Category Archives U.S. Government and Regulatory Agencies

The U.S Department of Agriculture’s Food Safety and Inspection Service, the Food and Drug Administration and the U.S. Department of Health and Human Services have announced a February 23, 2012, public meeting in College Park, Maryland, to provide information and receive public comments on draft U.S. positions to be discussed at the 6th Session of the Codex Committee on Contaminants in Food (CCCF) on March 26-30 in Maastricht, The Netherlands. CCCF is responsible for establishing or endorsing maximum levels “for contaminants and naturally occurring toxicants in food and feed.” Agenda items will include draft maximum levels for melamine in liquid infant formula, arsenic in rice, and deoxynivalenol and its acetylated derivatives in cereals and cereal-based products. See Federal Register, February 3, 2012.

The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a proposed rule that would regulate the use of synthetic methionine in organic poultry production after a current interim final rule expires on October 1, 2012. According to a February 6, 2012, Federal Register notice, the rule would amend the National List of Allowed and Prohibited Substances (National List) to permit the following maximum levels of synthetic methionine per ton of feed: (i) two pounds for laying and broiler chickens; and (ii) three pounds for turkey and all other poultry. NOP has requested public comments on the proposed rule by April 6. The National List currently classifies methionine “as an essential amino acid because it cannot be biologically produced by poultry and is necessary to maintain viability.” The substance occurs naturally in feed sources that include blood meal, fish meal, crab meal, corn gluten meal, alfalfa meal, and sunflower…

Three consumer advocacy organizations have filed a petition with the Office of Food Additive Safety of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition requesting that ABT Technologies’ application to approve genetically engineered (GE) salmon be reviewed under the food additive provisions of the Food, Drug, and Cosmetic Act. The company’s new animal drug application for the GE salmon is currently pending before the agency’s Center for Veterinary Medicine. According to Food & Water Watch, Consumers Union and the Center for Food Safety, the company’s GE process “significantly alters the salmon’s composition . . . in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns. Under the Agency’s regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety…

U.S. Representatives Frank Pallone Jr. (D-N.J.) and Rosa DeLauro (D-Conn.) have proposed legislation (H.R. 3984) that would require the Food and Drug Administration (FDA) to establish standards for arsenic and lead in fruit juices within two years. Titled the “Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012,” or the “APPLE Juice Act of 2012,” the proposal is designed to “protect children from harmful health effects of significant juice consumption,” the lawmakers said in a joint press release. Calling for lead and arsenic to be as strictly regulated in juice as they are in bottled water, the lawmakers said the bill came in response to a Consumer Reports investigation revealing “alarmingly high levels” of the toxins in apple and grape juice in New Jersey, New York and Connecticut. “We must ensure that the juices our children drink are safe, particularly when 70 percent of the apple juice…

The Food and Drug Administration (FDA) has issued a report outlining eight proposals to make its “publicly available compliance and enforcement data more accessible and user-friendly.” Under the initiatives described in the report, FDA will explore different ways to (i) “improve data quality and facilitate more timely data disclosure”; (ii) expedite error reporting; (iii) “present its compliance and enforcement data graphically and better utilize mobile web applications”; (iv) “better integrate its compliance and enforcement data”; (v) improve the search capabilities of the inspections database; (vi) post additional data compilations or analysis; (vii) “better utilize social media”; and (viii) “provide appropriate context for the compliance and enforcement data that it discloses.” See Federal Register, February 1, 2012.

A federal court in the District of Columbia has determined that the U.S. Department of Agriculture (USDA) had the authority to and properly promulgated a rule “requiring that almonds produced domestically be pasteurized or chemically treated against bacteria.” Koretoff v. Vilsack, No. 08-1558 (D.D.C., decided January 18, 2012). So ruling, the court granted USDA’s motion for summary judgment. Further information about the challenge brought by U.S. almond growers appears in Issue 274 of this Update. The almond rule was adopted in response to Salmonella outbreaks traced to raw almonds in 2001 and 2004. USDA adopted it under the authority of the Agricultural Marketing Agreement Act of 1937 and the California Almond Marketing Order (Almond Order), promulgated in 1950. At issue in the dispute between the U.S. almond growers and USDA was whether safety regulations are encompassed by the law’s use of the term “quality,” over which USDA specifically has regulatory…

A federal court in Iowa has denied a motion seeking to preliminarily enjoin the Food and Drug Administration (FDA) from enforcing regulations prohibiting the interstate sale of raw milk. Farm-to-Consumer Legal Defense Fund v. Sebelius, No. 10-4018 (N.D. Iowa, decided January 23, 2012). The plaintiffs, who either produce or consume raw milk, filed their motion under the All Writs Act, claiming that FDA has taken enforcement actions against third parties in other jurisdictions while the plaintiffs’ lawsuit challenging the validity of the rules is pending and that such action usurps the court’s jurisdiction to decide whether the interstate sale of raw milk is legal. According to the court, “[t]he plaintiffs have not cited, and I have not found, any authority for the proposition that the first federal court to entertain a challenge to a federal regulation has the power to forestall enforcement of that regulation by a federal agency in other…

The U.S. Department of Agriculture’s Food Safety Inspection Service and U.S. Environmental Protection Agency have announced a February 14, 2012, public meeting in Arlington, Virginia, to provide information and receive public comments on draft U.S. positions to be discussed at the 44th Session of the Codex Committee on Pesticide Residues (CCPR) on April 23-28 in Shanghai, China. CCPR is responsible for establishing maximum pesticide-residue limits in specific food items, food groups or in “certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health.” See Federal Register, January 23, 2012.

The U.S. Department of Agriculture (USDA) has issued a final rule updating the National School Lunch and School Breakfast Programs “to align them with the Dietary Guidelines for Americans.” Effective March 26, 2012, the rule seeks to reduce childhood obesity by requiring schools to (i) “increase the availability of fruits, vegetables, whole grains, and fat-free and low-fat fluid milk in school meals”; (ii) “reduce the levels of sodium, saturated fat and trans fat in meals”; and (iii) “meet the nutrition needs of school children within their calorie requirements.” According to USDA, the new standards reflect the recommendations of an Institute of Medicine expert panel as well as 132,000 public comments. Estimated to add $3.2 billion to school meal costs over five years, the final rule only partially implements the Healthy Hunger Free Kids Act (HHFKA) of 2010, which also includes a mandate to set nutritional standards for foods and beverages…

A U.S. Food and Drug Administration (FDA) official has declared seafood from the Gulf of Mexico safe for human consumption after 2010’s Deepwater Horizon oil spill. In December 2011, eight U.S. Senators urged the agency to “publicly and vigorously” defend the safety of Gulf seafood. In a January 11, 2012, FDA blog post, Deputy Commissioner for Foods Michael Taylor said that more than 10,000 seafood specimens were tested for polycyclic aromatic hydrocarbons (PAHs) after the spill and that PAH levels were “100 to 1,000 times below the levels which would raise a health concern.” Taylor added that FDA feels “confident that the levels that were set are safe and protect the health of anyone who eats seafood, including children and pregnant women.”

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