The Food and Drug Administration (FDA) has released for public comment a report on pilot projects established under the Food Safety Modernization Act (FSMA) “with the food industry to explore and evaluate methods for rapid and effective tracking and tracing of foods.” The report includes the recommendations of the Institute of Food Technologies, the agency’s project partner, on improving tracking and tracing of food, and FDA will use public comments on those recommendations in finalizing its report to Congress on the matter. Electronic or written comments are requested by April 4, 2013. See Federal Register, March 5, 2013.
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.
The Food and Drug Administration (FDA) has announced the availability of revised draft guidance related to the evaluation and safety of veterinary drug residues in human food.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 Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a final rule designating “Cachaça” as a type of rum and a distinctive product of Brazil. Effective April 11, 2013, the final rule recognizes Cachaça as a distinctive distilled spirit made from sugar cane “in compliance with the laws of Brazil regulating the manufacture of Cachaça for consumption in that country.” In return, the Brazilian officials who petitioned TTB and the U.S. Office of the Trade Representative for the designation have reportedly agreed to recognize bourbon whiskey and Tennessee whiskey as distinctive products of the United States. Under the final rule, products that meet the identity standards for Cachaça may be labeled as such and no longer need to include the term “rum” on the packaging. In addition, TTB has noted that distilled spirits containing corn or corn syrup will not be recognized as either rum or Cachaça and must…
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 has debarred seafood importer Richard Stowell from importing food into the United States for three years based on his felony conviction for instructing his company’s employees to mislabel shrimp from Thailand and Malaysia as shrimp from Ecuador and Honduras and then selling it to a supermarket chain. Stowell pleaded guilty to three felony counts in July 2011 and failed to respond to the notice of proposed debarment. See Federal Register, February 26, 2013.
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…
U.S. Reps. Henry Waxman (D-Calif.) and Louise Slaughter (D-N.Y.) recently introduced legislation (H.R. 820) that would require drug manufacturers “to provide better information on the amount and use of antibiotics and other antimicrobials given to animals raised for human consumption,” according to a February 26, 2013, press release. The Delivering Antimicrobial Transparency in Animals (DATA) Act would also compel, “for the first time, large-scale producers of poultry, swine, and livestock to report data on the medicated feeds provided to their animals.” Under the DATA Act, drug manufacturers would report to the Food and Drug Administration (FDA) on how their products are used “by determining (or estimating) the amounts of their drugs used in each food-producing animal for which they are approved.” In addition to general data about their antibiotic use, livestock producers administering medicated feed under a Veterinary Feed Directive would submit “detailed information” about “the quantities, dosages and duration…
A recent study has purportedly linked increased sugar availability to the prevalence of type 2 diabetes among overall populations. Sanjay Basu, et al., “The Relationship of Sugar to Population-Level Diabetes Prevalence: An Econometric Analysis of Repeated Cross-Sectional Data,” PLOS One, February 2013. Researchers with Stanford University, the University of California, Berkeley, and University of California, San Francisco, apparently used nutritional and economic data provided by the U.N. Food and Agricultural Organization, International Diabetes Federation and World Bank to examine whether “alternations in sugar intake can account for difference in diabetes prevalence in overall populations” from 175 countries. The findings evidently showed that “every 150 kcal/person/day increase in sugar availability (about one can of soda per/day) was associated with increased diabetes prevalence by 1.1% (p <0.001)” after controlling for other food types, conditions such as obesity, and socioeconomic variables. In particular, the study’s authors reported that “no other food types yielded significant…
Duke University researchers have identified the mechanism by which bisphenol A (BPA) allegedly affects nervous system development by suppressing a gene “vital to nerve cell function,” according to a February 25, 2013, press release. Michele Yeo, et al., “Bisphenol A delays the perinatal chloride shift in cortical neurons by epigenetic effects on the Kcc2 promoter,” PNAS, February 2013. The study focused on cortical neuron development, during which time a protein called Kcc2 expels chloride ions that would otherwise “damage neural circuits and compromise the nerve cell’s ability to migrate to its proper position in the brain.” Using cell cultures from rats and humans, researchers purportedly found that BPA suppresses the gene responsible for Kcc2 production, raising concerns about whether BPA “could contribute to neurodevelopmental disorders such as Rett syndrome, a severe autism spectrum disorder found only in girls… [and] characterized by mutations in the gene that produces MECP2.” When exposed…
