Reference Manual for the WHMIS Requirements of the Hazardous Products Act and Controlled Products Regulations

CPR Section 10.1 - [Exemptions, MSDS]; Radioactive nuclides and non-radioactive carrier material, mixtures of

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[Mixtures of Radioactive Nuclides and Non-Radioactive Carrier Materials]

10.1 The sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials is exempt from the application of paragraph 13(a) or 14(a) of the Act if

1. the carrier material
   
   1. is present in an amount that is
      1. in the case of a liquid or gaseous carrier material, no more that 1.0 ml in volume, or
      2. in the case of a solid carrier material, no more than 1.0 g in weight, and
   2. is not
      
      1. a carcinogen under Subdivision A of Division 2 of Class D referred to in section 54,
      2. a toxic or reactive material under Division 1 of Class 6 and Packing Group I of the Transportation of Dangerous Goods Regulations, or
      3. an infectious material under Division 3 of Class D of these Regulations or Division 2 of Class 6 of the Transportation of Dangerous Goods Regulations and can be handled in accordance with the physical containment requirement set out in Schedule I.1 to these Regulations;
2. the carrier material is a vehicle for radioactive nuclides or radio-labelled compounds that are injected or ingested during medical or veterinary diagnostic or therapeutic procedures that have been approved by the Department of Health for routine clinical use; or
3. the quantity of each radioactive nuclide is greater than the quantity specified for that radioactive nuclide in Part I of Schedule I to the Transport Packaging of Radioactive Materials Regulations

Interpretation / Discussion of Section 10.1

The Nuclear Safety and Control Act (NSC Act), S.C. 1997, c.9, which came into force on May 31, 2000, and replaced the Atomic Energy Control Act, redefines "nuclear substance", (formally defined as "prescribed substance"), to include only the radioactive components of radioactive nuclide mixtures. As a result, non radioactive controlled product carrier materials in radioactive nuclide mixtures are now subject to the WHMIS requirements of the HPA even though the exclusion for nuclear substances pursuant to paragraph 12(d) of the HPA remains.

Paragraph 10.1(a)

Paragraph 10.1(a) provides an MSDS exemption for very small quantities of liquid, solid or gaseous controlled product carrier materials (except where the carrier material is a carcinogen, very toxic or reactive or is a biohazardous infectious material included in Risk Group 2, 3 or 4). This exemption takes into account that in chemical and clinical laboratory environments:

• radioactive mixtures usually involve very minimal quantities of carrier materials;
• laboratory workers who handle radioactive nuclides receive specific training to avoid any exposure; and
• existing levels of regulatory health and safety control in relation to the radioactive component affords a considerable safety margin to the handling of the carrier component.

With respect to infectious materials, clause 10.1(a)(ii)(C) limits the small quantity exemption to infectious materials included in Risk Group 1. Schedule I.1 is an extract from the Health Canada Laboratory Biosafety Guidelines, 1996, 2 nd edition, Subchapter 5.1: Containment Level 1 for Risk Group 1 microorganisms (or low individual or community risk agents):

http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-96/index.html

Paragraph 10.1(b):

This paragraph provides an exemption for carrier materials used in diagnostic or therapeutic procedures which are approved by Health Canada. The carrier material, which may serve as a vehicle for injected or ingested radio nuclides or radio-labelled compounds, is usually innocuous.

Paragraph 10.1(c):

Paragraph 10.1(c) provides an MSDS exemption for radioactive nuclide/carrier materials which are highly radioactive. As these materials are handled by remote control in entirely closed, shielded "hot cells", personal contact is not possible and any exposure is avoided.

Note: The Transport Packaging of Radioactive Materials Regulations, referred to in paragraph 10.1(c), has been renamed the Packaging and Transport of Nuclear Substances Regulations. These regulations are established under the Nuclear Safety and Control Act. They do not include the table of A1 and A2 values that were included in Part I of Schedule I to the previous regulations. Instead, they refer to the Regulations for the Safe Transport of Radioactive Material of the International Atomic Energy Agency (IAEA) which includes this table. (Paragraph 1(2)(d) of the Packaging and Transport of Nuclear Substances Regulations replaces the values for molybdenum 99.) The Canadian Nuclear Safety Commission distributes reprints of the IAEA Regulations.