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GE Industry Propaganda on Labelling

The Latest GE Industry Propaganda on Labelling


SCIENCE, Volume 284, Number 5419 Issue of 28 May 1999, pp. 1471 - 1472


A Rational Approach to Labeling Biotech-Derived Foods

Henry I. Miller

Scientists around the world are using recombinant DNA techniques to improve
plants. These transgenic plants can have enhanced resistance to pests,
drought, salinity, frost, and herbicides, as well as enhanced nutritional
improved processing characteristics, and better taste. In 1998, they were
cultivated on about 69.5 million acres (1).

In the United States, the Food and Drug Administration (FDA) is responsible
ensuring the safety and wholesomeness of the nation's food supply (except
poultry and most meats). Most biotechnology-derived products are regulated
the agency's official policy on foods derived from new plant varieties (2),
which applies irrespective of whether the plant arose by molecular or
conventional methods. The policy elaborates a scientific and
is, clear and predictable) regulatory approach, mandating when consultations
with the FDA are necessary, when labeling is required, and what information
should be conveyed in labels. At a time when there are international debates
regarding food labeling (see also related News story), it is useful to
the rationale behind the FDA approach.


Counterproductive labeling? The labeling on consumer products may actually
increase public anxiety.

Risk-Based Policy

The FDA does not routinely subject foods from new plant varieties to
review or to extensive scientific safety tests, although there are
The agency has judged that the usual safety and quality control practices
by plant breeders, such as chemical and visual analyses and taste testing,
generally adequate for ensuring food safety.

Additional tests are performed, however, when suggested by the product's
of use, composition, or characteristics. If present, certain safety-related
characteristics of new foods require greater scrutiny by the agency. These
include the presence of a substance that is completely new to the food
(and that therefore lacks a history of safe use) or of an allergen presented
an unusual or unexpected way (for example, a peanut protein transferred to a
potato). New carbohydrates with unusual structural or functional groups, or
that contain new or unusual fatty acids, may require premarket approval as
additives (2). Other characteristics of potential concern are changes in
of major dietary nutrients or increased concentrations of toxins normally
in foods. For example, potatoes are generally tested for the glycoalkaloid
solanine--which has been linked to the birth defect spina bifida
toxic amounts of this natural toxicant have been detected in some new potato

This focus by the FDA on safety-related characteristics, rather than on the
method by which the plant was genetically modified, reflects the scientific
consensus that, as expressed in an analysis by the National Research
+ACI-the same physical and biological laws govern the response of organisms
by modern molecular and cellular methods and those produced by classical
methods,+ACI- and therefore, +ACI-no conceptual distinction exists+ACI-
(4). Following
logic, the use of any particular genetic manipulation should not in itself
determine the need for or the degree of governmental review. However, this
not universally followed by other U.S. and foreign regulatory agencies. The
Department of Agriculture and Environmental Protection Agency oversee the
testing and use of biotechnology under regulations that are triggered by the
of recombinant DNA techniques+ADs- in other words, regulation is focused on
rather than risk (5). This unscientific approach has elicited widespread
condemnation from the scientific community (6).

The +ACI-Guidance to Industry+ACI- section in the FDA's 1992 policy statement
food producers who use novel plants to consider the characteristics of the
plant that is modified, the donor organism that contributes genetic
and the genetic material and other substances introduced or modified. It
enumerates the safety-related characteristics for determining whether a
substance intentionally introduced or altered by genetic modification will
require premarket review and approval. The lengthy premarket review process
requires submission of data to demonstrate safety.

In general, neither premarket review nor consultation with the FDA is
for introduced or modified proteins of known function if they are derived
food sources or are substantially the same as existing food substances, if
are not known to be toxic or to raise food safety concerns, and if they will
be a major constituent of the diet. Nevertheless, the FDA intends to follow
development of foods made with new biotechnology (7) via noncompulsory
consultation procedures.+ACI-

To Label or Not to Label

The question of whether foods derived from organisms containing recombinant
(+ACI-biotech foods+ACI-) should be specially labeled has received a great
deal of
attention (8). The FDA's approach to the labeling of foods, including those
genetically engineered or otherwise novel, is that the label must be
and +ACI-material.+ACI- There are only two situations in which the FDA can
a transgenic origin or ingredient be disclosed on the food label: (i) The
may mandate the disclosure of facts on a product label that relate to
consequences that can follow the consumption of a food (for example, certain
beans that must be soaked and cooked before eating). (ii) The FDA can
that a label reveal facts necessary to correct or balance other
made by the manufacturer or seller (9). Accordingly, labeling is required
+ACI-if a
food derived from a new plant variety differs from its traditional
such that the common or usual name no longer applies, or if a safety or
issue exists to which consumers must be alerted+ACI- (2). The policy statement
emphasizes that no premarket review or approval is required unless
characteristics of the biotech food explicitly raise safety issues, and
that--inasmuch as the genetic method used in the development of a new plant
variety does not meet either of the two criteria for
+ACI-materiality+ACI---the FDA
cannot require the labeling to include this information.

The policy has already been tested, in a way that constitutes a kind of
control. Pioneer Hi-Bred International produced a recombinant soybean for
feed that contained an allergenic protein transferred from Brazil nuts (10).
Before release of the product, during consultation with the FDA, Pioneer
identified the allergen. Confronted with potential product liability and the
costs of labeling all products derived from the new plant variety, the
abandoned plans to use the new soybeans in consumer products. No consumers
exposed to injury.

The FDA's approach is consistent with the scientific consensus that the
associated with recombinant organisms, and with products derived from them,
fundamentally the same as for nonrecombinant products. Dozens of new plant
varieties modified with traditional genetic techniques (such as
and mutagenesis) enter the marketplace every year without premarket
review or special labeling (11). Many are from +ACI-wide crosses+ACI- in
which genes
have been moved across natural breeding barriers, that is, from one species
genus to another. None of these plants exist in nature. Nonetheless, they
become an integral, familiar, and safe part of our diet+ADs- they include
durum wheat, corn, rice, oats, black currants, pumpkins, tomatoes, and

The massive accumulation of sequencing data shows extensive genetic
between genomes of organisms that are only remotely related. For example,
of the nucleic acid sequence of Escherichia coli are identical to that of
organisms such as oilseed rape, amphibians, birds, grasses, and
mammals--including humans (13). Such findings put in doubt the value of
assigning genes to a particular species.

Economics and Psychology of Labeling

Special-interest groups have called for stringent labeling requirements, but
these may not be in the best interest of consumers. Labeling can add
significantly to production costs of foods, particularly those that are
from pooled fresh fruits and vegetables. To maintain the accuracy of such
labels, recombinant DNA-modified fruits and vegetables would have to be
segregated through all phases of production (planting, harvesting,
and distribution), which would add costs and compromise economies of scale.
These added production costs constitute, in effect, a special tax levied on
producers who use a new technology. They reduce profits to plant breeders,
farmers, food processors, grocers, and others in the distribution pathway,
also decreasing competition and increasing prices.

Furthermore, overregulation in the form of compulsory labeling could change
course of future research and development. In the United States and other
countries, under current regulatory regimes for field testing that focus
exclusively on organisms manipulated with recombinant DNA techniques, R+ACY-D
become limited primarily to a small number of commodity crops that are grown
a vast scale, at the expense of opportunities to improve important
crops (5). In 1998, the top four recombinant crops (soybean, corn, cotton,
oilseed rape) accounted for more than 99+ACU- of the global acreage (1)+ADs-
seldom targets the genetic improvement of environmentally threatened species
such as trees, or of subsistence crops such as millet, cassava, and yams.
The language of the FDA's principal enabling statute--the federal Food,
and Cosmetic Act--firmly supports (indeed, to a large extent, dictates) the
FDA's policies toward biotech foods. These policies were upheld indirectly
the U.S. Court of Appeals for the Second Circuit, which found in a pivotal
decision regarding another product of biotechnology that food labeling
cannot be
compelled just because some consumers wish to have the information. In
overturning a Vermont law that required labeling of dairy products from cows
treated with recombinant bovine somatotropin, the court found that such
regulation merely to satisfy the public's +ACI-right to know+ACI- is a
violation of commercial free speech. +ACI-Were consumer interest alone
there is no end to the information that states could require manufacturers
disclose about their production methods,+ACI- the court wrote (14).

Why is so much attention paid to the issue of labeling? The answer lies in
intentions and actions of ideological opponents of the new biotechnology.
Labeling raises costs, which discourages producers and consumers and
markets for new products, so for those wishing to block the
commercialization of
biotech products, forcing an increase in costs is an effective strategy.
Regulatory stringency is also an unmistakable signal to the public that
there is
something fundamentally different and worrisome about biotech foods.

Anti-biotechnology activists argue that we need regulation because consumers
apprehensive, and then, when consumers become apprehensive because the
are stringently regulated, these activists say we need more regulation to
assuage consumers' concerns. A similar strategy was used by activists in the
1980s to increase consumer anxiety regarding irradiated foods. The
aspect of this general strategy was conveyed to the National Biotechnology
by the head of a national consumer advocacy group: +ACI-The consumer views the
technologies that are most regulated to be the least safe ones. Heavy
involvement by government, no matter how well intended, inevitably sends the
wrong signals+ACI- (15).

The FDA's policy toward labeling biotech food is in contrast to that in
and Asia, where regulators have permitted politics, public misapprehensions,
blandishments of anti-technology activists, and nescience to dictate policy.
Perhaps the scientifically defensible and risk-based approach of the FDA in
United States can illustrate that sound public policy can safeguard public
health and stimulate new technology.


    C. James, Global Review of Commercialized Transgenic Crops (ISAAA Briefs
    8, ISAAA, Ithaca, NY, 1998). Excludes acreage in China.
    Federal Register, +ACI-Statement of Policy: Foods Derived from New Plant
    Varieties+ACI- 57, 22984 (29 May 1992).
    M. Chrispeels and D. Sadava, Plants, Genes, and Agriculture (Jones and
    Bartlett, Boston, 1994), p. 348.
    National Research Council, Field Testing Genetically Modified Organisms:
    Framework for Decisions (National Academy Press, Washington, DC, 1989).
    H. I. Miller, Policy Controversy in Biotechnology: An Insider's View
    (Landes, Austin, TX, 1997), chapters 3 and 4.
    Appropriate Oversight for Plants with Inherited Traits for Resistance to
    Pests: A Report from 11 Professional Societies (Institute of Food
    Technologists, Chicago, 1996).
    Foods Derived from New Plant Varieties: Consultation Procedures (Center
    Food Safety and Applied Nutrition and Center for Veterinary Medicine,
    June 1996).
    T. Ayers, Science 281, 714 (1998)+ADs- N. Williams, ibid., p. 769.
    Compilation of Food and Drug Laws (Food and Drug Law Institute,
    DC, 1993), pp. 30-62.
    J. A. Nordler et al., N. Engl. J. Med. 334, 688 (1996).
    H. I. Miller, J. Am. Med. Assoc. 269, 910 (1993).
    R. M. Goodman, H. Hauptli, A. Crossway, V. C. Knauf, Science 236, 48

    K. Takemoto, M Yano, Y. Akiyama, H. Mori, GenoBase 1.1 Escherichia coli,
    March 1994.
    International Dairy Foods Association v. Amestoy, 92 F. 3rd 67 (2nd Cir.
    Consumer Alert, before the National Biotechnology Policy Board, 20
    1991, as quoted in National Biotechnology Policy Board Report (Office of
    Director, National Institutes of Health, Bethesda, MD, 1992), p. E-27.

The author is at the Hoover Institution, Stanford University, Stanford, CA
94305, USA, and is an Adjunct Scholar, Competitive Enterprise Institute,
Washington, DC 20036, USA. E-mail:

Ms. Renske van Staveren, Coordinator
International Forum on Food & Agriculture (IFA)
c/o Institute for Agriculture and Trade Policy (IATP)
2105 First Avenue South
Minneapolis, MN, USA  55404-2505
ph: 612-870-3423       fax: 612-870-4846>
"During times of universal deceit, telling the truth becomes a
revolutionary act."  George Orwell

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