Several significant developments have the potential to shape the types of claims that producers make about the genetically engineered (GE) content of their foods. These developments are playing out at both the federal and state levels, with labeling programs in various stages of development and implementation. Depending on how these events unfold, we may begin to see their effects as early as next year.
Federal GE Standards
The House of Representatives passed a bill this summer that would establish a federal standard for labeling GE and non-GE foods and preempt state laws that would impose mandatory GE labeling requirements. The House approved Representative Mike Pompeo’s (R-KS) Safe and Accurate Food Labeling Act (H.R. 1599) by a vote of 275 to 150, garnering the support of 45 Democrats. Unlike last year’s version of the bill, which gave the Food and Drug Administration (FDA) jurisdiction to establish a federal GE labeling program, H.R. 1599 grants this authority solely to the U.S. Department of Agriculture (USDA).
The bill would establish a voluntary certification program that would operate similarly to USDA’s organic certification program. Under the proposed program, USDA’s Agricultural Marketing Service (AMS) would accredit certifying agents, who in turn would be responsible for certifying claims asserting whether or not a food was produced with the use of genetic engineering. Certified products would bear a USDA seal affirming that the product satisfies the USDA standard for a GE or non-GE food.
The bill also lays out what would or would not be considered a GE food. Under the bill, the program’s standard for non-GE claims would require that the product be subject to supply chain process controls to ensure a non-GE seed is planted and that the crop is kept segregated from GE crops throughout production. GE processing aids or enzymes would be allowed in non-GE products if the food contained no other GE ingredients. Products derived from livestock that consumed GE feed (e.g., milk from cows fed GE feed) would not qualify for a non-GE claim.
The bill also includes several provisions to align the new program with the National Organic Program. State officials or private parties already accredited under the National Organic Program would be deemed automatically accredited to certify GE and non-GE claims. Similarly, foods produced at certified organic farms and handling operations automatically would be deemed non-GE foods.
Like the USDA organic certification, the USDA GE and non-GE certification program would become the sole mechanisms through which food producers could include GE and non-GE claims on their products. Current private certification programs such as the Non-GMO project could continue their operations by becoming certified through the USDA-administered program. The bill would establish a civil penalty of $10,000 per violation, with each day considered a separate violation, for parties that make claims about the GE content of their foods without first receiving the necessary accreditation. The bill would allow food producers to continue making existing, voluntary claims about the GE content of their products for three years after the bill is enacted. After three years, those claims may continue to be made, provided they meet the program’s standards for GE and non-GE claims.
The bill would preempt any state law mandating labeling for GE foods immediately upon passage. But it would not preempt any voluntary state labeling standards, so long as the state program is accredited by USDA and establishes standards identical to the USDA certification program. The bill’s preemption provision would prohibit mandatory state labeling laws such as those already established in Vermont, Maine, and Connecticut. Thus, if Congress passes the bill, these state laws would be preempted immediately.
In addition to defining standards for GE and non-GE foods, the bill also directs FDA to establish a federal definition for the use of “natural” claims on food. The bill similarly would preempt any state law definitions of natural that are not identical to FDA’s federal standard.
If passed, the bill potentially could stem the tide of class action litigation addressing claims that products are natural or non-GE by requiring USDA and FDA to set uniform standards for use of the labels.
Chipotle Mexican Grill, Inc., for example, is currently facing such a lawsuit. The plaintiff in the proposed class action litigation alleges that Chipotle’s claim that it uses only “non-GMO” ingredients, meaning ingredients that do not contain genetically modified organisms (GMOs), is false and misleading because it serves meat products from animals that ate GE feed and soft drinks that contain GE ingredients.
Although Chipotle discloses this fact on its website, the plaintiff argues that Chipotle does not disclose this information in the restaurant’s advertisements that claim “all” ingredients are “non-GMO.” National standards for GE, non-GE, and natural claims could provide a defense for companies facing these types of lawsuits, provided their products satisfy the requirements for the claims.
It is unclear whether the Senate will take action on companion legislation this year or next. So far, no Senator has introduced companion legislation. Unless the Senate adopts a bill identical to that adopted by the House, any final legislation could differ from the House bill.
Vermont’s GE Labeling Rules
Whether Congress will finalize the bill before Vermont’s new GE labeling requirements take effect is also an open question. Vermont adopted Act 120 in May 2014, establishing new mandatory labeling requirements for GE foods sold in the state. Vermont finalized the regulations implementing the GE labeling law, Consumer Protection Rule 121, in April 2015.
The regulations establish distinct requirements for packaged and unpackaged foods, as well as for raw agricultural commodities or processed foods. Depending on the type of food and the processes used to make it, the regulations require that GE foods bear conspicuous labels stating “Produced with Genetic Engineering, “Partially Produced with Genetic Engineering,” or “May be Produced with Genetic Engineering.” The law also would prohibit GE foods from bearing natural claims. Once in effect, the law will become the country’s first set of state-level mandatory GE labeling requirements. (Maine and Connecticut’s requirements do not take effect until more states pass similar laws.)
Though the Vermont regulations will become effective July 1, 2016, the state will not begin enforcing the rules against packaged processed foods until January 1, 2017. The rules create a presumption that any packaged processed food subject to the rule and offered for sale before January 1, 2017, was packaged and distributed prior to July 1, 2016.
Manufacturers, however, should not view the delayed enforcement as a delayed effective date. Vermont indicates in the final regulation that it expects companies to comply with the labeling requirements for products distributed into Vermont on or after July 1, 2016. Thus, packaged processed foods on the retail shelf as of July 1, 2016, will not be required to bear GE labeling unless they were distributed on or after July 1, 2016.
In addition to Congressional action on GE labeling standards, pending litigation may also impact the implementation of Vermont’s labeling law. Shortly after Vermont passed Act 120, the Grocery Manufacturers Association (GMA) and several other trade organizations filed a lawsuit challenging the law on constitutional grounds.
The plaintiffs requested that the federal district court hearing the case grant a preliminary injunction to suspend Vermont’s implementation of the law temporarily while the litigation is pending, but the court denied the request. The plaintiffs have appealed this decision to the Second Circuit Court of Appeals. A ruling in the plaintiffs’ favor on the request for a preliminary injunction would delay implementation of the law until the court reaches a decision on the merits of the plaintiffs’ claims. Like passage of H.R. 1599, a favorable court ruling on the merits of the plaintiffs’ claims could also prevent Vermont from implementing the law entirely.
USDA Process Verified Claims
While debate continues at the federal and state levels as to the correct standard and form for GE and non-GE food labeling, one producer has potentially started a trend by voluntarily seeking federal certification that its products are not genetically engineered. Earlier this year, USDA announced that its Process Verified Program had for the first time verified a company’s non-GMO claim.
USDA’s Process Verified Program is an existing program within AMS. Through the program, participating companies establish their own standards for their marketing claims (e.g., a standard for a claim that their animals are “humanely raised”), and AMS works with the companies to develop an auditing program that allows the companies to demonstrate their claims have been verified by an independent third party.
For the first time, AMS worked with a company, SunOpta Grains and Foods, Inc., to develop testing and verification processes to verify a non-GMO claim. According to AMS, the agency verified that the products SunOpta sought to label as “Non-GMO” are: (1) made from ingredients that were not produced using genetic engineering and (2) meet SunOpta’s standard of a 99.1% Non-GMO/Non-GE minimum, or a testing specification of 0.9% GMO/GE maximum. Like other products verified through the program, the company’s products will bear the USDA Process Verified Shield.
AMS evaluated SunOpta’s products based on the company’s chosen non-GMO standard; AMS did not develop its own non-GMO standard. Moreover, SunOpta’s standard is not binding on any other companies that seek to obtain USDA verification of their non-GMO claims. Other companies seeking claim verification may develop their own non-GMO standards and enlist AMS’s assistance in verifying that they can meet the standards. Going forward, we may begin to see more companies participating in the program to certify their non-GMO claims. Indeed, USDA Secretary Tom Vilsack stated in a letter announcing the new certification that “other companies are already lining up to take advantage of this service.” Interest in the GE content of food continues to draw attention from a broad cross-section of stakeholders. Regulatory initiatives at the federal and state level create a dynamic regulatory framework. Time will tell what form of state or federal requirements will guide how food marketers communicate to consumer’s via food labels. Stay tuned. There is certainly more to come.
Steven B. Steinborn is a partner with Hogan Lovells’ Washington, DC, office. He practices food and drug law with a focus on food labeling, advertising, and food safety. He works closely with food processors, restaurants, foodservice operators, and supermarkets with respect to compliance with nutrition and related labeling regulations. Readers may contact him at email@example.com.
Leigh Barcham is an associate Hogan Lovells’ Washington, DC, office. She advises clients on food and drug law matters with a particular focus on the regulation of food, food labeling, and consumer products. Readers may contact her at firstname.lastname@example.org.
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