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Societal Issues Posed by Commercialization of Aquatic GMOs

Eric M. Hallerman

Department of Fisheries and Wildlife Sciences

Virginia Polytechnic Institute and State University

Blacksburg, VA 24061-0321

ehallerm@vt.edu

ABSTRACT

Issues associated with commercialization of transgenic fish and shellfish are discussed to suggest how benefits of aquaculture biotechnology might be realized while minimizing risks to human health and the environment and promoting public confidence. To favorably influence environmental safety and public acceptance, I suggest that USDA and other agencies take the following actions. The Council on Environmental Quality and the Office of Science and Technology Policy should clarify legal authorities applicable to aquaculture biotechnology, promulgate new policies if needed, identify agency roles, and mandate consultation between key regulatory agencies. USDA should require adherence to the Performance Standards for Safely Conducting Research with Genetically Modified Fish and Shellfish among all bodies receiving its support. USDA should ensure that biotechnology risk assessment research receives sufficient support that the knowledge base needed for effective regulatory oversight is generated in a timely fashion. USDA should attach priority to support of research developing GM food and fiber products clearly benefiting the consumer. To promote an adaptive approach to oversight of aquaculture biotechnology, USDA and other agencies should support efforts to synthesize knowledge of benefits, risks, and regulatory experience relevant to development or revision of oversight policy.

KEYWORDS: genetically modified organisms, GMOs, food safety, risk assessment, risk management, consumer acceptance

INTRODUCTION

The application of biotechnology poses a revolution for agriculture. The first products of agricultural biotechnology, derived from genetically modified (GM) crop plants, have been commercialized. These plants express introduced genes to protect themselves against insects, diseases, or herbicides. Despite obvious benefits to producers, commercialization of products from GM plants has proven highly controversial. For example, detection of StarLink GM corn in taco shells and other products caused consumer outrage and major disruptions to wholesalers and processors of corn. Noisy protests against "Frankenfoods" have accompanied recent meetings of the International Monetary Fund. Commercialization of products from GM plants has proven controversial, in part, because potentially contentious issues were not addressed before commercialization. Commercialization of the first food products from GM animals is expected within the next year or two. A/F Protein, a leading aquaculture biotechnology company, has petitioned the U.S. Food and Drug Administration (FDA) for approval to market GM salmon. This petition has proven controversial, receiving highly visible coverage in the news media. Here, I explore the controversies associated with commercialization of genetically modified aquatic organisms (aquatic GMOs), focussing on transgenics. My intent is to suggest how the potential benefits of aquaculture biotechnology might be realized while minimizing risks to human health and the environment, and while promoting public confidence. Towards these ends, I also recommend potential actions for the U.S. Department of Agriculture.

Potential benefits of gene transfer technology

Although fish and shellfish may be genetically modified using a variety of methods, the technique that has proven most controversial is gene transfer. Using this procedure, a gene from any species can be introduced into a new species by injecting it, within a well-designed gene construct, into newly-fertilized eggs of the intended host.

Gene transfer poses a range of benefits for aquaculture. Most gene transfer experiments have introduced additional copies of a growth hormone gene into an aquaculture species in hopes of producing a faster-growing aquaculture stock. A/F Protein, the company that aims to commercialize the transgenic Atlantic salmon, reports a 4-6-fold acceleration of growth rate, with a 20% improvement in the rate of conversion of feed to fish flesh (Entiss 1997). Several experiments have attempted to increase the cold tolerance of sensitive species by introduction of antifreeze protein genes from Arctic or Antarctic fishes. Improvement of other traits will depend on identification of key genes. For example, should genes conferring resistance to key diseases be identified, they could be transferred into susceptible species or strains. If a key biochemical pathway has been disrupted by lack of one enzyme, the function of that pathway can be restored by expression of an introduced gene. Such pathways might include those for synthesis of vitamin C or omega-3 fatty acids, now required nutrients in fish feeds.

SOCIETAL ISSUES POSED BY COMMERCIALIZATION OF TRANSGENIC

FISH AND SHELLFISH

The prospect of commercial production of transgenics poses a variety of issues. Resolution of these food safety, environmental safety, and public acceptance issues will determine whether commercialization or transgenic fishes succeeds.

Food safety

The safety of foods derived from GM plants has become a high profile issue. For example, the potential allergenicity of the Cry-9C transgene was the basis for the controversy associated with detection of StarLink corn in taco shells and other products. The prospect of marketing products from transgenic fish and shellfish raises the issue of their food safety. The food safety evaluation will compare food products from transgenic fish or shellfish with those from their traditional, non-transgenic counterparts (Berkowitz and Kryspin-Sorenson 1994).

The principles for assessing the food safety of a new protein are very similar to those for establishing the safety of other proteins taken orally (Berkowitz and Kryspin-Sorenson 1994). Most proteins are digested prior to absorption and are pharmacologically inactive after oral consumption. Since most transgenic fish lines express an introduced growth hormone gene, consideration of this gene product is particularly important. The food safety of the growth hormone protein was evaluated in depth when administration of growth hormone (also called somatotropin) to dairy cattle was considered by the U.S. Food and Drug Administration (FDA) in the late 1980s. FDA found that non-primate growth hormone molecules are not biologically active in humans, nor are fragments of the growth hormone molecule, nor are other hormones secreted in response to growth hormone administration (Juskevich and Guyer 1990).

Another food safety issue is raised by the potential allergenicity of a new protein or of a heightened level of a protein in GM food. Gene transfer raises this issue because it may introduce a protein from virtually any source into a fish or shellfish. More than 90% of allergic reactions can be attributed to eight foods or food groups: eggs, fish, shellfish, milk, peanuts, soybeans, tree nuts, and wheat (Lehrer 1999). If the new protein originates from a known allergenic source or its amino acid sequence is similar to that of a known allergen, the protein can be tested to determine whether it causes reaction with serum from individuals with known food allergies. A more difficult issue arises when a new protein comes from a source that is not historically a human food. However, evidence suggests no cause for concern about the allergenic potential of proteins from sources with no history of allergenicity, that have no amino acid sequence similarities to known food allergens, that are rapidly digested, and that are expressed at lower levels than major allergens (Lehrer 1999).

The potential toxicity of a new protein or a heightened level of a protein in a food poses another food safety issue. Toxins, however, are well studied, and would not be purposefully transferred into a food animal. Testing for toxicity is relatively straightforward, and would be required before a product is approved for marketing. Hence, toxicity is unlikely to prove a risk for foods derived from transgenic fish and shellfish.

Concerns about possible human health and environmental impacts of the products of biotechnology led to the development of the Coordinated Framework for the Regulation of Biotechnology by the federal government in the mid-1980s. Under authority of the Federal Food, Drug and Cosmetics Act, the U.S. Food and Drug Administration (FDA) was charged with the responsibility to oversee resolution of food safety issues posed by food products of biotechnology. Hence, FDA is the lead agency considering the petition to market GM salmon as human food. FDA considers the growth hormone expressed in the transgenic salmon as a new animal drug, and transgenesis as a means of delivering the drug to the salmon. This regulatory approach would allow the agency to impose conditions on the means of producing the "drug," e.g., in well-confined systems, but the petition is confidential and not disclosed to the public.

Environmental Safety

Commercial production of transgenic fish and shellfish raises issues of environmental safety. Concerns stem from the likelihood that transgenics will escape from production facilities, and that they might pose ecological or genetic hazards (Kapuscinski and Hallerman 1990, Hallerman and Kapuscinski 1992). Ecological hazards include the possibility that transgenics would prove voracious predators or competitors. They might colonize ecosystems outside the species’ native range, or negatively impact key ecological processes. Should the transgenics be reproductively fertile, they could interbreed with natural populations. Environmental safety concerns raised by commercial production of transgenic fish or shellfish must be considered on a case-by-case basis, focussing on the species, culture system, and ecosystem at issue in a given application. The few studies assessing the environmental safety of transgenic aquatic organisms (e.g., Farrell et al. 1997, Muir and Howard 1999, Devlin et al. 1999) suggest a considerable risk of hazards being realized.

There is a clear need for public policy to guide commercialization of aquaculture biotechnology. However, public policy concerning commercialization of transgenic fish and shellfish is not well developed. At the federal level, application of the Coordinated Framework to aquaculture biotechnology is complicated by lack of clear legal authority and by gaps in its coverage (Hallerman and Kapuscinski 1990). The U.S. Department of Agriculture (USDA) asserted its authority to oversee research and development activities with transgenic fish and shellfish. The need for practical tools for risk assessment and risk management led USDA to foster development of Performance Standards for Safely Conducting Research with Genetically Modified Fish and Shellfish (ABRAC 1995). The Performance Standards help a researcher identify any ecological or genetic risks posed by an experiment with genetically modified fish or shellfish, and to design confinement measures to manage any such risks. Under the Coordinated Framework, however, there is no clear policy for overseeing commercialization of transgenic fish and shellfish. An FDA decision to allow marketing of a transgenic fish might be construed a "significant federal action," triggering an environmental assessment under procedures required by the National Environmental Policy Act. The Concil on Environmental Quality and the Office of Science and Technology Policy recently completed a six-month inter-agency assessment of federal environmental regulations concerning agricultural biotechnology. The agencies approached the assessment by preparing case studies to identify strengths, weaknesses and potential areas of improvement in the existing regulatory structures. The case studies included transgenic Atlantic salmon and goldfish. The case studies showed the need to clarify the authority and roles of agencies, and the mandate for agencies to consult one another. Leading federal fisheries and aquaculture agencies – the U.S. Fish and Wildlife Service, National Marine Fisheries Service, and USDA – lack a clear role in oversight of transgenics.

The states have clear authority for oversight of agriculture and aquatic resources within their borders and of marine resources to the three-mile limit offshore. Most states require aquaculturists to obtain permits for their operations, generally granted conditionally on their adherence to water quality and fisheries management regulations. Fifteen states have adopted regulations concerning uncontained applications of genetically modified marine organisms (Stenquist 1998). Hence, it will prove worthwhile for the federal government to coordinate its oversight of aquaculture biotechnology with these and all states.

Agricultural and fisheries or marine resources authorities should review proposed activities concerning commercial production of transgenic fish and shellfish when such activities may pose risk of escape into the environment. Descriptions of proposed activities should describe possible risks and proposed risk management measures. The petition for the permit should be open to public scrutiny and comment, both oral and written. Granting of a permit may be conditional on the producer demonstrating the effectiveness of confinement and agreeing to share data relevant to risk assessment and risk management. The present lack of knowledge of environmental risk suggests that commercial production of transgenic fish and shellfish should be permitted only in well-confined systems. At least at the outset, commercial production of transgenic fish and shellfish might be limited to indoor, recirculating aquaculture systems. A particularly well-designed program of confinement measures would be needed for production in outdoor systems, such as ponds or raceways. Reproductive confinement should be required. This could be achieved cost-effectively by producing triploid or monosex stocks. A practical means for promoting effective confinement would be to require adherence to the Performance Standards or to the subsequent Scientists’ Working Group on Biosafety (1998) protocol.

USDA and fisheries and marine resources management agencies should promote research to advance risk assessment and risk management for aquaculture biotechnology. The USDA Biotechnology Risk Assessment Program traditionally was allocated just 1% of the federal biotechnology research budget. In 2000, the Clinton administration directed USDA to support risk assessment research under its large Initiative for Future Agriculture and Food Systems (IFAFS) Program. However, in 2001, the IFAFS request for proposals excludes submissions regarding risk assessment research. With future advances in our understanding of risk, public policy for oversight of commercial production of GM fish and shellfish must be revisited frequently following an adaptive management approach (Kapuscinski et al. 1999).

Public Acceptance

To address the full range of issues regarding commercialization of transgenic fish and shellfish, we must go beyond narrowly scientific issues to also consider social issues. Ongoing controversies regarding products from transgenic crop plants suggest that consumer acceptance is the key factor determining the success or failure of commercialization of GM foods. Many surveys of consumer attitudes have been conducted, and tend to report similar findings. Most consumers (65%) express confidence in the ability of FDA to oversee food safety aspects of biotechnology (Hoban and Kendall 1993). Despite confidence in food safety oversight, 85% of respondents favor explicit labeling of GM food products. Producers of GM foods, however, have resisted labeling their products as containing GM components, arguing that no food safety problem has ever been attributed to GM ingredients. Producers claim that such information is not material to legal labeling requirements and would prove confusing to consumers. Proponents argue that labeling of GM foods would allow individuals suffering apparent allergic responses to infer what caused their reaction, that labels routinely relate other information not required by law, and that interested consumers readily interpret complex labels. Survey results also show that for consumers to favor GM over conventional foods, they will have to perceive consumer benefits from unique product qualities (such as improved nutritional value) or lower price. So far, the benefits of GM foods have accrued only to producers. USDA should attach priority to support of research developing GM food and fiber products benefiting the consumer.

Successful commercialization will depend on public confidence about the environmental safety of producing GM foods. Following rather limited environmental safety research, rapid commercialization of transgenic crop plants led to controversies regarding the toxicity of GM pollen to non-target species such as monarch butterflies, and the pollenization of conventional crops and related wild plants by wind-borne GM pollen. Policies for commercialization of GM fish and shellfish must benefit from the experience of these controversies. Commercialization must be accompanied by monitoring, supporting advances in risk assessment and risk management. A precautionary regulatory regime must evolve only with justifying knowledge gathered during commercialization. Regulatory decision-making must be transparent to the public.

Opponents of GM foods have raised a number of other social and political issues, including opposition to the dominance of multinational corporations in the commercialization of plant biotechnology, perceived threats to small farmers, and disputes over intellectual property rights. Some of the most vocal opposition to GM foods is based on these and other values-based issues.

CONCLUSIONS AND RECOMMENDATIONS

Successful commercialization of transgenic fish and shellfish will require public confidence that food safety and environmental risks are thoroughly addressed and that key consumer and societal interests were respected. USDA has the opportunity to favorably influence environmental safety and public acceptance, and hence, the prospects for successful commercialization of aquaculture biotechnology. Towards these ends, I make the following recommendations:

Short-term (1-3 years):

REFERENCES