Second Joint Symposium on Food Safety and Nutrition:
Current Issues in Food Biotechnology

Stanley H. Abramson
Arent Fox Kintner Plotkin & Kahn, PLLC
1050 Connecticut Avenue, NW
Washington, DC 20036
abramsos@arentfox.com

University of Maryland
Adelphi, MD
July 11, 2001

Abstract

STARLINK -- A CASE STUDY

Any meaningful discussion of biotechnology-derived foods must begin with the recognition of just how ill-prepared the general public is to grapple with issues related to food production and microbiology. Most people living in the developed world have little or no concept of how their food gets from the farm to the table and virtually no understanding of the science of genetics. The recent controversy over the StarLink^TM variety of corn will ultimately serve as an important step in a learning process that is long overdue.

Certainly there is enough blame to go around for government as well as industry when it comes to StarLink. But in contrast to the well documented risks associated with other food scares, including bacterial contamination and BSE, the economic losses resulting from the discovery that trace amounts of StarLink corn were present in the food supply are based on the perception rather than the reality of risk.

StarLink is one of several varieties of corn developed using techniques of modern biotechnology, specifically recombinant DNA technology or "genetic engineering." In this case, field corn has been engineered to produce a protein that protects the ear from the European corn borer, a caterpillar that can cripple a farmer's crop unless he sprays insecticides at the proper time. The protein was not dreamed up in a laboratory, but rather is derived from a common soil microorganism, Bacillus thuringiensis or "B.t.," whose insecticidal properties have been known for over 100 years. The first commercial spray containing Bt was developed in Europe nearly 60 years ago, and Bt products have been registered as pesticides in the United States for four decades. Conventional and organic farmers alike value the use of conventional B.t. sprays because B.t. is a natural product and leaves no chemical residue. But the greatest value of the B.t. protein is that, in contrast to chemical insecticides, it targets only caterpillars - the protein is essentially harmless to other insects and completely nontoxic to birds, fish, humans and other mammals. Unfortunately, because the sprayed version breaks down rapidly in sunlight and washes off plants easily, its ability to stop the corn borer is limited.

Looking for a better way to protect valuable crops, researchers first identified the family of B.t. proteins that confer pest resistance and the genes that direct the soil microbe to produce those proteins. In the mid-1980's, scientists began to transfer B.t. genes into plant cells and to grow B.t. plants in carefully controlled laboratory tests. Of course many plants produce their own protective proteins and the traits of insect and disease resistance have been bred into crops for years by conventional means without government oversight. But the U.S. had decided back in 1986 that biotechnology-derived crops that have pesticidal properties would be subject to review by three different regulatory agencies - the Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The decision to regulate biotechnology-derived plants was not made because they are inherently riskier than conventional hybrids. Indeed the National Academy of Sciences has consistently found no evidence to suggest that unique hazards exist either in the use of genetic engineering or in the movement of genes between unrelated organisms. Rather regulation was provided largely in response to public perceptions concerning the novelty and potential power of genetic engineering.

Beginning in 1988, hundreds of field experiments were conducted under government supervision and volumes of health, safety and environmental data were submitted for agency review. Finally, between 1995 and 1998, about a dozen B.t. plant products were cleared for commercial introduction, including corn, cotton, potatoes and a tomato. Recognizing the value of lower crop losses and decreased pesticide usage, U.S. farmers were quick to adopt the new varieties, planting B.t. corn on over 25 million acres by 1999.

Much has been said about the potential adverse effects of biotechnology-derived crops and about B.t. corn in particular. Allegations of environmental harm ranging from dwindling Monarch butterfly populations to B.t. resistant caterpillars have been carefully considered and ultimately rejected by the EPA based on sound science rather than political posturing or media hype. Public health concerns have been virtually nonexistent for B.t. crops and millions of people have eaten flour, syrup and finished foods made from B.t. corn without apparent difficulty. Indeed, after years of intensive governmental, commercial and academic oversight, not a single instance of actual harm to health, safety or the environment has ever been confirmed for any biotechnology crop on the market today.

So why is StarLink any different? While the protein in StarLink is nontoxic, it appears to break down somewhat slower than other B.t. proteins in simulations of the human digestive system leading some to speculate that it might cause allergic reactions in sensitive individuals. As a result, EPA approved StarLink for use in animal feed, but withheld approval for human consumption until these allergenicity concerns could be satisfactorily addressed. Conditions were imposed on StarLink's producer, Aventis, and a stewardship program was put in place to segregate StarLink seeds, fields and harvests from other varieties. Less than one-half of one percent of U.S. corn acreage was planted with StarLink in the 1999 and 2000 crop years. Although the matter is still under investigation, we now know that an even smaller percentage of StarLink was inadvertently commingled with other yellow corn.

Because of the manner in which commodities like yellow corn are handled after harvest and the relative ease of finding trace amounts of stray genetic material in the food supply, it was apparently not difficult for a miniscule amount of StarLink to contaminate relatively large quantities of grain, flour and finished goods, particularly dry-milled products. For that reason, and in light of the heavy publicity that ensued, it is particularly noteworthy that so few reports of allergic reactions were received by the government nationwide. To date, there is no confirmation of any of those reports, although the matter is still under review. A recent study by the Centers for Disease Control and FDA suggests that any reactions suffered were not as a result of exposure to StarLink. Nevertheless, without any confirmation that reports of allergic reactions were based on exposure to the StarLink protein or reflected a true allergenic response, Aventis withdrew the product from the market, voluntarily cancelled its EPA registration, retrieved over 90 percent of the 2000 crop and agreed to provide compensation for losses suffered by growers and elevators at a cost of hundreds of millions of dollars.

Benefits may yet emerge from the StarLink episode. Certainly it has lead to discussion of the future handling of biotechnology-derived commodities in the food supply. In hindsight, industry and government agree that B.t. and other pesticidal proteins will be approved in commodity grains only after all requirements have been met for both human and animal consumption. For those products that are approved, the biotechnology, grain and food industries agree that validated test methods for detecting biotechnology-derived proteins in grain should be in place and accessible at the time the product goes on the market. It is generally agreed that better techniques are needed for assessing the potential allergenicity of new foods and food ingredients, whether produced through genetic engineering or conventional means. The StarLink experience has lead to improved communications among industry stakeholders, including technology developers, seed companies, growers, food processors, retailers, feed and grain industries and exporters. It has also contributed to enhanced coordination among the three lead federal agencies. Finally, in order to avoid the costs and adverse publicity of another StarLink, technology providers, seed companies and growers will all be compelled to institute significantly enhanced product stewardship programs.

The following thoughts on the relationship between regulation and product stewardship are offered in the interests of promoting proactive stewardship efforts:

1. To the producer of biotechnology-derived products and others in the chain of commerce, government regulation provides assurance that appropriate safety standards have been met in bringing a product to market. But even the best efforts of regulators may prove inadequate, particularly when dealing with a new technology, without the development and implementation of proactive product stewardship programs.

2. In its broadest terms, product stewardship can be thought of as the legal, ethical and moral obligation to assess products and technologies to ensure that they are safe as well as socially and environmentally responsible. Stewardship includes the assessment, based on sound scientific principles, of the potential impact of a particular product or technology on human health and the environment, as well as those actions and principles necessary to protect the integrity and viability of a particular product or technology.

3. Not all stewardship efforts are necessarily confined to individual companies, nor should they be. Many activities are more appropriately industry-wide responsibilities, which are necessary or appropriate for the protection of products or technologies as a class. Such efforts have recently been successfully applied with regard to addressing insect resistance management and the assessment of potential non-target impacts for Bt corn products.

4. From a legal perspective, the organizational unit responsible for oversight of product stewardship must be empowered to ensure compliance with the letter and spirit of applicable regulatory requirements and to prevent potential product-related liabilities. Legal obligations in the U.S. include the submission of applications, notifications, data and information in order to obtain the appropriate approvals and clearances from USDA, FDA and EPA under the Coordinated Framework for Regulation of Biotechnology. In appropriate instances, those obligations may also extend to the post-market surveillance of agricultural biotechnology and crop derived products and to compliance with appropriate reporting requirements, such as those imposed by EPA for plant-incorporated protectants.

5. Examples of crop biotechnology stewardship issues include: risk assessment and risk management plans; seed quality and purity; protein safety, including potential for allergenicity; protein levels in food and feed; insect resistance management plans for certain plant-incorporated protectants; outcrossing and open pollination; biodiversity; identity preservation, product channeling and trade.

6. A successful risk management process should be a fundamental part of the product stewardship program, incorporated into each phase of product development and commercialization. Key elements of the risk management process include: identifying every potential source of harm (hazard); assessing the probability of occurrence of that harm (exposure); assessing the risk, if any, resulting from the potential combination of hazard and exposure; and the development of alternatives for the minimization and management of the assessed risks.

7. For products of agricultural biotechnology, the risks and risk management alternatives must be evaluated in the context of such factors as health, safety, environmental and agricultural impacts; regulatory acceptance; public acceptance; market acceptance; and civil liability. Prior to commercialization of any new plant biotechnology product, the developer would conduct a full, science-based risk assessment to identify and, to the extent possible, quantify every risk presented. Each risk would be reviewed in all relevant contexts and an appropriate management plan would be established, including an effective plan to mitigate any risk that becomes a reality.

8. Regulatory oversight and industry stewardship of crop biotechnology products, both pre-market and post-market, have occurred notwithstanding the fact that new conventionally bred varieties of food, feed and fiber crops receive virtually no governmental oversight in the United States or any other nation. Moreover, the National Academy of Sciences has repeatedly held that just because a plant is a product of biotechnology does not make it inherently hazardous.

9. It is the very nature of oversight of a rapidly developing technology that regulation and stewardship must be dynamic processes, always subject to reevaluation and modification based on new information and understanding. Our regulatory process is not perfect. The lead federal agencies have all taken or initiated actions to improve that process and should continue to be receptive to future improvement.

10. Rigorous, science-based safety assessments must be conducted for each new product or product category, first by the product developers and then by agency scientists. Conditions carefully tailored to address identified risks should be placed on approvals where warranted, and approvals should always be subject to review based on new data and information from any credible source.

11. Proactive product stewardship together with strong regulatory oversight will be critical to the minimization of regulatory and civil liability and, ultimately, to domestic and global acceptance of products of modern biotechnology.

The introduction of any new product or technology is not risk free. Exercising a cautious approach to products of biotechnology, the United States established a regulatory framework to minimize the chance that biotechnology-derived crops would ever adversely affect health, safety or the environment. The StarLink episode has already served to strengthen that framework in spite of the fact that no adverse effects have been confirmed for StarLink corn or any other biotechnology-derived crop on the market today.

Further Information

EPA Assessment of Alleged Environmental Risks of B.t. Crops:
Response to Petition for Rulemaking and Collateral Relief Concerning the Registration of Ceratin Genetically Engineered Plants Expressing Bacillus Thuringiensis Endotoxins (Apr. 19, 2000).

National Academy of Science Reports:
Genetically Modified Pest-Protected Plants: Science and Regulation (2000), citing and reconfirming Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues (1987); http://www.nap.edu.

U.S. Regulatory Framework:
http://www.aphis.usda.gov/
http://www.cfsan.fda.gov/~lrd/biotechm.html
http://www.epa.gov/oppbppd1/biopesticides/

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