送交者: Latino2 于 December 13, 2004 16:27:25:
回答: 关于转基因的小问题，有谁能给科普一下 由 IhopeIamwrong 于 December 13, 2004 13:58:35:
有详细实验数据 (Sci publications)，FDA又能批准的，说明是“组织上信得过”产品。
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U. S. Food and Drug Administration (FDA)
CFSAN/Office of Premarket Approval
CVM/Office of Surveillance and Compliance
March 24, 1998
(Effective June 18, 2001, Office of Premarket Approval is now Office of
Food Additive Safety
“Neomycin phosphotransferase II, also known as aminoglycoside 3'-phospho-transferase
II, is regulated as a food additive under 21 CFR 173.150 and 573.130 for
use as a processing aid in the development of new varieties of tomato, oilseed
rape and cotton. FDA evaluated NPTII as a food additive in response to a
petition filed by Calgene, Inc. At the time the petition was filed, the
use of NPTII as a processing aid in the development of new plant varieties
was new and a record of safe use in food for human and animal consumption
had not yet been established, nor had its use in food or feed been evaluated.
Since then, scientific studies and evaluations regarding the use of NPTII
in new plant development have been conducted. In FDA's review of NPTII, FDA
concluded that NPTII will not compromise the efficacy of antibiotic treatment,
the probability of transfer of the nptII (kanr) gene consumed as a component
of crops to microorganisms in the gastrointestinal tract is remote, and NPTII
does not have any properties that would distinguish it toxicologically from
any other phosphorylating enzyme in the food supply.
The nptII gene is expressed in the flax and levels of NPTII protein in Triffid
seed, as determined using an ELISA assay, are 432 picograms (pg)/mg total
protein or 0.000043% of the total protein. The submission states that no
active NPTII is expected to be present in flaxseed meal fed to animals due
to the nature of the processing that the seed undergoes.
The developer previously
indicated that human consumption of flaxseed is extremely minor, and thus,
the estimated dietary exposure to NPTII will not be substantially increased
over the current levels of consumption. The developer states that "There
is no indication that the gene or its product in Triffid poses any greater
risk to human or animals health than it does in tomato, potato, cotton or
canola."
It is FDA's understanding that, in essence, the developer has concluded
that the use of NPTII as a processing aid in the development of Triffid
transgenic flax is safe and has provided information regarding the safety
of NPTII with its safety assessment.”