Tag Archives GMO

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the agency's Plant and Animal Biotechnology Innovation Action Plan. Gottlieb describes the plan as identifying priorities in three areas: (i) "advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways;" (ii) "strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology;" and (iii) "increasing engagement with domestic and international partners on biotechnology issues." The plan indicates that FDA will "adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them." The statement also announced that the agency's Center for Veterinary Medicine will host a webinar on genome editing in animals on December 3, 2018.

A California federal court has granted class certification to a group of consumers alleging that Chipotle Mexican Grill Inc. misrepresented its food as made without genetically modified organisms (GMOs). Schneider v. Chipotle Mexican Grill Inc., No. 16-2200 (N.D. Cal., entered September 29, 2018). Chipotle has faced a number of similar suits, but other iterations have been dismissed. The court found that the plaintiffs met each of the requirements for class certification, rejecting Chipotle's argument that each class member may have seen significantly different marketing messages. "Plaintiffs rely primarily on the advertisements and statements issued and installed in all of Chipotle's stores," the court found, noting that three advertisements supported the plaintiffs' claims. "Based on Plaintiffs’ theory that 'reasonable consumers understood Non-GMO to include meat and dairy ingredients that were not sourced from animals fed GM feed,' [] the Court finds that the representations made on these three in-store signs are…

The Information Technology & Innovation Foundation (ITIF) has submitted a citizen petition to the U.S. Food and Drug Administration (FDA) challenging the use of labeling that asserts that products are free of genetically modified organisms (GMOs). "[T]he 'Non-GMO' Project's butterfly logo and language on consumer foods and goods misleads and deceives consumers through false and misleading claims about foods, food ingredients and their characteristics related to health and safety," the petition argues. ITIF urges FDA "to prohibit the use of the term 'Non-GMO' on consumer foods and goods" because it allegedly constitutes "misbranding under the law." ITIF objects to the Non-GMO Project's distinction between "natural" foods and those made with GMOs. "The techniques used to bioengineer crops and livestock to produce foods were discovered as natural phenomena, and the enzymes and reagents involved are all extracted or derived from sources in nature. While in vitro bioengineering methods may produce 'combinations…

The Center for Food Safety and the Center for Environmental Health have filed a lawsuit alleging that the U.S. Department of Agriculture (USDA) failed to comply with mandatory deadlines established by the 2016 Federal Bioengineered Food Disclosure Standards Act, which would require labeling of foods that contain genetically modified organisms (GMOs). Ctr. for Food Safety v. Perdue, No. 18-4633 (N.D. Cal., filed August 1, 2018). The act's statutory deadline for the completion of final regulations implementing the statute and establishing the national disclosure standard was July 29, 2018. The complaint alleges that “[t]he statute preempted state laws requiring [genetic engineering (GE)] labeling, but until USDA issues the regulations, the statute is an empty vessel: there can be no federally required disclosures.” “Due to the lack of mandatory labeling, many American consumers are under an incorrect assumption as to whether the food they purchase is produced with GE,” the plaintiffs allege.…

The U.S. Department of the Interior has reportedly withdrawn a 2014 memorandum prohibiting the cultivation of genetically modified organisms (GMOs) in National Wildlife Refuge areas. "There may be situations [] where use of GMO crop seeds is essential to best fulfill the purposes of the refuge and the needs of birds and other wildlife as described above. A blanket denial of GMOs does not provide on-the-ground latitude for refuge managers to work adaptively and make field level decisions about the best manner to fulfill the purposes of the refuge," a memorandum from U.S. Fish & Wildlife Service Principal Deputy Director Greg Sheehan states. "Therefore, by this memorandum, I am withdrawing the July 17, 2014 memorandum in full, thereby reversing the decision to universally ban the use of genetically modified crops on refuges."

The Court of Justice for the European Union has held that techniques to edit an organism’s genes without inserting foreign DNA—such as CRISPR/Cas9—result in the creation of genetically modified organisms (GMOs) subject to the EU GMO Directive. Confédération paysanne v. Premier ministre, No. C-528/16 (CJEU, entered July 25, 2018). The plaintiff, a French agricultural union, argued that French legislation exempting organisms produced with mutagenesis techniques such as CRISPR from GMO regulation conflicts with EU legislation governing GMOs. The court found that the mutagenesis techniques “alter the genetic material of an organism in a way that does not occur naturally, within the meaning of that provision. It follows that organisms obtained by means of techniques/methods of mutagenesis must be considered to be GMOs within the meaning of [the GMO Directive].”

Researchers at the University of Vermont have published the results of a study comparing consumer attitudes towards genetically modified organisms (GMOs) before and after implementation of the state's labeling mandate. Jane Kolodinsky et al., "Mandatory labels can improve attitudes toward genetically engineered food," Science Advances, June 27, 2018. Funded in part by the U.S. Department of Agriculture, the study reported that opposition to GMO food in Vermont dropped by 19 percent after the label law took effect. "Our findings put to bed the idea that GMO labels will be seen as a warning label,” one researcher was quoted as saying in a press release. “What we’re seeing is that simple disclosures, like the ones implemented in Vermont, are not going to scare people away from these products.”

The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) has released the proposed National Bioengineered Food Disclosure Standard, which would establish "a mandatory uniform national standard for disclosure of information to consumers." The proposal defines “bioengineered food” as food “that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques" "for which the modification could not otherwise be obtained through conventional breeding or found in nature.” AMS seeks comments on "how to interpret the statutory definition of 'bioengineering,' and thus the scope of the regulatory definition of 'bioengineered food,'" according to the announcement. "In particular, AMS is interested in any additional studies conducted on this issue, the cost of implementation under each policy, and whether certain policies describing the scope of foods subject to the disclosure standard would lower costs to affected entities." Comments on the proposed rule must be received by July…

As gene-edited foods advance and move “closer to supermarket shelves,” agricultural and biotechnology groups are looking to avoid a dispute over public perception of the technology, according to the Wall Street Journal. Gene-editing technologies such as CRISPR/Cas9, TALEN and zinc-finger nucleases are different from techniques that create genetically modified organisms (GMOs), which involve the insertion of genes from external species to create plants with new characteristics. In contrast, gene-editing technology allows researchers to alter the plant’s DNA; the industry reportedly describes the process as “an extension of plant breeding, the centuries-old practice of crossing plant strains to create improved offspring." Industry regulators, including the U.S. Department of Agriculture, have indicated that they will not regulate gene-edited plants as strictly as those engineered with external DNA. However, the Non-GMO Project has barred gene-edited plants and animals from bearing its verification label, and opponents reportedly refer to the new technique as “GMO 2.0.”…

A New York federal court has issued a decision seemingly aiming to spur action from the U.S. Food and Drug Administration (FDA), which has purportedly exhibited “no discernible activity” to establish a definition of “natural.” In re Kind LLC “Healthy and All Natural" Litig., No. 15-2645 (S.D.N.Y., entered March 2, 2018). Kind LLC previously filed motions to dismiss or stay claims in multidistrict litigation alleging that its labeling was false and misleading. After allowing stays, the court has indicated that it might proceed with the case without waiting for input from FDA or the U.S. Department of Agriculture (USDA) on the definitions of "healthy" and "natural." The court first found that the consumers' challenge to Kind's claim that its products are made without genetically modified organisms (GMOs) was not preempted by the National Bioengineered Food Disclosure Standard, holding that the relevant state consumer-protection statutes “do not impose a GMO standard or requirement.…

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