Category Archives Legislation, Regulations and Standards

The U.S. Food and Drug Administration (USDA) has proposed two new fees—a food import user fee and a food facility and inspection fee that the agency says will “enhance the safety protections for imported food and feed” as well as support “new and improved activities required by the Food Safety Modernization Act (FSMA) to modernize FDA’s inspection system.” According to FDA, programs to support FSMA are scheduled to cost $295 million next year and will apparently be 94 percent funded by user fees. “These investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply,” the agency asserts in its budget proposal. FDA has also proposed new user fees to support its cosmetic and food contact substance notification programs. In a statement releasing the budget, FDA Commissioner Margaret Hamburg said, “These are tight budget times, and the FDA…

U.S. Rep. Edward Markey (D-Mass.) and Sens. Richard Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have issued a joint report presenting the results of their investigation into the energy drink industry. Titled “What’s all the Buzz About?,” the report is based on survey responses from 14 energy drink companies asked to outline their current marketing, labeling and manufacturing practices. According to the lawmakers, the responses highlight various inconsistencies in how these companies market and label their products under current regulations, “leading to consumer confusion and a lack of transparency.” In particular, the report alleges that (i) “four out of the 14 companies surveyed classify and market one or more of its products as dietary supplements, as opposed to conventional beverages”; (ii) “concentrations of caffeine are not uniformly represented on the label of the brands evaluated,” with some concentrations exceeding safety levels set by the Food and Drug Administration (FDA) for soda;…

A coalition of more than 200 farm, consumer and environmental organizations has written a letter urging the U.S. Department of Agriculture (USDA) to support recently proposed changes to U.S. Country of Origin Labeling (COOL) requirements for meat products. USDA proposed new labeling rules in March 2013 in response to a World Trade Organization (WTO) ruling that the old labels discriminated against imported livestock from other countries. The proposed rules would require that that all meat from animals born, raised and processed in the United States bear a “born, raised and slaughtered in the USA” label. “The only acceptable way to respond to the WTO challenge is to make labels more informative for consumers, not water them down,” states the letter. “U.S. farmers and ranchers are proud of what they produce and should be allowed to promote their products.” “Consumers want more information about the source of their food, not less,”…

The California Assembly’s Environmental Safety and Toxic Materials Committee has scheduled an April 16, 2013, hearing on a bill (A.B. 227) intended to give small business owners two weeks to correct a purported violation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) without incurring any liability under the law. The measure was introduced by Assemblyman Mike Gatto (D-Silver Lake) at the request of a coffeehouse owner who received a 60-day legal notice after he started serving alcoholic beverages without the requisite Prop. 65 warning to customers about chemicals, such as alcohol, known to the state to pose a cancer or reproductive health risk. If the letter recipient demonstrates to the satisfaction of a city attorney, local district attorney or state attorney general that the violation has been corrected, no further enforcement action could be taken. As currently drafted, the bill would provide a safe harbor…

The Food and Drug Administration (FDA) has announced the availability of “Draft Compliance Policy Guide Sec.100.250 Food Facility Registration— Human and Animal Food” (draft CPG), which aims to “provide guidance for FDA staff regarding enforcement of the food facility registration provisions under a section [415] of the Federal Food, Drug, and Cosmetic Act .” To this end, the draft CPG outlines how FDA plans to implement provisions establishing food facility registration requirements as well as “FDA’s authority to suspend a food facility’s registration.” According to FDA, the finalized CPG “will replace ‘Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.’” Comments should be submitted by May 6, 2013. See Federal Register, April 4, 2013.

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has announced the availability of draft guidance concerning (i) “the classification of materials under USDA organic regulations (7 CFR part 205)” and (ii) “materials for use in organic crop production.” In particular, the first set of guidance “details the procedures and decision trees for classifying the materials used for organic crop production, livestock production, and handling,” while the second set includes “an itemization of allowed natural and synthetic materials and a limited appendix of materials prohibited in organic crop production.” AMS has asked “accredited certifying agents, certified operations, material evaluation programs, and other organic industry stakeholders” to submit comments on these documents through June 3, 2013. The agency will eventually publish the finalized version as part of the National Organic Program’s handbook for certifying agents and certified operations. See Federal Register, April 2, 2013.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) recently issued a notice directing import inspectors to increase “species sampling and testing” on products from countries affected by the European Union’s ongoing investigation into beef contaminated with horsemeat. According to the new order, FSIS has scheduled “increased species sampling for product from Iceland, Ireland, Poland, the United Kingdom, and Northern Ireland via PHIS [Public Health Information System],” but dropped Brazil from the list of those countries requiring special attention from inspectors. “We are confident that the inspection system at ports of entry ensures the safety of products that come into our country every day,” said FSIS spokesperson Catherine Cochran. “However, in response to recent events and consumer concerns, we are increasing species testing to enhance current safeguards and prevent fraudulently labeled products from entering the country.” See Bloomberg, April 4, 2013.

A U.S. Department of Agriculture Office of Inspector General audit report titled “FSIS E. coli Testing of Boxed Beef” concludes that the Food Safety and Inspection Service (FSIS) must reevaluate its E. coli testing methodology and “take additional steps to ensure that beef to be ground throughout the production process—from Federally inspected slaughter establishments to local grocery stores—be subject to FSIS sampling and testing for E. coli.” According to the report, “FSIS is not testing tenderized meat products for E. coli despite several recent recalls.” The Kansas City Star noted that the report was issued three months after the newspaper published a series of stories profiling individuals who had apparently been sickened with E. coli poisoning after consuming medium-rare, mechanically tenderized steaks in restaurants. The article highlighted that “the process of mechanically blading that meat uses automated needles or knives to tenderize tougher cuts of beef, forcing pathogens into the…

The Animal Legal Defense Fund (ALDF) and Compassion Over Killing have reportedly filed a complaint in a California federal court against the Food and Drug Administration, U.S. Department of Agriculture and Federal Trade Commission claiming that the agencies have failed to regulate animal-welfare labeling on egg cartons. According to ALDF, rulemaking petitions were filed in 2006 and 2007 asking for egg production methods to be fully disclosed on every carton of eggs sold in the United States. The agencies have not only allegedly failed to take action on these requests, they have also apparently failed to take action against “the often-misleading claims and deceptive imagery widely found on egg cartons.” The plaintiffs seek a court order requiring the agencies to adopt rules that would mandate that producers clearly label their egg cartons with egg production methods, including “Eggs from Caged Hens.” See ALDF News Release, March 28, 2013.

A federal court in California has dismissed with prejudice a complaint filed by groups concerned about ducks force-fed to produce foie gras against the U.S. Department of Agriculture (USDA) and its Food Safety and Inspection Service (FSIS), seeking to compel FSIS to ban force-fed foie gras from the human food supply as adulterated and diseased. Animal League Def. Fund v. USDA, No. 12-4028 (U.S. Dist. Ct., C.D. Cal., decided March 22, 2013). FSIS denied a petition to take such action, and the plaintiffs filed the lawsuit to challenge the legality of that denial under the Administrative Procedure Act. According to the court, while an agency’s denial of a petition for rulemaking can be challenged in court, the plaintiffs here did not ask FSIS to promulgate a new rule. “Though titled ‘PETITION FOR RULEMAKING,’ Plaintiffs’ request seeks to ban force-fed foie gras under existing law and regulations: it is not a…

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