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.
Category Archives Issue 474
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The Food and Drug Administration (FDA) has announced the availability of revised draft guidance related to the evaluation and safety of veterinary drug residues in human food.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…
