Challenge of international regulation
What a bio-safety protocol would mean
Attitude of industry and government supporters toward bio-safety campaign
That which has been is that which will be
And that which has been done is that which will be done.
So there is nothing new under the sun.--Ecclesiastes 1:11
The ambiguous and contested definition of "biotechnology" is subtly alluded to in Chief Justice Warren Burger's paraphrase of Ecclesiastes in his written opinion on Diamond v. Chakrabarty: "Congress intended statutory subject matter to include anything under the sun made by man" (OTA 1991: 201). As if providing for a double standard, the OTA offered two definitions of "biotechnology" in a report in 1984. The first, which includes recent biological tools, as well as traditional trait selection in agriculture and animal husbandry, and brewing, describes biotechnology as "any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop micro-organisms for specific uses." The second, more narrow definition refers to "new" biotechnology as the "industrial use of rDNA, cell fusion, and novel bioprocessing techniques" (29).
A newsletter from the Monsanto Company proclaims, "Farmers Discovered Biotechnology 10,000 Years Ago: It's Getting Better With Age" (New Bio News, n.d.). Similarly, a pamphlet by the Industrial Biotechnology Association, now the Biotechnology Industry Association (BIO), begins, "Stone Age farmers were, in a sense, the first genetic engineers" (Anonymous 1987). The hesitant phrase "in a sense" marks the double meaning of the term "biotechnology." When addressing the public, which might be concerned with the purpose and safety of biotechnology, industries are quick to suggest that their research and production are simply "extensions of traditional breeding methods." Thus another Monsanto publication asserts, "Whenever a bee carries pollen from one flower to another or a plant breeder crosses one plant with another, genetic information is exchanged. Precision is the only difference between this kind of exchange and the kind effected by genetic engineering" (Anonymous 1989). In short, if intellectual property protection is the issue, then the biotechnology industries are adamant about their methods and products being innovative, even revolutionary. However, when public accountability and regulation are in question, they insist that nothing has changed in millennia, and therefore modern biotechnology deserves no special treatment.
Biotechnology is a powerful new technology that poses substantial and often unique threats to biological diversity--as much as to human health, communities and economies. Many different researchers have detailed these threats. They are briefly summed up here. (See Lane and Schweiger 1995 for a more detailed account.) Genetically engineered crops are designed precisely for their ecological viability and therefore could invade various ecosystems, becoming destructive weeds in agricultural ecosystems. There is also the threat of "introgression," or gene flow, between genetically engineered organisms and related species (Kareiva and Parker, n.d.; Rissler and Mellon 1993). Engineered hybrid crop plants are being bred specifically to resist certain chemical herbicides and pesticides, and, like their conventional predecessors, may result in the pollutive use of these inputs, as well as in excessive consumption of water (Kareiva and Parker; Shiva 1991, 1993). Crop plants engineered to secrete "bio-pesticides" are already resulting in corresponding tolerances in the target populations (Anonymous 1994). This may lead to a vicious cycle of more specific pesticides and more widespread tolerances.
Genetically engineered microorganisms, such as those used for nitrogen fixation in plants or for "bio-remediation," have been shown to have unpredictable and deleterious effects on soils and soil ecosystems (Holmes and Ingham 1994; Jäger and Tappeser 1995). Genetically engineered organisms (GEOs) and biochemicals (such as bovine somatotropin, BST)--including medicines--may have profound long-term consequences on human health (Lacey and Heritage 1994).
One of the greatest fallacies maintained by the promoters of biotechnology is that one can determine the environmental and physiological impact of a genetically engineered product by studying its closest naturally occurring relatives. This is a misapplication of the "principle of familiarity" used in the natural sciences. It cannot account for previously unknown--or even previously nonexistent--trait-organism combinations and their expression in different circumstances and different ecosystems (Kareiva and Parker 1994).
Just as US and international intellectual property laws recognize "ingenuity," "invention" or "innovation" whenever these terms can help secure monopolies and be exploited to competitive advantage, so US and international health and environmental regulation of biotechnology reflects narrow economic priorities and not the actual and possible risks posed by GEOs. We will examine here the US regulatory framework, because the US is the greatest purveyor of biotechnology, and because the US government prides itself on the framework's adequacy and judiciousness.
Biotechnology in the United States is regulated by at least five Federal agencies in a Coordinated Framework: the Environmental Protection Agency (EPA), Department of Agriculture (USDA), National Institutes of Health (NIH), the Occupational Safety and Hazard Administration (OSHA) and to a small extent the Food and Drug Administration (FDA; Krimsky, Bergman, Connell, Shulman and Wilker 1989; Moore 1988; OTA 1991). None of these agencies is in charge of overseeing all regulation of the methods and products of biotechnology. Instead, the White House Office on Environmental Policy tries to coordinate the efforts of the separate agencies (OTA 1991).
As the Council for Responsible Genetics has emphasized time and again, the US Coordinated Framework is neither up to date nor specific to biotechnology. (See Krimsky, Bergman, Connell, Shulman and Wilker 1989.) Plant pest derivatives are regulated by the Animal and Plant Health Inspection Service (APHIS) of the USDA under the authority of the Plant Pests Act (PPA) and the Plant Quarantine Act (OTA 1991). Pesticidal microorganisms are regulated by the EPA under the Federal Insecticide, Fungicide and Rodenticide Act. The EPA also regulates the release of other microorganism under the authority of the Toxic Substances Control Act--TSCA (Krimsky, Bergman, Connell, Shulman and Wilker; OTA). The NIH have guidelines for rDNA experiments conducted with their funding. OSHA deals with work place hazards of genetically engineered products. The FDA provides guidelines for the sterilization of bio-reactors (Krimsky, Bergman, Connell, Shulman and Wilker).
Almost all these forms of regulation were designed for the last generation of industrial technologies, and none provides careful supervision of releases of GEOs. The TSCA, for example, is a notification statute that was passed in the 1970s to abate pollution from industrial chemicals--not self-replicating organisms. Under the TSCA manufacturers do not have to provide data attesting to the safety of their product, and the systsem is made cumbersome by the number of EPA reviews of products and the development of the requisite product-specific rules (Krimsky, Bergman, Connell, Shulman and Wilker). An official of the EPA rationalized the application of TSCA to genetically engineered microorganisms thus:
TSCA's applicability to the regulation of microbial biotechnology products is based on the interpretation that microbes are chemical substances under TSCA. The simplified basis for this interpretation is that all substances, living and non-living, have a chemical foundation at the most fundamental molecular level (Moore 1988: 2).To borrow an analogy used by Dr Phil Regal of the University of Minnesota, this is rather like to saying that there is no conceptual difference between birds and airplanes, since at some level they can be classified as "things that fly," and therefore their traffic should treated in the same way. (Let alone the fundamental sameness of rocks and rockets.)
Recently the APHIS rules on classifying genetically engineered plants as potential pests were loosened to permit the extension of "nonregulated" status to certain regulated varieties that are closely related to the organism for which the determination "nonregulated" has already been made (APHIS 1995). Industry was pleased. One of the first products to pass the new requirements was maize engineered to produce the insecticidal protein of the Bacillus thuringiensis (Bt) bacterium. (See Lane and Schweiger 1995 for discussion.) Richard Godown, Senior Vice President of BIO, stated, "The agency's review of Bt corn went relatively smoothly and rapidly." As a result, he believes prospects for agricultural biotechnology are "very, very positive.... Familiarity breeds acceptance where transgenic plants are concerned" (Anonymous 1995a: 1035). In fact the relaxation of APHIS regulation is a dangerous misapplication of the aforementioned principle of familiarity. Furthermore, USDA field tests of genetically engineered crop plants in general fail to address adequately major concerns about ecological and health risks: weediness, inadvertent gene transfer, the possible evolution of new viruses, and non-target effects (Mellon and Rissler 1995).
The most serious gap in the US framework is the lack of regulation of genetically engineered animals. Only the NIH funding guidelines cover the proper handling and use of such animals, but outside of contractual arrangements, they have no force of law (Krimsky, Bergman, Connell, Shulman and Wilker 1989; OTA 1991.). There is not even a requirement of notification for the release of genetically engineered animal species into the wild (Stabinsky, pers. comm.; see also Anonymous 1995b).
The Coordinated Framework has also been the scene of confusion over authority and interagency rivalry, due in part to there being no forward-looking, comprehensive statute for dealing specifically with the risks of GEOs (Rissler and Mellon, 1993; OTA 1991).
Challenge of international regulation
Article 19.3 of the CBD states that
[t]he [signatory] Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity (ISCBD 1994: 16).This call for a "bio-safety protocol" provides the opportunity for the development of comprehensive and progressive supervision and regulation of biotechnology, as well as the international monitoring of the transboundary effects of transporting and releasing GEOs. Without comprehensive international regulation the potential for the widespread use of biotechnological products to result in ecological and socio-economic disruption is significant. The development of high, legally binding, global standards for national and regional regulation would ensure that the biotechnological activities carried out by one country do not cause damage to other countries or areas beyond its jurisdiction (Lane and Schweiger 1995; Shiva 1993). Among existing international agreements only the CBD has a contemporary and accurate scientific context.
There are some terms that need clarification. The CBD defines "biotechnology" merely as "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use" (ISCBD: 4). Moreover, in the course of the negotiations of the CBD the US government forced the adoption of the term "living modified organism" (LMO) instead of "genetically modified organism" in article 19.3 and other relevant articles (Glowka, Burhenne-Guilmin and Synge 1994; Shiva 1993). "LMO" is not defined in the CBD and appears to be more comprehensive than "genetically modified organism." However, taken in the context of the negotiations, "LMO" is equated with GEOs, i.e. those produced by rDNA and other modern techniques. Article 19.3 also refers to "advance informed agreement," which likewise is not defined in the Convention. Nonetheless, it is widely interpreted as meaning substantially the same thing as the "prior informed consent" (PIC) clauses of a number of existing conventions on the international transfer of hazardous materials (Lane and Schweiger 1995; UNEP 1993). A "no intent to consent" clause might be added to an eventual protocol to strengthen the PIC clause. This would mean that Parties and companies under their jurisdiction intending to carry out biotechnological projects abroad would have to receive explicit permission to proceed.
What a bio-safety protocol would mean
The need for and modalities of a legally binding protocol on bio-safety have been discussed thoroughly elsewhere, including the provisions of the CBD relevant to article 19.3 (Anonymous 1994; Lane and Schweiger 1995; UNEP 1993). What a bio-safety protocol would mean foremost in terms of its substance is the assertion of the precautionary principle, instead of the principle of familiarity. The precautionary principle recognizes that optimism about the safety of previous technological advances did not always turn out to be correct, and that when dealing with powerful new technologies, cautious assessment and continuous oversight of the possible risks probably make the most beneficial long-term strategy. In terms of process a bio-safety protocol would mean notifying the public about and allowing its participation in matters directly affecting its health and livelihood.
In sum a meaningful and effective bio-safety protocol would cover, inter alia:
If the nations of the world do not act in concert to establish high minimum standards for bio-safety, biotechnology industries will continue to threaten to move their operations to countries that have new of no safety standards. Bio-safety will degenerate nearly everywhere into a façade, because poor and rich countries alike will fear economic losses and retribution. Poor countries will be most vulnerable to the temptation to take ecological risks in pursuit of "economic growth," but even wealthy countries have demonstrated that they will bend to such fears and adopt low or negligible standards of safety (Meister and Myer 1994).
By creating a model of high minimum standards for national and regional regulation, a bio-safety protocol would ensure that biotechnological activities carried out under the jurisdiction of one state do not cause damage to the environment of other states or areas beyond its national jurisdiction. This accords with the Principle of the CBD, set forth in article 3 (ISCBD 1994). Governments arguing that there is no risk in transfer of GEOs often themselves have had legally binding rules on bio-safety for many years and have followed those rules. However, because the products of biotechnology can have effects that cross political boundaries, separate national regulatory systems are not enough.
Attitude of industry and government supporters toward the bio-safety campaign
The industries' double standard about the nature of biotechnology has worked its way into the international negotiations of a bio-safety protocol to the CBD, verging on flagrant contradiction. The background paper for the meeting in July 1995 of the expert panel to consider the need for and modalities of a bio-safety protocol states in paragraph 23 that "LMOs are all organisms produced through recombinant DNA technology" (but more broadly defined for prokaryotes and yeast), a definition meant "only to distinguish modern from traditional biotechnologies" and not implying a greater risk (SCBD 1995: 5). However, paragraph 31 declares that "[b]y the mid-1980s it was widely considered that recombinant DNA techniques were an extension of conventional genetic procedures and that organisms produced by this technology present risks that can be the same in kind as those posed by any other organism" (6). The last clause is, of course, virtually meaningless; recombinant DNA organisms can present all kinds of risks. It is the unique ones that proponents of bio-safety are concerned with regulating.
The double definition of biotechnology was not the only evidence of industry pressure in the background document. There is a specious dichotomy between biotechnology's detractors and supporters: "Some, as a matter of faith, often see biotechnology as a great evil, while others proclaim biotechnology products to be as safe as those created by conventional methods. Others are confused by two conflicting positions." This is a subtle version of the suggestion that those who are concerned by the real and potential risks of biotechnology are not thinking scientifically, but rather according to creed. The biotechnology industries are quick to take refuge in the apparent unassailability of "science"--a term with almost religious connotations of "truth," "objectivity," and "incontrovertibility" in the dominant Europocentric culture. In a letter to US Senator Claiborne Pell, Chairman of the Committee on Foreign Relations, Carl Feldbaum, President of BIO, wrote,
We urge the Senate to obtain a[n] ... assurance [from the administration] ... that the United States will not seek, and will in fact oppose, the development of a biosafety protocol under the convention. We believe that creation of any such entity would not result in scientific oversight to further ensure human safety, but rather in promotion of a political agenda serving a purpose other than science (March 9, 1994).
At times industry's denunciation of groups advocating bio-safety seems fraught with conspiracy theory. Robert Fraley, Group Vice President and General Manager of the Monsanto Company, accuses "anti-science advocates" of exploiting the "public's lack of understanding of biotechnology and interweav[ing] political, societal and emotional issues (population control, animal rights, religion, concerns over the environment, etc.) for purposes of gaining visibility, credibility, membership, financial support and political presence" (Fraley 1994: 20). That advocacy groups might be struggling to prevent the real threats posed by unchecked exploitation of biotechnology, and that doing so might require an understanding of complex ethical, social, economic and ecological factors is not considered. He further insists that these groups "focus on peripheral, but more vulnerable issues, such as food safety, property rights, religious views etc." (20) Letting alone whether having safe food is "peripheral" to most people, one wonders what makes the listed issues "vulnerable." Perhaps it is because their consequences deserve serious consideration.
Not only do many Northern governments support such a view of bio-safety's advocates, as is evident in the expert panel background paper, but they sometimes proffer "regulation" and "harmonization" of statutes--if not bio-safety protocol--as a means of promoting industry. Chief US negotiator on consideration of a bio-safety protocol to the CBD, Terry Medley of the USDA, has written (in his personal capacity) that "[o]ne has to possess the ability to go out and discuss the importance of the technology--biotechnology--to humankind and to lay the foundation for technology development and transfer." He continues, "If structured and administered properly, regulations ca facilitate rather than impede expanded development, safe technology transfer, and commercialization of agricultural biotechnology products. Regulations should prevent or at least mitigate risks and not inhibit innovation and product development." Moreover, "It is axiomatic that positive public perception leads to public acceptance, but the latter is, in turn, the necessary basis for efficient technology transfer.... Public acceptance of applications of biotechnology is a prerequisite for technology transfer, commercialization, and utilization of the products of agricultural biotechnology" (74-5).
Public acceptance or rejection of biotechnologies depends on careful, objective exposition of the actual and potential risks of living modified organisms. This is an axiom of meaningful public participation and decision-making. Furthermore, it evades the purpose of article 19.3: the safe transfer, handling and use of products of biotechnology--not facilitation of their transfer. Basic democratic process requires that the question of their safety, as well as the safety of the methods by which they are produced, should not be begged by governments eager to promulgate biotechnology en bloc. A bio-safety protocol would help determine which biotechnologies and methods and techniques of risk assessment and management are appropriate to transfer.
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