The U.S. Food and Drug Administration (FDA) has announced a public meeting on February 20, 2014, in College Park, Maryland, to “discuss its proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism.” The agency has proposed the requirement as part of its implementation of the Food Safety Modernization Act. FDA will accept comments until March 31. See Federal Register, December 24, 2013.
Category Archives Legislation, Regulations and Standards
The New York City (NYC) Council has reportedly adopted legislation that would prohibit the use of foam food containers by 2015, if city sanitation officials determine that recycling the substance is not feasible. Favored by outgoing Mayor Michael Bloomberg, the legislation referred to as the Styrofoam ban—would include a six-month grace period, during which only warnings would be issued, as well as a hardship exemption for nonprofits and small businesses that could request a one-year renewable waiver. Bloomberg thanked the city council for approving the measure, saying “This legislation not only eliminates a product that cannot be recycled in New York City, it is a giant step forward in the City’s effort to recycle organic waste. Foam pollutes the waste stream, making it harder to recycle food waste as well as metal, glass and plastic.” See NYC Mayor Michael Bloomberg News Release and Law360, December 19, 2013. Issue 508
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has added diisononyl phthalate—a plasticizer used in food contact materials—to the list of chemicals known to the state to cause cancer. OEHHA’s Carcinogen Identification Committee determined that “the chemical was clearly shown, through scientifically valid testing according to generally accepted principles, to cause cancer.” The addition, made under the “state’s qualified expert” mechanism of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65), takes effect December 20, 2013. OEHHA will next set a safe exposure level for the chemical. See OEHHA News Release, December 12, 2013; Bloomberg BNA Product Safety & Liability Reporter, December 13, 2013. Issue 508
The Chinese Food and Drug Administration (CFDA) has announced a public consultation on a draft regulation, “Provisions on the Administration of the ‘Black List’ System for Food and Drug Safety,” that would give regulators the authority to blacklist companies that violate food safety laws. The regulation would allow information on manufacturers that violate laws and regulations concerning food, drugs, medical appliances, and cosmetics management, and receive administrative penalties, to be made public through government Websites. Producers and operators included on the “blacklist” would apparently face increased regulatory supervision. The draft regulation reportedly also covers food and beverage producers that fail to comply with production license requirements, mislabel products and do not respond appropriately to food safety incident cases. Companies using fallacious, unsubstantiated or misleading marketing would be ordered to suspend production and, in the case of serious breaches of regulations, have their business licenses revoked. Additions to the “blacklist” would…
The European Commission (EC) has published legislation listing the 10 smoke flavoring primary products authorized for use in food. According to Smoke Flavoring Regulation EC No. 2065/2003, these primary products include smoke condensates and tar fractions that can be used directly on foods such as meat and fish to impart a smoky flavor or in the production of derived smoke flavorings, which are then added to a variety of foods and sauces. Reflecting input from the European Food Safety Authority, the Commission’s latest list describes the maximum permitted level for each primary product and the foods to which they can be added. “When authorized smoke flavorings are used in or on food, their use must be in accordance with the conditions of use, including maximum levels, set in the Annex to this Regulation. When authorized smoke flavorings are used in combination, the individual levels should be reduced proportionally,” concludes the…
The European Commission (EC) recently proposed two draft directives that would prohibit the cloning of farm animals in the European Union (EU) as well as the importation of cloned animals. Designed to address animal welfare concerns and provide “legal certainty in this field,” the first directive would temporarily ban cloning techniques and the sale of live animal and embryo clones for commercial purposes, while the second directive would ensure that “food such as meat or milk from animal clones is not placed on the EU market.” At the same time, the Commission has also proposed revising current regulations to centralize the novel food authorization procedure at the EU level “with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.” Under these revised rules, the European Food Safety Authority would perform the risk assessment for the novel…
The European Commission (EC) has published a report titled “Origin labelling for meat used as an ingredient: consumers’ attitude, feasibility of possible scenarios and impacts” that provides an overview of the potential consequences of mandatory origin labeling of meat used as an ingredient in food. Based on an independent study completed in July 2013, the report explores three scenarios: (i) maintaining current voluntary origin labeling; (ii) introducing mandatory labeling for EU/non-EU or EU/specific third country indication; and (iii) introducing mandatory labeling indicating the specific EU member state or the specific third country. Among other things, the findings revealed that (i) overall there is “strong” consumer interest in origin labeling; (ii) a considerable difference exists among European Union (EU) member states on consumer preferences and understanding of origin information as well as on the levels of motivation and reasons for wishing to have such information; and (iii) consumer interest for origin…
The World Health Organization (WHO) has reported the first documented case of avian influenza A (H10N8) in a human patient from Jiangxi Province, China. Reiterating that no evidence yet indicates human-to-human transmission, WHO noted that the 73-year-old patient visited “a live bird market four days before date of onset” and eventually died from the disease. “Although China has previously detected H10N8 in wild and domestic birds, this is the first ever report of H10N8 isolated from a patient,” states the organization’s December 2013 fact sheet. “Given the potentially unpredictable behavior of influenza viruses, vigilance and close monitoring is needed… The Chinese government is actively investigating this event and has heightened disease surveillance for early detection, prevention and control measures.” See NBC News, December 18, 2013. Issue 508
The U.S. Food and Drug Administration (FDA) has extended until March 3, 2014, the period for submission of comments, scientific data and other information related to its draft document titled, “Draft Risk Profile on Pathogens and Filth in Spices.” Originally published in the November 4, 2013, Federal Register, the draft risk profile identifies the most commonly occurring microbial hazards and filth in spices and quantifies, where possible, the prevalence and levels of these adulterants at different points along the spice supply chain. It identifies potential sources of contamination throughout the farm-to-table spice supply chain and evaluates the efficacy of current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States. It also describes potential future mitigation and control options and identifies critical data gaps and research needs. FDA invites comments that can help improve the (i) data and information used;…
The U.S. Food and Drug Administration (FDA) has extended until March 8, 2014, the period for submission of comments and scientific data pertaining to its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. FDA published a notice in the November 8 Federal Register announcing this determination and requesting comments on (i) possible alternative approaches; (ii) the time needed for reformulation; (iii) the burden on small businesses; and (iv) other technical challenges to removing PHOs from the food supply. Additional details about FDA’s opinion on trans fat appear in Issue 503 of this Update. See CFSAN Constituent Update, December 17, 2013. Issue 508
