The Food and Drug Administration (FDA) has announced two public meetings to consider the labeling of food derived from genetically engineered (GE) salmon. During the first meeting slated for September 19-20, 2010, the Veterinary Medicine Advisory Committee will address general scientific issues surrounding GE animals, statutory and regulatory constraints, and “a new animal drug application (NADA) concerning AquAdvantage salmon produced by AquaBounty Technologies, Inc.,” which has inserted Chinook and ocean pout genes into Atlantic salmon to accelerate maturation. In addition, FDA has called a September 21, 2010, public hearing to explain “the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to food derived from AquAdvantage Salmon.” FDA has specifically invited participants to consider the following: (i) “Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any ‘material’ differences between foods…
Tag Archives GMO
A federal court in California has decided to stop all new planting of genetically modified (GM) sugar beets in light of its September 2009 ruling that the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) violated environmental law when it deregulated the crop without conducting an appropriate environmental assessment. Ctr. for Food Safety v. Vilsack, No. 08-00484 (N.D. Cal., decided August 13, 2010). Additional information about the court’s prior ruling appears in Issue 320 of this Update. While the court granted the plaintiffs’ request to vacate APHIS’s deregulation decision, it denied their motion for a permanent injunction. The court determined that vacatur was justified because APHIS’s errors were serious. “Moreover,” the court observed, “APHIS’s apparent position that it is merely a matter of time before they reinstate the same deregulation decision, or a modified version of this decision, and thus apparent perception that conducting the requisite comprehensive…
Researchers from the Environmental Protection Agency, University of Arkansas and University of California, Fresno, have reportedly identified populations of genetically modified (GM) canola growing wild in North Dakota. According to results presented at the Ecological Society of America’s (ESA’s) 95th Annual Meeting, scientists found that 347 of the 406 plants collected from roadsides contained either CP4 EPSPS protein, which confers tolerance to glyphosate herbicide, or PAT protein, which confers tolerance to glufosinate herbicide. “There were also two instances of multiple transgenes in single individuals,” University of Arkansas ecologist Cynthia Sagers was quoted as saying. “Varieties with multiple transgenic traits have not yet been released commercially, so this finding suggests that feral populations are reproducing and have become established outside of cultivation.” See ESA Press Release, August 6, 2010. Sagers has reportedly called for further research, suggesting that GM canola has been “part of the landscape for several generations.” She has conceded,…
The American Farm Bureau Federation (AFB) has issued a policy statement urging the Office of the U.S. Trade Representative (USTR) to “initiate a retaliation process” against the European Union over its de facto moratorium on genetically modified (GM) crops. Despite a 2006 World Trade Organization ruling that found fault with EU approval procedures for GM crops, the bloc has allegedly failed to implement “a timely and predictable regulatory process,” resulting in “substantial damage” to U.S. agriculture. Although AFB initially agreed to suspend formal action in favor of normalizing trade, the industry group has since reversed that decision. According to AFB, “If the EU does not immediately begin to make timely, science-based regulatory decisions on pending and future applications, soybean exports also are at serious risk.” See AFB Press Release, July 26, 2010. Meanwhile, the European Commission (EC) recently approved six GM corn varieties via “the usual and standard” authorization procedure,…
The Animal and Plant Health Inspection Service (APHIS) has issued a notice requesting voluntary participation in a program designed to improve compliance with regulations pertaining to the importation, interstate movement and environmental release of genetically engineered (GE) organisms. APHIS conducted a pilot Biotechnology Quality Management System (BQMS) Program in 2009 and has since refined its draft audit standard and procedures and program training sessions. The program is intended to help all regulated entities, including universities, small businesses and large companies, to develop “sound management practices through the creation and implementation of a customized biotechnology quality management system.” Participants will be expected to attend several training sessions, develop a BQMS within their organization, establish procedures addressing the movement and field testing of regulated GE organisms, participate in evaluations, and submit to a third-party verification audit. Letters of interest may be submitted at any time, but APHIS encourages submission as soon as…
According to news sources, a St. Louis jury has awarded more than $500,000 to a Louisiana farmer who alleged that when the U.S. rice supply was contaminated in 2006 with a genetically modified (GM) crop that was somehow released from testing facilities, he lost $1.5 million due to lost sales abroad. In re: Genetically Modified Rice Litig., MDL No. 1811 (E.D. Mo.). The lawsuit is the third to reach trial of more than 500 consolidated before a multidistrict litigation court in eastern Missouri; it marks the third loss in federal court for the defendant, which is facing more than $52 million in jury awards. Two state trials also resulted in plaintiff verdicts. While the defendant has not apparently disputed the contamination, it has denied that it was negligent and contends that rice sales recovered shortly after the initial plunge. See Bloomberg Businessweek and Post Dispatch, July 14, 2010.
The European Commission has proposed legislation that would allow member states to set their own policies for regulating genetically modified (GM) crops. If approved by the European Parliament and individual governments, the proposal would permit countries to approve, restrict or prohibit the cultivation of GM crops, even those deemed safe by the scientific mechanisms currently in place. Under this new framework, member states could bar GM crops for reasons “other than the identification of a risk for the environment, human or animal health.” See EC Citizen’s Summary, July 13, 2010. The proposed legislation apparently seeks to end a 12-year gridlock among member states with different stances toward GM crops. In light of this dilemma, the commission has also drafted new recommendations for avoiding the unintended presence of GM products in those marketed as GM-free. This non-binding guidance (i) “allows for measures aiming to limit GMO content in conventional food and feed…
“The Food and Drug Administration [FDA] is seriously considering whether to approve the first genetically engineered [GE] animal that people would eat—salmon that can grow at twice the normal rate,” reports New York Times biotechnology correspondent Andrew Pollack in this article about the decade-long regulatory process. Pollack identifies the petitioner as a Waltham, Massachusetts, company named AquaBounty Technologies, which has now submitted “most or all of the data the [FDA] needs to analyze whether the salmon are safe to eat, nutritionally equivalent to other salmon and safe for the environment.” The fish under review is an Atlantic salmon that contains “a growth hormone gene from Chinook salmon as well as a genetic on-switch from ocean pout.” As AquaBounty Chief Executive Ronald Stotish explained to Pollack, the accelerated maturation would not result in “salmon the size of the Hindenburg,” but would help bring fish to market in one half the usual…
In a 7-1 ruling, the U.S. Supreme Court has determined that a district court erred in enjoining the Animal and Plant Health Inspection Service (APHIS) from even partially deregulating Monsanto’s Roundup Ready® alfalfa while the agency takes steps to comply with the National Environmental Policy Act (NEPA). Monsanto Co. v. Geertson Seed Farms, No. 09-475 (U.S., decided June 21, 2010). The district court found that APHIS failed to prepare an environmental impact statement (EIS) as required under NEPA before granting Monsanto’s petition to deregulate the seed, which has been genetically modified (GM) to resist glyphosate, a weed killer used on GM crop fields. The court then enjoined APHIS from deregulating GM alfalfa until an EIS could be completed and further enjoined the seeds’ sale and planting beyond sales already made in March 2007. Farmers who had purchased the seed were allowed to plant it that year. Writing for the majority, Justice…
The United Kingdom’s environmental secretary has reportedly endorsed genetically modified (GM) crops, making the current Department for Environment, Food and Rural Affairs the most supportive of GM crops to date. In contrast to the previous government’s unwillingness to back what some apparently fear are “Frankenstein foods,” Secretary Caroline Spelman told a news source that she was in favor of GM foods “in the right circumstances.” Modifying plant genes could reduce the amount of chemicals needed to raise food crops, she said. “GM can bring benefits in food to the marketplace,” Spelman was quoted as saying. “There are benefits to developing countries, like drought resistance or resistance to high salt content in water. The principle of GM technology is [OK] if used well. The technology can be beneficial.” See The Guardian, June 4, 2010.
