The Food and Drug Administration (FDA) has issued a final rule amending 21 C.F.R. 175.300 to reflect the industry’s abandonment of bisphenol A (BPA)- based epoxy resins as coatings in infant formula packaging. As of July 12, 2013, the food additive regulations will no longer provide for this use of BPA. According to FDA, its action followed Rep. Edward Markey’s (D-Mass.) petition asserting that industry had stopped using BPA in infant formula packaging; the action “is not “related to the safety of BPA.” See FDA Center for Food Safety and Applied Nutrition—Constituent Update, July 11, 2013.
Category Archives U.S. Government and Regulatory Agencies
Finding the Food and Drug Administration’s (FDA’s) proposed “target time-frames” “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” a federal court in California will require the agency to publish all proposed regulations required under the Food Safety Modernization Act by November 30, 2013. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decided June 21, 2013). The court further ordered FDA to close each comment period no later than March 31, 2014, and to finalize the rules no later than June 30, 2015. The order follows the court’s determination that FDA violated the FSMA and Administrative Procedure Act by failing to comply with the food safety rulemaking deadlines established by Congress. Additional details about the litigation appear in issues 481 and 487 of this Update.
The U.S. Department of Agriculture (USDA) has issued a notice informing the public about upcoming sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex) and seeking comments on standards under consideration and recommendations for new standards. The notice, which also lists other standard-setting activities, including “commodity standards, guidelines, codes of practice, and revised texts,” covers the time periods from June 1, 2012, to May 31, 2013, and June 1, 2013, to May 31, 2014. See Federal Register, June 21, 2013.
The U.S. Department of Agriculture (USDA) has issued an interim final rule amending the National School Lunch Program and School Breakfast Program regulations “to establish nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs.” Acting under Section 208 of the Healthy, Hunger-Free Kids Act of 2010, the agency considered scientific recommendations and voluntary standards for beverages and snack foods, as well as more than 250,000 public comments, in developing the “Smart Snacks in School” standards, which must also adhere to the most recent Dietary Guidelines for Americans. Effective July 1, 2014, the final rule requires all competitive foods sold in schools to meet the following guidelines: (i) “be a grain product that contains 50 percent or more whole grains by weight or have as the first ingredient a whole grain”; or (ii) “have as the first ingredient one of the non-grain…
The U.S. Government Accountability Office (GAO) recently issued a report criticizing the U.S. Department of Agriculture (USDA) for its “limited” response to school districts that had trouble implementing the new school lunch nutrition standards for the 2012-2013 school year. According to GAO, which gathered feedback from eight districts, schools reported that restrictions on the amount of meats and grains served each week during lunch required them to eliminate popular menu items and made it difficult “to meet minimum calorie requirements for lunches without adding items, such as gelatin, that generally do not improve the nutritional quality of lunches.” In addition, some school food authorities (SFAs) observed that calorie range requirements posed a particular challenge in schools with both middle and high school students “[b]ecause the required lunch calorie ranges for these two grade groups do not overlap.” To address these issues, GAO has recommended that USDA “remove the meat and…
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service has reportedly approved a Non-GMO Project certification seal and “Non-GMO” statement on labels for products from animals that did not consume feed containing genetically modified (GM) ingredients, such as corn, soy and alfalfa. The certification will attest that the meat, poultry and liquid egg products meet the third-party certifying organization’s standards, which USDA vetted before approving the label. The agency action followed a petition filed by the owner of Mindful Meats, which makes and sells organic grass-fed beef to Northern California restaurants and retailers, and two other companies, Hidden Villa Ranch and Pitman Farms. According to Mindful Meats’ statement, “this is the first time that a U.S. government agency has approved a non-GMO label for beef.” See The New York Times, June 20, 2013; Mindful Meats Blog, June 21, 2013.
The Center for Food Safety and the Food and Drug Administration (FDA) have filed separate proposals to implement a court order requiring the agency to complete its rulemaking under the Food Safety Modernization Act (FSMA) after finding that FDA had violated the law by failing to meet its rulemaking deadlines. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., proposals filed June 10, 2013). Additional information about the court’s order appears in Issue 481 of this Update. According to plaintiff’s proposal for injunctive relief, FDA “utterly fails to comply with the Court’s Order and FSMA,” because the agency has insisted on establishing “a schedule of target timeframes” that the agency “will endeavor to meet” with caveats that could require new timeframes. The Center proposes May 1, 2014, as the date on which seven final implementing rules must be submitted to the Federal Register. It would add an additional year to…
A federal judge in California has notified the parties to a consumer-fraud action against the company that makes Mission® tortilla chips of her inclination to stay the litigation for six months and refer to the Food and Drug Administration (FDA) the question “whether products containing GMO [genetically modified organisms] or bioengineered ingredients may properly be labeled ‘Natural’ or ‘All Natural.’” Cox v. Gruma Corp., No. 12-6502 (N.D. Cal., notice filed June 7, 2013). The plaintiffs have opposed the tentative stay order, arguing that a prompt regulatory determination is unlikely given FDA’s past inaction on the matter. They reportedly cited a recent Florida decision denying a soup company’s motion to dismiss similar litigation on preemption grounds because FDA does not regulate “Natural” or “All Natural” food labeling claims. The court, however, cited a Ninth Circuit ruling deferring to FDA’s regulatory authority so that the agency’s “considered judgments” would not be undermined…
The Food and Drug Administration (FDA) has issued a final rule that amends color additive regulations to provide for “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis.” The action follows a petition filed by E. & J. Gallo Winery and takes effect July 15, 2013. See Federal Register, June 12, 2013.
The Animal Welfare Institute (AWI) has submitted a petition to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) asking that the agency require all slaughter establishments to create and implement written animal-handling plans to decrease the “needless suffering of animals during slaughter.” Citing more than 1,000 humane slaughter violations that allegedly occurred at state and federally inspected slaughter plants from 2007 through 2012, AWI calls on FSIS to write regulations that require (i) “all workers who have contact with animals be trained in humane handling,” (ii) “stunning equipment be routinely tested and maintained,” and (iii) “backup stunning devices be available in both the stunning and holding areas of every slaughter plant.” According to AWI, the agriculture department recommended eight years ago that all slaughter plants take a “systematic approach to humane slaughter by developing a comprehensive, written animal handling plan,” yet just 35 percent of federally inspected…
