Parliamentary Research Branch

PRB 98-1E

THE REGULATION OF rbST IN CANADA

Prepared by:
Frédéric Forge
Science and Technology Division
October 1998

Recombinant bovine somatotropin (rbST) is a veterinary medication produced with the assistance of genetic engineering. When it is used on lactating cows, it can help to increase milk production by between 10 and 15%. Approval of such a medication falls under the Food and Drugs Act and Regulations.

Health Canada is the only department responsible for approving rbST in Canada. Approval would be based on a finding that the product is harmless for both the animals and for human consumption. Regulations also evaluate the purity, effectiveness, potency and stability of a medication. When the medication meets the regulatory requirements, Health Canada issues a notice of compliance. As long as rbST has not received this notice, it may not be legally sold in Canada.

Somatotropin is referred to in Schedule F, Part I of the Food and Drugs Regulations. A medication included in this Schedule may be sold only by an authorized practitioner in Canada. If rbST receives a notice of compliance, it may be sold to a dairy producer only by an authorized veterinarian, who will be responsible for recommending to his or her client how best to use the product. The practice of veterinary medicine is governed by the provincial organizations responsible for issuing the licence that every veterinarian must have in order to practise. Thus, the fact that only authorized practitioners may sell veterinary medicines constitutes a control over the sale of these products and acts as a means of restricting any abuse of them.

Health Canada is responsible for mandatory labelling requirements dealing with such health issues as the presence of allergenic products or changes in the nutritional composition of a product. The Canadian Food Inspection Agency (CFIA) is responsible for any labelling that does not relate to food safety; that is, voluntary labelling and labelling designed to protect consumers against fraud. Thus, the CFIA ensures that Canadian and imported dairy products comply with the regulations governing quality and labelling.

It is very likely that products such as cheese and yogurt made from milk produced by rbST-treated cows have been imported into Canada. In fact, the use of rbST has been approved in the United States since February 1994. In that country, milk from treated cows is considered to be as safe as milk from untreated cows and there is no labelling requirement concerning rbST on dairy products. Furthermore, according to the CFIA, there is no means of identifying these products.

However, because dairy products are identified by their country of origin, the consumer can decide whether to purchase products from countries that have already approved rbST. On the other hand, products in which milk is only one ingredient among many (ice cream, for example) are classified as Canadian products, no matter where their raw materials may have originated.

If rbST is approved for use in Canada, the issue of a notice of compliance would imply that the product had been found not to pose any particular threat to human health. When a product does not pose a threat, Health Canada does not require any mandatory labelling, but voluntary labelling is permitted if the information is verifiable.