I’ve been corresponding with individual email-writers and I’ll occasionally post versions of my responses here because they tend to touch upon multiple issues related to genetically engineered (GE) crops in one piece (whereas I usually focus on fewer issues in my posts otherwise) and because I hope to open up the conversation to more participants.

Here’s my response to a reader who wants to know whether the fact that he could not “at this time find any long-term health test data, that is test results in advance of FDA approval/certification, …mean[s that] the [GE] product was perhaps released with minimal, if any long-term health testing…”:

I’m afraid that the only long-term safety information in which chronic effects of any GE food or feed product were looked for over the lifetime of the animals (that I’m aware of) are contained in the paper by Séralini et al. (“Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize” in Food and Chemical Toxicology 50:4221-4231) originally published in Sept 2012 but retracted by the journal, after a huge outcry from practitioners of crop genetic engineering, more than a year later and another by Carman et al. (“A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and  GM maize diet” in the Journal of Organic Systems 8 (1): 38-54; Open access full text: http://www.organic-systems.org/journal/81/8106.pdf) published last year.

(I am not an expert on animal feeding studies, however, and Monsanto has, for example, looked at production type variables (weight at slaughter? e.g.) in long-term studies of chickens, etc.; scientists who conduct animal-feeding studies themselves would be much better judges of the value of these chicken (etc.) studies than I would.)

There was also a paper published in The Lancet [Ewen SW, Pusztai A (October 1999) “Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine” Lancet 354 (9187): 1353–4. doi:10.1016/S0140-6736(98)05860-7. PMID 10533866] that documented effects (I’m not sure how “long-term” they were) on rats of a GE potato that had not yet been commercialized.

Unfortunately, all three of these studies that suggested there could be adverse effects associated with the GE crops under investigation were attacked by scientists utilizing genetic engineering themselves and, worse, follow-up studies have not been carried out.

As I’ve pointed out recently on my blog, the proper scientific response to these papers is follow-up science but I’ve contacted Monsanto scientists about Séralini’s data, for example, and I’ve been informed that they have no plans to carry out any long-term (chronic) studies of the GE corn, NK603, in question.

And, apparently, they don’t have to. The FDA does not officially “approve” or “certify” genetically engineered (GE) foods or feeds; in fact, interaction with that agency prior to commercialization of a new GE food or feed is on a voluntary basis (with very few exceptions such as if the foreign gene in question was isolated from an organism known to cause human allergens). Developers of these GE products are responsible for ensuring that their products are safe and wholesome, however, (or so the letter developers receive from the FDA after completion of a voluntary consultation states) so it seems to me that the FDA should now follow-up with Monsanto, for one, regarding some of these published data.

And in regard to regulation of these GE products, I don’t think you are “missing” anything. “Substantial equivalence” is not, in my opinion, a science-based concept. The FDA may think sweet corn that produces multiple insecticides in all of its cells is “substantially equivalent” to non-GE sweet corn, for example, but I do not.

Originally, the FDA did officially approve at least the foreign protein produced in the world’s first GE food, the Flavr Savr™ tomato. But in an illogical, unscientific move, the FDA found that GE tomato so safe it decided that subsequent GE foods/feeds need not go through the Food Additive Petition process like the developer of that tomato, Calgene, Inc. (subsequently purchased by Monsanto), did.

Back in the 1980’s, before GE foods were ready for the marketplace, the U.S. government decided to use the agencies already in place and the laws already on the books to deal with GE products, hence the idea to use the food additive laws to regulate foreign proteins produced in GE foods. But, as I’ve described above, use of the food additive laws on the books was discarded after the approval of the first GE protein in a GE food. And, because of loopholes in our cobbled together “coordinated framework” for regulating GE crops in the U.S., we now have a situation in which a developer of a GE product can avoid pre-market regulation completely depending on the design/composition of the foreign gene/DNA it inserts into its crop of choice.

All that said, the word on the street is that all developers of GE foods have voluntarily consulted with the FDA prior to commercializing their products in the U.S. (although this claim would be difficult to substantiate). And if the GE food produces pesticide, like all the Bt corn varieties do, then the EPA must approve it. And if the GE food was produced using a pest on the USDA’s “plant pest” list (most GE foods are produced using DNA from the cauliflower mosaic virus (CaMV) and many using an organism associated with crown gall disease), then the USDA must “deregulate” it. But, to reiterate, GE crops can be engineered without CaMV or A. tumefaciens and to produce proteins that are not pesticides; and such GE crops would not be required to undergo pre-market regulation based on the current system for “regulating” them in the U.S.

As far as I know, developers of GE crops do not have to submit risk plans with FDA but I’m not sure about requirements at USDA or EPA. “Recalls” (if that is a proper way to refer to them) of GE crops in the U.S. have occurred, however. One was over a Bt corn variety developed by Syngenta, Bt10, which was inadvertently released by that company (http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm121416.htm); Bt10 contained a gene that confers resistance to ampicillin and other related antibiotics used frequently for human therapy and FDA essentially “approved” the release of that gene’s protein product “post-commercialization”. Another was a joint effort between the EPA and FDA over StarLink™, another Bt corn variety; the Bt protein in StarLink failed tests related to human allergenicity so EPA approved it only for animal consumption; corn being wind-pollinated, StarLink inevitably contaminated the human food supply anyway and the CDC spent 7 years monitoring the U.S. corn crop before it decided the levels of StarLink Bt in it were low enough that they could stop worrying about it. (I wrote about StarLink not too long ago on my blog: https://biotechsalon.com/2013/08/14/how-slate-com-botched-a-story-about-genetically-modified-food/.)

Perhaps developers have to have risk plans in place when their GE crops produce industrial chemicals or drugs…. There have also been “issues” related to these types of GE crops in the recent past.

The bottom line for me is that 1) unintended, unexpected changes are not just theoretically possible as a result of the genetic engineering process as currently employed, GE crops with unintended, unexpected “problems” (like StarLink and Bt10 corn) have been commercialized and, therefore, 2) we need to get to the scientific bottom of any putative adverse effects that are identified in such crops, one way or the other, and 3) we certainly need to make it mandatory for every product of this agricultural biotechnology to go through a pre-market regulatory process.