GENTECH archive


Re: B-GE: GE Industry Propaganda on Labelling

Thanks for the article!!! I took a deep breath and thought: AAAAAAAAAAAAAAAAAAARRRRRRRRRGGGGGGGGGGGGGGHHHHHHH!!!!!!
Looking for the meaning this came up:  ATTACK and RESIST GENETIC HELL!!!!!!

Peter M. Ligotti wrote:

> 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,
> 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.
> 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
> 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
> (+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
> 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:
> __________________________________________
> 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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