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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Analysis of DGXXIV Report on Public Health Aspects of BST

April 13, 1999

FDA approved Monsanto Company's recombinant bovine somatotropin (rbST) product, Posilac® , in November 1993 after a comprehensive review of the product's safety and efficacy, including human food safety. Recently, FDA reviewed the European Commission Directorate General XXIV "Report on Public Health Aspects of the Use of Bovine Somatotropin -- 15 -16 March 1999."

The conclusions of the DGXXIV report with respect to the safety of IGF-I do not appear to be consistent with the current state of scientific knowledge. Specifically, the report states that establishing an in vivo quantitative dose-effect relationship for IGF-I is virtually impossible because of the diverse biological effects attributable to the intrinsic activity of IGF-I. In fact, there are standard hazard assessment procedures for assessing the hazard associated with all types of compounds that exert a broad variety of metabolic effects. These procedures have been applied to determine the safety of vitamins, food additives, and drugs, including hormones, for over twenty-five years.

Numerous independent researchers and scientific committees have examined the data on the dietary exposure of IGF-I and related proteins present in milk. The data provide ample evidence that the amount of IGF-I and truncated forms excreted in milk following the administration of rbST to dairy cows is safe for all consumers, including infants. Additional exposure data are not necessary.

FDA's determination that food products from cows treated with rbST are safe for consumers has been supported by numerous scientific and regulatory bodies including the Joint Food and Agricultural Organization/World Health Organization Expert Committee on Food Additives (JECFA), an international panel of experts in the field of toxicology and chemistry of animal drug residues that meets to evaluate the safety of animal drugs. In 1992, the JECFA concluded that "the lack of oral activity of rbST and insulin-like growth factor I (IGF-1) and the low level and non-toxic nature of the residues of these compounds, even at exaggerated doses, results in an extremely large margin of safety for humans consuming dairy products from rbST-treated cows." In 1998, JECFA reaffirmed the safety of milk and meat from rbST-treated cows.

Recently, FDA reviewed the issues raised in Health Canada's report on the food safety of rbST, and concluded that there were no biologically significant effects. Based on the current body of science relative to the safety of rbST, FDA has reaffirmed that meat and milk from rbST-treated cows are safe for human consumption.

The full FDA report, "Report on the Food and Drug Administration's Review of the Safety of Recombinant Bovine Somatotropin," is available on CVM's Internet Home Page. A copy of this report may also be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Please include a self-addressed adhesive label to assist in processing your request.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855