Genetic Engineering and agronomic crops: What are the issues?
Part 2 of 3 | 1 | 2 | 3

J. Lynne Brown
Department of Food Science

When the genetically engineered Flavr Savr tomato appeared in the marketplace in 1994, great fanfare in the media produced little public reaction. Now many different genetically engineered varieties of plants, mainly different types of soybeans, corn, squash, tomatoes, potatoes, radicchio and fruits, are in the food system and public reaction is no longer muted. A recent survey sponsored by the Pew Initiative on Food and Biotechnology reported that 46% of the public are undecided about the safety of GE foods while 25% believe they are unsafe and 29% believe they are safe. Other surveys, focus groups conducted with the public by FDA and FAO internet discussion groups among scientists all reveal some underlying concerns about the use of this technology in agronomic crops. What are some of the issues that are reflected in this ground swell of concern? I would propose three for the reader's consideration.

How should the government regulate genetically engineered plants and ingredients?

Three federal agencies, FDA, EPA and USDA, share the responsibility of evaluating the safety of GE crops and food ingredients and operate under a web of regulations largely based on monitoring chemical pesticides or residues (EPA), or adulterants or food additives (FDA). USDA monitors field-testing of GE crops and their interstate transport. In the case of Bt corn, EPA was responsible for assessing the safety of the protein product of the inserted gene for humans, animals and non-target insect populations. FDA was responsible for evaluating the rest of the Bt corn kernel's impact on humans and animals and determining if the remainder was generally recognized as safe (GRAS) based on information submitted by the developer. Both EPA and FDA regulations have come under criticism. Critics of EPA feel its scientific framework and regulations are inadequate to assess the safety of gene transfer and its possible multiple effects on both the host plant and the environment. The Monarch butterfly story highlighted the need for more in-depth analysis of the effects of GE crops on non-target organisms than initially provided by EPA. Development of pest resistance and pollen drift that contaminates non-GE crops represent some of the tough environmental problems EPA faces.

FDA is criticized for using a voluntary review system and for allowing GE ingredients to enter the food system as GRAS as well as after food additive review. Companies introducing GE foods or food ingredients are anticipated to consult with FDA since it is in their best interest to do so, especially if their new product falls into one of the eight scenarios outlined by FDA to represent situations in which consultation should be done. Although both FDA and the biotechnology industry claim all products on the market have been examined to date, critics feel this voluntary system is open to abuses when companies need market advantage and because the principle of 'substantial equivalence' that often leads to GRAS status is ill-defined. FDA recently proposed to move to a mandatory pre-market notification policy in which companies must let FDA know 120 or more days ahead that a new GE food is being introduced into the food supply and provide safety data that can be posted on a federal website. However this has yet to be enacted. This proposal was based partly on public reactions to current regulations recorded in focus groups and public hearings conducted by FDA. FDA was also likely influenced by legislation introduced in Congress last year to alter the regulations under which it evaluates these foods. Critics feel this proposed policy is still not sufficient as it still relies on data provided by industry and does not require independent verification of safety data.

Supporters of the current regulatory framework feel the regulatory system is working because nothing adverse has so far occurred. However, in science, the absence of negative evidence does not prove safety. The Consumer Federation of America recently published an assessment of the current regulatory process in the US comparing it to systems evolving in the European Union and Brazil. The authors, from the University of Texas School of Law, found the current patchwork quilt of US regulations leaves regulatory gaps, prevents comprehensive environmental assessment of the impact of GE plants and fails to adequately protect human health in its human health assessment. This report provides important food for thought.

The sufficiency of this regulatory system is of great consequence for land grant institutions. The assurances we provide to the public about the safety of GE foods are based on our belief in the current regulatory system's adequacy. Its adequacy is crucial to resolving many concerns about GE crops and retaining public trust. Lack of public trust in this system produces a cascade of reactions throughout the food system from consumer demand for labeling, farmers' indecision about planting GE crops, food processors rejecting GE crops and ingredients and friction between conventional and GE growers. Strengthening the regulatory system is one way to resolve this issue.

Who should control GE plants and germ plasm?

Since the 1980s, private companies have been spending more on agricultural research in GE and plant breeding than the land-grant institutions, partly because USDA funding for research has remained constant for a number of years. As a result many of the tools and outcomes of plant breeding research are now controlled by the private sector. Scientists who want to do research using new techniques often must reach agreements with biotechnology companies for access to these patented techniques in exchange for rights to commercial development. Now a small group of companies dominates the seed business and also hold the most agricultural biotechnology patents. These are Pharmacia (by acquisition of Monsanto, Asgrow, Calgene, DeKalb), Dupont, Syngenta, Dow Chemical and Aventis which together hold over a thousand patents. Of course, patents and grower agreements insure a viable market for these companies. But this raises questions of control of the food system and the ability of new enterprise in seeds and plant breeding to emerge. The land grant system used to be an incubator of such enterprise by providing free distribution of its research discoveries. In fact this is what spurred the Green Revolution in the late 1960s. Now universities also own patents in agricultural biotechnology with the University of California holding the most (48). The vertical integration seen in animal production is occurring in plant production as these five large corporations contract with farmers to produce their patented seeds which are processed in corporation owned mills. Such concentration of ownership has implications for consumers (what does this mean for availability, selection and price?), for farmers, food processors (whose choices and ability to control costs may be compromised), for retailers who work with slim profit margins and for local economic development.

How should the US agricultural system respond to global perceptions of the safety of GE crops?

The European Union, Australia, New Zealand, Japan and South Korea have instituted regulations that require the labeling of foods with GE ingredients. Other countries like China, Brazil, the Philippines and Thailand are considering labeling regulations or bans on GE crops. Even Canada has been debating mandatory labeling. These decisions outside the United States are fueling a great debate among US agribusiness groups and government officials about the need to segregate GE from non-GE crops. The StarLink experience has demonstrated that the current US system of growing, shipping and milling crops cannot easily segregate GE from non-GE material. Pollen drift from GE to non-GE crops contributes uncertainty about our ability to do this even with new regulations. In April 2001, USDA reported on a survey of seed companies to determine the degree of StarLink contamination of their seed. That survey of 282 companies revealed that 78 seed companies have found some degree of contamination of their seed corn with the Cry9C protein derived from the StarLink gene while 143 companies have indicated they have no StarLink contamination. The other 61companies were still testing. In response to what some view as wide spread, low level contamination of conventional corn and soybeans by GE varieties, an USDA advisory board has urged to development of 'de minimis' or threshold levels of allowable amounts of GE protein in conventional crops. At the same time, US food trade associations are currently reviewing draft traceability regulations from the European Commission that apply to all levels of marketing and are designed to provide a safety net in case adverse effects occur. The US faces developing a grain handling system that includes testing at every point where commingling could occur with appropriate record keeping. On the positive side, some have confidently predicted the rapid growth of companies perfecting methods of detecting proteins derived from genetic engineering in foods. Congressional leaders, business and producer interest groups will be struggling with the issue in the immediate future. Its solution may require resolving the larger issue listed first in this article.

References:

Institute of Food Technologists expert panel. 2000. IFT expert report on biotechnology and foods. Food Technology 54 (8), 124-136.

J. W. Looney, P.G. Crandall and A. K. Poole. 2001. The matrix of food safety regulations. Food Technology 55 (4), 60-76.

T. O. McGarity and P. I. Hansen. 2001. Breeding Distrust: An assessment and recommendations for improving the regulation of plant derived genetically modified foods. A report prepared for the Food Policy Institute of the Consumer Federation of America. January.

A. Pollack. 2001.The green revolution yields to the bottom line. The New York Times, Tuesday May 15, D1.

D. Barboza. Gene-altered corn changes dynamics of grain industry. The New York Times. December 11, A1, 20.

Numerous reports in Food Chemical News of April and May 2001.