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
Category Archives 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
According to U.S. Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor, the agency will revise proposed rules under the Food Safety Modernization Act (FSMA) “affecting farmers,” who have apparently expressed concern about the potential impact on their livelihoods. Among provisions to be revised and re-published for public comment in early summer 2014 are (i) “sections covering water quality standards and testing,” (ii) “standards for using raw manure and compost,” (iii) those “affecting mixed-use facilities (such as a farm that has a food-processing operation),” and (iv) “procedures used to withdraw the qualified exemption to these requirements for certain farms.” Taylor also noted that the agency continues to review the comments already submitted to the rulemaking docket and may decide to include other changes for public comment. See FDA Voice, December 19, 2013. Issue 508
The U.S. Food and Drug Administration (FDA) has proposed a rule that will implement those provisions of the Food Safety Modernization Act addressing “hazards that may be intentionally introduced by acts of terrorism.” Under the rule, domestic and foreign facilities that manufacture, process, pack, or hold food would be required to register and implement certain measures to protect against the intentional adulteration of food. These facilities, with certain exemptions, would be required, among other things, to “prepare and implement a written food defense plan that includes actionable process steps, focused mitigation strategies, and procedures for monitoring, corrective actions, and verification.” The proposal is expected to be published in the December 24, 2013, issue of the Federal Register, and will have a 30-day public comment period. See FDA News Release, December 20, 2013. Issue 508
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