Elizabeth Beisel R.D. LLC
GMO Free CT/Right to Know CT
November 24, 2013
Dear Donna, and Members of the CT Academy,
Thank you so much for your response and for your interest in learning more about genetically engineered foods.
First, I want to stress that our primary goal right now is to get a labeling law in CT, so that consumers can make informed decisions. We will be very grateful for any and all CT RDs and DTRs to support this labeling law, as The Academy did last year. Members may not consider GMOs a threat, may be ambivalent about their infiltration into our food supply, or may be outraged and frightened by their presence. But no nutrition professional should disagree that they should be labeled, so that consumers -our clients- can make their own informed choices about what they put into their bodies!
In 1996 genetically engineered foods were secretly infiltrated into our food supply, without thorough safety investigations. In fact, genetically modified foods were given GRAS status, even though they did not meet any of the criteria which are specified for products to meet GRAS status. Below is testimony from Steven M. Druker, J.D., the attorney who sued the FDA for sealed documents from internal FDA scientists who were concerned about the dangers of GMOs.
Not only does FDA policy violate sound science, it violates the U.S. Food, Drug and Cosmetic Act. In the food additive amendment to this statute, Congress instituted the precautionary principle and definitively decreed that no new substance shall be added to our food unless that substance has been demonstrated to be safe through standard scientific testing.
While the FDA agrees that the foreign genes that get inserted into a plant, along with the substances they produce, are in principle food additives, it maintains they are exempt from regulation because they fall under the exception for substances that are "generally recognized as safe" (GRAS). It argues they are sufficiently similar to substances that are GRAS to support an inference that they are likewise safe. However, as already noted, FDA records indicate that because such manipulations can induce unpredictable side effects, they are not even recognized as safe among the agency's own scientists let alone by a consensus in the scientific community.
Second, the law is explicit that any recognition of safety must be based on "scientific procedures," and both the FDA and the courts have heretofore consistently interpreted "scientific procedures" as referring to studies published in peer-reviewed literature. 21 CFR Sec. 170.3(h).
Further, the FDA's own regulations emphasize that the tests supporting a general recognition of safety "...require the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive." 21 CFR Sec. 170.30(b). This means, in the FDA's words, that the tests must demonstrate "a reasonable certainty... that the substance is not harmful under its intended conditions of use." 21 CFR Sec. 170.3(i). Yet, neither the FDA's records nor the scientific literature indicate that such a test exists for even one genetically engineered food.
In fact, the main study that attempted to demonstrate the safety of a bioengineered food through standard toxicological testing failed to do so. That food was Calgene's "Flavr Savr" tomato, the first genetically engineered organism the FDA reviewed. In his comments on the study, Dr. Robert J. Scheuplein, director of the FDA's Office of Special Research Skills, stated it raised a safety issue that was not resolved. He wrote: "... the data fall short of 'a demonstration of safety' or of a 'demonstration of reasonable certainty of no harm' which is the standard we typically apply to food additives. To do that we would need, in my opinion, a study that resolves the safety question raised by the current data." Yet, the agency approved that product anyway on the grounds it was generally recognized as safe -- even though the law requires such recognition be based on precisely the kind of test that had failed to demonstrate safety. Interestingly, FDA officials claim that the Flavr Savr passed muster so well that the rigor of its testing will not have to be repeated for other bioengineered foods.
So, although the "generally recognized as safe" exemption was intended to permit marketing of substances whose safety has already been demonstrated through sound testing, the FDA is now using it to circumvent testing and to approve substances based on inferences drawn from less rigorous forms of analysis -- inferences that are dubious in the eyes of many of its own as well as numerous other experts. … There is more than enough evidence to convince a reasonable man or woman that current FDA policy is unscientific, irresponsible, and illegal. If bioengineered foods once again kill and cripple, those in the private and public sectors who have consistently made statements calculated to cloud the facts and confuse the public will be morally and legally accountable.
To summarize this, GMOs did not meet ANY of the criteria established by our government, to be Generally Recognized As Safe – and yet, they were illegally given GRAS status anyway, despite warnings from FDA’s internal scientists and inadequate safety testing.
Since GM foods were infiltrated into our food supply, we have seen:
An 800% increase in autism (since 2000)
An 8000% increase in birth defects, (due to excessive use of Roundup)
A 40% increase in Crohn’s disease (since 1992)
A 30% DROP in fertility rates (in the last three years)
An increased incidence in inflammatory bowel disease directly correlates with the advent of GMOs and the excessive use of glyphosate (Roundup.)
(The above information was recently stated by Dr. Don Huber, Professor Emeritus of plant pathology at Purdue University. He has spent the last 55 years researching how to improve nutrition and safety of food crops.)
When I graduated from St. Joseph College in 1986, I don’t believe “Celiac Disease” had ever been mentioned! Today, there is not a dietitian among us who doesn’t know at least one person who suffers from this debilitating disease.
I commend the CT Academy for wanting more science based evidence. Unfortunately, until recently, there has been very little. Most was conducted by the very company that genetically engineers the food, and makes the Round up that the food is resistant to, (the same corporation that brought us PCBs, DDT, and Agent Orange –and told us those products were safe.)
The Union of Concerned Scientists is a leading science-based nonprofit working for a healthy environment and a safer world. UCS combines independent scientific research and citizen action to develop innovative, practical solutions and to secure responsible changes in government policy, corporate practices, and consumer choices.
What began as collaboration between students and faculty members at the Massachusetts Institute of Technology in 1969 is now an alliance of more than 400,000 citizens and scientists. UCS members are people from all walks of life: parents and business people, biologists and physicists, teachers and students. Here is a link to what UCS Scientists have to say about GMOs:
and more recently:
Additionally, I recommend that you download and review the Document GMO Myths and Truths, written by three biotech scientists with many years of experience in the field of genetic engineering. This document addresses a large number of myths about GMOs and the scientific facts to refute those myths.
And finally, I refer you to the Seralini study, which is the first long term study to ever be conducted on GM foods. Despite its controversy, many scientists contend that it must be taken seriously.
Here is a letter written by 60 scientists who speak out against the smear campaigns and even threats of violence against researchers who have found GMO risks. After all of the signatures, please read the footnotes. This is the most interesting part of this letter, since it describes the ramifications scientists face if they try to study or publish negative information on GMOs.
http://www.carighttoknow.org/seralini_and_science_an_open_letter
Like you, I wonder if there may be some future benefits of genetically engineered foods. Unfortunately, as previously stated, the current crops were pushed into the food supply before it was proven that they were safe... in the interest of corporate greed and with no regard for the safety of the human race or our environment.
Transgenically modifying something by forcing genes from an unrelated species into its DNA can cause many unpredictable and unexpected consequences and side effects, (collateral damage.) This is why we are concerned with something as “harmless as making apples that don’t turn brown.” Although that procedure is cisgenic and not transgenic, it may be equally as dangerous. IT IS THE COLLATERAL DAMAGE, (SIDE EFFECTS) THAT IS THE BIGGEST CONCERN!
Is there a safe GMO? Possibly, if it is one that has been independently tested on a long term basis and peer reviewed. Currently, nothing falls into that category.
Donna, although the tomato topic was addressed above in Steve Druker’s testimony, I have included more information below, since you asked about tomatoes in your email. I hope this is helpful.
The very first crop submitted to the FDA's voluntary consultation process, the FlavrSavr tomato, showed evidence of toxins. Out of 20 female rats fed the GM tomato, 7 developed stomach lesions.[4] The director of FDA's Office of Special Research Skills wrote that the tomatoes did not demonstrate a "reasonable certainty of no harm,"[5] which is their normal standard of safety. The Additives Evaluation Branch agreed that "unresolved questions still remain."[6] The political appointees however, did not require that the tomato be withdrawn.[*]
Calgene had submitted data on two lines of GM tomatoes, both using the same inserted gene. They voluntarily elected to market only the variety that was not associated with the lesions. This was not required by the FDA, which did not block approvals on the lesion-associated variety. The FlavrSavr tomato has since been taken off the market. After the FlavrSavr, no other biotech company has submitted such detailed data to the FDA, and the superficial summaries they do present to the agency are dismissed by critics as woefully inadequate to judge safety.
http://www.responsibletechnology.org/posts/?p=552
I hope this answers some of the questions you and The Academy have about GMOs, and provides the “science based” information they are looking for. I hope The Academy will once again support labeling. This will allow us to do our jobs more easily. This will allow the public to be informed, as they should have been from the beginning.
Once again, I thank The Academy for their support last year, and hope they will continue to support CT’s Right to Know this year.
With warm regards,
Beth Beisel, R.D. LLC
