Bovine Somatotropin - Regulation

Regulation

Use of the recombinant supplement has been controversial. The assessment of the United States FDA is that there is no significant difference between milk from treated and untreated cows. 21 other countries have also approved marketing of rBST: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Honduras, Jamaica, Lebanon, Mexico, Panama, Pakistan, Paraguay, Peru, Salvador, South Africa, South Korea, Uruguay and Venezuela. However, regulatory bodies in several countries, such as the EU, Canada, Japan, Australia and New Zealand, rejected Monsanto's application to sell rBST because rBST increases the risk of health problems in cows, including clinical mastitis, reduced fertility, and reduced body condition. In Canada, bulk milk products from the United States that have been produced with rBST are still allowed to be sold and used in food manufacture (cheese, yogurt etc.).

In 1990, the European Union placed a moratorium on its sale by all member nations. It was turned into a permanent ban starting from 1 January 2000; the decision was based solely on veterinary concerns, laws, and treaties. An in-depth report published in 1999 analysed in detail the various human health risks associated with rBST.

Canada's health board, Health Canada, refused to approve rBST for use on Canadian dairies, citing concerns over animal health. The study found the occurrence of an antibody reaction, possible hypersensitivity, in a subchronic (90-day) study of rbST oral toxicity in rats that resulted in one test animal's developing an antibody response at low dose (0.1 mg/kg/day) after 14 weeks. However, the board stated that, with the exception of concerns raised regarding hypersensitivity, "the panel finds no biologically plausible reason for concern about human safety if rBST were to be approved for sale in Canada."

The Codex Alimentarius Commission, a United Nations body that sets international food standards, has to date refused to approve rBST as safe. The Codex Alimentarius does not have authority to ban or approve the hormone—but its decisions are regarded as a standard and approval by the Codex would have allowed exporting countries to challenge countries with a ban on rBGH before the World Trade Organization.