Processing and Distribution of Semen for Assisted Conception Regulations (SOR/96-254)

5. No person shall import semen for distribution unless

• (a) it meets the requirements set out in subsection 4(1); and

• (b) the outer shipping container in which the semen is transported displays clearly, on the outside surface of that container,

  • (i) the name and business address of the processor, and

  • (ii) a declaration, signed by the processor or an authorized agent of the processor, certifying that the semen has been processed in accordance with these Regulations and quarantined for a minimum of six months.

5.1 Despite subsection 4(1) and section 5, a person may distribute or import for distribution semen that has not been processed in accordance with the requirements of paragraphs 4(1)(b) and 9(1)(a) and section 10 or that has been reserved for special access distribution if the person does so in accordance with a special access authorization issued under section 20.

• 6. (1) Every person who processes or imports, or intends to process or import, semen for distribution shall give written notice to the Minister of the processing or importing at least 10 days before the date on which they begin processing or importing semen.

• (2) The notice shall be signed and dated by the processor or importer, or an authorized agent of the processor or importer, and shall include

  • (a) the name and business address of the processor or importer;

  • (b) if the notice is signed by an authorized agent, the name and title of the agent; and

  • (c) the date of beginning to process or import semen.

7. A processor or importer of semen shall provide any additional information that the Minister may in writing request, on or before the date set out in the request, in order to establish that the semen has been processed in accordance with these Regulations.

• 8. (1) Every person shall, within 90 days after they have stopped processing or importing semen, give written notice to the Minister indicating that they have stopped processing or importing semen.

• (2) The notice shall be signed and dated by the processor or importer, or an authorized agent of the processor or importer, and shall include

  • (a) the name and business address of the processor or importer;

  • (b) if the notice is signed by an authorized agent, the name and title of the agent; and

  • (c) the date on which the processor or importer stopped processing or importing semen.

• 9. (1) Every person who processes semen for distribution shall

  • (a) take the following measures:

    • (i) determine that the donor is not within a group set out in the Directive under the heading “Exclusions”,

    • (ii) perform the tests specified in the Directive under the headings “Work-up”, “Repeat Screening & Quarantine” and “Microbiology” or other tests that are at least as effective as those tests in detecting the infectious agents specified therein, and

    • (iii) take the non-testing measures specified in the Directive under the headings referred to in subparagraph (ii); and

  • (b) where a donor is rejected as a result of measures taken in accordance with paragraph (a),

    • (i) if none of the donor’s semen, whenever donated, has been distributed, destroy all of the donor’s semen that is in the processor’s possession, or

    • (ii) if some of the donor’s semen, whenever donated, has been distributed, take the measures set out in sections 15 to 18.

  • (c) [Repealed, SOR/2000-410, s. 8]

• (2) Any test referred to in subparagraph (1)(a)(ii) must meet the requirements set out in clause 3.5.1.1 of the Directive.