The U.S. Food and Drug Administration has announced that it has "made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring." The agency determined that the product does not raise any safety concerns and that the product developer is not expected to pursue FDA approval before marketing the product, which is produced from cattle with an intentional genomic alteration (IGA) ensuring a short-hair coat. "To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs," the announcement notes. “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat…
Tag Archives GMO
The U.K. Department for Environment, Food & Rural Affairs (Defra) has opened a consultation on the regulation of genetic technologies in food. "It mainly focuses on the regulation of gene edited (GE) organisms possessing genetic changes which could have been introduced by traditional breeding," the consultation states. "[W]e are using this opportunity to engage separately and start gathering views on the wider regulatory framework governing genetically modified organisms (GMOs)." "EU legislation controlling the use of GMOs was retained in the UK at the end of the transition period (after 31 December 2020). This retained legislation requires that all GE organisms are classified as GMOs irrespective of whether they could be produced by traditional breeding methods[1]. Defra’s view is that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods. Leaving the EU provides an opportunity…
The U.S. Food and Drug Administration (FDA) has announced the approval of GalSafe pigs, which have a "first-of-its-kind intentional genomic alteration (IGA)," for use in food. "This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses," the announcement states. "The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb)." FDA reportedly found that "food from Galsafe pigs is safe for the general population to eat" and that the potential impact of the pigs is no greater than from conventional pigs.
A California federal court has ordered the U.S. Food and Drug Administration (FDA) to conduct an assessment on the effects that could ensue if genetically engineered (GE) salmon escaped aquaculture farms and established themselves in the wild. Inst. for Fisheries Resources v. FDA, No. 16-1574 (N.D. Cal., entered November 5, 2020). The court found that the agency did not "meaningfully analyze what might happen to normal salmon in the event the engineered salmon did survive and establish themselves in the wild," "[e]ven if this scenario was unlikely." The court noted that FDA knew that AquaBounty was likely to establish additional farms. "Obviously, as the company’s operations grow, so too does the risk of engineered salmon escaping. Thus, it was particularly important at the outset for the agency to conduct a complete assessment of the risks posed by the company’s genetic engineering project, including an assessment of the consequences for normal salmon…
The Center for Food Safety and several food retailers have filed a lawsuit against the U.S. Department of Agriculture (USDA) alleging that the agency "fell far short of fulfilling the promise of meaningful labeling" of bioengineered (BE) foods with its 2019 labeling rules. Natural Grocers v. Perdue, No. 20-5151 (N.D. Cal., filed July 27, 2020). The complaint takes issue with four aspects of USDA's BE labeling rule. First, the plaintiffs allege that allowing companies to use QR codes to disclose BE ingredients will "discriminate against major portions of the population—the poor, elderly, rural, and minorities—with lower percentages of smartphone ownership, digital expertise, or ability to afford data, or who live in areas in which grocery stores do not have internet bandwidth." The plaintiffs also object to the terminology USDA chose. The rule uses "bioengineered" rather than "genetically engineered" (GE) or "genetically modified" (GM) and prohibits the use of the latter…
The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) will accept comments on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Recommendations include the addition of sugarcane and an amendment to reflect that the only currently available trait for bioengineered summer squash is virus resistance. AMS also noted that it does not find cowpea or rice to qualify for addition to the list but is accepting comments on its assessment. Comments will be accepted until August 24, 2020.
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has released a final rule updating regulations on genetically modified organisms (GMOs). The rule adjusts the regulatory process for specific GMOs created to combat plant pests that pose no increased plant pest risk than conventionally bred plants.
Chipotle Mexican Grill Inc. has agreed to pay $6.5 million to settle allegations that it misleadingly marketed its food as free of genetically modified organisms (GMOs). Schneider v. Chipotle Mexican Grill Inc., No. 16-2200 (N.D. Cal., motion for preliminary approval filed September 11, 2019). Under the agreement, class members can receive 10 meals with proof of purchase, with a limit of 15 meals per household, or $2 per meal up to five meals without proof of purchase.
In testimony before the House Agriculture Subcommittee, Under Secretary of Agriculture Greg Ibach suggested that genetically modified organisms (GMOs) could potentially be used in the production of organic foods eventually. "As the National Organic Standards Board set the rules originally, right now GMO or transgenics are not eligible to be in the Organic Program, but we've seen new technology evolve that includes gene editing that accomplishes things in shorter periods of time that can be done through a natural breeding process," Ibach stated. "I think there is the opportunity to open the discussion to consider whether it is appropriate for some of these new technologies that include gene editing to be eligible to be used to enhance organic production and to have resistant varieties—drought-resistant, disease-resistant varieties as well as higher-yielding varieties—available." Meanwhile, the European Food Safety Authority (EFSA) released guidance on how human dietary exposure to newly expressed proteins in…
Bloomberg has published an article on companies looking to create dairy products from laboratory-grown whey that could compete with the livestock-derived whey that sold an estimated $10 billion in 2018. One featured start-up, Perfect Day, reportedly asserted that "its proteins require 98% less water and 65% less energy than that required to produce whey from cows" but the company must overcome "consumer squeamishness and regulatory reviews that may end up focusing more on the genetically modified organisms [GMO] used to make lab-grown whey." Perfect Day "wants to rebrand microbes used in food—yeast, fungi, bacteria—as flora, a more consumer-friendly term," Bloomberg reports, to attract vegans who may avoid something labeled "milk protein" and other consumers who may skip products described as "lab-grown" on the label. "We are trying to explore how we can get a term for this industry that's outside of plant-based," one of the founders reportedly told Bloomberg. "Something…
