News Release

1999-03
January 14, 1999

Health Canada rejects bovine growth hormone in Canada

OTTAWA - Health Canada announced today that it will not approve the bovine growth hormone rbST for sale in Canada.

Health Canada officials noted that the decision was based on more than nine years of comprehensive review of the effects of rbST on animal and human safety, and consideration of the recent findings by two independent external committees. The expert committees were formed in the spring of 1998 to review the adequacy of scientific data and broader issues related to the use of bovine growth hormone in Canada. The two reports were received and reviewed by Health Canada in December and early January. Panel reports were reviewed by Health Canada scientific evaluators who concurred with the key findings.

"With all of this scientific information available, we saw no reason to delay the decision any longer," said Joel Weiner, Acting Director General for Policy, Planning and Coordination at Health Protection Branch.

Dr. Stuart MacLeod, a professor of clinical epidemiology and biostatistics, medicine and pediatrics at McMaster University and founding director of the Father Sean O'Sullivan Research Centre at St. Joseph's Hospital in Hamilton, led the panel put together by the Royal College of Physicians and Surgeons of Canada on human safety implications of rbST. Dr. MacLeod has served on numerous national and international advisory committees related to his expertise in clinical pharmacology and toxicology, pediatric pharmacology, medical education and international development.

The committee's review found no significant risk to human safety through ingestion of products from rbST-injected animals. Among its key findings were that rbST poses no carcinogenic risk, that rbST-induced IGF-1 (insulin growth factor) is insignificant when compared with naturally-occurring IGF-1, that there is little likelihood of increased antibiotic resistance, and only a small potential for allergic reactions.

Dr. Ian Dohoo, Associate Dean of Research and Graduate Studies at the Atlantic Veterinary College of the University of Prince Edward Island, was Chair of the panel organized by the Canadian Veterinary Medical Association looking at implications of rbST on animal health. Dr. Dohoo is a veterinarian and epidemiologist with 20 years experience in teaching, clinical service, research and development, and administration in the area of health and productivity of livestock.

The veterinary experts cited an increased risk of mastitis of up to 25%, of infertility by 18%, and of lameness by up to 50%. These increased risks and overall reduced body condition lead to a 20-25% increased risk of culling from the herd.

"The findings of the animal safety committee, when combined with our own assessment, made it quite clear that Health Canada had to reject the request for approval to use rbST in Canada, as it presents a sufficient and unacceptable threat to the safety of dairy cows," said Weiner. "The safety of both human and animal health are critical considerations when assessing a new veterinary drug," he explained.

Recombinant bovine somatotropin, or rbST, is a veterinary drug, produced through biotechnology, which is intended to increase milk production in lactating cows by 10 to 15%. It was approved for use in the United States in 1994. It was also declared safe by the European Union in 1990; however, a moratorium was placed on its sale in EU countries in 1993 to extend until the end of the decade.

"This is a very complicated issue, and not only in Canada," said Weiner. "Part of Health Canada's evaluation process entailed monitoring the research and issues as they developed outside Canada and following judgements of other national and international regulatory agencies on issues related to rbST. Health Canada's evaluations are rigorous in order to ensure that all health and safety concerns are addressed. This evaluation was particularly complex and Health Canada would like to recognize the hard work of employees who worked on this issue."

Health Canada has planned a technical briefing for media on Friday, January 15 at 9 a.m. at the Banting Theatre at Tunney's Pasture in Ottawa. Drs. MacLeod and Dohoo will present their panel findings at the briefing. Joel Weiner will also make a statement regarding the Department's review of rbST.

-30-

Media Inquiries
Lynn LeSage
Health Canada
(613) 941-8189

Public Inquiries
(613) 957-2991