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GE Industry Propaganda on Labelling




The Latest GE Industry Propaganda on Labelling

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

GENETIC ENGINEERING:

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,
disease,
drought, salinity, frost, and herbicides, as well as enhanced nutritional
value,
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
for
ensuring the safety and wholesomeness of the nation's food supply (except
poultry and most meats). Most biotechnology-derived products are regulated
under
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
+ACI-transparent+ACI-
(that
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
review
the rationale behind the FDA approach.

+AFs-GRAPHIC+AF0-

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

Risk-Based Policy

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

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

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
Council,
+ACI-the same physical and biological laws govern the response of organisms
modified
by modern molecular and cellular methods and those produced by classical
methods,+ACI- and therefore, +ACI-no conceptual distinction exists+ACI-
(4). Following
this
logic, the use of any particular genetic manipulation should not in itself
determine the need for or the degree of governmental review. However, this
is
not universally followed by other U.S. and foreign regulatory agencies. The
U.S.
Department of Agriculture and Environmental Protection Agency oversee the
field
testing and use of biotechnology under regulations that are triggered by the
use
of recombinant DNA techniques+ADs- in other words, regulation is focused on
process
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
instructs
food producers who use novel plants to consider the characteristics of the
host
plant that is modified, the donor organism that contributes genetic
information,
and the genetic material and other substances introduced or modified. It
also
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
required
for introduced or modified proteins of known function if they are derived
from
food sources or are substantially the same as existing food substances, if
they
are not known to be toxic or to raise food safety concerns, and if they will
not
be a major constituent of the diet. Nevertheless, the FDA intends to follow
the
development of foods made with new biotechnology (7) via noncompulsory
+ACI-informal
consultation procedures.+ACI-

To Label or Not to Label

The question of whether foods derived from organisms containing recombinant
DNA
(+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
accurate
and +ACI-material.+ACI- There are only two situations in which the FDA can
require
that
a transgenic origin or ingredient be disclosed on the food label: (i) The
FDA
may mandate the disclosure of facts on a product label that relate to
material
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
require
that a label reveal facts necessary to correct or balance other
representations
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
counterpart
such that the common or usual name no longer applies, or if a safety or
usage
issue exists to which consumers must be alerted+ACI- (2). The policy statement
also
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
positive
control. Pioneer Hi-Bred International produced a recombinant soybean for
animal
feed that contained an allergenic protein transferred from Brazil nuts (10).
Before release of the product, during consultation with the FDA, Pioneer
Hi-Bred
identified the allergen. Confronted with potential product liability and the
costs of labeling all products derived from the new plant variety, the
company
abandoned plans to use the new soybeans in consumer products. No consumers
were
exposed to injury.

The FDA's approach is consistent with the scientific consensus that the
risks
associated with recombinant organisms, and with products derived from them,
are
fundamentally the same as for nonrecombinant products. Dozens of new plant
varieties modified with traditional genetic techniques (such as
hybridization
and mutagenesis) enter the marketplace every year without premarket
regulatory
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
or
genus to another. None of these plants exist in nature. Nonetheless, they
have
become an integral, familiar, and safe part of our diet+ADs- they include
bread
and
durum wheat, corn, rice, oats, black currants, pumpkins, tomatoes, and
potatoes
(12).

The massive accumulation of sequencing data shows extensive genetic
similarity
between genomes of organisms that are only remotely related. For example,
parts
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
produced
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,
processing,
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,
while
also decreasing competition and increasing prices.

Furthermore, overregulation in the form of compulsory labeling could change
the
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
has
become limited primarily to a small number of commodity crops that are grown
on
a vast scale, at the expense of opportunities to improve important
small-acreage
crops (5). In 1998, the top four recombinant crops (soybean, corn, cotton,
and
oilseed rape) accounted for more than 99+ACU- of the global acreage (1)+ADs-
innovation
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,
Drug,
and Cosmetic Act--firmly supports (indeed, to a large extent, dictates) the
FDA's policies toward biotech foods. These policies were upheld indirectly
by
the U.S. Court of Appeals for the Second Circuit, which found in a pivotal
1996
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
constitutional
violation of commercial free speech. +ACI-Were consumer interest alone
sufficient,
there is no end to the information that states could require manufacturers
to
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
the
intentions and actions of ideological opponents of the new biotechnology.
Labeling raises costs, which discourages producers and consumers and
destroys
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
are
apprehensive, and then, when consumers become apprehensive because the
products
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
psychological
aspect of this general strategy was conveyed to the National Biotechnology
Board
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
Europe
and Asia, where regulators have permitted politics, public misapprehensions,
the
blandishments of anti-technology activists, and nescience to dictate policy.
Perhaps the scientifically defensible and risk-based approach of the FDA in
the
United States can illustrate that sound public policy can safeguard public
health and stimulate new technology.

References

    C. James, Global Review of Commercialized Transgenic Crops (ISAAA Briefs
No.
    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
for
    Food Safety and Applied Nutrition and Center for Veterinary Medicine,
FDA,
    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,
Washington,
    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
(1987).

    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.
    1996).
    Consumer Alert, before the National Biotechnology Policy Board, 20
September
    1991, as quoted in National Biotechnology Policy Board Report (Office of
the
    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: miller+AEA-hoover.stanford.edu


__________________________________________
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
rvanstaveren@iatp.org>
http://www.iffah.org
__________________________________________
"During times of universal deceit, telling the truth becomes a
revolutionary act."  George Orwell


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