The Food Safety and Inspection Service (FSIS) has issued a final rule, effective May 6, 2013, that amends federal meat and poultry products inspection regulations to remove sodium benzoate, sodium propionate and benzoic acid from the list of substances prohibited for use in meat or poultry products. According to FSIS, after considering the comments and petitions it received, as well as confirming that the Food and Drug Administration (FDA) had no objections to the safety of the substances, the agency has determined “that sodium benzoate, sodium propionate, and benzoic acid, under the conditions proposed in the petitions, are both safe and suitable for use as antimicrobial agents in certain RTE [ready-to-eat] meat and poultry products.” FSIS said that new uses of these substances in meat or poultry products will continue to be approved by FDA for safety and by FSIS for suitability. See Federal Register, March 7, 2013.
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has announced the availability of revised draft guidance related to the evaluation and safety of veterinary drug residues in human food. Both sets of guidance are part of the agency’s efforts under the Registration of Veterinary Medicinal Products to harmonize technical requirements for the approval of veterinary medical products in the European Union, Japan and the United States. The guidance titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI)” offers a plan for assessing “the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.” To this end, the guidance (i) “outline[s] the steps in determining the need for establishing a microbiological [ADI]”; (ii) “recommend[s] test systems and methods for determining no-observable adverse effect concentrations (NOAECS) and no-observable effect concentrations (NOAELs) for the…
The Department of Agriculture (USDA) has issued a proposed rule that would update regulations regarding genetically engineered (GE) organisms “by adding provisions for sharing certain business information with state and tribal government agencies.” According to USDA, the proposed provisions would govern the sharing of certain information contained in permit applications and notifications for importations, interstate movements or releases into the environment of GE organisms. The agency also says that the provisions “would allow the Animal and Plant Health Inspection Service (APHIS) to share certain business information with state and tribal governments without impairing [USDA’s] ability to protect confidential business information from disclosure.” Apparently, APHIS currently withholds such information when it shares applications with non-federal government agencies. USDA says that the action would improve collaborative and cooperative efforts with state and tribal governments and improve effectiveness of its notification and permitting procedures as APHIS continues to regulate certain GE organisms. See Federal…
The Food and Drug Administration (FDA) has released its “International Food Safety Capacity-Building Plan,” which aims to enhance “the food safety capacity of countries that export food to the United States.” As directed by the Food Safety Modernization Act, the plan provides direction on how FDA can (i) “expand the technical, scientific, and regulatory capacity of foreign governments and their food industries,” (ii) “prioritize its capacity-building efforts based on risks,” and (iii) “work in partnership with counterpart authorities, industry, and other organizations in order to achieve lasting food safety results.” To this end, the plan promotes efficiency across the Foods and Veterinary Medicine Program, evidence-based decision-making, the exchange of information between FDA and foreign government agencies, and enhanced technical support for foreign programs. “This capacity-building plan recognizes the need for a change in agency strategy,” states FDA’s report. “Instead of focusing primarily on intercepting harmful products, FDA will attempt to…
The D.C. Circuit Court of Appeals has dismissed a challenge to U.S. Department of Agriculture (USDA) rules requiring California almonds sold domestically to be treated with heat or chemicals to prevent the spread of Salmonella. Koretoff v. Vilsack, No. 12-5075 (D.C. Cir., decided February 22, 2013). According to the court, the almond producers who mounted the challenge had waived their claims “by failing to raise them during the rulemaking process.” They had contended that the USDA secretary exceeded his authority in requiring the treatment of all almonds “irrespective of whether they are contaminated” and that the secretary failed to determine that the treatment rule was “the only practical means of advancing the interests of the producers.” Finding no error in the lower court’s disposition, the court affirmed its grant of summary judgment for the secretary.
The Food and Drug Administration (FDA) has extended the comment periods on two proposed rules related to foodborne illness prevention and produce safety that appeared in the Federal Register on January 16, 2013. In response to a request for a 90-day extension, the agency has increased until May 16, 2013, the comment periods for the proposed rules titled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” Under the Food Safety Modernization Act, the two new rules would (i) require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness,” and (ii) establish “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Additional details about the rules appear in Issue 466 of this Update. See Federal…
The Food and Drug Administration (FDA) has announced that the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have filed a petition requesting that the agency amend the standard of identity for milk and 17 other dairy products “to provide for the use of any safe and suitable sweetener as an optional ingredient.” FDA is seeking comments and other information by May 21, 2013. IDFA and NMPF have evidently asked FDA to amend the milk standard of identity to allow optional characterizing flavoring ingredients used in milk— such as chocolate—to be sweetened with any safe and suitable sweetener, including non-nutritive sweeteners such as aspartame. According to IDFA and NMPF, the proposed amendments “would promote more healthful eating practices and reduce childhood obesity by providing for lower-calorie flavored milk products.” In particular, the petitioners claim that lower-calorie flavored milk would assist “in meeting several initiatives aimed at…
In the wake of an antitrust lawsuit filed by the U.S. Department of Justice (DOJ) seeking to enjoin the acquisition of Mexican brewer Grupo Modelo, Anheuser-Busch InBev (ABI) has reportedly agreed to sell a massive Modelo brewery, including full U.S. rights to the Corona® and Modelo® brands, to Constellation Brands, said to be the world’s largest wine company, for $2.9 billion. Additional information about the antitrust litigation appears in Issue 469 of this Update. The brewery, Compañía Cervecera de Coahuila, situated near the U.S.-Mexico border, produces Corona®, Corona Light® and Modelo Especial®. Constellation, which filed a motion to intervene in the DOJ lawsuit to protect its interests, stands to gain greater access to the American beer market under a revised agreement that would establish Constellation’s Crown Imports beer division as completely independent. Under the deal’s original terms, Constellation would have paid its joint venture partner Modelo $1.85 billion for the 50…
During oral argument before a Second Circuit Court of Appeals panel, the Food and Drug Administration (FDA) reportedly argued that it had “no obligation” to complete proceedings that the agency initiated to withdraw approval from certain uses of antibiotic drugs in livestock. Natural Res. Def. Council v. FDA, No. 12-2106 (2d Cir., argued February 8, 2013). Assistant U.S. Attorney Ellen London said, “It’s completely discretionary as to when to enforce the law as to certain drugs,” in urging the court to reverse a district court order requiring it to hold the withdrawal proceedings announced in 1977 notices. According to a news source, one of the panel judges appeared to agree with FDA’s position, suggesting that it could, in theory, be forced to divert resources from high priorities on the basis of lawsuits filed against it. More information about lower court rulings in the case appear in Issues 432 and 442 of this…
The Food and Drug Administration (FDA) has announced two additional public meetings to discuss proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule), and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). The meetings are scheduled for March 11-12 in Chicago and March 27-28 in Portland, Oregon. FDA anticipates that the proposed produce safety rule would “reduce foodborne illnesses associated with the consumption of produce.” The proposed preventative controls rule would evidently apply to human food and require domestic and foreign facilities that must register under the Federal Food, Drug, and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results and act to correct problems that arise. See…
