By Rob Hebert
Consumer advocacy groups are a strange animal. It seems that for every influential lobbying group with a senator’s ear, there are hundreds or thousands with only vague mission statements and no clear agenda for attaining their stated goals. I once spent a summer working for the latter type. A hallmark of this kind of crew is the use of the petition (bonus points if it’s online and has been circulating for more than a year). Issue-specific petitions almost never work when directed at agencies; they are often unsophisticated (in a legal sense) and rife with ambiguous language and emotional rhetoric. If I were more cynical, I might point out the possibility that many people in charge of these groups are aware of their petitions’ minuscule chances for success and instead use them to gin up controversy and interest in their cause, which is always a great way to get a few email addresses or financial contributions–some petitions even have a convenient donate button right next to where you “sign” your name!
A quick google search for “gm labeling petition” pulls up, well, more petitions than I really care to count. Most make seemingly modest demands about the “right to know,” consumer education, and truth in advertising. Is that an accurate view of the debate: Consumer education versus corporate secrecy? Truth is, the legal reality is a little more complex than these petitions would seem to indicate. Below, I’ve written a short synopsis of the government’s current stance on GMO labeling. It’s written for people without any legal training, so it’s only a sketch. I’ve also listed a few helpful resources at the bottom for anyone who wants to dig a little deeper. This is exclusively about U.S. law, but in future posts, I’ll discuss recent developments in the biotech laws of Canada, the European Union, and Japan.
Food Labeling in the U.S.
In the U.S., food labeling is overseen by the FDA according to the Food, Drug, and Cosmetic Act (FDCA). The FDA first discussed the labeling of biotechnology food products in 1992, with a policy statement titled “Foods Derived From New Plant Varieties.” In it, the FDA said it had no reason to single out bioengineered foods for special labeling, because recombinant DNA techniques were really just extensions of traditional methods for developing new plant varieties–such as hybridization–which had not received special attention in the past. Without decent evidence that bioengineered foods differed from their conventional counterparts in terms of safety, the FDA determined that they should be labeled with the same name (called the “common” or “usual” name) as the conventional crop (i.e., “corn” or “tomatoes”).
Safety is basically the main issue whenever the FDA requires new labeling for foods. For instance, if a tomato is created using a peanut protein, the FDA may require its producer to put a label saying “this tomato has been bioengineered with a peanut protein that may be allergenic to some individuals with nut allergies.” In the past, the courts have found that consumer curiosity alone is not enough to require special labeling (see International Dairy Foods Assoc. v. Amestoy, 92 F.3d 67 (2d Cir. 1996). http://openjurist.org/92/f3d/67; Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000)). The reasoning behind this is simple: First, it places an enormous financial burden on industries that would have to investigate, document, and label the “level” of bioengineering that went into their product; second, it may mislead consumers into thinking that bioengineered crops are somehow less safe than their conventional counterparts; third, it places a burden on the FDA itself which must then divert efforts from safety labeling issues to consumer curiosity labeling issues; and fourth, it places no end on the information that consumers could require manufacturers to disclose.
Some groups are now demanding that the FDA allow voluntary labeling for “No GMO” or “GMO Free” products. While the FDA does not punish producers for labeling their products as such, they do discourage that practice. In January 2001, the FDA announced a “draft guidance” (a non-binding document that informally tells people how to act in a way that won’t attract the ire of the agency) outlining the reasons against voluntary labeling of food products as “GMO Free.” The FDA had three major concerns, which I’ve taken the liberty of paraphrasing below:
1) that the terms “GMO,” “GM,” and “GE,” were not technically precise and did nothing to inform the average consumer, and that “genetic modification” was overly broad, since it would include conventional means of generating new plant varieties (the FDA prefers the terms “bioengineering” or “biotechnology”–which they use interchangeably–to distinguish newer transgenic processes from conventional practices);
2) that the term “free” implied “zero,” and that the prevalence of bioengineered products made such a claim false, misleading, or unprovable; and
3) that the label would be misleading to the extent that it implied that foods not labeled as “GMO free” were in some way unsafe or inferior (a claim that is, in the FDA’s opinion, unsubstantiated by the scientific literature).
The FDA did express support for certain types of voluntary labeling, so long as the information contained therein is not vague or inaccurate. For example, a producer may use a label that says “Our tomato growers do not plant seeds developed using biotechnology” (assuming such a label would be accurate). On the other side, another producer may use a label that says “Our tomato growers use genetically engineered tomato seeds to increase total crop yields,” adding a purposive explanation to the label for greater consumer understanding. The FDA reserves the right to ask for substantiation, through validated testing means or appropriate record keeping, for any claims a producer makes through labeling. A quick side note: this draft guidance has been neither finalized nor withdrawn since its announcement almost nine years ago, and therefore does not itself create legal duties or liabilities. In the meantime, the FDA has not chosen to actually go after anyone touting their product as “GMO Free,” despite their draft guidance. Just today I drank an overpriced (but tasty) Odwalla juice that proudly advertised itself as “No GMO.”
So, if you want to label your product “GMO Free,” knock yourself out–the FDA probably won’t do anything (except maybe send you a strongly worded letter if you’re being blatantly dishonest). As for mandatory labeling, I hate to break it to the numerous purveyors of all those internet petitions, but the FDA is unlikely–absent some very convincing evidence showing the danger of bioengineered food (and, no, eyewitness reports of chickens turning their noses up at Bt corn do not count)–to reconsider its position on the matter. This might change through two ways: Either the FDA can initiate a rule-making procedure to make consumer curiosity a material issue (highly unlikely and easily challenged in court), or Congress can amend the FDCA to make special provisions for bioengineered products (still a longshot considering it doesn’t have traction right now, but you never know). Technically, President Obama, et al. have little, if anything, to do with the decision, so petitions directed towards them will have no effect on the labeling law. But they sure are a good way to add emails to your list-serv!
Disclaimer: The information contained on this page has been compiled for educational purposes only; though it is wholly accurate to the best knowledge of me, the author, it does not constitute legal advice and should not be taken as such.
FDA policy statement for regulating biotechnology products. 43 Fed. Reg. 50878 (Dec. 31, 1984), 51 Fed. Reg. 23309 (June 26, 1986).
Food and Drug Administration, Statement of Policy: Foods Derived From New Plant Varieties. 57 Fed. Reg. 22984 (May 29, 1992).
International Dairy Foods Assoc. v. Amestoy, 92 F.3d 67 (2d Cir. 1996). http://openjurist.org/92/f3d/67
Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000).
Food and Drug Administration, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance. 66 Fed. Reg. 4839 (Jan. 18, 2001). http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059098.htm
Rob Hebert is a second-year student at Georgetown Law. Before moving to DC, he lived in Brooklyn, NY, just blocks from a bar that had over twenty-five beers on tap and thirty arcade machines that all played for a quarter. He can draw you a pretty interesting graph relating “Drinks Consumed” to “Last Score on Pac-Man.”