Category Archives Legislation, Regulations and Standards

According to a news source, the Hilo, Hawaii, Circuit Court has granted the request of an anonymous papaya farmer to stay the March 5, 2014, deadline imposed by Hawaii County for growers of genetically engineered (GE) crops to register or face a $1,000 penalty per day. Doe v. Cty. Of Hawaii, No. 14-1-0094 (Hawaii Cir. Ct., order entered March 7, 2014). According to the farmer, who is among those raising GE papaya, which resists a devastating ringspot virus, the registration requirement “provides a roadmap for extremists who wish to target GE growers, identifying exactly who to target and where to target them.” The farmer contends that he and other GE farmers in Hawaii County “have been the target of a highly disturbing pattern of vandalism, intimidation, and extremism” and that the perpetrators “have destroyed hundreds of thousands of dollars of GE crops.” See Law360, March 10, 2014.   Issue 517

Maryland lawmakers have proposed legislation (H.B. 1273) that would prohibit the sale of energy drinks to youth younger than age 18. Defining energy drink as a “beverage, an energy shot, or a powdered drink mix that contains 71 milligrams or more of caffeine per 12-ounce serving and the ingredients taurine, guarana, panax ginseng, inositol, or L-Carnitine in any amount,” the bill would also prohibit minors from possessing such drinks and prohibit their sale in vending machines. In a related development, Maryland lawmakers have also proposed legislation (H.B. 1255) that would prohibit the inclusion of “any beverage other than bottled water or low-fat milk in a fixed-priced children’s menu or meal.” See BaltimoreCBSLocal.com, March 7, 2014.   Issue 517

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has scheduled an April 14, 2014, public workshop to discuss “a possible regulatory action to change the existing regulation governing Proposition 65 warnings.” The Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) requires manufacturers to warn consumers if their products contain any substances known to the state to cause cancer or reproductive toxicity. Failure to provide such warnings exposes manufacturers to enforcement actions filed by private entities or state prosecuting authorities and the possibility of significant fines. While the draft proposed changes hyperlinked to the meeting announcement could change before OEHHA takes any final action, they were developed on the basis of public input provided in 2013, after the agency conducted a pre-regulatory workshop, and respond to the governor’s proposal to reform Prop. 65 to, among other things, “require more useful information to the public on what they…

The company that has developed a genetically modified (GM) salmon has reportedly filed an application with Health Canada seeking its approval to market the fish for human consumption. AquaBounty received the approval of Environment Canada in November 2013 to produce GM salmon fish eggs at its Prince Edward Island hatchery—a decision that has been challenged by three environmental groups—and is still awaiting U.S. approval before its fish and eggs can be sold there. The company said that it “currently expects to market AquAdvantage Salmon in the United States, Canada, Argentina, Chile, and China following receipt of required regulatory approvals in the applicable jurisdiction.” See The Canadian Press, March 11, 2014.   Issue 517

The European Food Safety Authority (EFSA) has issued a call for data from member states and other stakeholders on a third batch of food additives, including tertiary-butyl hydroquinone, agar, carrageenan, and xanthan gum, used in food and beverages. The action follows Commission Regulation No. 257/2010 of the European Parliament and the Council on Food Additives, requiring re-evaluation of substances permitted in the EU before January 2009. Specifically, the agency seeks (i) “figures from industry on the amounts of these additives they report using in their products”; and (ii) “data derived from analyses indicating actual levels of these additives found in foods and drinks from national food authorities, research institutions, academia, food industry and other stakeholders.” EFSA will accept data submissions until July 31, 2014, and will reportedly publish further calls for similar data later this year.   Issue 517

The European Food Safety Authority (EFSA) has asked member states “to monitor the presence of brominated flame retardants (BFRs) in food over the next two years.” In light of six scientific opinions published by the Scientific Panel on Contaminants in the Food Chain between September 2010 and September 2012, EFSA has requested additional information on the following BFR classes and their presence in human food: (i) polybrominated diphenyl ethers; (ii) hexabromocyclododecanes; (iii) tetrabromobisphenol A and its derivatives; (iv) brominated phenols and their derivatives; and (v) emerging and novel brominated flame retardants. In addition, the agency noted that “levels of [BFRs] in food of animal origin could be related to the presence of these substances in animal feed, therefore, based on the first results of the monitoring of food in 2014, a recommendation as regards the monitoring of animal feed could follow in 2015.”   Issue 517

The European Parliament has reportedly rejected draft rules mandating the labeling of engineered nanomaterials used in food. According to a March 13, 2014, press release, MEPs voted to scrap the proposed measure over concerns that the European Commission’s definition of nanomaterial “would exempt nano-sized food additives already on the market.” In particular, MEPs noted that although the European Union currently defines engineered nanomaterials “as any intentionally produced material whose size is under 100 nanometres,” the commission’s draft rules stipulated that “a nanomaterial should consist of at least 50% of particles having a size between 1-100 nanometres,” an increase over the European Food Safety Authority’s recommended threshold of 10 percent. “The EP has repeatedly called for proper nano-labeling and it is highly surprising that the Commission even tried to weaken what has been decided by both Parliament and the Council,” MEP Carl Schlyter was quoted as saying. “Consumers have the right…

The U.S. Department of Agriculture’s National Organic Standards Board (NOSB) has announced an April 29-May 2, 2014, public meeting in San Antonio, Texas, to discuss the work of its six subcommittees and receive input on proposed changes to the National List of Allowed and Prohibited Substances (National List), which governs what may be used in organic handling and production. Among other things, the meeting will address several petitions proposing the addition, extension or deletion of substances scheduled for reassessment under the National List’s sunset review rules. In particular, petitioners have requested (i) a National List extension for streptomycin—slated to expire October 14, 2014—to allow “adequate time for the transition from strep over to non-antibiotic, biological alternatives for fire blight control”; (ii) revisions to provisions governing the use of synthetic methionine in poultry feed; (iii) the addition of several synthetic substances used in aquaculture production; and (iv) the removal of synthetic…

The U.S. Food and Drug Administration (FDA) has rejected objections filed after publishing its final rule amending “the food additive regulations authorizing the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food.” According to the agency, “the objections do not provide any basis for us to reconsider our decision to issue the final rule,” and thus FDA has made no changes to it. See Federal Register, March 11, 2014.   Issue 517

The U.S. Food and Drug Administration (FDA) will convene an April 4, 2014, public meeting in College Park, Maryland, to discuss “the scope of the Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption (the produce safety proposed rule).” The agency has also extended the comment period for the EIS scoping period to April 18, 2014, to incorporate meeting input. Having discovered a number of areas where potential environmental impacts are likely, FDA notes that alternatives have been identified for the following key provisions: (i) “microbial standard for agricultural water used during growing activities for covered produce (other than sprouts) using a direct water application method”; (ii) “minimum application intervals for biological soil amendments of animal origin”; (iii) “measures related to animal grazing and animal intrusion”; and (iv) “scope of proposed rule and implications to land…

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