Category Archives Legislation, Regulations and Standards

The U.K. Food Standards Agency has reportedly issued a nationwide warning about misleading and illegal claims for manuka honey, a product derived from the manuka tree in southeastern Australia and New Zealand and endorsed by many celebrities who claim that it contains unique anti-bacterial and medicinal properties. According to news sources, manuka honey commands prices 10 to 20 times higher than other types of honey. Tests by the U.K. Food Environment Research Agency (Fera), New Zealand’s Unique Manuka Factor Honey Association (UMFHA) and others, however, suggest that many of the products labeled “manuka honey” contain none of its unique active properties, prompting industry leaders to demand a crackdown on a “potentially huge fraud.” Industry data have apparently revealed that New Zealand—the main source of manuka honey—produces only 1,700 tons of the honey each year, while consumption data show that an estimated 10,000 tons is sold worldwide annually, with 1,800 tons…

The European Chemicals Agency (ECHA) has announced a public consultation seeking feedback on a proposal submitted by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) to reclassify bisphenol A (BPA) based on its alleged reproductive toxicity. According to ECHA, the proposal would upgrade the harmonized classification and labeling (CLH) of BPA from reproductive toxicity category 2 (hazard statement code H361f, “suspected of damaging fertility”) to reproductive toxicity category 1B (hazard statement code H360F, “may damage fertility”). “France welcomes any new classification proposal for other endpoints such as carcinogenicity, development or lactation but believes that the emergency for regulating BPA is high enough justifying targeted CLH report and ATP inclusion at [sic] the first place,” states ANSES in its dossier, which includes an evaluation of BPA studies published since the last CLH evaluation was undertaken in 2002. In addition, ECHA has emphasized that the current public consultation…

The Food and Drug Administration (FDA) has announced an information collection requiring “renderers, feed manufacturers, and others involved in feed and feed ingredient manufacturing and distribution to maintain written procedures specifying the cleanout procedures or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment.”Intended to ensure compliance with regulations that prohibit certain animal proteins in ruminant feed to prevent the spread of bovine spongiform encephalopathy, the information collection will allow inspection personnel to confirm that an individual firm’s written procedures have been followed at the time of inspection. FDA has estimated that this information collection will involve an average annual burden of 14 hours per recordkeeping. Comments are requested by September 26, 2013. See Federal Register, August 17, 2013.    

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a request for comments regarding changes to its procedure for Salmonella verification sampling of raw beef products. Among other things, FSIS stated that it will (i) begin “analyzing for Salmonella all raw beef samples that it collects for Shiga toxin-producing Escherichia coli (STEC) analysis,” including all raw ground beef, beef manufacturing trimmings, bench trim, and other raw ground beef components; (ii) increase the raw ground beef sample used for Salmonella analysis from 25 grams to 325 grams; and (iii) discontinue Salmonella sampling set procedures in ground beef products, except in those establishments that exceeded the standard for Salmonella in their most recent tests. FSIS intends to use the results from its verification sampling program to develop new Salmonella performance standards for ground beef products and to estimate Salmonella prevalence in raw ground beef and trimmings. Comments will be accepted…

U.S. Rep. Rosa DeLauro (D-Conn.) has sent an August 23, 2013, letter to U.S. Department of Agriculture (USDA) Under Secretary for Food Safety Elisabeth Hagen about “the ongoing problems with the Public Health Information System (PHIS) used by the Food Safety [and] Inspection Service (FSIS).” Citing reports that PHIS recently experienced a system-wide shutdown that lasted three days and allowed “millions of pounds of meat products” to leave processing plants without being tested for E. coli, DeLauro has asked USDA to provide a record of similar major incidents as well as an “analysis of the problems with the system, the impact on food safety and steps being taken to remedy these problems, including those related to software and connectivity.” She has also asked for details about the parameters of the PHIS contract “that ensure long-term solutions are made to issues that arise in the system,” in addition to “the metrics…

A federal court in the District of Columbia will consider on August 27, 2013, whether to issue a preliminary injunction to stop the U.S. Department of Agriculture (USDA) from implementing country-of-origin labeling (COOL) program changes required by a 2011 World Trade Organization (WTO) determination that, as initially drafted, the rules gave less favorable treatment to cattle and hogs imported from Canada and Mexico. Am. Meat Inst. v. USDA, No. 13-1033 (filed July 8, 2013). Information about the revised COOL rule appears in Issue 485 of this Update. A number of meat-processing interests, including the American Meat Institute, Canadian Cattlemen’s Association, Confederación Nacional de Organizaciones Ganaderas, National Cattlemen’s Beef Association, and National Pork Producers Council, challenged the new rule alleging that it violates First Amendment rights under the U.S. Constitution, exceeds USDA’s authority and violated the Administrative Procedure Act. In early August, the U.S. Cattlemen’s Association (USCA), National Farmers Union, American…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has published a table providing information on the status of chemicals considered for addition to the Proposition 65 (Prop. 65) list under the authoritative bodies mechanism. “The table lists the authoritative body, the document or documents providing the basis for the possible listing, the endpoint (toxic effect) relevant to the possible listing, and the next step in the listing process. OEHHA will update this table on a regular basis.” The chemicals subject to a notice of intent to list in 2014 if criteria are met include pulegone (a flavoring agent), emissions from high-temperature unrefined rapeseed oil (used in animal feed and as a vegetable oil), nitrite in combination with amines or amides (present in foods), atrazine (a herbicide) and its metabolites, genistein (an isoflavone in soybean foods), and ethylene glycol (used in bottling). Styrene, which is used in food containers, may…

According to a news source, U.S. Food and Drug Administration (FDA) personnel have experienced significant delays in obtaining visas from China to staff food and drug inspection offices in that country. One staff member reportedly withdrew his application after waiting nine months for approval to work in China. The delays are seen as a setback for the agency’s efforts to improve supply chain safety; FDA planned to use $10 million in additional appropriations to increase its food inspection staff from two to nine and its drug inspection unit from just one to 11. FDA currently has three offices in the country—in Beijing, Shanghai and Guangzhou—staffed with eight U.S. civil servants and five Chinese nationals. An FDA spokesperson said, “We believe that timely issuance of visas for FDA staff will be beneficial to both the U.S. and China, and that it’s in China’s best interest to issue these visas and move…

The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a proposed rule that would amend the National List of Allowed and Prohibited Substances to permit the use of biodegradable biobased mulch film in organic crop production and the use of Citrus hystrix and curry leaves in organic processing. NOP has also proposed removing two nonorganic agricultural products from the National List—hops (Humulus lupulus) and unmodified rich starch—“as their use exemptions expired on January 1, 2013, and June 21, 2009, respectively.” According to NOP, biodegradable biobased mulch film is a synthetic substance “used as an alternative to petroleum-based plastic mulches that do not biodegrade,” while the leaves and fruit of Citrus hystrix are traditional ingredients in Lao, Thai and other Southeast Asian cuisines, and curry or sweet neem leaves are an important ingredient in Indian, Sri Lankan, Malay, and other Southeast Asian cuisines. The agency will accept comments on…

The Food and Drug Administration (FDA) has apparently filed a petition submitted by the Dean Foods Co. and the WhiteWave Foods Co. “proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food.” In particular, the petition seeks to amend (i) 21 C.F.R. 172.39 “to provide for the safe use of vitamin D2 as a nutrient supplement in edible plant-based food products intended for use as alternatives to milk and milk products,” and (ii) 21 C.F.R. 172.80 “to provide for the safe use of vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted.” FDA has also noted that because the action will not have any significant effect on the human environment, there is no need to undertake an environmental assessment or prepare an environmental impact statement. See Federal Register,…

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