Tag: genetically engineered

Congress Passes GE Labeling Standard

GE Labeling Standard Genetically Engineered DNAOn July 14, 2016, the U.S. House of Representatives passed a genetically engineered (GE) labeling standard with bipartisan support. The bill is identical to S. 764, which passed the Senate last week, and represents a compromise brokered by Sens. Debbie Stabenow and Pat Roberts. The White House has indicated that President Obama will sign the legislation into law.

Significantly, the legislation sets a national standard that preempts current and future attempts by states to require labeling of foods containing genetically modified ingredients, including Vermont’s mandatory labeling standard that went into effect July 1.

The legislation establishes a mandatory disclosure standard that applies to all food products intended for human consumption containing bioengineered ingredients. Food companies may satisfy the disclosure requirement through text, a symbol, or by use of certain embedded electronic or digital links, such as a QR Code.

Animal-based products such as beef, pork, poultry, eggs and milk are prohibited from being considered bioengineered foods solely because the animal consumed feeds containing GE ingredients. The legislation does not require animal feed to comply with the disclosure requirement.

Under the legislation, the Secretary of Agriculture is required to promulgate rules that implement the national standard within two years. The legislation requires the Secretary to provide additional flexibility for small food manufacturers in the regulations, including additional disclosure options and more time to comply with the standard. Some very small food manufacturers will be exempt under the regulations.

White House press officials indicated that the administration was pleased with the Roberts–Stabenow compromise effort. “While there is broad consensus that foods from genetically engineered crops are safe, we appreciate the bipartisan effort to address consumers’ interest in knowing more about their food, including whether it includes ingredients from genetically engineered crops,” spokeswoman Katie Hill told reporters in an e-mail.

The federal standard comes just days after Vermont’s standard, passed in 2014, went into effect and follows failed attempts to mandate labeling in states such as Colorado, Oregon, and California. Food manufacturers expressed concern that a patchwork of state laws would make compliance difficult and potentially reduce consumer choice if manufacturers elected to pull products off store shelves rather than implement costly labeling requirements. After being signed into law, the focus will quickly turn to the U.S. Department of Agriculture’s implementation of the legislation and how the agency will define key terms that directly impact applicability (for example, the definition of “small” and “very small” food manufacturers).

ARTICLE BY Seth A. Mailhot & Leah Hurtgen Ziemba of Michael Best & Friedrich LLP

© MICHAEL BEST & FRIEDRICH LLP

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP