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CITY OF TORONTO

TORONTO FOOD POLICY COUNCIL

February 21 1994

To: Board of Health

Origin: Board of Health (September 20, 1991, p:\1994\ug\hld\hl940026.hld)

Subject: The current status of the licensing of recombinant Bovine Growth Hormone (rBGH)

Recommendations:

1. That the Board of Health continue to express its reservations about the licensing of Bovine Growth Hormone, as a result of continued questions about animal health, long-term public health implications, and the economic implications for the dairy sector.

2. That the Board of Health request that Health Canada and Agriculture Canada require labelling of all foods produced by genetic engineering, including genetic manipulation to create non-naturally occurring characteristics and products, transgenic plants and animals, and plants and animals resulting from the deliberate short-circuiting (forced foreshortening of time sequence) of natural processes.

3. That the Board of Health forward a copy of this report to:

- all school boards in Ontario, requesting that, in the event of licensing of rBGH, they consider passing a resolution requesting that Bovine Growth Hormone be labelled, and that dairy suppliers indicate whether rBGH-produced milk is being sold to the schools;

- all Medical Officers of Health in Ontario.

Background:

At its meeting of September 20, 1991, the Board of Health adopted the following recommendations:

1. That, until its concerns about the drug and the evaluation process have been adequately addressed, the Board of Health oppose the licensing and use of Bovine Growth Hormone (BGH).

2. That the Board of Health communicate the concerns raised in this report to: Health and Welfare Canada, Agriculture Canada, the Ontario Ministry of Agriculture and Food, the Ontario Ministry of Health, the Dairy Bureau of Canada, and the Ontario Milk Marketing Board.

3. That the Food Policy Council report back to the Board of Health when responses have been received.

The Board of Health also requested that the Food Policy Council hold a public forum.

The purpose of this report is to provide information on the degree to which the Board of Health's concerns have been addressed, and the results of the public forum.

Comments:

Canada has yet to license rBGH (also referred to as BGH, and bovine Somatotropin, bST). However, on November 5, 1993, the US Food and Drug Administration (FDA) licensed the use of rBGH. The drug has just been allowed on the market following a 90-day moratorium to allow for a study on the impact of the drug on the economic health of the dairy sector and dairy farmers.

It remains unclear what actions the Canadian government will take. It is clear, however, that many of the questions raised by the Board of Health continue to be identified as concerns, particularly amongst those organizations who, like the Food Policy Council analyze issues within the framework of what promotes health and agricultural sustainability.

Regarding the Board of Health's first recommendation from September 91:

The scientific literature reveals on-going concerns on the part of critics with the issues outlined below. In the USA, regulators and professional bodies associated with the regulatory apparatus continue to reject suggestions that most studies to date have failed to provide a comprehensive evaluation of the drug. As a result of the FPC's efforts to solicit responses from Canadian regulators, we have concluded that these same matters are not being fully addressed by the Canadian policy making process:

A. The impact of Insulin-like Growth Factor (IGF-1) on human health

The official position of regulators and some academic and medical bodies remains that IGF-1 levels, although elevated in milk from rBGH-treated cows, do not pose a health threat (Juskevich and Guyer, 1990). This conclusion has been reached despite recognition that we do not fully understand how IGF-1 functions (Page et al., 1989; Wallis, 1989), and contradictory evidence in the scientific literature regarding its biological activity in the human gut. Two recent reviews by Mepham (1992) and Feenstra (1993) concluded that this IGF-1 might survive the human digestive tract and be absorbed through the gut wall. Because bovine and human IGF-1 are identical and because IGF-1 appears to play a useful role in newborns, elevated levels of IGF-1 in older children and adults could trigger biological activity not normally found in older humans.

Mepham (1992:738) concludes that "it would be imprudent to assume that the increased concentration of IGF-1 in milk of bST[rBGH]-treated cows presents no risks to human health until more information has been obtained on a number of issues. These include: (i) accurate determinations of the effect of bST on concentrations of total IGF-1 in milk; (ii) the effect of bST on the percentage of IGF-1 in the free form in milk, and its physiological significance; (iii) the effect of bST on the concentration of -3N:IGF-1 in milk; (iv) the local action of IGF-1 on tissues of the upper gastrointestinal tract of consumers; (v) the degree to which IGF-1 is absorbed across the gut wall in consumers." This research agenda is not being actively pursued by industry and government regulators.

B. The impact of rBGH on herd health

The official position of industry and regulators is that any negative impacts on herd health are associated with increased milk production, not specifically the use of rBGH and that these impacts are manageable at toth the farm and milk supply level. Following extensive review of industry data, Kronfeld (1993) has concluded, however, that higher levels of infertility and mastitis are evident in many studies, and that this higher incidence is due, in part, to the use of rBGH, not just to higher levels of milk production.

Monsanto's required drug warning label sold with their version of rBGH states that "use of [the product] may result in reduced pregnancy rates.... [It} has also been associated with increases in cystic ovaries and disorders of the uterus during the treatment period." The warning label also reports increased risk of clinical mastitis, subclinical mastitis and increased use of medication to control these and other health problems. The product may also result in increases in digestive disorders, such as indigestion, bloat and diarrhoea (NADA # 140-872, Approved by FDA, Animal Sciences Division of Monsanto Company).

Evidence of possible data suppression by manufacturers and researchers has been emerging as well. Hansen (1993), in testimony to the Joint Meeting of the Food Advisory Committee and Veterinary Medicine Advisory Committee of the FDA, highlighted 2 cases of the FDA not following its own rules on the reporting of relevant data. Monsanto, one of the manufacturers of the drug, was accused by a farm organization in Vermont of suppressing data on the negative impacts of rBGH on mastitis incidence. Following these allegation, and under threat of Congressional subpoena, Monsanto and the University of Vermont agreed to release some of its raw data to the US government (Cicero, 1992). The drug companies and investigators were cleared of allegations by the US government, but these controversies have reduced public confidence in the licensing process and the FDA's conclusion that the product be approved for sale.

C. The impact of licensing on consumer acceptance of dairy products and the resultant implications for human health

Several surveys of US consumer attitudes suggest that 15-40% of consumers will reduce their consumption of dairy products from rBGH-treated cows (Hansen, 1990; see studies reviewed by Feenstra, 1993). A 1993 survey of the US economic literature concluded that under current conditions, consumers "will be unequivocally worse off, in the aggregate, than if bST were never made available. They will enjoy little or no reduction in the prices of dairy products, and will have no choice but to purchase dairy products deriving from bST-treated cows, despite a preference for milk from untreated cows" (Raboy and Simpson, 1993:xvi). The draft USA Executive Branch (1994) study attempted to downplay the results of these surveys, but still acknowledged that reduced consumption is likely.

These consumer concerns have provoked a number of market and governmental responses. Some dairy processors have indicated that they will not purchase milk produced from rBGH-treated animals. One processor has petitioned the FDA for a method of detecting rBGH in milk, and believes that the absence of a detection method is grounds for non-approval (Food Chemical News, 1993). Two states approved in 1990 temporary moratoria on the sale or use of rBGH. Chicago had for several months, an ordinance requiring the labelling at the grocery level of genetically engineered foods (PR Newswire, 1993; Davis, 1993). The Ethical Committee on Genetic Modification, convened by the British Agricultural Ministry, has recommended that "ethically sensitive genes" be labelled to permit consumer choice (Reuter, 1993; Financial Times, 1993). Two US school districts have passed resolutions expressing strong doubts about rBGH-produced milk, requesting that their suppliers not buy it and that the government require labelling (McNair, 1993). Australia, New Zealand and the EEC have indicated that, because of consumer concerns, they will attempt to gain an economic advantage by marketing their products internationally as rBGH-free (Feingold, 1994).

The FDA has not required labelling, but does permit voluntary use of labels. Reports from those planning to label suggest, however, that the FDA does not actually want labels to be used (Feingold, 1994; Schneider, 1994). The drug manufacturers are opposed as well. A recent US study (Tauer, 1994) suggests, however, that labelling would be economically advantageous to both farmers and consumers.

Consumer acceptance has not been adequately studied in Canada. The National Dairy Council, representing major dairy processors, has asked for a 2-year moratorium on the use of rBGH because it fears negative consumer reaction (Gallagher, 1993). The Dairy Farmers of Canada are also reported to be worried, and have requested a delay in the decision on approval.

If the product is approved for use, there is no indication yet whether the Canadian government will respect consumers' right to know and require labelling.

D. The impact of the licensing of BGH on the dairy sector and farmers

This remains an area inadequately studied by Canadian policy setters. Some farm-level studies have been performed by consultants and academics, but these have not looked adequately at the system-level impacts. A report released by Agriculture Canada in 1991 suggests positive system-wide benefits and highlighted how, in the Canadian system, the determination of who would receive the (milk consumers, farmers, or taxpayers in general) would be a public policy, rather than strictly market place, decision. This study, however, is also limited because it assumed that consumers would have no concerns about the product, and did not attempt to analyze the broader social and economic implications of licensing.

Significantly, because of its concerns about the negative impacts of licensing on its dairy farmers, the European Commission is recommending to the European Parliament a seven-year extension of the current ban on rBGH (European Commission, 1993). Seven USA studies reviewed by Campbell (1993) concluded that approval of rBGH will result in increased concentration of milk production by large farms and declines in numbers of midsize and small farms. The Executive Branch (1994) study concludes that aggregate dairy farm income will drop over the next 6 years. The USA government's dairy price support costs are likely to increase (Campbell, 1993; Feingold, 1994).

Regarding the second recommendation of the Board of Health (September 91):

Eight responses were received, involving both letters and written reports. On reviewing these communications, the Food Policy Council is of the opinion that the full range of issues with which the Board is concerned have not been addressed by other levels of government in Canada. The focus of the Canadian regulatory apparatus has remained on the efficacy of the drug, and its impact on human and animal health. Given their failure to respond fully to the Board's concerns, we are unable to determine whether any of these issues have been given adequate treatment during the secret regulatory review process.

Regarding the Board of Health's request that a forum be held:

The Toronto Food Policy Council worked with representatives of the agri-food industry to plan a public forum on biotechnology. The forum was held on October 7, 1992 at the St. Lawrence Centre. The forum was organized by members of the Toronto Food Policy Council, St. Lawrence Centre, Canadian Animal Health Institute, Ontario Farm Animal Council, and Agri-food Network.

Approximately one hundred and fifty people, including many high school and university students and representatives of the farm and rural community, attended the forum. Genetic engineering, its effects on societal structures, and decision making concerning biotechnology research and use in food production were the major concerns expressed by audience participants. The importance of two way communication between researchers, industry and the public was repeatedly stressed. Attendance from the Board of Health and the Food Policy Council was, unfortunately, limited.

An evaluation of the event indicated the forum was successful in providing a vehicle for obtaining public input on a matter of social concern. The existing St. Lawrence Centre forum series, and the excellent cooperation of St. Lawrence Centre staff, provided an established and efficient venue through which to reach the public. The forum also benefitted from the involvement of various issue stakeholders in its planning and delivery.

The Toronto Food Policy Council's biotechnology working group followed up on some of the issues and concerns expressed at the forum, by developing a new event to solicit public input. A forum to discuss the ability of consumers to make fully informed food choices was held on November 9, 1993. It attracted an audience of similar size, and revealed the extent to which consumers feel confused by the contradictory information provided by the food system.

The FPC has also attempted, unsuccessfully, to convene a workshop on the full information issue for professionals, business people and regulators. Unfortunately, it appears that many food business organizations and government regulators are unwilling or unprepared to speak to this issue at this time.

Summary and Recommendations:

The Food Policy Council has concluded, based on the review presented here, that the approval for use of rBGH would represent a very significant failure in the Canadian food and agriculture policy making system. This failure stems primarily from a drug review process that does not require consideration of issues such as long-term public health implications (in this case, consumer acceptance of dairy products), and the impacts on the structure of the dairy industry and dairy farmers. Nor does the review process begin with the most basic questions: what problem is BGH designed to solve? is there a problem with the quality of the Canadian milk supply? do we have a milk shortage in this country? is milk production inefficient?

Instead, the regulatory review process confines itself to considerations of the drug's efficacy, whether any exposure to the product (or its associated products, such as IGF-1) is possible and whether such exposure would have a negative impact on human health, and the effects of the product on animal health. Even within this mandate, many critics point out the limited set of questions that are being asked, and the reliance on industry data to answer the questions. This entire review process is conducted in secret.

There is little acknowledgement in this process of the consuming public's right to know about how food is produced. There is significant resistance in government and industry circles to labelling, despite interest from many in the food marketplace in such labelling, and decisions taken by other jurisdictions to use labelling to create a marketing advantage.

Consequently, the Food Policy Council believes that this product should not yet be approved, and if it is, that consumers should be informed that rBGH has been used to produce the milk.

Recommendations:

1. That the Board of Health continue to express its reservations about the licensing of Bovine Growth Hormone, as a result of continued questions about animal health, long-term public health implications, and the economic implications for the dairy sector.

2. That the Board of Health request that Health Canada and Agriculture Canada require labelling of all foods produced by genetic engineering, including genetic manipulation to create non-naturally occurring characteristics and products, transgenic plants and animals, and plants and animals resulting from the deliberate short-circuiting (forced foreshortening of time sequence) of natural processes.

3. That the Board of Health forward a copy of this report to:

- all school boards in Ontario, requesting that, in the event of licensing of rBGH, they consider passing a resolution requesting that Bovine Growth Hormone be labelled, and that dairy suppliers indicate whether rBGH-produced milk is being sold to the schools;

- all Medical Officers of Health in Ontario.

Russell Christianson Barbara Hall

Co-chair Co-chair

Literature cited:

Campbell, D. 1993. The economic and social viability of rural communities: BGH vs. rotational grazing. In: B. Liebhardt (ed.). The Dairy Debate: consequences of Bovine Growth Hormone and Rotational Grazing techniques. University of California, Davis, CA. Pp. 277-315.

Cicero, K. 1992. Leaked test data fuel BGH battle. New Farm May/June.

Davis, R. 1993. Watch out for the velociradishes, and beware the brontocelery. Chicago Tribune, Aug. 4, 1993.

Dillon, J. 1993. Farmers may earn more for BST-free milk. Sunday Rutland Herald, Oct. 10, 1993.

European Commission. 1993. Commission proposes a ban on the use of Bovine Somatotropin (BST). Press Release of the European Commission, December 1, 1993.

Executive Branch of the Federal Government (USA). 1994. Use of Bovine Somatotropin (BST) in the United States: its potential effects. Office of the Management of the Budget, Washington, DC.

Feenstra, G. 1993. Is BGH sustainable? the consumer perspective. In: B. Liebhardt (ed.). The Dairy Debate: consequences of Bovine Growth Hormone and Rotational Grazing techniques. University of California, Davis, CA. Pp. 1-63.

Feingold, Senator R. 1994. Administration's draft report confirms the devastating impact of BGH on the federal deficit and the dairy industry. Press Release, January 5, 1994.

Financial Times. 1993. Genetic food for thought. Financial Times, Sept. 21, 1993.

Food Chemical News. 1993. Dairy petitions FDA for practicable detection method for BST. Food Chemical News. January 4, 1993.

Gallagher, P. 1993. Dairy Council wants delay on bST. Ontario Farmer, December 15, 1993.

Hansen, M.P. 1990. Biotechnology and Milk: benefit or threat? Consumers Union, Mt. Vernon, NY.

Hansen, M.P. 1993. Testimony before the Joint Meeting of the Food Advisory Committee and the Veterinary Medicine Advisory Committee on whether to label milk from rBGH-treated cows. Consumer Policy Institute, Consumers Union, New York. May 6, 1993.

Juskevich, J. and Guyer, C.G. 1990. Bovine growth hormone: human food safety evaluation. Science 249:875-884.

Kronfeld, D.S. 1993. Recombinant Bovine Growth Hormone: cow responses delay drug approval and impact public health. In: B. Liebhardt (ed.). The Dairy Debate: consequences of Bovine Growth Hormone and Rotational Grazing techniques. University of California, Davis, CA. Pp. 65-111.

McNair, J. 1993. School Districts blast BGH. AGRI VIEW, December 16, 1993.

Mepham, T.B. 1992. Public health implications of bovine somatotropin use in dairying: discussion paper. J. Royal Society of Medicine 85:736-739.

Page, M.D., Dieguez, C. and Scanlon, M.F. 1989. Neuroregulation of Growth Hormone Secretion. In: R.B. Heap, C.G. Prosser and G.E. Lamming (eds.). Biotechnology in Growth Regulation. Butterworths, London, UK. Pp. 47-55.

PR Newswire. 1993. NFPA decries Chicago ordinance requiring sign for biotechnology foods. PR Newswire, August 26, 1993.

Raboy, D.G. and Simpson, T. 1993. The Implications of bST for Consumers, Farmers and Taxpayers: a survey of the economic literature and additional analysis. Patton, Boggs & Blow, Washington, DC.

Reuter. 1993. People should know about genes in food. Reuter, Sept. 20, 1993.

Schneider, K. 1994. F.D.A. warns the dairy industry not to label milk hormone-free. New York Times.February 8, 1994.

Stennes, B.K. et al 1991. Bovine Somatotropin and the Canadian dairy industry: an economic analysis. Agriculture Canada, Ottawa.

Tauer, L.W. 1994. The value of segmenting the milk market into bST-produced and non-bST-produced milk. Agribusiness 10:3-12.

Wallis, M. 1989. Species specificity and structure-function relationships of growth hormones. In: R.B. Heap, C.G. Prosser and G.E. Lamming (eds.). Biotechnology in Growth Regulation. Butterworths, London, UK. Pp. 3-14.

Copyright 1994 Toronto Food Policy Council. Reprinted with permission. All rights reserved.


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