The European Food Safety Authority (EFSA) has announced an April 9, 2013, scientific meeting to discuss its draft opinion on the re-evaluation of aspartame (E951). Issued by the agency’s Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS Panel), the re-evaluation declined to revise the current Acceptable Daily Intake (ADI) for aspartame after concluding that the substance and its breakdown products “pose no toxicity concern for consumers at current levels of exposure.” Additional details about this conclusion appear in Issue 466 of this Update. The follow-up meeting seeks to clarify any comments received during the draft opinion’s consultation period, which ended February 15. Before adopting its final opinion on aspartame, the ANS Panel will take into account these responses and meeting discussions, as well as issue a separate report that outlines these proceedings. EFSA has asked “scientific experts in the field of food safety and parties who…
Category Archives Issue
The European Food Safety Authority (EFSA) and European Medicines Agency (EMA) have agreed to conduct a health risk assessment of phenylbutazone after officials reportedly discovered the anti-inflammatory drug “in a small number of horse carcasses intended for the food chain.” According to a March 7, 2013, news release, the European Commission requested the assessment as part of an EU-wide investigation into beef contaminated with horsemeat. “[U]sed sparingly in human medicine for the treatment of severe inflammatory conditions where no other treatment is considered suitable,” phenylbutazone is also approved for veterinary use but only in non-food producing animals such as dogs and sport horses. EFSA thus considers the drug a contaminant in food and will work with EMA to determine whether residues found in horsemeat pose any health risks to consumers. To this end, the agencies will consider “both the risk posed from consumption of the horsemeat itself as well as…
The Food and Drug Administration (FDA) has reopened the comment period for its 2005 interim final rule on the “Use of Materials Derived From Cattle in Human Food and Cosmetics,” which prohibited the use of certain cow components to prevent the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics. The interim final rule stated that a cow’s small intestine was safe for use in human food and cosmetics provided the distal ileum was removed. According to the agency, new scientific data confirms the presence of low levels of BSE in other parts of the cow’s intestine, including the proximal ileum. Interested parties can comment on the new studies until May 13, 2013. See Federal Register, March 4, 2013.
According to a news source, the Food and Drug Administration (FDA), which has released for public comment just two of five major proposed rules to implement the Food Safety Modernization Act (FSMA), will allow the public to comment on all of them once they have all been made available. FDA spokesperson Shelly Burgess said, “We have received some feedback regarding this and FDA will adjust the comment periods to allow the opportunity for the public to comment as a package.” Thus, no comment period will close until all five rules have been published. Information about the initial proposals appears in Issue 466 of this Update. See Law360, March 5, 2013.
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.
