Category Archives Legislation, Regulations and Standards

The National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration (NOAA) has published a final rule “to enhance the requirements for documentation to support labels on tuna products that represent the product as dolphin-safe.” According to NMFS, the rule “is intended to better ensure dolphin-safe labels comply with the requirements of the DPCIA [Dolphin Protection Consumer Identification Act] and to ensure that the United States satisfies its obligations as a member of the World Trade Organization (WTO).” Information about an adverse WTO ruling in a dispute with Mexico over U.S. dolphin-safe labeling provisions appears in Issue 424 of this Update. See Federal Register, July 9, 2013.  

According to a news source, the U.S. Department of Agriculture (USDA) has granted permission for slaughterhouses in New Mexico and Iowa to convert their facilities into horse-processing plants, the first such facilities to be licensed since Congress banned the practice seven years ago. Other applications for horse-processing plants are reportedly being considered in Missouri, Oklahoma and Tennessee. Before horse slaughter can begin, however, plants must be inspected by USDA inspectors who have reportedly not yet been hired. “This is very far from over,” an attorney for the New Mexico plant was quoted as saying. “The company is going to plan to begin operating in July. But with the potential lawsuits and the USDA—they have been dragging their feet for a year—so to now believe they are going to start supplying inspectors, we’re not going to hold our breath.” See The Associated Press, June 28, 2013; Emporiagazette.com, July 11, 2013.  

The Food and Drug Administration (FDA) has issued a final rule amending 21 C.F.R. 175.300 to reflect the industry’s abandonment of bisphenol A (BPA)- based epoxy resins as coatings in infant formula packaging. As of July 12, 2013, the food additive regulations will no longer provide for this use of BPA. According to FDA, its action followed Rep. Edward Markey’s (D-Mass.) petition asserting that industry had stopped using BPA in infant formula packaging; the action “is not “related to the safety of BPA.” See FDA Center for Food Safety and Applied Nutrition—Constituent Update, July 11, 2013.  

The Food and Drug Administration (FDA) has proposed “an ‘action level’ of 10 parts per billion (ppb) for inorganic arsenic in apple juice,” the same level established by the U.S. Environmental Protection Agency for drinking water. According to a July 12, 2013, press release, FDA set this threshold based on its latest analysis of organic and inorganic arsenic in apple juice as part of its draft guidance to industry. “The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health,” said FDA Commissioner Margaret Hamburg. “We have been studying this issue comprehensively, and based on the agency’s data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults.” The agency will accept comments on the proposed action level and draft guidance for 60 days after publication in the Federal Register.…

Finding the Food and Drug Administration’s (FDA’s) proposed “target time-frames” “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” a federal court in California will require the agency to publish all proposed regulations required under the Food Safety Modernization Act by November 30, 2013. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decided June 21, 2013). The court further ordered FDA to close each comment period no later than March 31, 2014, and to finalize the rules no later than June 30, 2015. The order follows the court’s determination that FDA violated the FSMA and Administrative Procedure Act by failing to comply with the food safety rulemaking deadlines established by Congress. Additional details about the litigation appear in issues 481 and 487 of this Update.  

The U.K. Food Standards Agency (FSA) has requested public comments about a novel foods application submitted by a U.S. company seeking permission to use refined oil from Bugglossoides arvensis seeds in its food products. The company suggests in the application that the oil is a rich source of omega-3 and omega-6 fatty acids and could be consumed by people who want to increase their intake of omega-3 fatty acids, but are unwilling or unable to consume fish oils—vegetarians, for example. The applicant also indicated that oil made from Bugglossoides arvensis seeds is similar in composition to Echium oil, which is already approved for use in foods in the European Union. FSA will accept comments until July 15, 2013. See FSA News Release, June 25, 2013.

The U.K. Advertising Standards Authority (ASA) has upheld a complaint against a print advertisement by the People for the Ethical Treatment of Animals (PETA) Foundation alleging that meat consumption raises heart disease and cancer risk. According to ASA’s report, the poster under review featured a child smoking a cigar and the following text: “You Wouldn’t Let Your Child Smoke. Like smoking, eating meat increases the risk of heart disease and cancer. Go vegan!” After considering two complaints questioning whether the link between meat consumption and disease risk could be substantiated, ASA concluded that the studies provided by PETA to support its claims failed to show any strong association between general meat consumption and increased risk of heart disease and various cancers. “We considered that because the ad likened the risks associated with eating any kind of meat to the risks of smoking, consumers would understand from the ad that the…

The European Food Safety Authority (EFSA) has launched two public consultations on draft guidance for feed additives. Issued by EFSA’s Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP), the first draft document offers guidance “for the preparation of dossiers for the renewal of the authorization for feed additives.” Under Article 14 of Regulation (EC) No. 1831/2003, FEEDAP currently requires applicants to renew feed additive permits every 10 years by providing enough technical information to “enable an assessment to be made of additives based on the current state of knowledge.” The panel has also requested feedback on draft guidance stemming from its updated assessment “of the toxigenic potential of Bacillus species used in animal nutrition.” According to EFSA, “Bacillus species are used in animal production directly as microbial feed additives or as the source of other feed additives, notably enzymes,” although certain strains—such as those in the…

The European Food Safety Authority (EFSA) recently published its recommendations for improving meat inspection procedures in the European Union (EU) after a previous assessment found that “traditional practices... are not always suitable for detecting the main meat borne hazards such as Campylobacter and Salmonella or contamination by chemical substances.” Billed as “a major piece of work that will provide the scientific basis for the modernization of meat inspection across the EU,” the four new opinions address the potential public health risks of meat derived from solipeds, farmed game, sheep, goats, and cows, in addition to setting “harmonized epidemiological indicators” for identifying biological hazards. Looking at data on the incidence and severity of foodborne diseases in humans as well as the outcomes of various residue testing programs, EFSA’s experts ranked the biological and chemical hazards of particular concern for each species, singling out verocytotoxin-producing E. coli, dioxins and dioxin-like polychlorinated biphenyls as…

The European Commission (EC) has announced a public consultation on the Nanomaterial Annexes to the regulations governing the Registration, Evaluation, Authorization and Restriction of Chemical (REACH) substances. As recommended in the General Review of REACH published in February 2013, the consultation will contribute to the Commission’s “impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety regulations demonstrated in registration dossiers.” To this end, the EC has asked “informed experts user[s]” to complete a questionnaire about the technical provisions of the REACH Annexes, including whether the current definition of nanomaterials has changed the way companies account for nanomaterials in their portfolio or conduct safety assessments. The survey also seeks input on five proposals being considered by the Commission as it looks to update REACH’s registration requirements by the end of 2013. These proposals include (i) altering…

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