It is striking that nowhere in AMA document H-480.958, amended June 2012, is it mentioned that both of the major methods currently utilized to genetically engineer crop plants are highly mutagenic processes.  Foreign genes transferred from one organism to another recipient plant often, estimates can be 30-40% or higher (Walbot 1992 Annu. Rev. Plant Physiol. Plant Mol. Biol. 43:49-82; Latham et al. 2006), land within recipient genes thereby mutating them.  The two major processes, transformation utilizing Agrobacterium tumefaciens or the biolistics technique of literally shooting DNA into a recipient plant’s cells, both cause other unintended perturbations of recipient DNA at high frequencies (Latham et al. 2006).

The mutagenic nature of the current transformation technologies could lead to problems in animals that eat them like those that have been observed in rats in connection with transgenic potatoes (Ewen and Pusztai 1999), transgenic tomatoes (Martineau 2001 First Fruit McGraw-Hill, pp 149-153), and transgenic corn (Spiroux de Vendomois et al. 2009).  And because of the random nature of transgene insertion into a recipient’s genome, additional experiments in which the same transgene is inserted into additional recipients, like those cited in AMA document H-480.958 with regard to a lectin transgene inserted into rice plants (Poulsen et al. 2007 Food Chem. Toxicol. 45:350-63), are not an appropriate means of testing whether the process of genetic engineering was the cause of any observed problems related to the original GE plant; additional transgenic plants will have insertions in additional, different locations of the recipient’s genome, locations not the same as the original insertion site(s).

These mutagenic methods of producing transgenic plants pose a safety risk to human consumers of GE foods and, in conjunction with the fact that the FDA does not currently require all GE foods to systematically undergo safety assessments with the agency, I believe these safety concerns related to the mutagenic production methods utilized to produce GE crops provide the FDA with a science-based, legal basis for labeling GE foods.

I agree with the AMA that there should be mandatory pre-market systematic safety assessments of bioengineered foods but, unfortunately, that is not the current situation in the United States.  Not only is the current process for “regulating” GE foods a purely voluntary process at the U.S. FDA (with the two exceptions mentioned in the AMA document), but it is possible to design GE crops that don’t require any regulation at the USDA or the EPA as well (Waltz 2011). The current “coordinated framework” for regulating GE foods in the United States is therefore inadequate for regulating this powerful new technology of genetic engineering and protecting the public. The fact that FDA’s labeling policies require that “water” be listed as an ingredient on food labels (FDA Food Labeling Guide) but that the agency is prohibited from listing insecticides on food labels, despite the fact that insecticides are being produced in every cell of, for example, every kernel of some GE fresh corn products, is another example of the inadequacy of the current regulatory system in the United States.  I believe that, as examples, insecticides or proteins conferring resistance to antibiotics in GE crops make them “materially different” than their non-GE counterparts and these differences provide another legal basis for FDA to label GE foods.

To summarize, I agree with the AMA that “thorough pre-market evaluation is considered to be the most effective tool to protect the public.” However, GE foods can currently be marketed in the United States without thorough pre-market evaluation.  There are additional good reasons why GE foods should be labeled in a capitalist, democratic society like the United States which is home to international companies that label their GE products for sale in other countries. But, especially since GE foods are currently under-regulated in the U.S., consumers have the right to know how the foods in their grocery stores were produced. Therefore, I support California’s Proposition 37, which requires labeling of GE foods.