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[SANET-MG] a bureaucratic ecology
February 16, 2006
Prof. Joe Cummins
Approving Genetically Modified Crops : A Bureaucratic Ecology
In the United States approval of genetically modified (GM) crops
involves interaction of several bureaucratic domains. These include
primarily the USDA Animal and Plant Health Inspection Service (APHIS)
and the Food and Drug Administration (FDA), while the Environmental
Protection Agency (EPA) has a limited role in reviewing plant
incorporated protection against pests. There seems to be rigid
bureaucratic niches that are guarded by bureaucrats who seem willing to
sacrifice the public and the environment to maintain the hegemony of
their niche. The bureaucratic environment seems to consist of weasel
holes leading to burrows or lairs providing protection from discomfort
resulting from the ire of multinational corporations. An example of what
I am trying to describer is the approval of lysine enhanced maize and
the response to public comments , a part of the approval process.
Maize is a major food and feed crop worldwide. However, existing
commercial maize lines are not a complete food or feed because they are
deficient in the essential amino acid, lysine. For many years efforts
have been made using traditional breeding to produce lysine enriched
lines and advanced opaque lines have fulfilled that need. However, the
Monsanto corporation developed a maize line using genetic engineering to
introduce a bacterial gene into the maize that lead to enhanced lysine
production in the GM maize. Maize was modified with a bacterial gene to
enhance lysine production, that construct included a promoter from
maize, an intron from rice, a chloroplast targeting sequence from maize
and a transcription terminator from maize. The original genetic
construction included adjoining lox recombination signals surrounding a
CaMV promoter driving a paromomycin antibiotic resistance selection
marker , a bleomycin antibiotic resistance marker along with a
transcription termination signal from Agrobacterium. An ampicillin
antibiotic resistance marker was present on the plasmid containing the
integration cassette but that gene was not added to the maize
chromoeomes. The original maize line included a gene for Cre recombinase
which could be triggered to cut the integration cassette at the lox
signal genes removing the antibiotic resistance amerkers from the maize.
The cre recominase gene was removed from the final commercial maize line
using crossing and selection (1,2).
FDA-APHIS approved the lysine enhanced maize for production as animal
feed and that approval was rapidly followed by FDA approval of the maize
for human consumption. Aphis undertook an environmental assessment which
led to a finding of no significant impact but limited the review to the
issue of the GM maize becoming a plant pest. FDA concluded their
consultation for approval of high lysine maize allowing use of the crop
for consumption in food and feed(4) APHIS undertook public consultation
but limited the discussion to the issue of whether or not GM high lysine
maize could be considered a plant pest. APHIS defines Pest: “Any form of
plant or animal life, or any pathogenic agent, injurious or potentially
injurious to plants or plant products. Other injurious pests are those
capable of causing damage to the agriculture, forestry, and natural
resources of a country whether or not the pest is already established in
the country”.
Replying to comments APHIS declares “The commenter suggests that APHIS
has not adequately evaluated all possible unintended effects of
integration or expression of the transgene. He further cites a specific
example of an unintended effect due to posttranslational modification of
the protein in the host organisms as compared to the native state that
affected the allergenicity of the protein.” Strangely, APHIS seems to
consider that allergenicity does not deem a plant to be a pest even
though it is certainly an injurious trait and should have been
considered. The FDA consultation (2) considered allergenicity but failed
to deal with the case in which a bean gene specifying an enzyme was
transferred to pea leading to the production of a modified enzyme that
was immunologically active producing a strong inflammatory response in
mammals fed the modified peas (6). Both APHIS (1) and FDA (2) considered
allergenicity and both noted that the transgenic protein was
immunologically active but neither agency took time to look for
inflammatory responses or other immunotoxic effects which can be toxic
to fatal in mammals. Certainly, crops that are fatal to mammals should
be considered pests, or one might think so.
APHIS further comments “A similar point was made by another commenter
regarding potential of ‘genome-wide’ damage due to the use of ‘cre’
recombinase in the development of this variety. APHIS disagrees with
these suggestions. Differences detected in such genome-wide analyses are
only relevant to APHIS’ assessment if they result in measurable
phenotypic changes that affect plant pest risk. APHIS is satisfied that
the phenotypic data submitted by the applicant is sufficient to
determine that LY038 in no more likely to be a plant pest risk than the
non-modified recipient organism.” Strangely, APHIS really made no effort
to scrutinize phenotypic data which would result from chromosome
instability. Normally, it would be common sense to examine the
chromosomes of recombinant organisms and that would be easier than
looking for phenotypic changes resulting from chromosomal instability.
In conclusion, APHIS preferred to ignore observation from public
consultation that certainly fit their own definition of the term “plant
pest”. Along with that both APHIS and FDA allowed submission of chicken
feeding studies of the GM high lysine maize that showed the maize did
not kill the birds outright and immediately but there was no necropsy
data provided in the data set used to review the GM maize. The tissues
and organs of the animals should have been examined by qualified
veterinary pathologists.Both USDA/APHIS and FDA should have reviewed
feeding studies with at least one mammal along with the chickens.
Certainly, the data from which the GM maize was approved are not
sufficient to insure that the GM maize is not a “plant pest” according
to the APHIS definition. Neither .the USDA/APHIS review nor the FDA
review seem to be realistic appraisals of the human and environmental
impacts of the modified maize and both dealt with immunological and
genetic impacts in a cavalier manner. It would be better to have a
single agency oversee the approval of GM crops and to have an
adjudication of such approvals by an independent body,
Reference
1.Luca,D. Petition for determination of non regulated status for lysine
maize LY038 2004 http://www.aphis.usda.gov/brs/not_reg.html
2. FDA CFSAN/Office of Food Additive Safety Biotechnology Consultation
Note to the File BNF No. 000087 2005
http://www.cfsan.fda.gov/~rdb/bnfm087.html
<http://www.cfsan.fda.gov/%7Erdb/bnfm087.html>
3.USDA/AP{HIS Environment Assessment and Finding of No Significant
Impact Petition for determination of non regulated status for lysine
maize LY038 2005 http://www.aphis.usda.gov/brs/not_reg.html
4. FDA CFSAN/Office of Food Additive Safety Biotechnology Consultation
Agency Response Letter BNF No. 000087 2005
http://www.cfsan.fda.gov/~rdb/bnfl087.html
<http://www.cfsan.fda.gov/%7Erdb/bnfl087.html>
5. APHIS Definitions 2006
http://www.aphis.usda.gov/ppq/pim/exports/glossary_definition.html#16
6. Prescott VE, Campbell PM, Moore A, Mattes J, Rothenberg ME, Foster
PS, Higgins TJ and Hogan SP. Transgenic expression of bean alpha-amylase
inhibitor in peas results in altered structure and immunogenicity. J
Agric Food Chem. 2005 Nov 16;53(23):9023-30
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