December 22,2003
Got Hormones?


The Debate of Bovine Somatotropin (BST) – Links to Pros and Cons

Hormones in Your Milk - Janet Raloff
Four dairies got their proverbial hands slapped by the U.S. Food and Drug Administration for marketing what it charges is "misbranded" milk. The regulatory agency recently issued warning letters to the companies—which sell whole milk, reduced-fat milk, and ice cream—saying that their product labels contain false statements about the food's hormone status.
FDA's Sept. 24 letter to a Sauk Centre, Minn., dairy, for instance, informed the chief manager that the dairy's products are misbranded because its labels "contain the statement 'No Hormones,' which is false." The agency's contention is that naturally occurring hormones are present in all milk and milk products. Indeed, the warning letter charged, "milk cannot be produced in a way that renders it free of hormones." Even a mother's milk is laced with natural hormones.

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.

On April 20, 2000, FDA responded to a Citizen Petition (Docket No. 99P-4613) from Mr. Robert Cohen concerning Posilac®, the only FDA-approved recombinant bovine growth hormone (rbGH) product for increasing milk production in dairy cattle. FDA's Center for Veterinary Medicine (CVM) approved Monsanto Company's rbGH product, Posilac in November 1993 after a comprehensive review of the product's safety and efficacy, including human food safety.
The petition requested that FDA rescind the approval of Posilac, and immediately remove it from the market based on "new evidence" that the product poses "serious health consequences for human consumers." Later, Mr. Cohen amended this petition, most recently on December 2, 1999. As amended, the petition raised three primary issues in support of the request for withdrawal of Posilac. These issues are as follows: (1) that a recently reported increase in serum levels of insulin-like growth factor-1 (IGF-I) in humans following milk consumption represents absorption of dietary IGF-I, invalidating a basic premise of FDA's safety assessment and proving that IGF-I in milk represents a hazard to human health; (2) that Monsanto changed the manufacturing process for rbGH after the studies supporting the New Animal Drug Application (NADA) were completed, thereby invalidating the research used to support the approval; and (3) that the 90-day toxicology study and/or the information derived from the additional 90 days of the study demonstrate both that rbGH is absorbed and that it is not safe.

BOVINE SOMATOTROPIN (BST) - Institute of Food Science & Technology, Position Statement
Special Note: Having regard to the current conflict of interpretation of evidence, this Information Statement represents an IFST overview of the present position in relation to this topic, and does not imply that IFST has adopted a position in relation to the continuing controversy.
The effects of BST treatment of cows in relation to human health and animal health have been re-evaluated by the Food and Drug Administration (FDA) in USA, and have been evaluated by independent assessments for the Canadian authorities, by Codex Alimentarius and by scientific committees of the European Union.
The US and Canadian assessments both concluded that products from BST-treated cows present no hazard to human health, and this is supported by the Codex assessment. However, the EU assessment is inconclusive, while drawing attention to potential hazards requiring more research.
The US reassessment reaffirmed that BST treatment is not harmful to animal health, but both the Canadian and EU assessments concluded that it is harmful to animal health.

FREEDOM OF INFORMATION SUMMARY :NADA 140-872 POSILAC ® (sterile sometribove zinc suspension)
Please note - due to the large size of this document, it has been broken into multiple sections to improve downloading time. At the end of each section, there will be a link to the next and previous sections and to this Table of Contents.
Human Safety
a. Drugs for Use in Food Animals
The FDA Guideline for Toxicological Testing recommends appropriate toxicology tests for veterinary drugs in general and provides for the development of alternate testing procedures for certain classes of compounds such as, for example, biologically active proteins. As discussed in detail by Juskevich and Guyer ("Bovine growth hormone: human food safety evaluation," Science 249:875-884, 1990), the tests recommended are dependent on the potential exposure of people to residues and the possible biological effects of the protein in man. A determination of the potential oral activity of the protein in laboratory animals is the first step in the testing process. This determination involves the oral administration of exaggerated dosages daily for an appropriate time period. If the compound is determined to be orally active, more testing may be required. In the case of sometribove, there is convincing medical evidence that non-human somatotropins, like bovine somatotropin, are not biologically active in man (Recent Prog Horm Res. 15:71-114, 1959).

Biotechnology and Bovine Somatotropin (BST or BGH):Position of the International Dairy Foods Association
The International Dairy Foods Association (IDFA) believes that biotechnology offers a broad range of benefits to the food industry and to consumers throughout the world, so long as its applications are shown to be scientifically sound and safe. IDFA believes that the value of agricultural biotechnology has been amply demonstrated over the past 10 years.
Recombinant Bovine Somatotropin (rBST), sometimes called Bovine Growth Hormone (BGH), is a product of biotechnology that went through years of rigorous scientific review, and has been used commercially in dairy herds in the United States for almost a decade. About one-third of the nation's dairy operations use rBST to some extent in their herds.
The Food and Drug Administration (FDA) made initial rulings on the safety of rBST in 1985. Since the commercial approval of rBST in 1993, Americans have safely consumed literally billions of gallons of milk from herds where rBST is used.

Can You Afford to Use Bovine Somatrophin (Bovine Growth Hormone)? - Jeffrey F. Keown, Extension Dairy Specialist
Factors to consider before using Bovine Somatrophin in your dairy herd are covered here.
Much has been written recently about the effect of administering Bovine Somatrophin (BST) to dairy animals. The expected increase in income that could be generated by the use of BST catches producers' attention.
Before any producer uses BST, however, there are a few questions that should be addressed. The most crucial is, "Can BST administration be cash flowed in my dairy operation?"
The answer to this question is dependent on three crucial areas--your current herd average, herd management situation, and the costs involved in the application of BST.

Getting It Straight: Hormones and Milk -
It isn’t unusual, especially around TV-rating "sweeps" months and on the tabloid news shows, to see and hear some rather outlandish things about the food we eat — whether it is a fad diet of some sort or "hidden dangers" in our food supply.
So it is that you might see some attention given to an activist, without scientific or medical standing, who claims in his self-published book that milk is loaded with a myriad of negative substances — many of his objections being focused on the use of synthetic bovine growth hormone. And then there are actresses and other celebrities who come out with their books touting a certain "eating lifestyle." They dart from one talk show to another, making their claims, often without any serious challenge to the validity of their views or their "facts."
Without any hype, we present to you a summary of findings (with references) about Bovine Somatotropin (BST) from qualified scientists, as prepared by the National Dairy Council. And we invite you to visit other professional dietary sites, such as those of the American Heart Association and the American Dietetic Association, to read their assessments of dairy products and good nutrition.

Labeling Problems:

Negative Labeling Of Genetically Modified Organisms (GMOs): The Experience Of rBST - C. Ford Runge and Lee Ann Jackson, University of Minnesota
Voluntary negative labeling may provide a solution to the current controversy over labeling of Genetically Modified Organisms (GMOs) in agriculture. The US experience in the dairy sector with milk from cows treated with recombinant bovine somatotropin offers an example of how a voluntary negative labeling strategy evolved.

Got Hormones? The simmering issue of milk labels boils over when an agrochemical giant sues small farmers in Maine – Margot Roosevelt Leeds, Time Monday, Dec. 22, 2003
Down a dirt road, tucked in rolling fields, John Nutting's farm is a picture of tranquillity. A wintry breeze sighs through the forest. Black-and-white Holsteins chew their cuds in a lazy rhythm. Only the large sign hammered onto a red barn attests to the defiant mood in Maine dairy country: OUR PLEDGE — NO ARTIFICIAL HORMONES.
Hormones are a hot issue in these parts. As do at least 85% of Maine's milk producers, Nutting signs an affidavit each year vowing not to inject his cows with recombinant bovine somatotropin (RBST), a genetically engineered growth hormone. "We're proud of the way we farm," says the third-generation dairyman. "Consumers have the right to know how their milk is made."
Not necessarily. A food fight has erupted in New England between those who would label their produce as they see fit and those who argue that some of those labels give customers a false impression. Chief among the latter is Monsanto Corp., the agrochemical giant that markets RBST and is fighting a rearguard action to quell consumer resistance to its product.,9171,1101031222-561486,00.html

More on Monsanto Suing Maine Dairy over rBGH Issue - From Agribusiness Examiner, Al MAINE DAIRY SUED BY MONSANTO, CLAIMS IT DISPARAGES rBGH, DAVID BARBOZA, NEW YORK TIMES
In another sign of how contentious food labeling issues have become in recent years, the Monsanto Company has sued a small milk producer in Portland, Maine, over the labeling of its dairy products.
Monsanto has accused Oakhurst Dairy Inc. of engaging in misleading and deceptive marketing practices by carrying labels that seem to disparage the use of artificial growth hormones in cows.
Monsanto is the maker of the only major artificial growth hormone, Posilac. It has been on the market since 1994 and is used in about a third of the nation's nine million dairy cows.

Burlington Free Press article: August 8th decision of the US Court of Appeals, second circuit, International Dairy Foods Association et al v. Attorney General of Vermont, on rBST labelling - Richard L. Grossman, 15 August 1996
In April, 1994, the State of Vermont enacted a law requiring products containing rBST to be labeled. rBST is a genetically-engineered "bovine growth hormone" sold by Monsanto to dairy farmers, who inject it into their cows to increase milk production. Possible changes in the milk itself, and the potential human health consequences of such changes, have been the subject of intense national debate for about 3 years.--P.M. That same month, The International Dairy Foods Assn, The Milk Industry Foundation, The International Ice Cream Association, The National Cheese Institute; The Grocery Manufacturers of America, Inc., and The National Food Processors Association -- all trade, lobbying, promotional and lobbying corporations -- filed suit asserting that the Vermont statute was unconstitutional.