Chronology of Major bST Studies and Events

1936 Russian scientists reported that injecting dairy cows with crude bovine pituitary extracts of bST increased milk yield (Asimov, et al.). However, wide-spread commercial use of the extracts was never seriously pursued since only very small and impure amounts were obtainable from cows at slaughterhouses.

1950s Scientists injected U.S. children with pituitary extracts of bST with the hope of treating hypopituitary dwarfism. It was found that supplemental bST did not stimulate growth and had no effect on humans.

1970s Recombinant DNA technology was developed, leading to commercial volume production of bST.

1979 Professor Dale Bauman at Cornell University conducted the first study in which high-producing cows were supplemented with pituitary bST.

1982 Recombinantly produced human insulin was introduced. It was found to be identical to natural human insulin and was made by a process similar to that used for bST.

1982 Professor Bauman at Cornell University conducts and reports results from the first study in supplementing cows with recombinant bST.

1982 Four major companies openly acknowledged that they were developing and experimenting with synthetic bST, and later authorized FDA to provide information to the public concerning their new animal drug applications (NADA's).

1984 First report was issued on the economic impacts of bST (Kalter. et al.).

1984-5 FDA ruled that milk and meat from bST-treated cows is safe for human consumption, and that milk and meat from bST-treated cows in experimental herds could be marketed for commercial consumption with no withdrawal period.

1985 The first long-term study (188 days of lactation) with bST was reported for lactating dairy cows. Daily bST (sometribove) injections increased milk production up to 41 percent (Bauman et al.).

1987 A "National Invitational Workshop on Bovine somatotropin" was held in St. Louis, Missouri, sponsored by the USDA Extension Service. Some 24 papers and/or presentations were made in five separate sessions:

• bST: An Emerging Technology
• bST: Research Update
• Herd Management Considerations
• Workshop - Wrap-Up Session

1987 A bST-symposium was held in Germany. Proceedings were published as "Landbauforschung Volkenrode", Ellendorff, Farries, Oslage, Rohr and Smidt., (ISSN 0376-0723, Jan. 1988).

1988 A seminar on the use of somatotropin in livestock production was held in Brussels as part of the European Community (EC) program for the Coordination of Agricultural Research. Proceedings were published in a book "Use of Somatotropin in Livestock Production", edited by Sejrsen, et al., 1989.

1989 A conference organized by Cornell University's Cooperative Extension Service, Dairy Management Division, and Department of Animal Science entitled "Advanced Technologies Facing the Dairy Industry: bST" was held. Economic, social, and scientific issues were discussed. Thirteen papers were presented and then published in the proceedings.

1989 A worldwide symposium "bST -- From Promise to Practice" was held in Lexington, Kentucky, August 4-5. Eight invited papers were, presented at the symposium giving a comprehensive worldwide review of the effects of bST in lactating dairy cows and published in The Journal of Dairy Science, Volume 74, Supplement 2, 1991.

1989 A book was published in the EC "Use of Somatotropin in Livestock Production" Elsvier Press; edited by K. Sejrse, M. Vestergaard and A. Neiman-sorensen.

1990 In the August 24 issue of Science magazine, FDA scientists summarized more than 120 studies that examined the human safety of bST, concluding that there were no increased safety concerns in the composition of milk from bST-treated cows.

1990 An international symposium "Biotechnology for Control of Growth and Product Quality in Meat Production: Implications and Acceptability" was held in Rockville, Maryland on December 5-7. Some 30 papers were presented at the conference and published in a book in 1991 by the Centre for Agricultural Publishing and Documentation (Pudoc), Wageningen, Netherlands, under the same title as the symposium. The sponsors of the program were the Commission of the European Communities; United States Department of Agriculture (Agricultural Research Services; Animal and Plant Health Inspection Service; Cooperative State Research Service; Economic Research Service; Extension Service; and Food Safety and Inspection Service); Food and Drug Administration Center for Veterinary Medicine; the Dairy Industry; and the National Pork Producers Council.

The Symposium Was Organized in Six Sessions:

• Perspectives of Introducing Biotechnology in Meat Production
• Biotechnologies Affecting Growth and Product Quality
• The Target Animal: Safety, Welfare and Requirements
• Human Safety
• Social and Consumer Acceptance
• Environmental and Socio-Economic Implications

1990 The National Institutes of Health reviewed the data on bST and found that there should be no alarm raised about the milk from cows receiving bST. A panel of 13 veterinarians, toxicologists, pediatricians, and statisticians drew the conclusion in a two-day meeting held December 6-7 that there was no human safety risk from the use of bST with lactating dairy cows.

1991 The Journal of the American Medical Association (JAMA) published a special communication, "NIH Technology Assessment Conference Statement on Bovine somatotropin" and a Council on Scientific Affairs report, "Biotechnology and the American Agricultural Industry." Both affirmed the human safety of milk from cows supplemented with bST.

1991 The Journal of Clinical Endocrinology and Metabolism published a peer-reviewed paper, "The Efficacy and Safety of Growth Hormone for Animal Agriculture'" which affirmed the efficacy and human safety of recombinant bST.

1992 The 38th Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and the Food and Agricultural Organization of the United Nations confirmed the human food safety of recombinant bST products.

1992 A journal article, "Bovine somatotropin: Review of an Emerging Animal Technology" was published in the December issue of The Journal of Dairy Science. (Bauman). The paper references 97 published papers in the author's review of the development of bST technology.

1993 The drug regulatory body of the European Union issued a scientific report, "Final Scientific Report of the Committee for Veterinary Medicinal Products on the Application for Marketing of Somatech and Optiflex 640." The report concluded that food products from bST-treated cows were safe and that there was no scientific basis for EU regulatory bodies not to approve bST for commercial use.

1993 The UK Medicines Commission determined that milk and meat from cows receiving bST are safe for human consumption.

1993 Monsanto Company receives U.S. FDA approval for POSILAC bovine somatotropin. FDA Commissioner David A. Kessler, M.D., said "There is virtually no difference in milk from treated and untreated cows. In fact, it's not possible using current scientific techniques to tell them apart. We have looked carefully at every single question raised, and we are confident this product is safe for consumers, for cows and for the environment… This has been one of the most extensively studied animal drug products to be reviewed by the agency. The public can be confident that milk and meat from bST-treated cows is safe to consume."

1994 Monsanto Company commercializes POSILAC bovine somatotropin.

1996 The Veterinary Medicine Advisory Committee (VMAC) of the Food and Drug Administration (FDA) provides unanimous support of the results of PAMP, the most extensive post-approval monitoring program ever conducted for an animal-health product.

1998 POSILAC^®, the one-piece, ready-to-use pre-filled syringe introduced.

1998 Groundbreaking for a 150,000 sq. ft. manufacturing plant for POSILAC in Augusta, Georgia.

1998 A milestone completed with more than 100 million POSILAC doses delivered.

1998 The Food and Agriculture Organization (FAO) of the United Nations released a committee report reconfirming that supplementing cows with POSILAC is safe.

1999 Animal scientists published a study supporting the effectiveness of POSILAC in on-farm settings over a four year period. This Northeast Dairy Herd Improvement (DHI) study involved 27,000 cows in 340 northeastern commercial dairy herds with cows supplemented with POSILAC and herds with cows that were not. The scientists concluded supplementation with POSILAC significantly and consistently increased milk production throughout multiple years of use. The average days in milk and average age of the herd remain consistent between control herds and the herds supplemented with POSILAC.

2000 Completion of manufacturing plant for POSILAC 1STEP in Augusta, Georgia.

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