Category Archives Issue 521

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has determined that the evidence is insufficient to proceed with the Proposition 65 listing process for genistein, a constituent of soy infant formula. Under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) regulations, to identify the reproductive toxicity endpoint, “it is considered necessary that the evidence for developmental toxicity has resulted entirely or predominantly from prenatal exposure,” OEHHA states. “That is not the case for genistein.” The National Toxicology Program monograph on soy infant formula apparently found “clear evidence of adverse effects of genistein in studies with gestational, lactational, and post-weaning treatment, but does not conclude that the effects could result entirely or predominantly from prenatal exposure.” See OEHHA News Release, April 16, 2014. As to OEHHA’s consideration of potential amendments to Proposition 65’s clear and reasonable warning regulations, the agency has agreed to extend the public…

Vermont lawmakers have reportedly passed the nation’s first state bill (H.B. 112) to require mandatory labeling of foods made with genetically modified (GM) ingredients. Passed in the Vermont House of Representatives, 114-30, and in the state Senate, 28-2, the bill would require foods containing GM ingredients sold in retail outlets to be labeled as either “partially produced with genetic engineering,” “produced with genetic engineering,” or “may be produced with genetic engineering.” The legislation would also make it illegal to describe any food product containing GM ingredients as “natural” or “all natural.” Backers of the legislation reportedly expect Governor Peter Shumlin (D) to sign it within the next few weeks, with the law taking effect July 1, 2016. “I am proud of Vermont for being the first state in the nation to ensure that Vermonters will know what is in their food,” Shumlin was quoted as saying. “The even more thrilling…

The U.K. Advertising Standards Authority (ASA) has upheld a complaint claiming that alcohol ads were shown during YouTube videos intended for children. According to the agency, a series of children’s nursery rhyme videos featured advertisements for liquors sold by Wm Morrison Supermarkets PLC (Morrisons) even though both the company and YouTube took action “to prevent alcohol content from being served during content that was family-friendly.” Despite these precautions and YouTube’s warning that users should not access accounts “that declared they were over 18 years of age if they were watching YouTube with a minor,” ASA ruled that the ads in question violated CAP Code rules governing social responsibility, children and alcohol. “The ASA noted that both Morrisons and YouTube had processes in place that were intended to ensure that ads for alcohol were not directed at those under 18 years of age,” it explained. “However, we considered that the YouTube video…

The U.K. Advertising Standards Authority (ASA) has reportedly dismissed a complaint about a controversial National Health Service advertisement showing a tumor growing in the bottom of a beer glass with the tag line “the more often you drink, the more you increase your risk of developing cancer.” Promoted by the alcohol awareness charity Balance and shown in a section of England reported to have the country’s highest rates of alcohol related health problems, the advertisement depicts a man preparing a meal and pouring a beer into a glass. As the man drinks the beer, a tumor appears to slowly grow at the bottom of the glass and slide toward his mouth. A voice-over then states, “The World Health Organization classifies alcohol as a group one carcinogen … The more you drink and the more often you drink, the more you increase your risk of developing cancer.” Calling the ad “misleading and irresponsible,…

The European Food Safety Authority (EFSA) has launched a public consultation on its draft scientific opinion determining “the essential composition of infant and infant follow-on formulae.” Drawing on new evidence as well as dietary intake guidelines for infants and young children, the draft opinion addresses requirements for protein, fat, carbohydrates, micronutrients, and other ingredients found in formula. It also notes that nutrients should be added to formula only “in amounts that serve a nutritional or other benefit.” Among other things, the agency concluded that (i) “cow’s milk, goat’s milk and isolated soy protein are safe and suitable sources of protein for use in infant and infant follow-on formula based on intact protein”; (ii) “formulae containing protein hydrolysates are insufficiently characterized by the declared protein content even if they fulfill regulatory criteria concerning amino acid patterns and contents”; (iii) “infant and follow-on formula should provide indispensable and conditionally indispensable amino acids…

The Environmental Working Group (EWG) has requested that the U.S. Environmental Protection Agency (EPA) halt the use of a “post harvest growth regulator”—diphenylamine (DPA)—on apples “until a rigorous analysis (re-registration) by EPA of the chemical can prove that it poses a reasonable certainty of no harm to consumers.” EWG cites in support of its request a 2012 European Food Safety Authority finding that “it could not confirm the safety of [DPA] because producers had not provided information about DPA on European apples and pears,” the European Commission’s (EC’s) ban on the chemical’s use on pears and apples in June 2012, and the EC’s decision to reduce the allowable level of DPA on imports to 0.1 part per million. According to EWG, some 80 percent of domestic apples tested had measurable levels of the chemical on them, with the average level four times the European import limit. DPA is apparently applied after…

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued guidance for identifying, controlling and labeling allergens and other ingredients of public health concern through hazard analysis and critical control point (HACCP) plans, standard operating procedures (SOPs) or other prerequisite programs. Geared toward meat and poultry products, the guidance seeks to ensure “that product labels declare all ingredients, as required in the regulations, and that the product does not contain undeclared allergens or other undeclared ingredients.” In particular, the agency points to “a sustained increase in the number of recalls of FSIS-regulated products that contained undeclared allergens,” noting that such recalls are “preventable, as many have been due to ingredient changes, product changes, products in the wrong package, or products with misprinted labels.” In addition to establishing best practices for SOPs and HACCP plans, the recommendations clarify how to properly process, handle, store, and label a product…

The U.S. Department of Agriculture (USDA) has announced that it will require reporting of Porcine Epidemic Diarrhea Virus (PEDv) and Swine Delta Coronavirus infections to curb the spread of the diseases. In addition, USDA will track “movements of pigs, vehicles, and other equipment leaving affected premises.” Hog farms in 29 states have already reported incidents of PEDv, which has killed more than six million piglets since it was first identified last spring. The virus poses no food safety concerns because it only affects pigs, but it has contributed to higher domestic pork prices. No PEDv vaccine is approved for use in the United States, but earlier this month, six senators from pork-producing states pressed Senate subcommittee leaders to provide funding to develop a vaccine for PEDv and Swine Delta Coronavirus. See Agriculture Secretary Tom Vilsack Announcement, April 18, 2014.   Issue 521  

The U.S. Food and Drug Administration (FDA) has released its Food Code Reference System (FCRS), a searchable database that provides information for industry about FDA’s positions and responses to questions related to the FDA Food Code. With an aim “to promote nationwide consistency and increase transparency about the Food Code,” FCRS contains entries that clarify issues such as (i) storing foods that require temperature control for safety; (ii) food establishment design and food equipment cleaning; (iii) bare hand contact with ready-to-eat foods; and (iv) preventing food contamination. FDA plans to add entries that are “important to the uniform application of the Food Code and that may have implications across all jurisdictions that regulate food establishments.” These entries will reflect questions previously answered by FDA as well as responses to future inquires that FDA receives. The Retail Food Protection Team in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will…

The U.S. Food and Drug Administration (FDA) has issued a final rule, effective April 14, 2014, amending its food additive regulations to allow the use of ionizing radiation on crustaceans (e.g., crab, shrimp, lobster, crayfish, and prawns) to control foodborne pathogens and extend shelf life. In response to a petition first filed in 2001, FDA concluded that use of irradiation to treat chilled or frozen raw, cooked or partially cooked crustaceans, or dried crustaceans, with or without spices, minerals, inorganic salts, citrates, citric acid and/or calcium disodium EDTA used in accordance with applicable laws and regulations, is safe, provided that the absorbed dose does not exceed 6.0 kGy. At this dose, FDA notes, ionizing radiation will reduce but not entirely eliminate, the number of illness-causing microorganisms in or on crustaceans. The agency also observes that irradiation is not a substitute for proper food-handling practices and that crustaceans treated with ionizing…

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