The U.S. Food and Drug Administration (FDA) has issued draft guidance for the food industry titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).” Intended to address questions received since publication of the second edition in May 2004, the guidance includes information related to the Food Safety Modernization Act, which requires prior notice indicating whether a food article has been refused entry by any country. FDA will accept comments at any time, but suggests submitting them by May 30, 2014, to ensure consideration before the agency begins work on the final version. See Federal Register, March 31, 2014. Issue 519
Category Archives Legislation, Regulations and Standards
After reportedly receiving more than 2,000 comments criticizing its proposal to tighten regulations concerning the transaction of spent grain between brewers and farmers, the U.S. Food and Drug Administration (FDA) has apparently decided to revise its original plan, stating that it will release an amended version of the proposal this summer. According to news sources, brewers, who for years have donated or sold their spent grain to farmers to use as animal feed, were outraged at the proposed regulation—part of FDA’s Food Safety Modernization Act—claiming it would turn an ages-old practice into a heavy burden, requiring them to alter processes and testing requirements and add additional recordkeeping tasks. Brewers also note that under the currently proposed terms, they would either be required to dry and package spent grain before sending it off as animal feed or to discard it entirely, leaving it to sit in landfills. See VoiceofSanDiego. org, April 3, 2014;…
The International Chewing Gum Association (ICGA) recently submitted comments to the U.S. Food and Drug Administration (FDA) about the agency’s proposal to revoke the generally recognized as safe (GRAS) status for partially hydrogenated oils (PHOs). Noting that PHOs are used in some chewing gum products “as softeners or texturizers at levels typically in the range of 0.2 to 2 percent of the finished gum,” ICGA has criticized FDA’s tentative determination as “misguided and overly broad.” In particular, the association has argued that FDA’s blanket revocation violates “the legal and scientific elements of the GRAS standard, which require a safety assessment for intended use by experts in ingredient safety.” According to ICGA, the tentative determination not only represents “a significant departure” from past efforts to reduce trans fat consumption through labeling initiatives, but discards a previous determination that PHOs in amounts less than 0.5 grams per serving “are effectively not present”…
The D.C. Circuit Court of Appeals has affirmed a lower court ruling denying the motion for preliminary injunction filed by meat producer interests in litigation challenging U.S. Department of Agriculture (USDA) regulations requiring retailers of “muscle cuts” of meat to list the countries of origin and production (country-of-origin labeling or COOL) as to each step of production—born, raised or slaughtered. Am. Meat Inst. v. USDA, No. 13-5281 (D.C. Cir., decided March 28, 2014). The regulations at issue were adopted in 2013 in response to a World Trade Organization (WTO) ruling finding their predecessor to violate the WTO Agreement on Technical Barriers to Trade. They “increased the required level of precision” to address each production step and also “eliminated the special allowance for commingled meat.” The plaintiffs argued that the amended rules ban commingling and thus alter “production practices over which the COOL statute gives the Secretary no authority,” and that the…
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has added methyl isobutyl ketone to the list of chemicals known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). The chemical is used as a solvent for vinyl, epoxy, acrylic and natural resins, and as a synthetic flavoring adjuvant and a fruit flavoring. According to OEHHA, the listing is based on the authoritative body listing mechanism because the U.S. Environmental Protection Agency has identified it as a chemical that causes reproductive toxicity. The listing is effective March 28, 2014, and will require exposure warnings to consumers. See OEHHA News Release, March 28, 2014. Issue 518
A French Senate committee has issued a report, “Taxation and Public Health: Evaluation of Behavioral Taxation,” urging lawmakers to implement a “behavioral tax” to counteract poor dietary habits and help cover health care expenditures associated with consumption of “unhealthy” foods. While emphasizing the need for a sugar-sweetened beverage tax, the report also advocates harmonizing tax rates on vegetable oils, aligning cigarette and other tobacco product taxes, and repealing value-added tax breaks for certain foods and drinks linked to increased health care costs. See Tax-News.com, March 20, 2014. Issue 518
The U.S. Department of Agriculture’s Food Safety and Inspection Service and the U.S Environmental Protection Agency have announced an April 10, 2014, public meeting in Arlington, Virginia, to provide information and receive public comments on agenda items and draft U.S. positions for discussion during the 46th Session of the Codex Committee on Pesticide Residues of the Codex Alimentarius Commission in Hong Kong, China, on May 5-17, 2014. Agenda items include (i) revision to the Codex classification of food and feed for step 6-selected vegetable commodity groups (roots and tubers); (ii) draft discussion paper on guidance for setting maximum residue limits (MRLs) for pesticides for minor uses and specialty crops; (iii) revision of the committee’s risk analysis principles on pesticide residues; (iv) priority list for establishing MRLs for pesticides; and (v) guidance for assessing pesticide residue analysis methods. See Federal Register, March 26, 2014. Issue 518
The U.S. Food and Drug Administration (FDA) has secured the participation of all but one animal drug company in the agency’s plan to phase out the use of medically important antimicrobials in food animals for food production purposes, such as artificial weight gain. Each company has “committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.” See FDA News Release, March 26, 2014.
The U.S. Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking under the Food Safety Modernization Act (FSMA) that seeks information to help the agency “implement and enforce” amendments to the reportable food registry (RFR) provisions of the Federal Food, Drug, and Cosmetic Act. Among other things, the new provisions permit FDA to (i) require that parties submit to FDA “consumer-oriented” information regarding certain reportable foods—defined as foods for “which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals”; (ii) use such information to create consumer notification summaries for the agency’s Website; and (iii) obligate certain grocery stores that sell reportable food to display the notification summaries. FDA has requested input from the food industry, consumer organizations and other parties on certain topics, including (i) “what information should be required in…
The Center for Science in the Public Interest (CSPI) and Mercury Policy Project have sued the U.S. Food and Drug Administration (FDA), seeking a declaration that the agency’s delay in responding to their citizen petition on labeling fish with high levels of mercury is unreasonable and violates the Administrative Procedure Act and Federal Food, Drug, and Cosmetic Act. CSPI v. FDA, No. 14-0375 (D.D.C., filed March 10, 2014). Further details about the petition, which seeks labeling on seafood packaging and point-of-purchase signage, appear in Issue 401 of this Update. The plaintiffs also seek an order compelling the agency to issue a final response by a court-imposed deadline. According to the complaint, the plaintiffs submitted the petition to FDA in July 2011 and received a tentative response from the agency beyond the 180-day limit required by FDA regulations. The plaintiffs claim that they have not received any communication from FDA since then…
