Biotechnology-Aquaculture Interface: The Site of Maximum Impact Workshop | |
|
Contents
Appendix
|
Workshop Report
-Preface
-Final Report
Market Introduction of Transgenic Aquaculture Products:
An Overview of the Societal Issues
Elliot Entis
Aqua Bounty Farms
Waltham, Mass
eentis@aol.com
ABSTRACT
The use of transgenic technology to enhance the production of food fish raises the same issues with regulatory authorities, industry groups, activists, and consumers, as those posed by the introduction of other food products derived from biotechnology.
For regulatory authorities, the issues are to develop and maintain a science-based approach to the safety assessment of food and environmental impacts; to assure consumer confidence in the regulatory process; to maintain confidentiality with regard to proprietary industry information. Unfortunately, these requirements are often in conflict with one another and complicate the task of regulators.
For industry groups, the primary concern lies in the need to judge potential consumer acceptance of biotechnology-derived products and the economic risk that is engendered.
For activists, the issue is more frequently straightforward: how to maximize doubt on the part of industry groups, consumers and politicians regarding the safety of biotechnology-derived products in order to limit or prevent their market approval.
In the end, consumers are left in the unenviable position of attempting to sort through conflicting claims and charges of risk emanating from institutions that they endow with varying levels of trust.
In this complex set of interrelationships, several things are clear: in the near-term, the degree to which genetic modification is used in agriculture and aquaculture may depend more on the relative strength of key interest groups than on objective demonstrations of safety and efficacy; consumer perception of safety may be less important than "the perception of that perception" by opinion leaders, e.g., the media, politicians, and producers; and cultural differences will continue to be highly influential in shaping each nations degree of acceptance of agricultural biotechnology.
However these forces may come in to play, the ultimate acceptance of biotechnology-derived products requires reliance on a small number of simple rules: transparency, willingness to educate, good science, objective debate and patience. Following these rules may not always result in commercial success, but failure to do so makes success less likely.
REGULATORS
From a strictly legal perspective, the mandate of regulatory agencies extends only to examining science-based questions related to health and safety. However, to be effective, regulatory agencies must conduct such assessments in ways that inspire public confidence. This is not always a simple task, particularly when historically accepted procedures for doing so come under attack. For example, historical reliance on industry for the development of basic safety-related data, and a product labeling policy that does not require description of the manufacturing process have now been called into question. Moreover, the very definition of safety has also been called into question by some. The outstanding public safety and environmental record of agbiotech foods to date clearly indicates that regulatory authorities are continuing to exercise their mandate quite effectively; nevertheless, as public skepticism attests, their actions have been much less effective in inspiring confidence. To a certain extent, this is unavoidable, and should be considered the consequence of introducing new technology, inexperience on the part of industry, and the effect of interest group attempts to gain credibility through subjective, rather than objective, protest.
Limits on the Utility of Science-Based Regulatory Oversight
Regulatory agencies are charged first and foremost with the responsibility to interrogate matters of public safety: Is the product safe for human consumption and is the product or method of production safe for the environment? Of course, both of these principal queries are dependent upon the definition of "safe" and the methods and procedures that one would employ in making that determination. Unfortunately, the new technologies have presaged debates regarding both the testing strategies and the standards by which "safe" has been historically defined.
United States regulatory agencies have generally responded to questions of safety by relying on historical testing paradigms (e.g., those derived from the Food Drug and Cosmetics Act and NEPA). The underlying assumption is that genetically modified organisms derived from biotechnology pose no new or peculiar set of safety concerns that have not been encountered previously in the context of older technologies, including for example, standard crossbreeding, irradiation and chemical mutagenesis. While this approach has a solid scientific foundation, some segments of the general public clearly have not been satisfied with respect to its adequacy in carrying out the regulatory mandate. In short, significant difference of opinion exists with regard to an appropriate application of safety procedures as defined by regulatory authorities and scientists and much of the general public.
A large proportion of Western society has withheld its trust from scientists who suggest that the assessment of safety requires an examination of the product and not the process by which that product is derived. This is accompanied by an implicit belief that the well-understood tenets of biology including toxicology somehow dont apply to biotechnology-derived products. One result of this loss of faith, for example, is the frequent demand that testing should continue for far longer time periods than has normally been required for new products.
Mistrust of the relevance of historically acceptable safety tests finds a natural extension in mistrust of the mechanisms used to administer and report the results of those tests. Thus, reliance on industry for data collection, the confidentiality of proprietary information, and lack of mandatory labeling become further cause for concern. What the public does not understand is that the mechanisms for oversight that are built into the generation of safety data by industry are substantial, and that the role of industry in this regard is critical: safety evaluation would become an insurmountable obstacle were we to place the burden of testing on regulatory authorities themselves. Existing legal requirements to maintain the confidentiality of industry data are misinterpreted as a requirement to protect industry at the expense of public safety. Finally, the lack of mandatory labeling has become "evidence" that industry and government are withholding information that the public has a right to know.
The issue of applicable safety standards has a normative base. Those seeking to redefine safety are attempting to apply to the technology a principle not generally used in past public policy the precautionary principle, defined here as the likelihood of no risk under any foreseeable circumstance. While the precautionary principle has been a staple of environmental groups for some time, it has clearly gained greater public credibility only with the advent of biotechnology, the fear of which provides fertile ground for growth of the idea that only the precautionary principle can provide a proper degree of protection against the inherent assumption of catastrophic destruction.
For those with draconian environmental perspectives, as well as those who support an ideological stance in opposition to science itself, to capitalism, to world trade, or to other supposed evils, the advent of agbiotech has proven to be a most useful weapon. Fear of agbiotech has become the fulcrum by which groups would swing the existing balance of political power in their direction. Consequently, the acceptance of biotechnology will continue to be fraught with difficulty, the outcome not being determined by scientific or regulatory expertise alone. Underestimation of the fear of new technologies on the part of regulatory authorities, political leaders, and the private sector, and the lack of foresight that such fears would be manipulated, whether in cynicism or good conscience, has led to the present circumstance whereby no regulatory scheme for the oversight of these products would be acceptable in many parts of the world in the near term. The confluence of a natural fear of the unknown with a desire of certain interest groups to garner support for a variety of ideological visions has made the current debates exceedingly volatile and frequently non-scientific.
In sum, while regulatory authorities will continue to evaluate the acceptability of current regulatory codes in meeting the needs of government and society to assure the public safety, they will continue to confront questions of social policy with regard to making these codes both transparent and comprehensive to the average consumer. What is at stake is not just safe passage for the new foods from biotechnology, but maintenance of trust in government itself.
INDUSTRY
In contrast to regulatory authorities who must answer to many publics, industry in effect only answers to one: the consumer. The economic strength of a given company and its assessment of consumer acceptance will largely determine the risks that an enterprise is willing to assume. In one form or another, any company that thinks about the development of a transgenic product must ask itself the following questions:
While most companies and industries in North America have decided to proceed with the use of transgenics based on their analyses, most in Europe have decided against its use even where permissible. This has occurred despite the fact that many measures of consumer attitude even in Europe indicate less resistance to biotechnology products than is commonly assumed. The conclusion to be drawn is that actual consumer behavior may be less important to corporate decision-making than the fear of how consumers may behave in the future. In competitive, high- volume, low-margin industries, the gain or loss of a few percentage points in sales volume can determine a companys profitability and pre-emptive behavior to avoid even marginal sales erosion may be critical.
It is also clear that different companies and industries have varying attitudes with respect to the assumption of risk, dependent upon cultural attitudes as well as the political and consumer climate. In Europe, most food companies and grocery distributors have reacted far more cautiously than their US counterparts with regard to transgenics, and have, in fact, publicly opposed GM products use no matter how benign. Recent concerns regarding BSE and dioxin contamination, as well as the influence of Green Parties, an hysterical media, and a generally protectionist attitude against US initiatives, have played major roles in fostering anti-transgenic attitudes. Compounding the problem is that Europe does not have a respected equivalent to the FDA, trust in governments ability to assure food safety is far lower than that in North America.
The real question with regard to the pre-emptive anti-GM approach of the European food industry is whether the industry is leading or being led by consumer attitudes. While there may be no simple answer to this question, public statements by these companies indicate a fear of consumer reaction to GM foods that is almost incomprehensible to a North American. Adding to the suspicion that producers themselves are overreacting is the belief of many (as conveyed in private conversations) that GM food products have not been accepted in the US, or at least that the tide of opinion is about to massively change to reflect Europes attitudes. This misreading of US public opinion lends weight to the assumption that producers are inaccurately reflecting consumer perception, or that their perceptions of consumer attitudes are shaped more by the media, politicians, and anti-GMO activists than by actual behavior on the part of the buying public.
The fear of a consumer backlash is particularly true in the salmon aquaculture industry, which is the most publicly averse to transgenic technology of all of the segments of the food industry. Several factors may be responsible for this exceptional negativism. First, European corporations principally in Norway and the UK control salmon aquaculture worldwide. An initial bias therefore exists that consumers (even in North America) will refuse to buy transgenic fish. Second, the aquaculture industry is under great pressure from environmentalists as a result of concerns over sustainability, pollution, gene introgression, and destruction of coastal wetlands. In this climate of adversity, aquaculture companies are understandably reluctant to exacerbate the conflict by publicly accepting controversial production technologies. It has, in fact, become fashionable for salmon companies to defend their present methods of operation by claiming that they do not now and never will employ transgenic technology. Finally, because it is a relatively new industry, salmon farmers fear that their customer base could quickly erode in the face of additional criticism. Most believe that a consumers choice to purchase farm-raised salmon is an option that could be foregone entirely.
From a practical perspective, efforts to gain acceptance for transgenic aquaculture products must be focused at least as much on the producers as on the consumers. Producers must be convinced that consumers will purchase these products in some parts of the world and that economic benefits outweigh the risks. Producers must also convince themselves that there are environmental benefits to be gained that will address certain criticisms with which they are presently faced.
NON-GOVERNMENTAL ORGANIZATIONS (NGOs)
The NGOs active in the GM debate are almost universally opposed to implementation of the technology, and often radically so. The head of Greenpeace in Europe, Benedikt Haerlin has been reported as saying that it would be preferable to let people die from starvation than to grow GM crops: "In remarks to reporters afterward, Mr. Haerlin dismissed the importance of saving African or Asian lives at the risk of spreading a new science that he considered untested. The Greenpeace position, he said, was that research could continue as long as no seeds or animals were ever released." (1999). While there are many issues that underlie NGO opposition to biotechnology, the emotional roots of the argument appear to derive from distrust of government, opposition to corporate "globalization", a mistrust of science, and a belief that saving the planet can be achieved only by reversing the tide of technology and returning to a simpler, "organic" lifestyle. Perhaps the only unifying thread among these groups is an undercurrent of fear regarding the modern world. Despite diffuse ideals and the absence of concrete goals, most of these groups are certainly clear about the fact that opposition to GM technology offers greater hope of political influence and organizational power. Fear is an easy product to sell, and in this campaign NGOs have willing sales partners in the mass media.
The influence of NGOs varies considerably by country and region. In North America they have less persuasive power, and tend to be more moderate; in Europe, they have proven to be both radical and politically powerful. Although some of these groups may be amenable to modifying their positions (for example, the Center for Science in the Public Interest has come out in favor of GM technology), gaining acceptance of GM products by these groups will likely prove to be impossible under any circumstance.
The question for producers of GM products, therefore, is not how to convince these groups, but how to marginalize their influence when it derives from unsubstantiated and technically unsound claims. Accomplishing this will require a convincing demonstration of the safety of GM technology, which can only occur over time. Institutions and groups trusted by the public must vocally support the technology based on fact, the media must be convinced to balance its approach, and the developing safety record of agbiotech foods must be exemplary. Opinion leaders must also be convinced especially in Europe to lead opinion rather than pander to it. Some of this will occur only glacially, so the effort must be continuous and geared for the long run.
CONSUMERS
Given the public debate and conflict among institutions and opinion leaders, it is perhaps surprising that gene modification has been as widely accepted by the general public as it has been in recent years.
When Thomas Edison attempted to introduce electricity to cities in the US, for six years he was unsuccessful. Only Appleton, Wisconsin, was willing to engage in the risky enterprise of electrification, which many thought would result in the burning of cities and the electrocution their inhabitants. A parade down Broadway with marchers glowing from the light of electric bulbs strapped to their heads was needed before New Yorkers would consider changing from gas lamps. We often forget that major changes require overcoming innate conservatism, that fear of the unknown is not any less powerful today than it was in previous eras. In the present circumstance, when central cultural values such as food and nature are at stake, these fears are understandably high. Simple proofs of safety are not sufficient to overcome these fears: the proofs have to be repeated many times over, the cultural institutions that are trusted by the majority of people have to offer continuous support, and consumers must recognize a benefit that clearly outweighs any sense of risk. The questions consumers ask are rational and require answers:
Answering these questions will require patience and a willingness on the part of those developing this technology to engage in long-term efforts to increase the public understanding. Educational efforts and a willingness to share product information beyond what may be legally required or even considered prudent under the conditions of normal competition, may be necessary. Products that confer obvious benefits must have the highest priority for development. And finally, commercial companies must maintain a willingness to view the long-term benefits of this technology and not allow obstacles in the immediate path to dissuade them from continuing. The successful introduction of biotechnology as a routine tool in food product development is more akin to a marathon than a hundred yard dash.