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.
Category Archives U.S. Government and Regulatory Agencies
According to counsel for a company that makes dietary supplements containing selenium, the Food and Drug Administration (FDA) has agreed to allow the company to make qualified health claims for the products that include brief disclaimers. The company will apparently be able to label its products with claims that selenium “may reduce the risk” of prostate, colon, bladder, and thyroid cancers as long as it includes the following: “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers.” The negotiations that led to the breakthrough reportedly followed a federal district court ruling in May that FDA violated First Amendment commercial speech standards by censoring specific qualified health claims for the company’s products and requiring the use of a lengthy contradictory qualification. The parties are apparently continuing to discuss disagreements over the effect of selenium on other…
The Food and Drug Administration (FDA) has issued a report titled “Advancing Regulatory Science for Public Health,” that outlines the agency’s plan to develop new scientific and technological tools, standards and approaches to improve its ability to assess the safety, efficacy, quality, and performance of FDA-regulated products, including foods and tobacco. FDA expects to use President Barack Obama’s $25 million increased budget request for fiscal year 2011 to expand the initiative and “build additional partnerships with academia, industry and government around the country.” According to a news source, FDA’s budget has been frozen under a continuing resolution Congress passed before taking its latest recess. A new office dedicated to regulatory science will be created, and the initiative’s goals include protecting the food supply by focusing on “the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for…
The Federal Trade Commission (FTC) has determined that its “Green Guides,” which “help marketers avoid making deceptive claims by outlining general principles that apply to all environmental marketing claims,” should be retained and updated. Initially developed in 1992 and last revised in 1998, the guides also provide information about how “reasonable consumers are likely to interpret particular claims, how marketers can substantiate them, and how they can qualify those claims to avoid consumer deception.” The proposed changes include new guidance on the “use of product certifications and seals of approval, ‘renewable energy’ claims, ‘renewable materials’ claims, and ‘carbon offset’ claims.” They do not address use of the terms “sustainable,” “natural” and “organic.” Public comments are requested by December 10, 2010. FTC Chair Jon Leibowitz was quoted as saying, “In recent years, businesses have increasingly used ‘green’ marketing to capture consumers’ attention and move Americans toward a more environmentally friendly future.…
A World Trade Organization (WTO) panel has determined that the United States has violated its trade obligations by refusing to allow Chinese chicken parts into the U.S. market, an action that was apparently taken in a 2009 federal spending bill that denied the use of any U.S. Department of Agriculture funding to establish or implement any measure that would allow the importation. The law extended a five-year U.S. ban on Chinese chicken that was imposed during a bird flu outbreak. While the WTO can sanction countries that violate trade rules, this could take several years because the United States has the option to appeal the verdict. According to a news source, the Office of the U.S. Trade Representative has indicated that the restrictions were temporary and are due to expire soon. See USA Today, September 29, 2010.
The European Food Safety Authority’s (EFSA’s) panel on food contact materials, enzymes, flavorings, and processing aids has released its latest risk assessment for bisphenol A, concluding that there was not any “new evidence which would lead them to revise the current Tolerable Daily Intake [TDI] for BPA of 0.05 mg/kg body weight set . . . in its 2006 opinion and re-confirmed in its 2008 opinion.” The CEF panel undertook the reassessment at the request of the European Commission, which directed scientists to (i) decide on the basis of recent literature whether to update the TDI; (ii) “assess a new study on possible neurodevelopmental effects”; and (iii) advise on a risk assessment made by the National Food Institute at the Technical University of Denmark. Although one minority opinion evidently raised questions about “adverse health effects below the level used to determine the current TDI,” panel members agreed on shortcomings in…
The Food and Drug Administration (FDA) has announced a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, which reviews and evaluates available scientific data concerning the safety of products that might transmit spongiform encephalopathies such as Creutzfeldt-Jakob disease and the bovine variant commonly known as mad cow disease. Agenda items for the October 28-29, 2010, meeting in Gaithersburg, Maryland, include (i) “FDA’s risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII” and (ii) “labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.” The committee will also discuss ways to reduce transmission risks and hear updates on the “development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.” FDA requests written comments by October 21, 2010. See Federal Register, September…
The Food and Drug Administration (FDA) has released a draft strategic priorities document for fiscal years 2011-2015 that outlines four key cost-cutting strategic priorities and four strategic program goals designed to help FDA achieve its public health mission. According to an October 1, 2010, Federal Register notice, the four cost-cutting priorities seek to (i) “advance regulatory science and innovation,” (ii) strengthen the safety and integrity of the global supply chain,” (iii) “strengthen compliance and enforcement activities,” and (iv) “expand efforts to meet the needs of special populations.” Among the program goals, FDA has highlighted intentions to establish effective tobacco regulation as well as advance food safety and nutrition by ensuring the safety of the food supply from farm to table and promoting healthy dietary practices and nutrition. FDA will accept comments until November 1, 2010.
Pinnacle Foods Group LLC has reportedly agreed to reformulate its Log Cabin Syrup® after Vermont Representative Peter Welsh (D) called on the Food and Drug Administration (FDA) to investigate the company for selling a product in apparent violation of agency regulations. Welsh’s September 8, 2010, letter noted that the company’s “All Natural Syrup” contains caramel color, among other ingredients. Welsh suggested that consumers outside the state “who have come to expect quality from natural Vermont products may be fooled by this misleading labeling.” The product is apparently being sold in a beige plastic jug similar to real maple syrup packaging, raising the ire of maple syrup producers. While FDA has not defined the term “natural,” the agency allows it to be used if the claim is truthful and “the product does not contain added color, artificial flavors or synthetic substances,” according to an agency spokesperson. Claiming that its product “provides consumers…
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…
