Bovine Growth Hormone (BGH) in Canada

In Canada, the controversy surrounding BGH began in 1984 when Monsanto, Elanco and Cyanamid made requests to Health Canada regarding rBST based products, and hit full stride in February 1990 when Monsanto asked Health Canada to consider the approval of Nutrilac. At this time Monsanto’s application was not the only file before Health Canada reviewers, but joined a New Drug Submission (NDS) made by Elanco Canada two years earlier. However, Monsanto’s application was pushed to the forefront when Elanco voluntarily placed a hold on their submission, choosing to wait and see how the Monsanto NDS evolved. In hindsight this was probably a wise decision as Monsanto’s submission has been beset by public controversy. Initial concerns about the safety and health aspects of rBST were further exacerbated by allegations that Health Canada has become overly acquiescent towards the demands of industry and to those of Monsanto in particular. In May, 1998 these ongoing concerns prompted the Canadian Senate to urge the federal government to place a one year moratorium on rBST. Furthermore, the Senate ordered that public hearings be held in order to examine the Health Canada review process along with the health and safety aspects of rBST. Alongside these specific goals, the committee also raised key questions concerning the economic impact of rBST on the dairy industry, the role of the public in the Health Canada decision making process and Health Canada’s reliance on foreign decision making bodies such as the FDA and JECFA. It is within this context that after a decade of deliberation Health Canada rejected Monsanto’s drug submission in January, 1999 stating that Nutrilac did not fully meet its scientific standards of efficacy, human safety and animal welfare (Health Canada, 1999)⁶.

The Challenge: Sorting Through the Confusion

Within the context of this regulatory confusion, the question which remains to be answered is, ‘why, in Canada, did rBST and Nutrilac receive such a cold reception?’ What makes this scenario even more puzzling is that early on it appeared that Health Canada management was moving to accept rBST. For instance, less than a month after receiving Monsanto’s NDS, the chief of Health Canada’s human safety division indicated to Monsanto that their submission had met all human safety requirements. Again in 1995 it seemed that rBST had been placed on the fast track when Health Canada issued an initial Experimental Studies Certificate concluding that rBST produced milk was safe for human consumption (Senate, 1999a: pp. 8–11). Moreover, during the Senate Committee hearings Health Canada management, despite reassuring the Committee that rBST would not be passed until its safety and efficacy were fully assured, often mimicked the scientific and economic positions of Monsanto. At one point Health Canada officials even went so far as to fly in a representative of JECFA, well known for his pro-rBST position, to testify on their behalf (Senate, 1998d: pp. 30–32).

Faced with the inconsistency of rBST’s regulatory history, how can we begin to speculate about why rBST was rejected when it appeared its approval was immanent? Was rBST merely revealed as an example of poor science whose dangers had originally eluded its evaluators? Was Monsanto no longer able to escape allegations that Nutrilac placed corporate profits above industry welfare and consumer health? Were rBST’s opponents simply able to win the day? Or, are Monsanto’s failures a reflection of increasing public apprehensions about biotechnology? By foreshadowing these possibilities I do not wish to argue that any one of them holds the solution to the puzzle itself, or that taken together they delineate all the potential explanations for the failure of rBST. Instead, they highlight the uncertain, complex and heterogenous nature of the regulatory arena in which rBST was cast. The task for the remainder of the paper is, therefore, to sort through this confusion.


Constructing Science and Technology / Constructing Nature

In order to meet this challenge I will draw on two overlapping theoretical traditions: i) social constructivist theories of science and technology, and ii) cultural studies of nature and the environment. The first allows social analysis to disrupt the autonomy and determinacy of scientific knowledge and technological innovation by proposing that each is socially constructed. The second argues that nature is itself a cultural construction whose definition is subject to the influences and politics of its social surroundings. Together they allow rBST to be envisioned as the embodiment of a diverse array of social and political interests and furthermore recognize how these constructions themselves reflect and define social conceptualizations of nature and the environment.

Constructing Science and Technology: Black Boxes and Actor Networks

“Once upon a time”, Nelly Oudshoorn suggests, “life was rather simple, at least for philosophers of science” (Oudshoorn, 1996: p.122). It was assumed that truths were real and that scientific inquiry could unravel the complexity of nature within the knowing hands of humanity. Likewise, technologies were habitually seen as the corporeal embodiment of this knowledge and either imbued with enlightened promises of progress or criticized as monstrous signs of social regress.

Although broadly taking a critique of these assumptions as a starting point, the novelty of a constructivist perspective extends beyond a relativistic challenge of the determinacy of scientific knowledge and technological innovation. For instance, Woolgar defines social constructivism not only as a critique of scientific positivism — the idea that science is “generated as a result of rational (reasonable, logical) extrapolation from either (or both) existing knowledge or observations of the world” (Woolgar, 1988: p.53) — but also proposes the inverse of this relationship. In other words, constructivism posits that our conceptualizations of the natural world are constituted, defined, accomplished, or constructed by science (Woolgar, 1988: pp. 53–66). Likewise, constructivist critiques of technology rally against the deterministic belief that technological innovations contain the force of their own construction. They argue instead that technologies are dependent on the various interactions, conflicts and compromises which occur between relevant actors at particular locations and key moments in an object’s history. It is in this light that Bijker concisely illuminates one of the principal tenets of social constructivism:

“A central adage for [constructivist studies of technology]... is that one should never take the meaning of a technical artifact or technological system as residing in the technology itself. Instead, one must study how technologies are shaped and acquire their meanings in the heterogeneity of social interactions. Another way of stating the same principle is to use the metaphor of the ‘seamless web’ of science, technology, and society, which is meant to remind the researcher not to accept at face value the distinctions between, for example, the technical and the social as these present themselves in a given situation.” (Bijker: 1995, p.6)

If science and technology are not discovered or determined, but the outcome of constitutive forces, it is necessary to ask why we often perceive them as such. A second tenet of the social constructivist approach therefore identifies power as the ability of the scientist or engineer to negotiate a stable definition of a scientific fact or technological object. On one hand, power can be identified in the ability of “researchers to impose themselves and their definition of the situation on others” (Callon, 1986: p.196), or to inscribe “a vision of (or prediction about) the world in the context of the new object” (Akrich, 1992: p.208). On the other hand, it is also perceived as the capacity to isolate the novel objects (scientific or technological) from their history, from their relationship with other objects, and from the interests and motives of the innovator. At each stage of an innovation, power is demonstrated in the processes by which the malleability of objects is camouflaged and the possibility for choice and the basic insight that things could have been otherwise is lost (Bijker, 1995: p.28).

The fait accompli of these processes, can be summarized with the use of the metaphors of the ‘actor network’ and the ‘black box’. Networks are made up of complex combinations of crisscrossing interactions which periodically link together at specific nodal or obligatory points of passage. The strands of the network are simultaneously social and natural and likewise composed of all variety of human and non-human actors (Latour, 1991). When the network achieves some form of consensus it appears to be impervious and seems to extend everywhere (Latour, 1987: p. 180). It is during these moments of accommodation, or stability, that black boxes begin to appear (Bijker & Law, 1992: p. 10). Whether we consider the double-helix shape of DNA (Latour, 1987), the gendered form of the bicycle (Bijker, 1995), or the intensity and colour of a fluorescent light bulb (Bijker, 1992), black boxes are the knowledge and technologies which we take for granted in everyday life. They are that which we assume to be common knowledge and whose meanings we no longer consider except when taken as a whole.

A social constructivist perspective of science and technology thus infers the need to interrogate black boxes and their actor networks. Within the context of rBST, this goal can be achieved by unearthing the reasons why attempts to black box rBST have eluded its proponents in Canada. Or, more precisely, to tie those instances in which rBST loses its perceived stability to Monsanto’s inability to dictate and solidify the network which surrounds rBST’s innovation.

Agricultural Biotechnology: Constructing a More Productive and Manageable Nature

However, we cannot see rBST as the outcome of network relations without also questioning the assumptions and ideologies of nature which are inextricably tied to the various actors populating the network. As a starting point to this argument I draw on Raymond Williams’ statement that nature is no more than an idea which “expresses mankind’s vision of itself and its place in the world” (Williams, 1980: p.67). Nature, in other words, is itself a cultural and social construct and functions as a political category which we fight over so as to enforce and legitimate certain social and ecological relations (Moser, 1995: p.8). Plainly stated by David Rothenberg: “nature is made” (Rothenberg, 1993: pp. 108).

Monsanto’s attempts to construct rBST and biotechnology thus both incorporate and construct images of the natural. If we take the model of an external and dominated nature proposed by the enlightenment as a starting point, we can also begin to see the image of nature constructed in relation to biotechnology. Characterized by the Cartesian division between nature and society, the enlightenment purported that it was a feasible social project to fully explore, conclusively understand and, in turn, to fully dominate an external nature. As David Harvey argues, the construction of a dominated nature was envisioned as a “a necessary prerequisite to emancipation and self realization” (Harvey, 1996: p.125).

This is a highly instrumental discourse which values nature not as a whole, but in terms of its extracted and exploitable components. Where the image of nature presented through biotechnology parts from the enlightenment model, is in relation to the precise forms of instrumentality each confers. For classical political economists such as Adam Smith and John Stuart Mill, the ideals of progress contained within the domination hypothesis could be best met by the market and the invisible balancing act of supply and demand. The goal of the market — achieved primarily through the mobilization of science and technology — was to more efficiently manage the exploitation and allocation of natural resources. Proponents of biotechnology extend this instrumental rationality to the level of the genetic structure of nature itself. Science and technology not only manage the exploitation of nature, but make the development of a more productive nature an explicit goal.

Innovators of biotechnology do not propose to dominate nature in the same sense that chemical fertilizers and pesticides attempted to externally manipulate the agricultural environment, but advance the idea that biotechnology can bring order to a ‘deficient’ and ‘unruly’ nature (Levidow, 1996). With the recognition that chemically based agricultural inputs created widespread environmental pollution and degraded farmland, biotechnology proposes a ‘cleaner’, ‘greener’, and more ‘natural’ way to manage agricultural resources. Kleinman and Kloppenburg, thus ironically note that “genetic engineering employs nature to surpass nature. It does what is natural or obvious, but it does so more ‘efficiently and safely’ than nature itself” [cited in (Levidow, 1991: p.553)]. Agricultural biotechnology proposes to make an inadequate nature better.

At the very heart of the promise to make nature better, and the deficiency which agricultural biotechnology seeks to address, is a lack of productive efficiency — getting the most out of nature with the minimal amount of inputs. And like the promises purported by the enlightenment, the life industry attaches widespread promises of progress to this instrumentality. These include the promises of sustainable agriculture and the ability to escape the starvation and chaos of the Malthusian dynamic, the potential for providing ecologically sound agricultural practices and assurances of economic competitiveness, security and wealth for a modern agricultural industry. Like the promises of the ‘Green Revolution’ two decades ago, Monsanto has constructed rBST as one of the first installments in the biotechnological revolution of the new century. It is with this vision that the life industries not only advocate the construction of a more productive and efficient nature, but suggest that industrial models of production and corporate science are the prerequisite managers of nature and progress (Levidow, 1991: p.555).

By combining these two perspectives — social constructivism and a cultural approach to the study of nature — we can begin to describe the construction of rBST in relation to the network which surrounds it. Echoing constructivist approaches to science and technology we will see that this network consists of conflicting experts and expertise, numerous contested scientific studies, papers and discourses. And interlaced within this network is the visage of an instrumental nature, a genetically industrialized model of agriculture and the presumptions of progress attached to a discourse of productive efficiency.


Constructing rBST: Exposing the Leaks in the Black Box

Closing the Black Box: What rBST Is, and What it Is Not

During the course of the Canadian Senate Committee hearings into rBST, Monsanto sought to close the lid on the black box by both constructing an image of what rBST is, and what it is not. At the centre of this dualistic definition is an attempt to pass rBST off as business as usual. The Canadian dairy industry already abounds with black boxes and rarely, if ever, do we consider the scientific and technological complexities which go into the production of our modern dairy supply. The addition of Vitamin D in milk is taken for granted, homogenization and hygiene controls are assumed, and genetic breeding records, high nutrition feeds and artificial insemination are not likely to even cross our minds. rBST, we are told, is simply another addition to this technological parade of black boxes which both improve the milk we drink, and do so in a more productive and efficient manner.

In one sense, the vision of biotechnology and rBST which Monsanto has tried so hard to construct relates simply to the lactogenic actions of the drug, but more importantly it also involves the rationalization of why Canadians need this technology in the first place. Although Monsanto touched on the environmental benefits of agricultural biotechnology⁷ and its potential to feed a hungry world, the majority of their testimony pertained to the relationship between rBST, productive efficiency and the strength of the Canadian dairy industry. Monsanto outlined this argument by asking the Senate three questions: “Was there a use [for rBST]? Was there a need for it in the Canadian marketplace? Would it be useful to Canadian farmers?” (Senate: 1998a, p. 5). The answer they provided in each case was strongly affirmative and they hinged their responses on the ability of rBST to reduce the cost of production for the farmer. For Monsanto, what rBST is, is a tool which would allow Canadian farmers to produce more milk with fewer inputs. The goal of which is not necessarily to produce more milk, but to produce milk more profitably (Senate,1998a: p.11).

However, as I have already suggested, Monsanto’s attempt to construct a black box is not limited to defining what rBST is, but also involves protecting this image by further defining what rBST is not. It is in this end that Monsanto attempted to apply a scientific discourse of truth and fact to rBST so as to legitimate their promises and isolate any opposition to their claims. After a decade of regulatory wrangling, Monsanto was well versed in presenting this stable image of rBST. When they finally came to Ottawa to enlighten the Senate Committee about the merits of rBST, they argued that there were no more scientific questions to ask. The science of rBST, in the words of Monsanto, was ‘complete’:

“Over 30 countries have approved BST and we will continue to work with Health Canada to gain regulatory approval in Canada. In addition to Health Canada's review, scientists around the world have extensively studied BST. The issues raised before this committee, including those expressed earlier this morning, are not new and have been fully addressed over the years by numerous governments, international organizations and scientific groups... Over 2,000 independent scientific studies have been conducted, and we feel that the science is complete. The consensus of these studies is clear and definitive. Milk from BST-supplemented cows is the same as milk from untreated cows.”
- Mr. Ray Mowling - VP Government and Public Affairs (Senate, 1998f: p.2)


In summary, the black box that Monsanto thought they had constructed defined rBST as no more than a productive aid. In line with other biotechnologies rBST is described as a clean and natural solution to improving the productive efficiency of the dairy industry. Through a process of bio-engineering and synthetic hormone injections Monsanto proposes to mimic and simply improve upon the natural lactogenic properties of the cow; to make the deficient cow better ⁸. Biotechnology, in other words, is a natural aid to a natural process, and to imagine any negative consequences, whether economic or in terms of human and animal health, would be absurd. The truth of which, they argue, has already been affirmed by an expansive network of scientific experts, governments and international regulatory bodies.

Unfortunately for Monsanto, during the course of the Canadian Senate hearings Monsanto lost control of this definition of rBST and the ‘consensus’ Mr. Mowling refers to became difficult to find in the ensuing controversy. This is to say that Monsanto’s attempt to construct a stable and autonomous black box began to show leaks⁹, and the networks on which it was supported looked increasingly less stable. In each of the following three examples, alternatives images of rBST were presented by alternative groups of experts. Experts which suggested that rBST was not simply a progressive and innocuous innovation in agricultural production, but a potential economic nightmare and possible health (human and animal) crisis.

Leak 1: Who Needs Productivity? Who Needs rBST?

The first leak to spring in Monsanto’s black box pertains to the corporation’s assurance that drugs such as Nutrilac would ensure the future competitiveness, security and wealth of the Canadian agricultural industry. They asserted that although the advantages of rBST are more evident in the open and competitive dairy producing market of the U.S., that the productive potentials of rBST are equally as important for the Canadian supply based system (Senate, 1998f: pp. 7–10). The argument follows that if a shrinking number of Canadian farmers are going to be able to meet national quotas, or compete in a growing export market, than they need to have access to the latest productive technologies. Dr. Bell, a veterinarian representing Monsanto, thus contended that in the current agricultural environment Canadian farmers have only a few options with which to accomplish these demands: “They either milk cows more often a day, so that milking three times a day becomes popular if milk production drops, or they milk more cows. RBST in a supply-managed system would offer a third alternative, which is not having to go out and make that capital expenditure on capital, but increasing milk production” (Senate, 1998f: p.8). Where technologies such as artificial insemination have been successful in allowing Canadian farmers to meet their productive needs in the past, Monsanto told the Senate that rBST and biotechnology are necessary for their success in the future. According to Dr. Bell, the majority of the Canadian farmers he works with are ready to meet these goals if they would only be given the opportunity by the government to use this product (Senate, 1998a: p.6).

However, following Monsanto’s presentation, the Senate heard a very different story from several organizations representing Canadian dairy producers and processors. In responding to Dr. Bell’s assertions, Lise Beauchamp, a Quebec dairy producer, agricultural economist and board member of the Dairy Farmers of Canada, was moved to make the following statement:

“I was here in June when the company that makes this product testified that they developed it because the producers want to utilize it. I want to say, on behalf of the producers, that that is their word. I do not appreciate it when companies speak for us, the producers.” (Senate, 1998c: p. 9)

Instead, it was repeatedly asserted during the course of the committee hearings that Canada already had one of the most efficient and successful dairy producing systems in the world (Senate, 1998c: p.3). Dairy producers felt no pressure to produce more milk as farmers were already meeting domestic milk requirements, and like most other developed nations, producing large milk surpluses. Nor did they feel that milk production needed to be increased to meet export needs, but that Canadian producers were already forced to export dairy products at 1/3 of their value due to a lack of foreign markets. Likewise, they contended that there is no clear evidence which demonstrates that the use of rBST is any more cost effective than current farming practices, and presented several alternative studies which suggest that the opposite might be true. Stated clearly, Canadian dairy producers argued that there is ‘no advantage’ to be gained by using rBST based productive aids (Senate, 1998c: pp. 9–11).

Furthermore, the Senate heard that the potential costs of rBST on the dairy industry far outweighed the likelihood of any imagined benefits. With so much public controversy surrounding the health consequences of BGH, and consumer apprehensions about biotechnology, there is a fear that rBST could diminish consumer confidence in Canadian dairy products. This is a trust which the dairy industry has gone to great pains to gain, and words such as pure, nutritious and natural have become synonymous with milk for most Canadians. Milk, as Busch points out, is the perfect food. “It is white — the symbol of purity in American Society. It is associated with children and motherhood, in short, much that is good in life” (Busch, 1991: p. 99). The Canadian Dairy Council of Canada asserts that the consequence of tarnishing this image would be to reduce national dairy sales, force processors to implement an expensive and impractical dual processing system (rBST & rBST-free milk), and surrender Canadian access to a growing health conscious and anti-rBST export market. These concerns are summarized well in the following statement made by the National Farmers Union (NFU). The outcome which they expect from these hearings could not be clearer:

“In conclusion, Canada currently produces sufficient milk to meet domestic demand. We do not need increased milk production. The drug rBST threatens to increase the Canadian milk supply while significantly reducing consumer demand. The result would be lower net farm incomes for dairy producers, a result they can ill afford...Canadian consumers want pure milk. The drug rBST has the potential to destroy public confidence in milk, as the Mad Cow disaster did in England for beef, if it appears that milk from rBST-treated cows can cause cancer... [rBST] erodes consumer confidence in dairy products, threatens to undermine our milk system and destroy farmers' incomes... For all these reasons, the National Farmers Union urges that the federal government extend the ban on rBST indefinitely. Health Canada must be prepared to stand up to corporate interests and state that, because rBST is unwanted by consumers and farmers alike, it will not be approved” (Senate, 1998d: p. 52).


If we accept the position that rBST is unwanted by farmers, processors and consumers then the above statement also begs the question of who does gain from the use of rBST. Echoing the position of the NFU the Dairy Farmers of Canada made the obvious answer to this question explicit for the Senators:

“We are really concerned because we do not see any advantages at the farm level. We do not see any advantages at the consumer level. Did the price of milk to the consumer drop in the United States following introduction of this hormone? No study has established this. In this whole matter, where are the advantages, excepting the fact that the manufacturer sells his product?” (Senate, 1998c: p .11)

Moreover, the potential gains for Monsanto go beyond the potential profits of this one product. More importantly, the Senate was also made aware of the importance of the rBST case in setting precedents for how governments and regulatory agencies are going to approach future submissions by the life industry. As one pro-rBST author writes, “the controversy over synthetic bovine growth hormone is much more than a dispute over health effects in cows and human. It’s the opening battle in a high stakes war over the future of biotechnology” (Kennedy, 1994: p. 40). This was a point that hit home when members of Health Canada management advised the committee that they were expecting an increase of 200–500 percent in the submission of biotechnology related products during the next decade (Senate, 1998d: p.27).

Leak 2: rBST and Human Health

The second leak in Monsanto’s attempt to black box rBST applies to the company’s attempt to assure governments, regulatory authorities and the Canadian public that there are no outstanding human health or food safety risks associated with rBST. This argument begins and ends with the assertion that rBST is not a foreign additive but something which is naturally present in the cows and the pure milk already consumed by Canadians. They contend that the fact that rBST is engineered exogenously from the cow is of little relevance since the science has conclusively shown that there are virtually no differences between naturally produced BST and genetically engineered rBST (one amino acid differs in a chain of 191). The only potential difference between rBST produced milk and rBST ‘free’ milk that Monsanto would hypothetically concede to is the potential for Nutrilac to increase the amount of BGH residues in milk. However, they assert that this is also irrelevant, as rBST is a protein and would be expected to break down during digestion. It would therefore be impossible for any trace of the drug to make it into the blood stream where its residues could adversely affect human health. Thus, for all sakes and purposes, the argument remains the same. Milk from cows injected with Nutrilac is identical to that which Canadian farmers currently provide to consumers:

“There is no need to do any long-term or short-term studies. I am not alone in this conclusion; all the other organizations that have looked at this issue feel the same. We are talking about a protein-based product, a substance already present in milk. It is natural in cow’s milk, the milk does not change. For that reason there is no difference”.
— Dr. Kowalczyk, Director of Regulatory Affairs for Monsanto (Senate, 1998a: p. 30)

The logic iterated by Dr. Kowalczyk suggests that any attempt to challenge that safety of rBST produced milk would be tantamount to questioning the properties of milk itself.

However, when it became evident that the Senate committee was unwilling to rely on the scientific opinions of Monsanto alone, these facts seemed much less secure. In particular, of the many witnesses they heard speak about the human health risks associated with rBST, a publically vocal and controversial scientific majority composed of two key witnesses stand out as casting the largest shadow over Monsanto’s conclusions. One of which was composed of the renegade group of Health Canada scientists who comprised the rBST internal review team. This group made headlines across the country when they openly challenged Monsanto’s scientific attestations and accused Health Canada management of pressuring them to pass rBST despite their concerns with the drug’s safety (Senate, 1998b). These critical voices were joined by Dr. Michael Hansen a representative of the US Consumer Policy Institute and active anti-rBST lobbyist. In each case the Senate heard that despite the physical similarity between BST and rBST, the milk produced by drugs such as Nutrilac is not necessarily the same as that produced without it.

Specifically, criticism of Monsanto’s conclusions centre around questions referring to the bioactivity of the rBST residues found in milk. Scientists have agreed for some time that when BGH is administered directly to humans it has no effect on any metabolic or growth processes¹⁰. However, this does not preclude the possibility that rBST is bioactive, and it is not what worried the Health Canada internal review team. Instead, they were distressed with the potential for rBST residues in milk to produce an immunological response in the consumer. The locus of these concerns is a 90-day rat study which Monsanto presented as confirmation of the full digestive breakdown of rBST which they hypothesized. This study, or rather the summary of the study, was a cornerstone of the FDA’s decision to approve rBST in the US and was presented as key evidence to Health Canada. However, when the Health Canada internal review team looked beyond the corporation’s summary to analyze the raw data themselves they found that 20–30% of rats receiving high doses of rBST orally were developing antibodies to the drug (Senate, 1998b: p.12). The appearance of these antibodies indicate that, despite Monsanto’s assurances, rBST was finding its way into the bloodstream of the study rats. More worrying for the committee was Dr. Hansen’s allegation that Monsanto had failed to report that their own data also pointed to the development of “cysts on the thyroid of male rats and mononuclear infiltration in their prostates when administered rBGH orally” (Senate, 1998e: p.9).

A second, and related concern presented to the Senate refers to the bioactivity of a secondary product of BGH labeled Insulin Growth Factor One (IGF-1) which increases with the use of rBST based drugs. IGF-1, like BST, is a protein which is present in ordinary milk and is associated with the regulation of cell growth and the mediation of growth hormone (GH) in the body. However, unlike BST, IGF-1 produced in cows is identical to that found in humans. Relatively large amounts of IGF-1 are produced in most human organs and are found in varying concentrations throughout the body (Senate, 1998b: p.24). The importance of which, Monsanto argues, is that even if IGF-1 survived digestion, that the amount absorbed into the blood stream would be minimal compared to what is already found in the human body. To paraphrase one JECFA representative, it would be analogous to adding a single drop to a virtual sea of insulin-like growth factor one (Senate, 1998d: p.47). Therefore, the chance that there could be a link between increased IGF-1 residues in milk resulting from rBST use and any dangers to human health is perceived as simply ludicrous:

“If you follow that line of reasoning, if I drink two glasses of milk, it must be more dangerous than drinking one. I am not aware that there is any data showing that two glasses of milk is more dangerous than one, or drinking four glasses of milk is more dangerous than drinking two. In fact, goat's milk contains four times the level of IGF-1 in cow's milk. I am not aware of anybody showing that goat's milk is dangerous for you. In fact, it is considered a health food.”
— Dr. Collier, Chief Dairy Scientist for Monsanto (Senate, 1998a: p.19).


However, as was the case concerning increased rBST levels in milk, the Senate heard testimony which suggested that the issues surrounding IGF-1 were not as clear cut as the above statement by Dr. Collier would make them appear. Dr. Mueller, a member of the Health Canada internal review team, testified that assumptions considered as fact 10 years ago, when Monsanto first made their submission, may no longer hold true today (Senate, 1998b: p.4). In particular, considerable attention was paid to recent scientific evidence which implicates IGF-1 as a tumor growth promoter, and which denotes a correlation between increased IGF-1 levels and certain types of cancer (Senate, 1999a: p.12). Dr. Hansen further testified that even though the potential increases in IGF-1 in the human bloodstream are small, it is not prudent to compare IGF-1 levels in milk with that already present in humans. This, he argues, is because IGF-1 in milk is protected from digestion by casein, another component of milk, which slows down the digestive process and which could expose the consumer to IGF-1 residues for up to 17 times longer than normal. For people with low functioning digestive systems (infants in particular), or who have diseases such as diabetes, Dr. Hansen argued that increased levels of IGF-1 in milk would be very significant for their health and safety (Senate, 1998e: p.16).

Mandated to find the gaps in the Monsanto submission, the Health Canada Internal Review Team concluded that the data, or as was more often the case, that the lack of data submitted by the company were inadequate to conclude that rBST based drugs have no health risks. Through their Gaps Analysis Report they requested that a wide variety of studies be completed which investigate the relationship between rBST use and long-term health risks such as sterility, infertility, birth defects, cancer and immunological responses (Senate, 1999a: p.12). Monsanto’s attempt to silence critics of rBST through a network of scientific studies, experts and discourses of truth could not maintain any stability in the face of this opposition. The Senate was confronted not by a science that was ‘complete’, but a science which was filled with ‘gaps’. Statements describing the scientific hero as the creators of biotechnology were now joined by statements lauding those that stood up to Monsanto and who sought to expose the health risks associated with rBST produced milk:

“I wish to finish by saying that we see sufficient scientific data related to human health issues to support a cautions approach on rBGH use. JECFA says that rBST can be used without any appreciable risk to the health of consumers. We disagree with this characterization, and felt that since there are so many important, unanswered questions that should be researched, the true risk cannot be accurately defined at this point... I salute the scientists from Health Canada who did the gaps analysis report, and who are putting their careers on the line to help publicize some of the problems with this product.”
— Dr. Michael Hansen, US Consumer Policy Institute (Senate, 1998e: p.16).

rBST, Mastitis, and Animal Health & Safety

The third leak in Monsanto’s attempt to black box rBST concerns the drug’s impact on animal health and safety. Although this was not the primary focus of the Senate Committee hearings, it became an important issue as animal health constitutes one third of Health Canada’s mandate in reviewing all new veterinary drugs¹¹. The committee heard of a wide variety of potentially negative consequences and side effects associated with the use of rBST based drugs such as Nutrilac. These included higher incidences of lameness and birth defects, increased susceptibility to infection and disease, higher rates of culling, shortened life-span and even the possibility of an outbreak of Bovine Spongiform Encephalopathy (BSE)¹² comparable to that which occurred in the UK.

Table 2: Selected Contradictions in the Posilac Package Insert

1. Cows injected with Posilac are at an increased risk of clinical mastitis.
2. The number of cows affected with clinical mastitis and the number of cases per cow may increase. In addition, the risk of subclinical mastitis (milk not visibly abnormal) is increased.
3. Use of Posilac is associated with increased frequency of use of medication in cows for mastitis and other health problems.
4. Cows injected with Posilac may experience periods of increased body temperature unrelated to illness.
5. Use of Posilac may result in an increase in digestive disorders such as indigestion, bloat, and diarrhea.
6. Studies indicated that cows injected with Posilac had increased numbers of enlarged hocks and lesions of the knee, and second lactation or older cows had more disorders of the foot region.
7. [At the injection site] some cows may experience swellings up to 10 cm in diameter that remain permanent but are not associated with animal health problems.
8. Use of Posilac has been associated with reductions in hemoglobin and hematocrit values during treatment.

Although these concerns were all raised during committee hearings, the issue that stands out above all the others is the link between rBST use and increased rates of mastitis — a common and painful infection of the udder. Despite stating that rBST “may increase the risk” of mastitis in an insert (table 2) which accompanies the sale of Posilac, Monsanto argued that their data shows very little risk of this ever being the case (Senate, 1998a: p.17). The proof, they contend, is demonstrated by the results of their Post-Approval Monitoring Program (PAMP), which shows no major outbreaks of mastitis in the US since the introduction of Posilac. Mastitis, Monsanto insists, is not a problem which is directly related to rBST, but a question of better managing higher producing cows. Linnea Koositra, an Illinois dairy farmer flown in by Monsanto to speak on their behalf, articulates this perspective, by stating that whether or not a cow gets mastitis: “comes down to keeping you cows clean and your equipment in good working order” (Senate, 1998f: p. 13). The incentive to improve farm management is assumed to be a given as healthy animals are the central ingredient to any successful dairy enterprise, and therefore mastitis is not a significant problem (Senate, 1998f: p. 18). Through this assertion Monsanto removes the burden of mastitis from the company and the drug and places it on the shoulders of dairy farmers and their farming practices.

However, like in the case of the economic benefits and human health consequences of rBST the committee also heard a variety of dissenting testimony. Groups, such as the Vermont Public Interest Research Group — Vermont’s largest consumer and environmental organization — expressed a deep dissatisfaction with the way in which Monsanto has presented their data, and were very concerned about the impact of rBST on livestock health. In particular they point to research which was underwritten by Monsanto and conducted at the University of Vermont in the early 1990's. This data they contend, appears to contradict Monsanto’s own assertion that there is no clear correlation between rBST use and increased incidents of mastitis. The committee heard that when comparing the pooled data derived across several herds, that these studies found that the cows which were administered rBST faced a 79% greater risk of developing mastitis (Senate, 1998e: pp.7–8).These findings were granted further authenticity when later in the same day Dr. Ann Oaks, a physiologist at Guelph University, provided the committee with evidence that suggested that Monsanto’s own data when studied independently at Sussex University¹³ demonstrated that there was indeed a significant relationship between rBST use and mastitis. Dr. Oaks further suggested that this discrepancy in findings demonstrates that Monsanto has mislead governments and regulatory offices by releasing only summary findings of their data and not allowing review teams access to the actual study results:

“Monsanto, at that point, if they really believed in their results, should have let everyone have their raw material, let everybody do the statistics, then we would know the correct answer. I believe from this example that we know that Monsanto is hiding information”. (Senate, 1998f: p.40)

The mastitis issue is particularly problematic for Monsanto as it adds an additional burden to their attempts to define rBST around the argument that milk produced with Nutrilac is the same as milk produced without the drug. Directly related to mastitis is an increase in the somatic cell count — less appealing referred to as pus — found in milk produced by infected cows. These cells are shed during normal milk production and therefore all milk contains a certain degree of pus, but a severe case of mastitis is capable of bringing somatic cell counts far above legally defined standards. Although somatic cell counts are of some concern themselves, a far more dangerous repercussion of the mastitis problem relates to the increased use of antibiotics in treating the infection. Specifically there is a growing cognizance of the relationship between increased antibiotic use and the development of ‘super-germs’ — bacteria which develop resistance to medicine’s most potent antibiotic cures. On one level there is concern that an animal’s constant exposure to the wide range of antibiotics used to treat mastitis will make a fairly routine infection very difficult to cure. More disturbing is the possibility that bacteria which develops out of, or comes into contact with, the mastitis bacteria will generate a variety of potentially far more dangerous veterinary infections. In a similar vein, there are also concerns that if humans are exposed to antibiotic residues in milk, that we will develop our own bacteria resistant ‘super germs’. The problem is compounded by the fact that many of medicine’s commonly used antibiotics are the same as those which would be potentially increased in treating chronic mastitis problems (Aboulafia, 1998: pp.627–632).

When the committee raised these concerns to Monsanto their response was predictable. Firstly, they assert that legislated Canadian standards which screen milk for a broad range of antibiotics and which entail severe penalties for those producers who over rely on antibiotic use are enough to encourage farmers to better manage their herds and ergo ensure the safety of Canadian dairy products (Senate, 1998f: p. 10). And secondly, Monsanto sought to validate this position by arguing that the PAMP studies conclusively show that there has been no increase in the number of antibiotic screening violations in the time since the FDA first permitted the use of rBST in the US (Senate, 1998f: p. 17).

Yet, once again, Dr. Hansen painted a very different scientific picture of the experience of the US regarding the relationship between mastitis and the antibiotic contamination of milk (Senate, 1998a: p.20). He portrayed Monsanto’s assumptions as irresponsible, fundamentally flawed and based on what he concluded was a very weak and indirect body of scientific evidence. PAMP studies were criticized for comparing the percentage of milk discarded due to violable antibiotic residues before and after rBST was introduced into the US, and not publishing tests which showed a correlation between rBST and antibiotic use. The Senate also heard that tests demonstrating statistically significant increases in the number of post rBST screening violations did exist, but were dismissed on the basis that these numbers simply reflected the innovation of more stringent testing methods. All of which suggested that the confusion surrounding the mastitis issue could not be negotiated until sufficient data is either gathered, or released, which tests: “the actual levels of antibiotic residues in milk from BGH-treated and untreated cows” (Senate, 1998e: pp. 11–13).

Through the above three examples, or leaks as I have called them, I have sought to demonstrate how the black box Monsanto sought to construct was disrupted during the course of the senate committee hearings. The stability of rBST became more uncertain as Monsanto failed to negotiate several obligatory points of passage. The equation of increased productivity as economic progress was transformed into an unneeded and unwanted risk. A pure image of milk was tainted by residues of BGH, IGF-1 and antibiotics. Rats which were supposed to demonstrate the safety of rBST instead suggested potential links to severe immunological responses and cancer. And finally, the more productive cow was not seen as better, but lame, unhealthy and a risk to industry and the quality of milk. Likewise, Monsanto’s extended network of scientific experts, regulatory agencies and even senior officials of Health Canada was infiltrated by renegade scientists, critical consumer groups, farmers, and dairy processors.

The chore facing the Senate was no less than to decide who and what to believe. Were Monsanto the benevolent harbingers and expert managers of technological and social progress they presented themselves as, or were they were dangerously self-interested, avaricious and deceitful. Was rBST a natural and innocuous substance which would simply provide dairy farmers with all the benefits which go along with ability to produce more milk, or was it a failed attempt to manage nature and a biotechnological risk.


Regulation, Inconclusiveness and Risk

In concluding the first section of this essay I proposed to pick up the challenge of sorting through the controversy surrounding rBST and to question the reasons for its failures. I have argued that Monsanto’s inability to gain the Senate’s approbation of rBST is a result of their own inability to negotiate this confusion. It failed, in other words, because the Senate demanded stability and scientific certainty in making their decision and Monsanto couldn’t solidify the network necessary to construct this image. They expected a solid black box on which to base their decision and what they got better resembled a leaky sieve, punctured by inconclusiveness, conflicting interests and uncertainty.

More Science and More Study

In March 1999, two months after Health Canada rejected the Nutrilac submission, the Senate released a report containing several recommendations concerning the health and safety aspects of rBST. Of the nine recommendations they released, the majority concerned the New Drug Submission (NDS) review process and the controversy surrounding Health Canada’s relationship with industry and the Canadian public. However, three recommendations (Table 3) speak directly to the science of rBST, and stand out as particularly pertinent for this paper. As should be expected, they do not demonstrate any conclusive interpretation (for or against) of the merit and safety of rBST, but reflect the uncertainty in which the Senate was mired. Without this stability, and still believing science to be the ultimate adjudicator of their decision, the Senate had no choice but to step back and request that further studies be carried out. Studies which they hope will conclusively determine the long-term health effects of rBST, the correlation between rBST, Mastitis and antibiotic usage, and which will also investigate all manner of implied socio-economic, political and ethical concerns.

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Table 3: List of Recommendations made by the Standing Senate Committee on Agriculture and Forestry (March, 1999)

4. The Committee recommends that no Notice of Compliance be issued for rBST until the manufacturer submits the long-term studies identified by Health Canada's rBST internal review team as data missing from its submission and until a review of those studies more precisely determines any risks to human safety.

5. The Committee recommends that Health Canada ask that the study requested by the evaluators of the former Central Nervous System/Endocrine/Antiparasitic Division be conducted and submitted in order to meet the requirement of section C.08.004.(2) of the Food and Drug Regulations.

6. The Committee recommends that once human and animal health and safety are assured, the government establish an ongoing mechanism that would stimulate public discussion on economic, trade, social, ethical and other considerations related to drugs and medical devices that are being considered by Health Canada. This mechanism should involve the Canadian Food Inspection Agency where relevant, and may be one outcome of the Health Protection Branch's Transition initiative.

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Where Nature and Tradition End: Politics and the Risk Society

However, the question which remains to be addressed asks whether this example of sociotechnical instability is limited to this one case, or is the story of rBST indicative of attempts to construct and regulate biotechnology generally. Asked differently, is the technological instability and scientific uncertainty associated with rBST an exception to the rule, or is it business as usual within the current regulatory arena? In responding to this question, I do not wish to use the case of rBST to define biotechnology as inherently stable or unstable. Instead, I wish to conclude this essay by exploring how social theories of instability can help us address the regulation and study of biotechnology as an increasing number of these commodities move towards the market.

It is in this regard that studies of the risk society provide a reevaluation of the cultural processes and relationships involving science, technology, nature and the politics of regulation. The basis of which is the proposition that we (society) no longer fear what nature can do to us, but fear what we may have done to nature. As Ulrich Beck argues: “the risk society, begins where nature ends” (Beck, 1998). The threats which we find in the risk society are not external risks which might strike at society unexpectedly, but, as Giddens states, are manufactured from within society itself:

“Manufactured risk is risk created by the very progression of human development, especially by the progression of science and technology. Manufactured risk refers to new risk environments for which history provides us with very little previous experience. We often don’t really know what the risks are, let alone how to calculate them accurately in terms of probability tables.” (Giddens, 1998: p. 28).


This idea of manufactured risk thus implies that science and technology are not society’s response to natural/external risks, but that they are themselves responsible for the uncertainties which we all face. They are the offspring of a history of failed attempts to dominate, manage and improve upon nature, and they permeate the minute details of our lives. Owning a car means contributing to global warming and the production of environmental risks associated with a shrinking ozone layer. Living in a nuclear powered society means fearing routine accidents such as Three Mile Island and Chernobyl. And indeed the genetic enhancement of food production means that we can never be entirely sure whether what we are eating is good for us, or endangering our health.

Moreover, the risk hypothesis also pulls down any remaining belief in the unquestioned authority of scientific knowledge and the political impartiality of corporate science in particular. Beck’s statement that risk begins where nature ends therefore presupposes that risk also: “begins where tradition ends, when in all spheres of life, we can no longer take traditional certainties for granted” (Beck, 1998: p.10). Scientists and engineers have lost the authority and trust which previously allowed themselves to appear autonomous and objective. Images which these ‘experts’ have relied upon to create their scientific and technological black boxes, and which regulatory bodies demand in order to create seemingly clean and decisive regulatory decisions. Conclusions, in other words, which they assumed could be trusted to be made with the best interests of society in mind.

This dual conception of risk as the end of nature and the end of tradition, clearly parallels many of the examples, or leaks, I have identified in relation to the social construction of rBST. The sociotechnical instability associated with rBST is clearly not limited to a discussion of whether it could do what Monsanto promised it would, but whether it could do so without risking human health, economic stability and animal welfare. The ability of Monsanto to offer biotechnology as a safe way to better manage nature eroded around these risks. Any pretensions about Monsanto’s role as the benevolent managers of nature through the production of scientific and technological progress likewise disintegrated. rBST in many cases became almost synonymous with notions of risk. On one hand the risks associated with rBST are recognizable and familiar, such as the links drawn between the use of rBST and cancer, or rBST and rising antibiotic usage. However, risk was also imagined as the potential consequences of rBST which science might speculate on, but which are undeterminable and which cannot be scientifically predicted. For example, I have identified some of the risks associated with the increased production of IGF-1 resulting from the use of rBST. But, as Dr. Chopra, a member of the Health Canada internal review team, suggests, there are likely many more secondary products of rBST which we can’t even begin to speculate about:

“When we come to substances like the rBST, we are walking into an unknown territory” (Senate, 1998f: p.11)... IGF-1 is only one of the indicators... Hormones are unlike any other drugs. They are like chemical switches. You give one, it triggers another one, another one and another one. Some we know, some we may not know -- as far as rBST is concerned. What we do know now is some evidence that IGF-1 increases when you give rBST to cows, in the milk.” (Senate, 1998vi: p.17)


It is quite understandable that when faced with this combination of uncertainty and risk, the Senate requested additional studies be carried out. However, we should not be too hasty in reducing the rBST example to a case of incomplete science and viewing the Senate’s recommendations as a confirmation of scientific authority. Instead, the risk hypothesis allows us to imagine the Senate’s response to scientific uncertainty as an inability to contend with a loss of traditional expertise and a lack of trust in the scientists they heard from. The often outspoken Senator and former Agricultural Minister, Eugene Whelan, articulates this distrust in his skepticism of the science presented by JECFA and their relationship with the life industry:

“You are not going to impress me by quoting WHO or FAO. I was associated with them for 12 years and I know how they operate. They operate on grants and their decisions sometimes depends on who pays their bills. As far as that goes, I have as much respect for some of their decisions as hell would have for a snowball. Do not try to impress me with them because I know how they work... The big companies sit behind them and tell them what to do.” (Senate, 1998i, p.10)


Furthermore, we must not limit the perception of distrust evident in this statement to the example of rBST and the corporate manipulation of the regulatory arena into which it was submitted. Instead, the hostility directed towards rBST can also be recognized in the culpability of Monsanto’s contribution to the generation of the risks with which we are all now forced to live. The case of rBST not only points to the risks associated with a badly designed and mal-intended product, but also of the scientists and the industry bosses behind its innovation. An article in The Globe and Mail (1999a) suggesting that the outcome of the Senate hearings reflected unfounded public fears of biotechnology thus elicited the following editorial response:

“Stating that ‘fear of new technology’ is the reason the public is opposed to genetically modified food or bovine-growth hormone is nonsense. It is fear of Monsanto Co. These folks who produced Agent Orange and DDT would have us believe their genetically modified seeds and their animal-growth hormones are for our own good. Monsanto’s only motivation is profit and not safety.” (The Globe & Mail, 1999b)


These examples of risk suggest rBST was entered into a new moral and political climate in which both Monsanto and the Senate were unable to cope with the routine uncertainty and risk with which they were faced. On some level this example demands that we must once again readdress how we approach the study of innovations in science and technology and their regulation. For sociologists of science and technology the challenge is to look beyond limited definitions of power which are described in terms of stability, and begin to look at the processes by which innovators attempt to cope with chronic uncertainty and a distrustful public. This means explicitly addressing the links between internal processes of innovation, definitions of value (natural & social), the identification of expertise, and the public consumption of risk (Irwin, 1995).

This need to look beyond questions of stability and the production of actor networks is clearly evident in the demands rBST placed on the Canadian Senate. Unable to rely on assumptions about the purity of scientific expertise and the promises of the benevolent capitalist, they were forced into a position where any decision favouring rBST would have had to contend with new processes of assessing and managing risks. As Giddens suggests, risks, although not originating in the political sphere, need to be politically managed (Giddens, 1998: p. 29). This means determining which risks are controllable, which risks are not, and recognizing the possibility that there are risks which exist outside of our scientific and social imaginations. At the end of the day this means assessing the possible benefits offered by a product in relation to its potential hazards, and determining where the boundary lies between erring on the side of safety and acquiescing to its social and technical potential. These dilemmas outline the public needs which governments must begin to address if we are to be able to properly question the role of biotechnology and the life industry in the Canadian dairy industry and in Canadian society more broadly. Without addressing these alternatives, the need to properly regulate the production and use of biotechnology will not be met, but will be left running in circles. In the example I have presented here, despite weighing decades of deliberation, the failure of the Senate to fully address these needs leaves them still seeking a definitive image of an uncertain, unstable and risky innovation:

“Given conflicting evidence and testimony, and differing opinions on the need for further study, the Committee believes that the scientific evidence does not lead directly to the conclusion that rBST residues are unsafe, or that people consuming the products of rBST-treated animals in countries where the drug is used are risking their health. Rather, in the Committee’s view, the evidence and testimony highlight the need for additional studies” (Senate, 1999a: p.15).


Conclusion

By employing a social constructivist perspective to the controversy surrounding rBST I have argued that it is no longer possible for social analysis to envision science and technology as pure, or that nature exists separate from its social and cultural contexts. Instead, I have argued that both science and technology are social and political constructs, and that nature itself is a cultural idea which is both embodied in, and further constructed by biotechnology. It in this dual sense of constructivism that I have followed the failure of Monsanto to produce a stable image of rBST both in terms of their inability to define the science of RBST as complete and to present the management of nature as a viable process. The image of rBST which the Senate faced in making their recommendations was therefore both inconsistent and contradictory. rBST is on one hand a safe, clean and efficient means to manage a deficient nature, and simultaneously the source of potential hazard and unspecified risk which are the results of these attempts. Inconsistencies which I have argued are not limited to the case of rBST, but which suggest the appearance of a new moral and political climate in which the development and attempt to regulate rBST has taken place. A climate which demands we challenge unmoving perceptions of the role of science, industry and governments in the production and regulation of biotechnology.


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Note: several typographical errors in the printed version of this article have been corrected in the web version.

Notes

* I would like to acknowledge the support of the sociology groups at both Carleton and Brunel University in supporting this research, and the assistance of Professors Rob Shields, Dwayne Winseck and Alan Irwin in particular.

¹ ‘Nutrilac’ is the commercial label of BGH in Canada. In the US, as well as in several other countries, BGH is marketed under the more common label of ‘Posilac’.

² In order to provide enough extracted BGH to inject one cow for one day it is necessary to harvest the pituitary glands of approximately 25 cattle (Monsanto, 1999a).

³ On December 19, 1999 Monsanto Company announced that they were merging with Pharmacia & Upjohn to form Pharmacia Corporation.

⁴ JECFA reports jointly to both the UN World Health Organization (WHO) and the UN Food and Agricultural Organization (FAO).

⁵ Codex is also jointly appointed to the WHO and the FAO. The commission met in July 1999 to discuss the regulatory aspects of rBST, and were unable to come to a consensus regarding the acceptable level of BST in rBST produced milk. They have thus deferred this decision until a later date (FAO, 1999).

⁶ It should be noted that despite Health Canada’s ruling, controversy is still transpiring around the possibility that Canadians are being exposed to milk produced using BGH. With the U.S. FDA’s approval of the drug this is certainly the case as current free-trade legislation would likely prevent the Canadian government from banning the import of American dairy products produced using rBST. The fact that there is no consistent and legally enforceable test to identify the presence of rBST in the milk supply further aggravates these concerns.

⁷ Monsanto argues that the environmental benefit of rBST is that by allowing cows to produce more milk farmers would be less inclined to increase their herd sizes, thus limiting the need to expand farm acreage and putting a check on the production of manure (Senate, 1998a: p.5). However, we need to approach this ‘less is better’ rationality cautiously as it does not weigh the detriment to the ecology resulting from the concentrated use of land and resources, or the concentrated production of waste, a more productively efficient farm entails (Krimsky & Wrubel, 1996: p.182).

⁸ What makes a cow better? From Monsanto’s position this simply means making it more productive. As Dr. Collier, Monsanto’s chief dairy scientist, is cited as saying: “let’s face it, a dairy cow is, metabolically, an appendage to the mammary gland” (Hiss, 1994: p.84). Thus to improve upon the cow is no more than to genetically improve upon the metabolic processes in relationship to the udder.

⁹ I have borrowed the idea of leaky black boxes from Susan Ormrod’s (1995) work on the social construction of gender/technology relations.

¹⁰ In the 1950's and 1960's scientists experimented with the use of BGH in helping shorter children grow and in trying to correct cases of dwarfism. Despite injecting BGH directly into the blood stream, BGH was found to offer none of the growth related results they desired. Growth hormones, in other words, are species specific (Juskevich & Guyer: 1990, p.877).

¹¹ When reviewing any new veterinary drug, Health Canada is mandated to review the drug in terms of human safety, animal safety, and efficacy (that it does what it is intended to do).

¹² BSE, commonly known as ‘mad cow disease’, is a degenerative disease affecting the central nervous system of cattle. BSE is know to be transmitted through nutrient and energy rich feed which is produced with the meat and bone meal derived from rendered livestock, most of which die of unexplained causes. Because rBST treated cattle require a tremendous increase in their nutrient uptake to support their production of milk, their chance of eating infected feed and developing BSE is increased (Gaard, 1995: p.7). BSE is a particularly troubling issue as there is increasing speculation that there are links between BSE and Creutzfeldt-Jacob disease (CJD), a degenerative disorder in humans.

¹³ The study Dr. Oaks is referring to was done by Millstone et al (1993) at the University of Sussex. Their data has never been published as Monsanto has prevented them from doing so by enforcing their ownership of the data and withholding their permission to publish the article.