Friday, August 31, 2012

"How Not to Label Biotech Foods"

"In November, Californians will vote on Proposition 37, a ballot initiative to impose a mandatory labeling requirement on all foods produced with or from genetically modified organisms (GMOs). For reasons I discuss in this New Atlantis article, this requirement is unnecessary, unwise and potentially unconstitutional.

"The effort has been endorsed by numerous progressive organizations and the California Democratic Party. Of note, those who usually police the misuse or politicization of science have been strangely quiet about the misleading and inaccurate scientific claims made by Prop. 37 proponents. Although the proposition warns of “adverse health consequences” from genetic engineering of foods, there is not a single documented case of adverse health consequences due to the use of GMOs. Yet about traditional crop-breeding techniques, we can say no such thing. It’s no wonder that the National Academy of Sciences has issued numerous reports concluding that the use of modern genetic modification techniques, in themselves, have no bearing on the relative safety of a food product. What was done to a specific GMO matters more than whether specific modification techniques were used...."
As I posted in the comments at that page:
"Although the proposition warns of “adverse health consequences” from genetic engineering of foods, there is not a single documented case of adverse health consequences due to the use of GMOs."

There's no requirement that these foods be tested for safety for human consumption in the long or the short term. And absence of evidence that they're not safe is not evidence that they are safe.

So we'll find out that that they're not safe in the same way we are finding out that thalidomide was not safe, or that Vioxx or some of the modern, traditionally bred wheat varieties are not safe: when millions of people start getting sick from consuming them. (Here we have hard evidence, btw. Incidence of celiac disease is up 400% since the modern varieties were introduced, and the disease has been called the most common genetically-determined disease in the world. According to the Grain Foods Association, 1% of the populations has celiac, and 7% of the population of the US gets ill from eating modern wheat.)

If we're expected to be the guinea pigs for these experiments, the least we can request is that we be allowed to participate in an informed way. Tell us whether our food contains GMOs or not, or test them for safety prior to their being released.
"The Federal Food, Drug, and Cosmetic Act, which delineates FDA's regulatory authority for foods, defines food as articles used for food or drink for man and other animals. The Act, however, does not require pre-market clearance of food and thus, many genetically modified plants do not require formal pre-market review by the FDA as they are food...

"...The labeling of food derived from genetically modified plants is a matter of some controversy. FDA does not consider the method of production, including genetic modification, to be meaningful information which is required to be on product labeling unless the modification results in a significant material change in the food product....

However, the majority of the plants which have completed the [voluntary] consultation process have not triggered any labeling requirement."
So Prof. Adler, your position must be that all laws requiring informed consent in human experiments are unconstitutional?
Those lasts quotes are from this post.

Here's a page at the National Institutes of Health detailing the laws related to the protection of human subjects:
"In the past, the role of human research subject has been fraught with danger and suffering. The ancient Hippocratic Oath specified a duty from a physician to avoid harming the patient, but that oath, highly honored today, was not even subscribed to by a majority of doctors at the time. Advances in protection for human subjects have often come in response to particular abuses or scandals. The German atrocities of World War II, some of which were committed in the name of science, led to the Nuremberg Code of international ethics, which in part spelled out the requirement that any human subject must give informed consent to the research undertaken. The disaster of thalidomide in Europe and Canada was largely averted in the United States, but thousands of patients had taken doses without being informed of the drug's experimental nature. The brush with thalidomide helped the U.S. pass the 1962 Kefauver-Harris amendments, which strengthened federal oversight of drug testing and included a requirement for informed consent. A 1966 study of abuses, written by Dr. Henry K. Beecher, helped inform government policies adopted in that year. Likewise, the discovery in the 1970s that unwitting subjects had been allowed to suffer syphilis in the 1930s Tuskegee Experiment preceded a call for tighter regulation of federally-funded human research."
The notion that a labeling requirement that would lead to informed consent of the participants in a human experiment is unconstitutional is a big stretch. I'm surprised a law professor would make it.

P.S. Some further stuff I put in the comments over there:
"Although the proposition warns of “adverse health consequences” from genetic engineering of foods, there is not a single documented case of adverse health consequences due to the use of GMOs."
Turns out this is not true.

Starlink corn was a corn that was not approved for feeding to humans. It was nevertheless found in food supply and some people seem to have had a reaction to it. There was no test to see whether or not it had an effect in humans, the test they derived after the fact may or may not have been accurate. Again, a lack of testing is not evidence of safety.

27 Wm. & Mary Envtl. L. & Pol'y Rev. 593 (2002-2003) Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco; Bratspies, Rebecca M.
"CDC developed a case definition that included a) a suspected anaphylactic reaction (e.g., dizziness, weakness, or loss of consciousness) that occurred within 1 hr of product consumption; or b) any of the following dermatological or oropharyngeal symptoms (hives, rash, pruritus, oropharyngeal tingling or swelling) that occurred within 12 hr of product consumption; or c) any of the following gastrointestinal symptoms (vomiting, diarrhea, abdominal cramping) that occurred within 12 hr of product consumption and that involved only one individual among meal companions. It was also necessary that these symptoms were not explained by a preexisting medical condition....

"Twenty-eight of the 51 reports were consistent with the case definition....

"...The StarLink experience demonstrates many of the limitations in using postmarket surveillance for adverse reactions to food as a method for assessing allergenicity to a protein that has been newly introduced into the food supply. Intensive epidemiologic investigation and laboratory test development by federal investigators was not sufficient to determine whether individual allergic reactions were associated with the inadvertent release of a geneticallymodified protein into the human food supply. It is also unlikely that postmarketing physicians or hospital-based surveillance would have been able to detect any increase in allergic reactions during the time that StarLink corn was available to consumers. The symptoms described in the case definition used inthis investigation are generic and could have been attributed to a variety of etiologies. The StarLink example demonstrates many of theproblems with any surveillance system that tries to capture rare and somewhat generic health events such as food allergy."
Clinical and laboratory investigation of allergy to genetically modified foods.

Development and Use of an ELISA Test to Detect IgE Antibody to Cry9c following Possible Exposure to Bioengineered Corn
And just one more observation: Prof. Adler makes the case, incorrectly, that there's no evidence of tainted GMO foods. What he doesn't seem to be aware of is that the issue of tainted foods allowed to be sold under current law may well be the biggest health issue we have today, and a major cause of our health-care crisis.

For instance, the trans fats that Mayor Bloomberg banned in NYC are a major problem, despite this being pooh-poohed by conservatives ignorant of the science. (I am a conservative, and I was ignorant of the science.)

In the scientific literature, they're widely regarded as toxic in any amount, and have been reliably demonstrated to cause severe health effects. 30% of the US population is currently sufferingfrom Non-Alchoholic Fatty Liver Disease. If you want to induce NAFLD in animals, you feed them trans-fats and sugar. Junk food, in other words.

Novel foods are being put into the food supply without any testing, and are making millions of people sick. This is not hypothetical. People who are aware of this fact are trying to avoid being the next victim of the next novel food introduced into the food supply without any safety testing whatsoever.

By law, no scientific experiment in the US can be performed without the informed consent of the participants in the experiment. Unless you're a food company introducing a novel food the safety of which is unknown. In that case, Prof. Adler argues, no information needs be provided to the participants of the experiment, the public buying the food. This is completely contrary to all the rest of the law in the country.

This is the language used to exempt food consumed:
" (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture." But the FDA does no testing to determine what the safe amounts [of GMOs] are.

It just assumes that they're safe.

What could possibly go wrong with that?