Tag Archives biotechnology

The U.S. Department of Agriculture has reportedly been asked by a Canadian biotechnology company to approve its genetically modified (GM) apple, which resists browning after it is sliced. The British Columbia-based company apparently licensed the non-browning technology from an Australian company that developed it for potatoes. Approval of the GM technology could take several years, and U.S. apple growers have reportedly expressed concerns about cross-pollination with conventional apple trees as well as the cost of replanting apple groves with the “Arctic” apples, a figure estimated at $10,000 to $20,000 per acre. Andrew Kimbrell, executive director of the Center for Food Safety, criticized the proposal, apparently claiming, “A botox apple is not what people are looking for. I’m predicting failure.” Yet, the sliced apple market has increased in recent years, with suppliers relying on calcium and ascorbic acid to maintain product freshness. The company seeking the GM apple’s approval claims that the…

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.

The Food and Drug Administration (FDA) has published a notice seeking public comments on its proposed collection of information on foods derived from new plant varieties including those created through biotechnology. Comments must be submitted by April 19, 2010. The types of information that developers of new plant varieties would be required to provide to the agency include (i) a description of the applications or uses of the bioengineered food, (ii) information about the sources, identities and functions of the introduced genetic material, (iii) information about any known or suspected allergenicity and toxicity, and (iv) information relevant to the safety and nutritional assessment of the bioengineered food. Commenters are asked to address whether the proposed collection “is necessary for the proper performance of FDA’s functions,” the accuracy of the agency’s estimate of the burden of the proposed information collection, ways to improve the quality of the information to be collected,…

The Food and Drug Administration (FDA) has entered a memorandum of understanding (MOU) with Boston’s Northeastern University to “develop collaboration between the two parties in the areas of education, research, and outreach.” Focusing broadly on biotechnology and analytical chemistry, the MOU is intended to “provide opportunities for exchanging of graduate and undergraduate students, faculty, and personnel and for advanced training and outreach; stimulate cooperative research, and information exchange in biological product characterization and regulation with Northeastern University’s Barnett Institute of Chemical and Biological Analysis; and develop training programs for FDA and potentially other Government agencies and Industry.” Northeastern University is home to law professor and anti-tobacco activist Richard Daynard who also formed the Public Health Advocacy Institute to address food and obesity issues through legislation and litigation. The law school received a $2.7 million grant from the National Cancer Institute in 2009 to conduct a five-year research project, headed by Daynard,…

The second of a five-part series, this article examines in some depth how a number of European countries came to turn their backs on genetically modified (GM) crops. Belgian scientists apparently experimented with GM plants in the 1980s and instituted 50 different field trials, positioning Europe to be a world leader in plant biotechnology. A public backlash, fueled by fears over mad cow disease and food safety, followed the European Union’s approval of a pesticide-resistant corn, and no GM crop has since been approved. European scientists, concerned about the politicization of science, are apparently considering ways to restore public confidence in scientific integrity and the safety of GM crops. The Dutch have apparently proposed that the EU allow each member nation to make its own decision about whether to allow GM crops after giving consideration to a broad range of issues, including human safety, biodiversity, “cultural heritage,” and economics. The Dutch…

The U.S. Department of Agriculture (USDA) has issued a proposed rule that would create a voluntary labeling program for ‘biobased” products under section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation and Energy Act of 2008. According to USDA, “Biobased products are products that are composed wholly or significantly of biological ingredients – renewable plant, animal, marine or forestry materials.” Looking to encourage the increased use of these products in all market sectors, USDA has already identified 15,000 commercially available biobased products across approximately 200 categories, from cleaning products to construction materials. Manufacturers seeking a BioPreferred label must ensure that their items meet or exceed USDA-established minimum biobased content requirements. USDA is accepting comments on the proposed rule until September 29, 2009. See the Federal Register and USDA Press Release, July 31, 2009; Meatingplace.com, August 3, 2009.

The Agricultural Research Service has requested nominations for individuals to serve two-year terms on the U.S. Department of Agriculture (USDA) Advisory Committee on Biotechnology and 21st Century Agriculture. The committee is charged with examining the long-term impacts of biotechnology on the U.S. food and agriculture system. A minimum of 12 committee slots need to be filled, including the chairperson’s. Written nominations must be received by fax or postmarked on or before April 29, 2009. See Federal Register, March 30, 2009.

Roll International Corp. Senior Counsel and former Agricultural Law Professor at the University of Arkansas School of Law, Michael Roberts discusses how disputes over the use of synthetic hormones in animal husbandry and food produced from genetically modified organisms are handled from the perspective of international trade law and international agreements addressing health, safety and environmental issues. Thus, he sets the stage to speculate how international disputes over cloned animals and nanotechnologies used in the human food chain may be addressed in the future. Among the legal issues the author sees arising from cloning and nanotechnology are (i) what international institutions and instruments will regulate these emerging technologies; (ii) whether religious, scientific, moral, and ethical concerns implicated in these technologies will change the international regulations pertaining to food safety and labeling, (iii) what role private standard-setting will take in the international regulation of cloning and nanotechnology, and (iv) how private…

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