rBGH/rBST: Recombinant Bovine Growth Hormone in US Dairy

rBGH — scientific infographic poster

Recombinant bovine growth hormone (rBGH), also known as recombinant bovine somatotropin (rBST or rbST), is a genetically engineered version of the growth hormone made by the pituitary gland of cattle. It is injected into dairy cows every 14 days to raise milk yield; a meta-analysis by an expert panel of the Canadian Veterinary Medical Association found increases of 11.3% in first-lactation cows and 15.6% in older cows. Treatment also raises insulin-like growth factor 1 (IGF-1) in the cow's blood and milk. The US Food and Drug Administration approved it in November 1993, and its safety has been disputed ever since. A 1999 Council Decision (1999/879/EC) prohibits placing it on the market and administering it to dairy cows in the European Union, and Health Canada announced in January 1999 that it would not approve its sale in Canada.

Table of Contents

  1. Key Points at a Glance
  2. Overview
  3. Regulatory History
  4. Mechanism of Action
  5. Health Effects
  6. Animal Welfare Findings
  7. IGF-1 Research and Cancer Risk
  8. Labeling Controversy
  9. Market Trends
  10. Related Articles
  11. Key Research Papers
  12. Connections
  13. Featured Videos

Key Points at a Glance

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1. Overview

Bovine somatotropin (BST) is a protein hormone naturally produced by the anterior pituitary gland of cattle. It helps regulate metabolism, growth and milk production. Recombinant bovine somatotropin is made by recombinant DNA technology and formulated for injection.

2. Regulatory History

United States: FDA Approval

The FDA's 1993 approval of rbST was contested by consumer groups and some scientists. Critics alleged industry influence over the review and the sidelining of dissenting reviewers; FDA scientists published their human food safety evaluation in 1990 and concluded that milk from treated cows presents no increased health risk to consumers.

Status Outside the United States

3. Mechanism of Action

rbST works through a chain of hormonal changes in the cow, and the human-health question turns on one link in that chain: IGF-1.

4. Health Effects

IGF-1 and Cancer Risk

These studies measured IGF-1 in people's blood; none tested milk from treated cows.

Mastitis, Antibiotics and Residues

5. Animal Welfare Findings

The health of the cows was the stated basis of both the Canadian and the EU decisions.

6. IGF-1 Research and Cancer Risk

Research on IGF-1 and cancer has continued since the late-1990s cohort studies. Two separate questions are often blurred: whether higher blood IGF-1 is linked with cancer, and whether milk from treated cows raises blood IGF-1 in people who drink it.

7. Labeling Controversy

Alongside the regulatory decisions abroad, a long dispute ran in the United States over whether dairy companies could tell consumers that their milk came from untreated cows. The manufacturer argued that such labels mislead consumers into thinking that milk from untreated cows is superior, and in 2007 it asked for regulatory action against what it called deceptive milk labeling and advertising.

rbST remains FDA-approved and has not been banned in the United States; its use has been shaped by consumer demand and company sourcing decisions.

Key Research Papers

Key research papers and authoritative sources. Links resolve to DOI, PubMed, or the issuing agency.

  1. Hankinson SE, Willett WC, Colditz GA, et al. Circulating concentrations of insulin-like growth factor-I and risk of breast cancer. Lancet. 1998;351(9113):1393–1396. — doi:10.1016/S0140-6736(97)10384-1
  2. Chan JM, Stampfer MJ, Giovannucci E, et al. Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study. Science. 1998;279(5350):563–566. — doi:10.1126/science.279.5350.563
  3. Ma J, Pollak MN, Giovannucci E, et al. Prospective study of colorectal cancer risk in men and plasma levels of insulin-like growth factor (IGF)-I and IGF-binding protein-3. J Natl Cancer Inst. 1999;91(7):620–625. — doi:10.1093/jnci/91.7.620
  4. Renehan AG, Zwahlen M, Minder C, O'Dwyer ST, Shalet SM, Egger M. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet. 2004;363(9418):1346–1353. — doi:10.1016/S0140-6736(04)16044-3
  5. Prosser CG, Fleet IR, Corps AN. Increased secretion of insulin-like growth factor I into milk of cows treated with recombinantly derived bovine growth hormone. J Dairy Res. 1989;56(1):17–26. — PubMed PMID: 2703558
  6. Kimura T, Murakawa Y, Ohno M, Ohtani S, Higaki K. Gastrointestinal absorption of recombinant human insulin-like growth factor-I in rats. J Pharmacol Exp Ther. 1997;283(2):611–618. — PubMed PMID: 9353376
  7. Epstein SS. What's in Your Milk? An Expose of Industry and Government Cover-Up on the DANGERS of the Genetically Engineered (rBGH) Milk You're Drinking. Victoria, BC: Trafford Publishing; 2006. ISBN: 978-1425101503.
  8. European Union Scientific Committee on Veterinary Measures Relating to Public Health. Report on Public Health Aspects of the Use of Bovine Somatotrophin. 15–16 March 1999. Brussels: European Commission; 1999.
  9. Health Canada, Bureau of Veterinary Drugs. Report of the Canadian Veterinary Medical Association Expert Panel on rBST. Ottawa: Health Canada; 1999.
  10. Outwater JL, Nicholson A, Barnard N. Dairy products and breast cancer: the IGF-I, estrogen, and bGH hypothesis. Med Hypotheses. 1997;48(6):453–461. — doi:10.1016/S0306-9877(97)90110-9
  11. Giovannucci E. Insulin-like growth factor-I and binding protein-3 and risk of cancer. Horm Res. 1999;51(suppl 3):34–41. — doi:10.1159/000053160
  12. Mepham TB, Schofield PN, Zumkeller W, Cotterill AM. Safety of milk from cows treated with bovine somatotropin. Lancet. 1994;344(8934):1445–1446. — doi:10.1016/s0140-6736(94)90618-1
  13. International Dairy Foods Association v. Boggs, 622 F.3d 628 (6th Cir. 2010). United States Court of Appeals for the Sixth Circuit. Decided September 30, 2010. — Sixth Circuit opinion 10a0322p
  14. Collier RJ, Bauman DE. Update on human health concerns of recombinant bovine somatotropin use in dairy cows. J Anim Sci. 2014;92(4):1800–1807. — doi:10.2527/jas.2013-7383
  15. USDA National Agricultural Statistics Service. Dairy 2007: Facility Characteristics and Cow Comfort on U.S. Dairy Operations. Fort Collins, CO: USDA APHIS; 2009. APHIS publication
  16. Dohoo IR, DesCoteaux L, Leslie K, et al. A meta-analysis review of the effects of recombinant bovine somatotropin. 2. Effects on animal health, reproductive performance, and culling. Can J Vet Res. 2003;67(4):252–264. — PubMed PMID: 14620861
  17. Bauman DE. Bovine somatotropin: review of an emerging animal technology. J Dairy Sci. 1992;75(12):3432–3451. — doi:10.3168/jds.s0022-0302(92)78119-3
  18. Dohoo IR, Leslie K, DesCôteaux L, et al. A meta-analysis review of the effects of recombinant bovine somatotropin. 1. Methodology and effects on production. Can J Vet Res. 2003;67(4):241–251. — PubMed PMID: 14620860
  19. Juskevich JC, Guyer CG. Bovine growth hormone: human food safety evaluation. Science. 1990;249(4971):875–884. — PubMed PMID: 2203142
  20. Collier RJ, Miller MA, Hildebrandt JR, et al. Factors affecting insulin-like growth factor-I concentration in bovine milk. J Dairy Sci. 1991;74(9):2905–2911. — PubMed PMID: 1779049
  21. Xian CJ, Shoubridge CA, Read LC. Degradation of IGF-I in the adult rat gastrointestinal tract is limited by a specific antiserum or the dietary protein casein. J Endocrinol. 1995;146(2):215–225. — PubMed PMID: 7561632
  22. Honegger A, Humbel RE. Insulin-like growth factors I and II in fetal and adult bovine serum. Purification, primary structures, and immunological cross-reactivities. J Biol Chem. 1986;261(2):569–575. — PubMed PMID: 3941093
  23. Epstein SS. Potential public health hazards of biosynthetic milk hormones. Int J Health Serv. 1990;20(1):73–84. — PubMed PMID: 2407676
  24. Epstein SS. Unlabeled milk from cows treated with biosynthetic growth hormones: a case of regulatory abdication. Int J Health Serv. 1996;26(1):173–185. — PubMed PMID: 8932606
  25. Qin LQ, He K, Xu JY. Milk consumption and circulating insulin-like growth factor-I level: a systematic literature review. Int J Food Sci Nutr. 2009;60(suppl 7):330–340. — PubMed PMID: 19746296
  26. Scientific Committee on Animal Health and Animal Welfare. Report on Animal Welfare Aspects of the Use of Bovine Somatotrophin. Adopted 10 March 1999. Brussels: European Commission; 1999. — archived report (PDF)
  27. Council of the European Union. Council Decision of 17 December 1999 concerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC (1999/879/EC). — EUR-Lex 31999D0879
  28. Forge F. Recombinant Bovine Somatotropin (rbST). Library of Parliament, Parliamentary Research Branch, background paper PRB 98-1E. Ottawa; October 1998, revised 11 August 1999. — Government of Canada Publications
  29. US General Accounting Office. Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved. PEMD-92-26. August 6, 1992. — GAO PEMD-92-26
  30. Sechen SJ, FDA Center for Veterinary Medicine. Bovine Somatotropin (bST) – Possible Increased Use of Antibiotics to Treat Mastitis in Cows. Report submitted to the 78th JECFA meeting. October 30, 2013. — FDA report (PDF)
  31. Pennsylvania Department of Agriculture, Bureau of Food Safety and Laboratory Services. Revised Standards and Procedure for the Approval of Proposed Labeling of Fluid Milk (Milk Labeling Standards 2.0.1.17.08). January 17, 2008. — PA.gov (PDF)
  32. FoodNavigator. Growth hormone free milk labels adopted by Pennsylvania. January 18, 2008. — FoodNavigator
  33. Horovitz B. Companies cut synthetic hormone from dairy products. USA Today. March 2009. — USA Today
  34. PubMed — rBGH rBST IGF-1 cancer search

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Connections

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