Bovine Somatotropin (bST) Safety Around the World

Terry D. Etherton

A common “sound bite” in the arsenal of individuals who oppose rbST use in the dairy industry in the United States is that it is banned in most countries around the world, especially Canada and all the European nations to protect the milk supply. This is inaccurate and misleading. Here are the facts:

The Facts:

No country has a regulatory ban on rbST. Registration of rbST for commercial sale simply has not been completed in many countries.

No country has banned the importation of milk or milk products from the U.S. produced from cows supplemented with rbST (statement by U.S. Dairy Export Council).

There are 20 countries that have a current registration of rbST for commercial sale. Chile is the most recent country to grant registration which was achieved in 2006.

There are 56 counties which have confirmed that rbST use is safe and does not threaten the human food chain, including Canada, and most of the European Union. Confirmation of human safety is the first step in a registration process.

All countries have regulatory agencies similar to the FDA in the United States that must approve pharmaceuticals for commercial sale within those countries.

While there are countries in which rbST has not received registration for commercial sale, the registration process is still open; however in some countries the process has been suspended or blocked, sometimes through a legislative ban, for political or economic reasons.

Economic impact is not usually a reason that can be cited in most countries for denying the grant of a pharmacological registration. Only efficacy, human safety, and animal safety are the key determinants.

Typically, the ploy “questions that need further investigation regarding animal safety” is used to delay or suspend the registration process when there are economic or political considerations.

The economic consideration for countries like Canada and many European nations is their current domestic milk marketing system is based on a quota system which discourages increases in milk production in order to protect the marketplace for producers (see Sidebar section below).


Numerous United States and international medical, scientific, and regulatory agencies have issued statements supporting and confirming the safety of rbST and that there is no threat to human health by rbST use (the list of agencies is presented below).

Quota Overview:

The primary purpose of a quota marketing system is to keep milk prices artificially high through supply limitation. Quota systems limit competition and therefore reduce the number of producers that exit an industry.

A producer has to own quota for every pound of milk produced in order to market all of their milk under the profitable market prices. Milk not covered by quota can only be marketed at severely discounted prices, making profit impossible for non-quota milk.

Quota is prohibitively expensive to obtain in order to discourage production increases thus discouraging the adoption of technology, farm expansion, and practices that improve production efficiency.

Furthermore quota is a capital asset and can be borrowed against in many countries.

A quota system is difficult to abandon once adopted because vested people and financial institutions with liens against quota value would lose net worth. Consequently, they fight to preserve the status quo. This makes it apparent why the availability of a production-enhancement technology with the impact of rbST would be disruptive to domestic marketplace status quo in countries with a quota system.

Scientific/Medical/Health/Governmental Organizations that have confirmed the Human Safety of milk and meat products from cows supplemented with rbST (list is not inclusive)

• American Cancer Society
• American Council on Science & Health
• American Dietetic Association (ADA)
• American Medical Association (AMA)
• Canadian Animal Health Institute
• Canadian Dietetic Association
• Canadian Institute of Biotechnology
• Canadian Medical Association
• Canadian Network of Toxicology Centres
• Canadian Pediatric Society
• Children’s Nutrition Research Center, Baylor College of Medicine
• Council on Agricultural Science & Technology
• European Union’s Committee for Veterinary Medicinal Products (CVMP)
• Federal Drug Administration (FDA)
• Food & Agriculture Organization of the United Nations (FAO)
• Food & Nutrition Science Alliance
• Food Marketing Institute
• Grocery Manufacturers of America (GMA)
• Health Canada (Royal College of Physicians & Surgeons)
• Institute of Food Technologists (IFT)
• International Dairy Foods Association (IDFA)
• Joint FAO & WHO (World Health Organization) Expert Committee on Food Additives (JECFA)
• National-American Wholesale Grocers’ Association
• National Dairy Council
• National Institutes of Health (NIH)
• The American Academy of Family Physicians Foundation
• Toronto Biotechnology Initiative
• University of California – Berkeley
• University of California – Davis
• U.S. Congress Office of Technology Assessment (OTA)
• U.S. Dairy Export Council
• U.S. Surgeon General’s Office

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