Temporary certificate TU 0764.4 – Test samples for COVID-19

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

Certificate Number: TU 0764 (Renewal 4)

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.

To ensure that health care professionals respond to suspected cases of COVID-19 as rapidly as possible, it is important that test samples be transported to laboratories for analysis without delay. The samples 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 samples be packed in Type P650 packaging. Since the samples are dangerous goods, appropriate TDG training is required for the handling, offering for transport, or transport of the samples. As testing is still ongoing for suspected cases of COVID-19, the challenge still remains to ensure that everyone involved in the transport chain has received the appropriate training.

To assist healthcare professionals to respond to this situation, the Minister authorizes the handling, offering for transport, or transporting of dangerous goods that are COVID-19 test samples by issuing a temporary certificate under subsection 31(2.1) of the TDG Act. This certificate takes into account existing safety and TDG requirements and the fact that some health care professionals may not be trained in accordance with the TDG Regulations.

In my opinion, the issuance of a temporary certificate is in the public interest, and I hereby authorize the handling, offering for transport, or transportation 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 3 (Documentation) of the TDG Regulations,
• Part 4 (Dangerous Goods Safety Marks) of the TDG Regulations,
• Part 5 (Means of Containment) of the TDG Regulations,
• Part 6 (Training) of the TDG Regulations,
• Part 8 (Reporting Requirements) of the TDG Regulations, and
• Part 12 (Air) of the TDG Regulations.

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

1. Classification
   1. The dangerous goods are SARS-CoV-2 (COVID-19) test samples classified as:
      • UN3373 – BIOLOGICAL SUBSTANCE, CATEGORY B, Class 6.2;
   2. The test samples are in transport for the purposes of screening or testing.
   3. Home test kits for COVID-19 are not covered under this temporary certificate.
2. Packaging
   1. The test samples are placed in a Type P650 packaging that complies with CGSB-43.125;
   2. Despite paragraph 2)a) of this temporary certificate, the test samples may be placed in a packaging that complies with the following conditions:
      1. The test sample is placed in a primary receptacle such as a glass or plastic tube;
      2. The primary receptacle is placed in a secondary inner packaging that provides additional protection for the primary receptacle. More than one primary receptacle may be placed in the same secondary inner packaging;
      3. If multiple glass primary receptacles are placed in a secondary inner packaging, the primary receptacles shall be individually wrapped or otherwise separated to prevent contact between them;
      4. The primary receptacles and the secondary inner packaging shall be leakproof or siftproof, as applicable;
      5. For test samples containing liquid, an absorbent material shall be placed between the primary receptacle(s) and the secondary inner packaging. The absorbent material must be in sufficient quantity to absorb the entire content of the primary receptacles;
      6. The secondary inner packaging shall be placed in an outer packaging;
      7. Either the secondary packaging or the outer packaging shall be rigid;
      8. The packaging, once assembled, should be capable of passing a 1.2 metre drop test so that the primary receptacles do not leak. The 1.2 metre drop test is performed by dropping the assembled packaging from a height of 1.2 m onto a solid surface. Once dropped, the package should be opened to confirm the primary receptacles were not damaged and did not leak. This test would be performed on a representative package only.
   3. The option to use alternative packaging as described in paragraph 2)b) does not apply to test samples containing liquid that are transported by aircraft. Test samples containing liquid that are transported by aircraft, must be transported in a Type P650 packaging that complies with CGSB-43.125. In addition, either the primary receptacle or the secondary inner packaging shall successfully pass, without leakage, the internal pressure test in accordance with section 7.5 of CGSB-43.125;
   4. Dry ice or liquid nitrogen must not be used as a refrigerant to keep the test samples cold when transported in a road vehicle, railway vehicle, vessel or aircraft. When ice is used as a refrigerant, the outer packaging or overpack shall be leakproof.
3. Marking
   1. The outer packaging shall be marked, on a contrasting background, with the following information:
      1. The mark illustrated below, where each side of the mark is 100 mm in length:
         
      2. The shipping name: “BIOLOGICAL SUBSTANCE, CATEGORY B” or “MATIÈRE BIOLOGIQUE, CATÉGORIE B”, next to the mark illustrated above in subparagraph 3)a)i);
      3. The words “Test Samples - COVID-19” or “Échantillons d’épreuve - COVID-19”;
      4. One of the following expressions:
         1. “TU 0764”,
         2. “Temporary Certificate - TU 0764”, or
         3. “Certificat Temporaire - TU 0764”;
      5. The name and address of the consignor and consignee;
      6. The words: “IN CASE OF DAMAGE OR LEAKAGE IMMEDIATELY NOTIFY LOCAL AUTHORITIES AND”, or “EN CAS DE DOMMAGE OU DE FUITE COMMUNIQUER IMMÉDIATEMENT AVEC”, followed by the telephone number listed in either condition 3)a)vii)A) or 3)a)vii)B).
      7. For the purposes of paragraph 3)a)vi), the telephone number shall be:
         1. a 24-hour telephone number where the consignor can be reached to provide information on the test samples, or
         2. 1-888-CAN-UTEC (226-8832), if the consignor is registered and has received written permission from CANUTEC;
   2. All information required by paragraph 3)a) above must be displayed on any side of the outer packaging other than the side on which it is intended to rest or to be stacked during transport;
   3. When packages are placed in an overpack, the information required by paragraph 3)a) above must be displayed on two opposite sides of the overpack, when the information is not visible through the overpack. In addition, the word "Overpack" or "Suremballage", in letters that are at least 12 mm high, must be written on two opposite sides of the overpack.
4. Documentation
   1. Instead of marking the outer packaging with the information required by subparagraph 3)a)v), the test samples may be accompanied by a transport document that contains the following information:
      1. The name and address of the consignor and consignee;
      2. The 24-hour telephone number of:
         1. the consignor where the consignor can be reached to provide information on the test samples, or
         2. CANUTEC, which is 1-888-CAN-UTEC (226-8832), if the consignor is registered and has received written permission from CANUTEC;
      3. The words “Test Samples - COVID-19” or “Échantillons d’épreuve - COVID-19”.
5. Additional Requirements for Air Transport
   1. An employee of an air carrier involved in the handling or transportation of the dangerous goods by aircraft must:
      1. possess a valid training certificate in accordance with Part 6 of the TDG Regulations, and
      2. be trained in accordance with Part 1, Chapter 4 (1;4) of the ICAO Technical Instructions;
   2. When the test samples are transported by aircraft, passengers and crew members are prohibited from transporting the test samples in carry-on baggage, checked baggage, or on their person.

The following definitions apply in this temporary certificate:

• air carrier means a person who, whether or not for hire or reward, has possession of dangerous goods while they are in transport by air.
• CGSB-43.125 means the National Standard of Canada CAN/CGSB-43.125, "Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical waste", published by the Canadian General Standards Board (CGSB), as amended from time to time.
• ICAO Technical Instructions means the Technical Instructions for the Safe Transport of Dangerous Goods by Air, published by the International Civil Aviation Organization (ICAO), as amended from time to time.
• Inner packaging means packaging for which an outer packaging is required for transport.
• Outer packaging means outer protection of a combination packaging (excluding an overpack) together with any absorbent materials, cushioning and any other components necessary to contain and protect primary receptacles or secondary inner packagings.
• Primary receptacle means a receptacle in direct contact with the regulated good.
• Type P650 packaging means packaging intended to transport an infectious substance of Category B, or an infectious substance of Category A that is not in the form of a culture nor listed in subsection 2.36(3) in the TDG Regulations.
• Secondary inner packaging means inner packaging, including absorbent material as required, that provides additional protection for the primary receptacle.

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 0764 (Renewal 4) replaces the Temporary Certificate TU 0764 (Renewal 3).

This temporary certificate takes effect on May 16, 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.)

Date: May 30, 2022

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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TDG-TMDAtlantic@tc.gc.ca

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TDG-TMDPNR@tc.gc.ca

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