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
Category Archives Legislation, Regulations and Standards
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
While Connecticut enacted legislation (H.B. 6527) in June 2013 requiring that foods containing genetically modified (GM) ingredients be labeled as such, once neighboring states have adopted similar laws, Governor Daniel Malloy (D) held a ceremonial bill signing in a health food café in Fairfield on December 11, 2013. Now known as Public Act 13-183, the bill’s provisions are summarized in Issue 486 of this Update. The governor said, “I am proud that leaders from each of the legislative caucuses can come together to make our state the first in the nation to require the labeling of GMOs. The end result is a law that shows our commitment to consumers’ right to know while catalyzing other states to take similar action.” See Press Release of Governor Daniel Malloy, December 11, 2013.
The European Food Safety Authority’s (EFSA’s) Panel on Food Additives and Nutrient Sources Added to Food (ANS) has published its full risk assessment on aspartame, concluding that the food additive is safe at current levels of exposure. In addition to noting that aspartame’s breakdown products— phenylalanine, methanol and aspartic acid—occur naturally in other foods, EFSA’s experts found that aspartame’s acceptable daily intake (ADI) of 40 mg/kg bw/day “is protective for the general population,” with the exception of those individuals with phenylketonuria, a medical condition that necessitates a diet low in phenylalanine. At the request of the European Commission, the ANS Panel analyzed “all available information” in an effort to resolve uncertainties related to the re-evaluation of aspartame as a food additive. In particular, the panel’s final scientific opinion assessed both human and animal studies submitted in response to public calls for data; previous evaluations; and additional literature that became available during…
The Federal Trade Commission (FTC) recently hosted a workshop on digital native advertising as part its effort to ensure that “consumers can identify advertisements as advertising wherever they appear.” Titled “Blurred Lines: Advertising or Content?,” the workshop examined “the practice of blending advertisements with news, entertainment, and other content in digital media,” bringing together publishers, marketers, consumer advocates, academics, and self-regulatory organizations to discuss: (i) “the ways in which sponsored content is presented to consumers online and in mobile apps”; (ii) “consumers’ recognition and understanding of it”; (iii) “the contexts in which it should be identifiable as advertising”; and (iv) “effective ways of differentiating it from editorial content.” Building on recent updates to FTC’s guidance on search engine advertising, dot com disclosures, and endorsements and testimonials, the workshop is reportedly the latest step in the commission’s efforts to ensure that digital advertisers conform to rules intended to help consumers distinguish between…
Due to the recent government shutdown, the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) have rescheduled the second meeting of the 2015 Dietary Guidelines Advisory Committee for January 13-14, 2014. Among those on the agenda are HHS, USDA and Institute of Medicine representatives, committee members and Food Systems Consultant Kate Clancy, who will address “Dietary Guidelines and Sustainability.” The public will have an opportunity to speak, and those who registered to do so before the originally scheduled October 3-4, 2013, meeting “will retain their designation.” Those choosing to participate by Webcast or in person must register by January 6, 2014. Comments are requested either by December 31, 2013, or throughout the committee’s deliberative process. See Federal Register, December 9, 2013.
The U.S. Department of Agriculture (USDA) has terminated proceedings on a proposed marketing agreement that sought to regulate the handling of fresh leafy green vegetables in the United States. Modeled after a 2006 initiative pioneered by California growers in the wake of an E. coli outbreak linked to fresh spinach, the National Leafy Green Marketing Agreement (NLGMA) would have authorized “the development and implementation of handling regulations (audit metrics) to reflect the United States Food and Drug Administration’s (FDA) Good Agricultural Practices, Good Handling Practices, and Good Manufacturing Practices.” According to the California LGMA, which participated in the NLGMA effort, the proposed program became redundant under the Food Safety Modernization Act (FSMA), which requires FDA to regulate produce farmers “to ensure their products are safe.” To this end, the California LGMA recently submitted comments on FSMA’s proposed Produce Safety Rule, asking the FDA to consider certified LGMA members as compliant…
The U.S. Food and Drug Administration (FDA) has announced plans to phase out the use of certain antibiotics in food animals as part of its effort to reserve medically important drugs for the treatment of human infection. Noting that voluntary participation “is the fastest, most efficient way to make these changes,” the agency will partner with industry to discontinue the practice of adding these drugs to animal feed and drinking water as a growth promoter. To this end, FDA has issued final guidance that urges animal pharmaceutical companies “to voluntarily revise the FDA-approved conditions on the labels of these products to remove production indications,” in addition to proposing an updated veterinary feed directive (VFD) “to facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs.” “The plan also calls for changing the current over-the-counter (OTC) status to bring…
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a request for public comments on draft templates for tabulating epidemiology studies and data from animal studies for use by members of the agency’s Science Advisory Board Development and Reproductive Toxicant Identification Committee. Comments are requested by December 23, 2013. See OEHHA News Release, December 4, 2013. Meanwhile, during the December 5 meeting of OEHHA’s Carcinogen Identification Committee, diisononyl phthalate, a plasticizer used in food-contact materials, and butyl benzyl phthalate, a chemical used in food conveyor belts, were discussed as candidates for addition to the Proposition 65 list of chemicals known to the state to cause cancer. See Proposition 65 News, December 5, 2013.
Environment Canada has published a significant new activity notice that will allow AquaBounty Technologies, Inc. to produce genetically modified (GM) salmon eggs. According to the company, the agency determined that GM salmon “is not harmful to the environment or human health when produced in contained facilities.” AquaBounty CEO Ron Stotish said, “This is a significant milestone in our efforts to make AquAdvantage® Salmon available for commercial production. However, our eggs and fish will not be available for sale until they are approved by the relevant national regulatory bodies.” The company notes that Environment Canada reached its conclusion “following a risk assessment conducted by Fisheries and Oceans Canada involving a panel of independent scientific experts knowledgeable in the fields of transgenics and fish containment technology.” See Canada Gazette, November 23, 2013; AquaBounty Technologies News Release, November 25, 2013.
