Senators Angle for Monsanto-Friendly FDA Voluntary GMO Labeling ‘Guidance’

By Katherine Paul and Alexis Baden-Mayer

While consumers battle on for laws mandating the labeling of genetically modified organisms (GMOs) in food products, some lawmakers are taking the GMO labeling debate in a different direction. And it’s a direction that’s anything but consumer friendly.
Last month, Sen. Elizabeth Warren (D-Mass.) and Sen. Mark Udall (D-Colo.) asked the U.S. Food & Drug Administration to finalize its 2001 guidance on voluntary labeling of genetically modified organisms (GMOs).
The senators advertised their request as a move intended to benefit consumers. But in fact, a federal voluntary labeling plan plays right into the hands of the biotech and big food industries.
How? Worst-case scenario, once the FDA finalizes its GMO labeling guidance, industry uses the FDA guidance to preempt state laws requiring mandatory labeling of GMOs. Currently, states have the right to enact GMO labeling laws precisely because the FDA has not formally ruled on GMO labeling.
Second, the FDA’s guidance on voluntary GMO labeling could be used to put an end to existing, legitimate voluntary non-GMO labeling efforts. By allowing the FDA, which has previously (and controversially) ruled that GMO and non-GMO foods are “substantially equivalent,” the FDA could rule against non-GMO or GMO-free labels on the basis that they mislead consumers by implying that there’s a difference between GMO and non-GMO foods.
The operative word: ‘voluntary’
On August 22, Sen. Warren and Sen. Udall sent a joint letter to the U.S. Food & Drug Administration urging the agency “. . . to finalize its guidance document on labeling of genetically modified organisms (GMOs) marketed as food or food additives.”

“We encourage the FDA to implement a regulatory framework that will promote transparency for consumers while providing producers with the certainty they need to label their products appropriately.”

Coming from Sen. Warren, whose reputation as a staunch consumer advocate is near-legendary, the letter to the FDA looks like another example of the Massachusetts senator going to bat for consumers – specifically, the 93 percent of Americans who want mandatory GMO labeling laws.
Until you take a closer look.
The 2001 guidance document, Docket Number 00D-1598, that Warren and Udall reference in their letter is intended to provide guidance for voluntary labeling, not the mandatory labeling consumers are fighting for. Yet nowhere in the letter to the FDA, or in the press release issued by Warren’s office, does the word “voluntary” appear.
Oversight? Or did Senators Warren and Udall intentionally omit the word “voluntary” in the hope that consumers wouldn’t notice?
Senators Warren and Udall both refused to support federal legislation that would have required mandatory labeling of foods containing GMOs. Both also voted against an amendment to the farm bill that would have protected states’ rights to label GMOs.
Are Senators Warren and Udall simply misinformed on the merits of voluntary labeling versus mandatory labeling? Or have they joined the cast of lawmakers toiling behind the scenes on behalf of Monsanto, not consumers?
A ploy to preempt state labeling laws?
Monsanto likes to cry “unfair” when it comes to the issue of state GMO labeling laws. The biotech giant has even threatened to sue states that attempt to pass their own GMO labeling laws, on the basis that state labeling laws violate interstate commerce rules, which makes them illegal.
Despite Monsanto’s yet-untested threats, current law supports states’ rights to enact their own food labeling laws, as long as two conditions are met. First, the state must produce compelling evidence that the law is needed to protect the health or safety of citizens. And second, there must be no pre-existing FDA regulation governing the label in question.
State GMO labeling laws currently meet those conditions. But that could change if the FDA heeds Senators Warren’s and Udall’s call to finalize its 2001 guidance on voluntary GMO labeling. And industry knows it.
In 2010, a consumer sued ConAgra for claiming that its Wesson-brand oil, made from genetically engineered canola oil, was “100% natural.” The lawsuit called for the courts to require ConAgra to accurately label the product. The courts ultimately dismissed the lawsuit on procedural grounds. But not before they addressed some of ConAgra’s arguments, including the food maker’s claim that, under the law, California had no legal right to establish its own standards governing the use of “natural” on food labels.
The court disagreed, stating that because the FDA had never defined what constitutes the words “natural” or “all natural” on food products, California could in fact define those words on a statewide basis. Absent any relevant federal standard, California’s law would pose no conflict with federal laws. ConAgra also had argued that any attempt to require the company to label its products as containing GMOs would be preempted by the FDA’s 2001 draft guidance on voluntary GMO labeling. Again, the court disagreed, citing the fact that the FDA guidance had never been finalized.

“As the guidance makes clear, it is merely a non-binding draft distributed for comment purposes. The guidance was not the product of a formal administrative process suggesting fairness and deliberation by the agency; it therefore cannot be said to have the force of federal law.”

The message to ConAgra and Monsanto? Get the FDA to finalize the 2001 draft guidance, and maybe you’ll have a case.
The end of legitimate non-GMO labels?
Increasingly, retailers see the wisdom (read marketing advantage) of voluntarily labeling products that contain GMOs. Whole Foods Market announced earlier this year that its stores would label GMOs by 2018. Consumers have no problem with retailers who voluntarily label GMO products in their stores. Nor do they have a problem with manufacturers who subject their products to GMO testing and have them certified by a third party, such as the Non-GMO Project.
But a voluntary labeling scheme written by the biotech industry-friendly FDA? That’s a whole other ball of wax.
Here’s our first clue that FDA guidance on GMO labeling won’t address consumer concerns. The “solution” proposed by Senators Warren and Udall has the support of industry, including the International Dairy Foods Association, and the Grocery Manufacturers Association, a big funder of campaigns in California and Washington aimed at defeating state GMO labeling laws.
Monsanto itself has publicly endorsed the FDA’s 2001 guidance on voluntary labeling, in a statement published on the company’s website.
And no wonder. The FDA has a history of using food labeling guidance to promote industry’s interests over those of consumers.
Case in point. In 1990, the FDA declared recombinant Bovine Growth Hormone (rBGH), a genetically engineered hormone used to increase milk production in dairy cows, safe. In 1993, the FDA gave Monsanto the green light to use rBGH.
Consumers, influenced by studies citing health risks associated with rBGH, raised a stink. Some milk producers responded to consumer concerns by refusing to use the hormone. They also began marketing their products as rBGH-free.
That didn’t sit well with Monsanto, which saw consumer demand for rBGH-free milk as a threat to its bottom line. The biotech giant complained to the FDA that rBGH-free labels were misleading because, after all, the FDA had ruled that GMO and non-GMO foods were “substantially equivalent.”
The FDA compromised. Under 1994 Food Labeling Guidance, the FDA said it would allow rBGH-free labels on dairy products, but only on the condition that the label also stated that there was “no significant difference” between milk produced using rBGH and milk produced without the hormone.
Not satisfied with the FDA’s ruling, rBGH-free dairies took Monsanto and the FDA to court. They won by proving that milk produced with rBGH is compositionally different than milk produced without the hormone.   But the courts and consumers could face a much higher climb when it comes to challenging the FDA on “GMO-free” labels. If the FDA heeds the call to finalize its 2001 guidance on voluntary labeling of GMOs, it could spell the end of GMO-free labeling. And that would leave consumers with no mandatory labeling, and no reliable voluntary labeling.
Here’s why. According to the FDA’s yet-to-be finalized 2001 guidance, “genetic modification” means the alteration of the genotype of a plant through the use of any technique, new or traditional. The word ‘modification,” says the FDA, covers a broad range of activities that could result in a change in the composition of food, including adding, deleting or altering hereditary traits.
Under those guidelines, most, if not all, cultivated crops have been genetically modified – though not necessarily through bioengineering technology. So, by the FDA’s reasoning, any label that includes the word “modified” – as in “not genetically modified” or “GMO-free” – is technically inaccurate, unless used clearly in a context that refers to bioengineering technology. Moreover, the term “GMO free” may be misleading on most foods, according to the FDA, because most foods do not contain organisms (seeds and foods like yogurt that contain microorganisms are exceptions). Again, by that reasoning, it would likely be misleading to suggest that a food that ordinarily would not contain entire “organisms” is “organism-free.”
And there’s more. The FDA says that any label suggesting that a food was not bioengineered or does not contain “bioengineered ingredients” could be considered misleading if it implies that the labeled food is superior to foods that are not labeled GMO-free. Again, based on its previous ruling that there GMO and non-GMO foods are “substantially equivalent.”
Bottom line? If the FDA finalizes its guidance on voluntary GMO labeling, where does that leave consumers? Right where they are now. In the dark.


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