The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has published a notice announcing the availability of its biotechnology compliance assistance program audit standard. The document “will be used by participating regulated entities to develop and implement sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered [GE] organisms in 7 CFR part 340.” APHIS developed a voluntary quality management assistance program to help regulated entities improve their management of domestic GE organism research and development. The new audit standard “provides criteria for the development, implementation, and objective evaluation of the entity’s [program].” See Federal Register, October 5, 2010.
Tag Archives GMO
A looseleaf reference book titled Products Liability: Design and Manufacturing Defects, 2d has been updated with sections considering legal issues relating to genetically modified (GM) foods. The section on “design defects in GM organisms used in food production” discusses the extensive regulatory review to which these substances are subject and notes that no known injury has yet been linked to the use of GM organisms. The section on “failure to warn of idiosyncratic reaction to GM foods” cites cases involving plaintiffs with allergies or unusual susceptibilities involving other types of products. The author adds the following observation: “The same technology that is used to create novel food will provide the tools for preventing risk. Properly managed, novel food can reduce the net incidence of food allergies, through creation of hypoallergenic varieties of common crops. This standard for ‘design’ of food may one day give rise to ‘design defect’ liability for failure…
A multidistrict litigation (MDL) court in Missouri has issued a number of rulings on motions for summary judgment and to exclude or limit expert testimony in the bellwether cases involving Texas rice farmers who allege that contamination of the U.S. rice supply with genetically modified (GM) rice caused a precipitous decline in prices for their crops on world markets. In re Genetically Modified Rice Litig., MDL No. 1811 (E.D. Mo., decided October 4, 2010). The court’s pre-trial rulings are similar to its rulings in previous bellwether trials involving farmers in Arkansas, Louisiana, Mississippi, and Missouri. The court determined, among other matters, that (i) the Texas farmers could not sue for violation of a North Carolina statute; (ii) the economic loss doctrine did not bar the plaintiffs’ claims; (iii) the plaintiffs could pursue claims for private nuisance but not for public nuisance; (iv) the defendants cannot assert as a defense that…
A federal court in California has determined that an agency decision to allow planting of genetically modified (GM) sugar beet stecklings (seedlings) without conducting an environmental assessment likely violated federal law and has ordered the parties to file briefs as to the appropriate remedy now that most of the stecklings authorized have been planted. Ctr. for Food Safety v. Vilsack, No. 10-04038 (N.D. Cal., decided September 28, 2010). Additional information about the lawsuit’s challenge to action taken by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) appear in Issue 363 of this Update. The court first addressed whether seed companies could intervene in the matter and ruled that they could do so as to the remedies, but not as to the merits, that is, whether APHIS violated federal environmental laws including the National Environmental Policy Act (NEPA) by issuing the permits without conducting an environmental review. The…
Led by U.S. Senator Mark Begich (D-Alaska), a group of legislators has asked the Food and Drug Administration (FDA) to halt its ongoing review of genetically engineered (GE) salmon, citing “serious concerns with the current approval process and many potential health and environmental risks that are associated with producing GE fish.” FDA recently held public hearings to decide the fate of a new animal drug application (NADA) for AquAvantage® salmon, an Atlantic variety that uses genes from ocean pout and Chinook to increase the speed of maturation. Additional details about these hearings appear in Issue 365 of this Update. In their September 28, 2010, letter to FDA Commissioner Margaret Hamburg, the Senators argue that the NADA process lacks transparency and does not adequately address the “creation of a new animal, especially one intended for human consumption.” The signatories specifically point to reports that GE salmon “‘have slightly higher levels of…
A Food and Drug Administration (FDA) advisory panel has reportedly declined to take action or make any recommendations about the safety of genetically modified (GM) salmon at the conclusion of hearings that drew considerable media and public attention. A Massachusetts based company has been trying to bring its AquAvantage® salmon to the market for more than 10 years. If it succeeds, the fish, which reportedly grow to full size in half the time as conventional salmon, will be the first GM animal sold for human consumption. According to a news source, FDA’s Veterinary Medicine Advisory Committee indicated that it lacked sufficient safety data to make a determination and suggested that the government undertake a more rigorous analysis of potential health effects and environmental impact. Agency documents made available before the hearing reportedly indicated that FDA was prepared to conclude that no biologically relevant differences between GM salmon and conventional salmon…
After the U.S. Department of Agriculture announced that it had begun issuing permits to sugar beet seed producers to plant genetically modified (GM) crops this fall, the Center for Food Safety and a number of other groups filed a lawsuit in federal court challenging the action. When Agriculture Secretary Tom Vilsack announced the agency’s “next steps” as to Roundup Ready® sugar beets, he acknowledged the August 2010 federal court ruling that returned GM sugar beets to regulated status until the Animal and Plant Health Inspection Service (APHIS) can complete an environmental impact statement (EIS) about the effects of deregulating the crop. According to APHIS, producers who have applied for the permits will be allowed to plant GM seedlings immediately but must not allow them to flower, and the agency will make decisions about interim regulatory measures by the end of the year on the seed producer’s request to partially deregulate…
The U.K. Food Standards Agency (FSA) has announced that as of September 1, 2010, the agency handed over several responsibilities to the departments of Health (DH) and Environmental, Food and Rural Affairs (Defra). Under the restructuring—which does not currently apply to operations to Scotland, Wales and Northern Ireland—FSA in England will continue to handle the following safety aspects of food labeling: (i) “expert scientific advice on the food safety aspects of date marking”; (ii) “assessment and labeling of ingredients/foods with food safety implications (e.g. allergens, glycols, high caffeine, high glycyrrhizinic acid)”; (iii) “food safety aspects of organic food and of foods controlled by compositional standards”; (iv) “treatments and conditions of use with food safety implications (e.g. quick frozen foods, raw drinking milk and pasteurisation, food contact materials)”; (v) “GM and novel foods (including use of nanotechnology)”; (vi) “animal feed, including Codex Intergovernmental Task Force on Animal Feeding”; (vii) “food safety…
The Food and Drug Administration (FDA) has released a briefing packet in advance of public meetings to discuss a new animal drug application for genetically engineered (GE) salmon. Produced by AquaBounty Technologies, Inc. (ABT), the AquAdvantage salmon contains genes from Chinook and ocean pout that accelerate maturation. Additional details about the September 19-21, 2010, meetings appear in Issue 362 of this Update. According to the FDA briefing packet, “[T]here are no material differences in food from ABT salmon and other Atlantic salmon.” The assessment therefore concludes that “triploid ABT salmon is . . . as safe as food from conventional salmon,” although it recommends further allergenicity studies for diploid salmon because the ones provided were of “low quality.” In addition, an environmental impact statement (EIS) has found that the fish “are not expected to have a significant impact on the quality of the human environment.” As the EIS summary notes,…
An Italian agronomist, frustrated by the government’s refusal to approve the planting of genetically modified (GM) crops, has apparently engaged in an act of civil disobedience by planting two fields of GM corn and publicizing his action with a news conference and YouTube® video. Environmentalists reportedly responded by descending on the fields near Vivaro, which had been seized by government officials; Greenpeace activists cut off the tassels in an effort to prevent the dissemination of pollen, and environmentalists with Ya Basta trampled the crop leaving signs stating “Danger—Contaminated—G.M.O.” According to a news source, while the European Union has approved the use of this particular seed, Italy requires farmers to submit any request to plant GM crops for government approval. To date, the Ministry of Agriculture has not apparently approved any GM crop for planting. The GM debate is particularly heated in Italy, where farmers are known for their specialized organic…
