the dangerous goods by air may be assisted, by videoconference, by a person who is adequately trained and holds a valid training certificate as per Part 6 of the TDG Regulations. The contact information of the person providing assistance must be given to an inspector immediately upon request;
3. Any person handling or offering for transport the dangerous goods covered by this temporary certificate must be knowledgeable and understand the conditions of this temporary certificate.

Unless the context requires otherwise, words and expressions used in this temporary certificate have the same meaning as in section 1.4 of the TDG Regulations.

For greater certainty, this temporary certificate provides no regulatory relief other than specifically stated herein. Therefore, all other requirements of the TDG Act and the TDG Regulations apply.

For greater certainty, this certificate TU 0886 (Ren. 2) replaces the Temporary Certificate TU 0886 (Ren. 1).

This temporary certificate takes effect on May 8, 2023. It remains in effect until the earliest of:

• July 31, 2025, or
• the day it is cancelled in writing by the Minister of Transport.

France Bernier
A/Executive Director
Regulatory Frameworks and International Engagement
Regulatory Affairs Branch

(The following is for information purposes only and is not part of the certificate.)

For more information:
Approvals and Special Regulatory Projects
Transportation of Dangerous Goods,
Transport Canada
300 Laurier Avenue West
Ottawa, Ontario K1A 0N5

E-mail: tdgpermits-permistmd@tc.gc.ca

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