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.
I heard Kathleen Merrigan speak to the issues of labelling in this podcast: http://nutrition.libsyn.com/index.php?post_id=410133&comments=on
She was quite even-handed I thought, and talked about the many issues around labelling.
I’ve seen some of those petitions and “call your congresscritter” emails. Some of them are flat-out fradulent. I’ve tried to contact the senders (with facts and data) and of course I was totally dismissed. I’m shocked at how false some of them are. Unfortunately for activists movements, too–now I’m skeptical of any action item that comes along.
Thank you for pointing out why the FDA does and does not label – it’s all about safety. The FDA doesn’t mandate many labels that some people want – such as “contains animal products”, Kosher, or rBST. Voluntary labels, as long as they are truthful, just make sense in a free market. I covered some of these ideas in What’s in a label? and Labeling GMOs.
You’re exactly right on the problems with huckster activists, MaryM. Too many groups are basically scams that just farm email addresses so they can pretend to wield more influence than they really do. Unfortunately, it makes things difficult for legitimate activist groups doing good work. I haven’t heard that Merrigan podcast; something to put on my ipod for the commute tomorrow.
Anastasia: You’re right as well, although I would add, as you did in your “Labeling GMOs” article, that even truthful labels should not be confusing. The initialisms “GMO,” “GM,” and “GE” are little more than scare terms to the average person at this point; that tells me that we should presume labels using them are misleading, IMHO. Personally, I’d like to see the FDA finalize the draft guidance (the current version) and actually enforce it. At least then, some people might have a better inkling of what they’re deciding not to buy.
It’s nice to have all of this clarified–though somewhat distressing when you consider how confusing it is otherwise. You say you’ll address changes in biotech laws in other countries, but I’m particularly curious about what cultural/social/political/corporate/agricultural factors affect different countries in distinct ways when it comes to GMO labeling. A little context would be great when you’re writing about these other countries for those of us who don’t know much about contributing factors. Thanks for all the insight!
I posted this on Tommorow’s Tabel, thought I’d put it here too:
I always wonder about this labeling thing, how would they feel about mandatory labeling of (non-)Kosher/Halal foods? “Not a Jew/Muslim? Too bad, pay for it anyway.” Can you imagine how well that one would go over? Why should the anti-GMO crowd get special treatment when my Arabic professor, who is a Muslim, has to read through the list of ingredients on a package of gummy worms to check for gelatin? If he wants certified halal, he has to pay for it himself. He’s not out there trying to force everyone else to support his beliefs. I just don’t see how mandatory GMO labeling is any different (except that they admit religious reasons; I’ve never seen a Muslim or Jew claim that haraam or non-kosher foods have mystery toxins in them).
And as for those mystery toxins, if someone pointed out a specific harmful agent present in all GMO foods that is not present in their non-GMO counterparts, and advocated that foods with that in them be labeled, then heck yeah, I’d want foods with that chemical labeled (or preferably taken off the market). But that’s not what they want. What they really have is an issue with the production, not the product (exactly like how practicing Jews/Muslims have an issue with how meat animals are to be slaughtered), because for all the hot air I’ve never seen anyone able to give a chemical/biological reason reason why all GMOs are supposedly dangerous, which makes it a belief or aesthetic ideal at best, not scientific fact. And that’s not enough for their own and their own tailor made law. Their beliefs don’t deserve a free pass.
I mean, hey, whatever the free market will bear for non-fraudulent “Contains no GMO” labeled products, their right to create a demand for them them and my right to not buy them, but some people seem to think that everyone else should subsidize their fears. You want products that you know have no GMOs? Fine by me, you pay for it.
Personally, I’d love to see “labeling”, but only if the label is actually informative. “Genetically-modified” is about as useless as “cross-bred” as a label.
A label that shows “SeedCo® SuperSoy®” or “OtherSeedCo® OrganoBananas®”, on the other hand, would at least tell me exactly what I’m getting and allow people who are willing to make the effort to actually pay attention to what they’re buying.
Of course, this would have to apply to ALL kinds of agricultural products to be really useful…
I like the idea of barcodes the best! Then the producers can put as much or as little info as they wish on a website that is pulled up by the barcode, and consumers can choose to pay for it or not.
I think the problem with just having a barcode system is that it would be equivalent to no labeling for pretty much all consumers, especially the most vulnerable among us (read: consumers that just don’t have the time, desire, drive, or education to use that program and accurately assess what “genetically modified” means or whether it should matter).
As far as just letting them put whatever they want on the label so long as it’s truthful, the FDA is pretty explicit about the fact that even technically honest labeling can be misleading. Imagine if an organic orange grower from Florida sold oranges that had a label that said: “Other orange growers cover their products with pesticides that contain cancer-causing chemicals. Florida’s Most Awesomest Oranges only uses 100% real Florida Oranges.” That could be totally true, but it’s misleading as hell. Similarly, let’s say the same orange grower had a (truthful) label that said “GE-Free!” Bet you dollars to donuts a large percentage of people (who have no idea what the label means) would pay a few extra cents to avoid the OTHER oranges that they just KNOW contain all that horrible GE. Voila, market imperfection. When thinking about what labels we would want to allow on foods, we need to remind ourselves of the general level of education, skepticism, and sophistication that the average consumer has.
Wonderful post. I really enjoyed reading it. Thanks a lot for sharing.
Another excellent article on the legal and scientific issues of GM food labeling.
“…it places no end on the information that consumers could require manufacturers to disclose.” Bingo
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