Category Archives Legislation, Regulations and Standards

California Governor Jerry Brown (D) has signed legislation (S.B. 27) that prohibits administration of a “medically important antimicrobial drug to livestock solely for purposes of promoting weight gain or improving feed efficiency” as of January 1, 2018. Under the statute, antibiotics may be used only when ordered by a licensed veterinarian through a prescription or veterinary feed directive. “The science is clear that the overuse of antibiotics in livestock has contributed to the spread of antibiotic resistance and the undermining of decades of life-saving advances in medicine,” Brown said. See Signing Message of Governor Edmund G. Brown Jr., October 10, 2015.

Three federal agencies are convening an October 30, 2015, public meeting in Silver Spring, Maryland, to discuss a July 2015 memorandum issued by the Executive Office of the President (EOP) directing the agencies to clarify their roles in the oversight of biotechnology products, develop long-term regulatory strategies and commission an independent study of the biotech landscape. The EOP memo defines biotechnology products as those “developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” The meeting will include presentations by representatives of the Department of Agriculture, Environmental Protection Agency and Food and Drug Administration (FDA) about each agency’s current approach to biotech product regulation. Information about registration, oral presentations and viewing the meeting via live webcast is available on FDA’s website. See Federal Register, October 16, 2015.   Issue 581

The National Toxicology Program’s (NTP’s) Office of the Report on Carcinogens and Office of Health Assessment and Translation (OHAT) are requesting information about six substances, including fluoride (CASRN 7681-49-4), nominated for possible review and inclusion in future editions of the Report on Carcinogens (RoC). More specifically, NTP seeks (i) data about the compound’s current production, use patterns and human exposure; (ii) exposure studies evaluating adverse health outcomes, e.g., cancer, reproductive or immunological disorders; (iii) scientific issues relevant to prioritizing adverse health outcomes; and (iv) names of scientists with proven expertise about the chemical. OHAT is also interested in obtaining material about non-cancer health outcomes related to fluoride exposure, e.g., developmental neurotoxicity and endocrine disruption. Information submissions must be received by November 6, 2015. See Federal Register, October 7, 2015.   Issue 581

A California federal court has denied the U.S. Department of Agriculture’s (USDA’s) motion to dismiss a lawsuit brought by environmental organizations challenging USDA’s issuance of a guidance document about the use of pesticides in compost without first having solicited public comment. Ctr. for Envt’l Health v. Vilsack, No. 15-1690 (N.D. Cal., order entered September 29). The Center for Food Safety (CFS), Center for Environmental Health and Beyond Pesticides challenged USDA’s actions on Administrative Procedures Act (APA) grounds, arguing the agency violated federal procedures by not allowing a formal rulemaking and public comment period about a guidance document permitting the use of compost with pesticides in the production of organic food. The court found that the organizations had sufficiently stated their claim under the APA and had standing to sue. “The agency’s unilateral action to allow compost contaminated with pesticides in organic production was contrary to federal rulemaking requirements as well…

Russia has imposed a moratorium on the use of genetically modified organisms in domestic food production. Deputy Prime Minister Arkady Dvorkovich reportedly made the announcement during a biotechnology conference in Kirov on September 18, 2015. Russia’s action follows similar moves by France, Germany and Scotland. See Reuters, September 18, 2015.   Issue 580

The Committees of Advertising Practice (CAP), a group that works in conjunction with the U.K. Advertising Standards Authority, has announced a pre-consultation with various stakeholders in advance of new rules targeting non-broadcast advertising of food and soft drinks high in fat, salt or sugar to children. Non-broadcast channels of advertising include online, outdoor, print media, cinema, and direct marketing. “Our decision to carry out a public consultation responds, in part, to changes in children’s media habits and evolving advertising techniques,” according to CAP. “It also reflects a growing consensus, shared by public health and industry bodies, about the role of advertising self-regulation in helping to bring about a change in the nature and balance of food advertising targeted to children.” CAP reportedly plans to launch the public consultation in early 2016. See CAP News Release, September 29, 2015.   Issue 580

The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) has linked a 2013-2014 outbreak of porcine epidemic diarrhea virus (PEDv) that killed more than 7 million piglets to Flexible Intermediate Bulk Containers (FIBCs), the reusable tote bags used to transport and store pig feed. According to an APHIS report, which seeks to explain why PEDv occurred in the United States but not Canada or the European Union, the bags were most likely contaminated in their origin country before distribution to feed mill customers across the Midwest, where they contaminated “feed or ingredients destined for delivery to the farm.” “Several of the farm investigations as well as an early case-control study suggested feed or feed delivery as the source of the outbreak; however, there were no common feed manufacturers, products, or ingredients in the initially infected herds,” states the report, which notes that the PEDv strain found…

The U.S. Food and Drug Administration (FDA) has issued a final rule allowing “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits.” Mica-based pearlescent pigments are currently approved as color additives in many foods and beverages, including distilled spirits containing “not less than 18 percent and not more than 23 percent alcohol by volume.” Effective November 5, 2015, the new rule permits the use of these pigments at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, while finding that “certification of mica-based pearlescent pigments prepared from titanium dioxide is not necessary for the protection on the public health.” “Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that…

The U.K. Advertising Standards Authority (ASA) has upheld a complaint against Internet advertisements for Drink Doctor Ltd.’s alcohol delivery service, ruling that two banners on the company’s Facebook page “drew a link between provision of alcohol and the provision of medical assistance.” In its ruling, the agency contends that even though consumers were unlikely to confuse Drink Doctor with genuine medical assistance, the use of medical imagery “presented alcohol as a product to be used in the same manner” as medicine. ASA also takes issue with the “boozebulance” vehicle and emergency phone number featured in the ads, as these reportedly implied that alcohol beverages were “necessary and indispensable.” “We also considered that the name ‘Drink Doctor’ in itself contained the same implication by conflating the role of a medical professional with the provision of alcohol,” concludes the ruling, which orders Drink Doctor to refrain from using medical imagery or terminology…

The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the U.S. Food and Drug Administration have announced an October 19, 2015, public meeting in Washington, D.C., to discuss draft U.S. positions for review at the 47th Session of the Codex Committee on Food Hygiene (CCFH) slated for November 9-13 in Boston, Mass. Among other things, CCFH is responsible for prioritizing topics related to microbiological risk assessments and drafting basic hygiene provisions applicable to all food. Agenda items for October 19 include proposed draft guidelines for controlling nontyphoidal Salmonella in beef and pork meat and a discussion paper about revising the Code of Hygienic Practice for Fresh Fruits and Vegetables. See Federal Register, August 25, 2015.   Issue 579

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