Does Labeling Satisfy the Ethical Concerns Over Genetically Engineered Food?

By Britt Bailey

Abstract
The principle of consumer autonomy dictates labeling and disclosure of any salient nutritional differences or new production methods in foods. In the case of patented genetically engineered foods, industry opposes disclosure because it flags genetically engineered products, permitting "discrimination" against such products and potentially fueling "irrational" fears of health risks. Biotechnology proponents assert transgenic food crops are completely equivalent to traditional crops, and hence require no special labeling. Our own research challenges this view because of findings of differences in the composition of transgenic and conventional soybeans. The necessity for labeling and disclosure is further reinforced by industry's greatly accelerated production of transgenic varieties and the absence of sufficient pre-testing or monitoring to determine where and when true differences exist between bioengineered and conventional varieties.

The ethic of informed consent and transparency in corporate operations which affect public welfare support the legitimacy of enforcing a "risk status unknown" disclosure on all current transgenic crops as a minimum requirement. However, simply labeling genetically engineered crops provides an inadequate remedy for disclosing genuine risks known or unknown posed by genetically engineered foods. Such risks however small, would affect a considerable number of consumers.

Food and Drug Administration Claims rDNA Foods Do Not Warrant Labeling
In the 1990's, the commercialization of transgenic crops expanded rapidly from barely 100,000 acres at the beginning of the decade to over 65 million worldwide acres at its end (Robinson, 1998). Public acceptance of the resulting genetically modified foods has varied widely. In one survey, 85% of those polled throughout the world thought labeling genetically engineered products was "very important" (Hoban and Kendall, 1991). In a later survey conducted by Novartis agribusiness company, 93% of Americans agreed bio-engineered food should be labeled (Feder, 1997). However, since 1992, the U.S. Food and Drug Administration's Center for Food Safety and Nutrition (hereinafter referred to as FDA) asserts recombinant DNA techniques and cell fusion techniques are an extension of traditional genetic modification and hence has obviated a duty to label or disclose the transgenic status of food (Federal Register, 1992, 22984).

The Difference Between Labeling and Disclosure
This view is not held elsewhere. In 1997-1998, the European Union and Japan agreed to label food sources created by transgenic technologies. The public often confuses the urge for labeling with the need for disclosure. Labels serve both proprietary (i.e. advertisement value) and public needs. In the case of virtually all contemporary food products in the United States and abroad, governments require labels of some kind be conspicuously placed . Generally, such labels inform a consumer what is known about the nutritional composition of a product. But in the U.S., labels may not make any unsubstantiated medical claims. A label may also identify the production methods used to prepare the products, i.e. "grown without the use of pesticides", "packaged without preservatives", "organic", or "does not contain rBGH". Such labels do not make safety pronouncements, although they do provide consumer information.

Labeling policies, whether for food sources or pharmaceuticals, are derived from an ethic established by the principle of autonomy. In its traditional sense, autonomy refers to the freedom to make decisions affecting one's own life; to consent to anything done on or to a person; and, to maintain privacy. Ideally, autonomy and its related concept, consumer sovereignty (Thompson, 1997), support a person's desire and right to know what they are ingesting, particularly when a product poses a foreseeable or potential harm.

The disclosure of information has its origins in medical ethics, particularly as a facet of informed consent. The primary function and justification of informed consent is to enable and protect autonomous choice. A key component of informed consent is full and sufficient disclosure of risks, benefits, and alternatives.For example, in the doctor-patient relationship a complete disclosure of relevant information is deemed essential to the informed consent of the patient. Occasionally, a patient may want information the physician deems unrelated to "medically" relevant data, such as "how will the medicine affect my appetite?" By analogy, a consumer might wish to know the features of a food that are not deemed "relevant" or salient by a regulator. Under such conditions, simple prudence and respect for the diversity of choice dictate labeling. It may desirable to disclose the existence of differences deemed important to the consumer even when a product has not been judged materially different by the manufacturer, ie. the method of slaughter used for religious purposes. Establishment of the equivalence of new products compared with those commercially available is the crux of the problem.

Likeness or Dissimilarity
In the United States, foods created through the use of recombinant technologies are regulated within the existing framework of the Federal Food Drug and Cosmetic Act and, thus, utilize an approach identical "in principle" to foods developed by traditional plant breeding (Federal Register, 1992, p.22984). The FDA believes that the new techniques are extensions, at the molecular level, of traditional methods. FDA has stated that it is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern. For this reason, FDA does not believe the new method of development would require disclosure in the form of labeling (Federal Register, 1992,p. 22991).

The FDA has also stated that it will require special labeling only if the composition of a food developed through genetic engineering or any other methods differs significantly from its conventional counterpart "such that the common or usual name no longer applies to the new food, or usage issue exists to which consumers must be alarmed "(Federal Register, 1992, p.22991).

The FDA does not support labeling or disclosure because at a core philosophical level they do not believe transgenic methods of farming are different in any material way from conventional methods of farming. Such differences in nutritional quality may exist. For example, Monsanto Company, quantifying nutritional and toxicological equivalence in glyphosate-tolerant soy (enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium sp. strain CP4), had only to perform rudimentary testing. Our preliminary research has shown transgenic varieties exhibit significant decreases in one isoflavone, genistin (Lappé et al, 1999). Our research into glyphosate-tolerant soybeans supports the necessity of complete long-term testing of nutritional and toxicological equivalence prior to marketing.

Inconsistencies and Ethical Standards
While labeling genetically engineered products may satisfy the desire and need for information about the simple origins of products, it does not satisfy the need for disclosure of the status of testing prior to full marketing. Such tests should extend to human health risks as well as ecosystem risks.

Contrary to the policies by the Center for Food, Safety, and Nutrition, another arm of the FDA does require full and complete safety tests be conducted prior to marketing modified versions of conventional products. The FDA's Center for Devices and Radiological Health requires industry to prove a new device is substantially equivalent to a marketed device that was or is currently in commerce (Premarket Notification 510(K) Regulatory Requirements for Medical Devices). If a device is deemed different in any salient way a full gamut of safety testing must be completed before the product is marketed. The Center does not approve of the commercialization of products while waiting for complete safety testing. By this analogy, transgenic crops would potentially not yet be available to the consumer.

The United Nations Food and Agriculture Organization (FAO) also requires that an assessment of "substantial equivalence" be carried out at the level of any food or food component used as human food. When substantial equivalence cannot be ascertained, the product must go through a tailored testing program. Again, a genetically engineered product would not be placed on the market until safety tests were complete and the health risks known. Both examples place the demonstration of equivalence and the burden of proof of showing absence of harm on the manufacturer.

The FDA's Center for Food Safety and Nutrition has taken the opposite approach. From the outset, FDA asserted transgenic products have been assumed to be similar to conventional ones. Only if industry judges a product component to be a food additive does the product require premarket approval and testing. In essence, U.S. regulators have given industry hegemony over its transgenic products, leaving the public to prove its difference or non-difference, and to call for labeling.

FDA Fails to Test Adequately New Transgenic Products
Although the FDA has "determined" foods derived from genetic modification processes are not significantly different from foods bred and produced traditionally, its evidentiary base is extremely limited. Little if any scientifically available data support this assertion. Only a single 1996 study "established" equivalence between the composition of glyphosate-tolerant and conventional soybeans (Padgette et al, 1996). In this study, equivalence was tested by using unsprayed soybeans, not the soy actually placed on the market which typically receives two over-sprays of Roundup® per growing season.

Conclusion
Were labeling on product packages required, it would afford little or no useful data on the manner of production, or equivalence of transgenic foods. Labeling methods of production may actually serve to dilute the value of labels which could otherwise serve to warn consumers of the existence of nutritional or other differences. Even with mode of production labeling, consumers are potentially misled into believing foods are equivalent in nutritional or toxicological content. Only a full and complete disclosure of testing status, e.g. "this product's nutritional status and safety have not been fully tested", would accurately describe most transgenic crops thereby satisfying the minimal ethical requirements of informed consent.

Acknowledgment
I am very grateful to Marc Lappé for his support in this paper.

References
Feder, B., "Biotech firm to advocate labels on genetically altered products," New York Times 24 February, 1997.

Federal Register, Volume 57, No. 104, Section I. 29 May, 1992, pp. 22984--23005.

Hoban, T.J., P.A. Kendall, "Public perception and communication of risk," Raleigh, N.C.: N.C. Cooperative Extension Service, 1991.

Lappé, M., E.B. Bailey, K. Setchell, C. Childress, "Alterations in Clinically Important Phyto-Oestrogens in Genetically Modified, Herbicide-Tolerant Soybeans," 1998, submitted for publication.

Padgette, S.R., N.B. Taylor, D.L. Nida, M.R. Bailey, J. MacDonald, L.R. Holden, R.L. Fuchs, "The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans," Journal of Nutrition,1996; 126: 702-716.

Robinson, Elton, "Many crop genetic improvements on horizon," Delta Farm Press 3 July, 1998, p.13.

Thompson, Paul B., "Food biotechnology's challenge to cultural integrity and individual consent," Hastings Center Report, July-August 1997,pp. 34--38.