RECOMBINANT BOVINE GROWTH HORMONE

Background
Recombinant bovine growth hormone (rBGH) is a synthetic hormone that is marketed to dairy farmers to increase milk production. The use of
rBGH in the United States was approved by the Food and Drug Administration in 1993, but has been banned in the European Union and Canada
since 1999. This document summarizes available information about the product and its potential effects on health.
What is synthetic (recombinant) bovine growth hormone (rBGH)?
The human form of growth hormone, also called somatotropin, is produced by the pituitary gland, and promotes growth and cell replication.
Bovine somatotropin is the naturally occurring form of this hormone in cattle. Synthetic or recombinant somatotropin (rBGH or rBST) refers to
bovine growth hormone that is manufactured in a laboratory using genetic technology. Some rBGH products on the market differ chemically
from a cow’s naturally occurring somatotropin by one amino acid (called methionine). Both the natural and synthetic forms of the hormone
stimulate milk production by increasing circulating levels of another hormone known as insulin-like growth factor (IGF-1).
Usage and regulatory status
Although the use of rBGH is still approved in the United States, demand for the product has decreased in recent years. A USDA survey
conducted in October, 2007 found that less than 1 in 5 (17%) cows were being injected with rBGH.
Summary
The available evidence documents adverse health effects from rBGH on cows. The evidence for potential harm to humans is inconclusive. To
date, there is no evidence that drinking milk produced using rBGH adds substantively to circulating IGF-1 levels in humans or to the risk of
developing cancer. The increased use of antibiotics to treat rBGH-induced mastitis does promote the development of antibiotic resistant bacteria,
but the extent to which these are transmitted to humans is unclear. The president of the American Medical Association has recommended that
hospitals serve milk produced without the use of rBGH.
The American Cancer Society (ACS) has no formal position regarding rBGH. Together with its advocacy affiliate, the ACS Cancer Action
Network (ACS CAN), the Society supports open, fair and transparent regulatory oversight of products containing rBGH. The ACS also
encourages continued and expanded scientific research and independent, credible assessment of potential relationships between the use of this
substance in cows and human cancer risk. We support regulatory standards based on rigorous scientific evidence to minimize exposure to
carcinogens, and we encourage the FDA to give the public information regarding known and suspected causes of cancer in the food system. The
need for an effective FDA in ensuring the safety of our food supply, medicines, and consumer products has never been greater.
Health Canada: Recombinant Bovine Somatotropin.

Accessed at http://www.hc-sc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/index-eng.php on February 17, 2009.

The four analogues of bovine somatotropins, somagrebove,

sometribove, somavubove, and somidobove, that are produced by
recombinant DNA techniques were evaluated by the Committee at its RECOMBINANT BOVINE SOMATOTROPINS (addendum)
fortieth meeting (Annex 1, reference 104). At that time, the Committee
allocated an ADI 'not specified' for recombinant bovine somatotropins
(rbSTs) because of the lack of activity of orally administered rbSTs First draft prepared by
and insulin-like growth factor I (IGF-I) and the low concentrations Professor F.R. Ungemach
and non-toxic nature of the residues of these compounds, even after Institute of Pharmacology, Pharmacy and
very high doses, resulting in an extremely large margin of safety for Toxicology
humans consuming dairy products from rbST-treated cows. The Veterinary Faculty, University of
Committee concluded that use of these drugs according to good practice in Leipzig, Leipzig, Germany
veterinary medicine did not represent a dietary hazard to human health and
and that there was no need to specify a numerical ADI. Accordingly,
Dr N.E. Weber
MRLs 'not specified' were recommended for milk and edible tissues of
cattle. The Codex Alimentarius Commission, when considering adoption Food and Drug Administration, Center of
of these recommended MRLs at its twenty-second session in 1997, Veterinary Medicine
postponed a decision pending re-evaluation of rbSTs by the Expert Rockville, MD, USA

Committee to consider scientific information that had become available Prepared by:
since its previous evaluation. The 50th meeting of the Joint
FAO/WHO Expert
Information was submitted by organizations and individuals
relating to the following concerns:
Committee on Food Additives (JECFA)
World Health Organization, Geneva
1998
* increased use of antibiotics, with a higher rate of violative
drug residues in milk due to a possible increase in the incidence
of mastitis in rbST-treated cows,

* the possibility that increased concentrations of IGF-I in the

milk of rbST-treated cows increase cell division and the growth of
tumours in humans,

* the potential effect of rbST on the expression of certain viruses in

cattle, particularly the retroviruses,

* the possibility that the incubation period of bovine spongiform

encephalopathy (BSE) is shortened by an IGF-I-induced increase in the
production of pathogenic prion proteins, and

* the possibility that early exposure of human newborns to milk from

rbST-treated cows increases the risk for developing insulin-dependent
diabetes mellitus.