Several dozen trade associations representing the interests of food and beverage producers, processors, shippers, and retailers have submitted their concerns about the Obama administration’s proposed 2014 Food and Drug Administration (FDA) budget, which includes $59 million in food facility registration and inspection fees to fund FDA activities under the Food Safety Modernization Act (FSMA). In their April 17, 2013, letter to the chair and ranking member of the Senate Appropriations Subcommittee for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, the industry groups call for FDA to submit requests for FSMA implementation funding through the appropriations process, “rather than seeking authorization of new regulatory taxes, which Congress has repeatedly rejected.”
Tag Archives food safety/FSMA
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly informed Senate appropriators that the agency would extend for 120 days the comment period for two proposed rules—one relating to fresh produce and the other to food processors issued in January 2013 to implement the Food Safety Modernization Act (FSMA). According to Hamburg, “We appreciate that these are complex rules, the proposed rules, to go through and analyze, and we do intend to extend the comment period so that we can hear all of the concerns and address them fully, and I think it’s a reasonable request.” Hamburg also reportedly indicated that a rule requiring restaurants to post calorie information is a “high priority” for the agency, but hesitated when asked if it would be issued by October 1, at the start of the new fiscal year. See CQ Healthbeat News, April 18, 2013.
The U.S. Food and Drug Administration (USDA) has proposed two new fees—a food import user fee and a food facility and inspection fee that the agency says will “enhance the safety protections for imported food and feed” as well as support “new and improved activities required by the Food Safety Modernization Act (FSMA) to modernize FDA’s inspection system.” According to FDA, programs to support FSMA are scheduled to cost $295 million next year and will apparently be 94 percent funded by user fees. “These investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply,” the agency asserts in its budget proposal. FDA has also proposed new user fees to support its cosmetic and food contact substance notification programs. In a statement releasing the budget, FDA Commissioner Margaret Hamburg said, “These are tight budget times, and the FDA…
According to news sources, the White House Office of Management and Budget (OMB) removed some provisions from the regulatory implementation package that the Food and Drug Administration (FDA) proposed under the Food Safety Modernization Act (FSMA). Analysis of documents submitted to the rulemaking docket apparently reveals that the following requirements were removed from the draft rules submitted for OMB review: (i) company programs to monitor the environment for pathogens, (ii) finished product testing for pathogens, (iii) the assumption that pathogens found on food contact materials are also in the food, (iv) a supplier approval and verification program, (v) company review of consumer safety complaints, and (vi) FDA authority to copy company records. See Food Politics and Law360, March 25, 2013. Meanwhile, the Center for Food Safety has reportedly called on a federal court in California to impose deadlines on FDA to implement food safety regulations, arguing that the FSMA set…
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 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 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 issued a final rule that adopts, without change, the interim final rule (IFR) titled “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption” that was published in the Federal Register on May 5, 2011. Effective February 5, 2013, the final rule affirms IFR’s change to the criteria for ordering administrative detention of human or animal food as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, “FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded.” See Federal Register, February 5, 2013.
The Food and Drug Administration (FDA) has announced a public meeting to discuss “the 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 preventative controls for human food (the preventative controls proposed rule).” Under the Food Safety Modernization Act, the new produce safety rules would impose “science- and risk-based standards for the safe production and harvesting of fruits and vegetables,” while the preventative controls rule would require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness.” Slated for February 28, 2013, in Washington, D.C., the public meeting aims to solicit comments on the proposed measures and inform the ublic about the rulemaking process. FDA has asked interested parties to submit oral presentation requests by February 8…
