Category Archives Legislation, Regulations and Standards

The U.S. Food and Drug Administration (FDA) has scheduled a November 13, 2014, public meeting in College Park, Maryland, to solicit stakeholder comments and respond to questions about revisions to four rules first proposed in 2013 to implement the Food Safety Modernization Act (FSMA). The proposals address (i) Preventive Controls for Human Food, (ii) Produce Safety, (iii) Preventive Controls for Animal Food, and (iv) Foreign Supplier Verification Programs. Information about registration and making oral presentations may be found at FDA’s website. See Federal Register, October 23, 2014.   Issue 542

The U.S. Department of Health and Human Services (HHS) and Department of Agriculture (USDA) have scheduled a meeting of the 14-member committee charged with developing the federal government’s “2015 Dietary Guidelines for Americans” for November 7, 2014, from 10 a.m. to 5:30 p.m. EST. The meeting is accessible to the public by Webcast only and registration is required to view the proceedings. Aimed at promoting consumption of foods and beverages that assist in maintaining a healthy weight and preventing disease, the guidelines were first issued in 1980, are revised every five years and provide the basis for federal food and nutrition policy and education efforts. The next iteration of the guidelines will be published during fall 2015. Information about the November 7 meeting agenda, Webcast registration and the committee’s requests for written comments may be found at the Office of Disease Prevention and Health Promotion’s website. See Federal Register, October 20,…

Confirming early reports discussed in Issue 536 of this Update, the World Trade Organization (WTO) has again ruled in favor of Canada and Mexico regarding U.S. country-of-origin labeling (COOL) regulations requiring pork and beef products originating outside of the United States to bear labels indicating where each step in the production process occurred. The compliance panel found that the measure “accords to Canadian and Mexican livestock less favorable treatment than that accorded to like US livestock.” The panel also found that the rule’s 2013 amendment “increases the original COOL measure’s detrimental impact on the competitive opportunities of important livestock in the US market, because it necessitates increased segregation of meat and livestock according to origin; entails a higher recordkeeping burden; and increases the original COOL measure’s incentive to choose domestic over imported livestock.” Following the decision’s release, Mexican and Canadian trade officials issued a joint statement calling the COOL rule “a…

Agribusiness & Food Safety Associates Ann Havelka and Jara Settles have co-authored an article titled “FDA Warning Isn’t Enough Proof for Takings Claim” published on October 17, 2014, by Law360. The authors discuss a recent Court of Federal Claims ruling that rebuffed a takings claim filed by tomato growers who alleged that a 2008 Food and Drug Administration (FDA) warning about a Salmonella outbreak purportedly associated with certain raw red tomatoes caused tomato sales to decline dramatically. The outbreak was eventually linked to Mexican peppers. The article concludes that while the plaintiffs may have focused on the wrong argument to support their claims, the ruling “should prevent a flood of takings claims in the wake of garden-variety governmental warnings,” which, the authors contend, will allow FDA the flexibility it needs to protect public health. Additional information on the ruling appears in Issue 539 of this Update.   Issue 542

California Governor Jerry Brown (D) recently signed a bill (A.B. 504) extending the prohibition of spawning, incubating or cultivating of genetically engineered (GE) salmon in the Pacific Ocean to all state waters. Hatchery production and stocking of transgenic fish is also prohibited. The legislation was sponsored by Assemblymember Wesley Chesbro (D-Arcata), who asserts that the specter of “frankenfish” escaping into California waters “could destroy our native salmonid populations through interbreeding, competition for food and the introduction of parasites and disease.” The new law also restricts medical or scientific research to that performed by “accredited California academic institutions or private entities for research only and not for commercial production,” provided such activities are conducted in closed systems that reduce the “risk of escape of transgenic finfish species and any potential disease they may transmit.” See Press Release of Assemblymember Wesley Chesbro, September 29, 2014.   Issue 541

Vermont Attorney General (AG) William Sorrell is inviting public comments on a draft rule intended to enforce the state’s new law requiring the labeling of genetically modified organisms (GMOs) in food products. The proposed rule defines relevant terms such as “food,” “genetic engineering” and “in vitro nucleic acid techniques,” providing standards for retailers and food manufacturers about how to label and display the foods. In addition, the draft rule lists exemptions from the GMO-labeling requirement, including alcoholic beverages, food prepared for immediate consumption, medical food, and processed foods containing less than 1 percent genetically engineered materials. The AG’s office is accepting comments by email and at hearings set for October 21, 22 and 24, 2014, in Burlington, Montpelier and Brattleboro, Vermont. Additional information about the law appears in Issue 521 of this Update, and a recent development on the lawsuit challenging the law appears in Issue 540 of this Update. See Office…

The U.S. Department of Agriculture (USDA) has scheduled a November 4-5, 2014, public meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Advisory Committee at the National Grain Center in Kansas City, Missouri. Issues for discussion at the meeting will reportedly include the reauthorization status and standardization of user fees paid by official agencies; commodity inspection fees; and updates on quality assurance, compliance, science, and technology programs. See Federal Register, October 14, 2014.   Issue 541

Senior executives from the National Association of Manufacturers (NAM) and U.S. Chamber of Commerce have co-authored an October 14, 2014, letter to members of Congress urging the lawmakers to “authorize and direct the Secretary of Agriculture to rescind elements of [country-of-origin labeling (COOL)] that have been determined to be noncompliant with international trade obligations by a final [World Trade Organization (WTO)] adjudication.” Citing Americans’ jobs as a primary concern, the executives argue that the regulations requiring muscle cuts of meat to include COOL would harm the United States’ relationship with its neighbors. “We are especially concerned that, should the WTO litigation conclude with a ruling of noncompliance by the United States, Congress would be unable to amend the statute prior to Canada and Mexico, our two largest export markets, instituting WTO-authorized retaliation against U.S. exports,” the letter said. “The history is clear. Buyer supply chain needs result in export markets being…

The Natural Resources Defense Council (NRDC) has joined the Center for Science in the Public Interest and other consumer groups in petitioning the U.S. Food and Drug Administration (FDA) to remove several chemicals from food contact materials. The first food additive petition asks FDA to promulgate a new rule “prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles,” and to amend existing regulations to ban the use of potassium perchlorate in food container sealing gaskets. Citing “the well-recognized toxicity of perchlorate,” the petition alleges that dietary exposure can impair fetal and infant development, especially when pregnant or nursing women do not consume enough iodine. A second petition urges the agency to revoke approval for “the use of long-chain perfluorocarboxylate [PFC] oil and grease repellents in paper and paperboard.” Noting that FDA has already asked some domestic manufacturers to…

A California federal court has granted in part and denied in part a motion for summary judgment in a lawsuit alleging that Mott’s violated the U.S. Food and Drug Administration’s (FDA’s) and California’s Sherman Law standards on the use of “no sugar added” on food packaging. Rahman v. Mott’s LLP, No. 13-3482 (N.D. Cal., order entered October 14, 2014). The plaintiff alleged that Mott’s 100% Apple Juice included a “no sugar added” label but failed to follow the additional FDA regulations requiring “a statement that the food is not ‘low calorie’ or ‘calorie reduced’ (unless the food meets the requirement for a ‘low’ or ‘reduced calorie’ food) and that directs consumers’ attention to the nutrition panel for further information on sugar and calorie content.” Mott’s moved for summary judgment on four grounds: the plaintiff (i) did not suffer damages as a result of purchasing the apple juice, (ii) lacked standing…

Close