Testifying before the House of Representatives Energy and Commerce Committee on February 5, 2014, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said that, while the agency has enough resources to issue the final rules for the Food Safety Modernization Act (FSMA), it lacks the resources to implement them. “We will continue efforts to make the best use of the resources we have, but simply put, we cannot achieve FDA’s vision of a modern food safety system and a safer food supply without a significant increase in resources,” Taylor said in his testimony. When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $580 million to fund the expanded food safety activities. Noting that FDA “cannot do all that is asked without additional resources,” Taylor cited in particular new FSMA mandates regarding imported…
Tag Archives food safety/FSMA
The U.S. Occupational Safety and Health Administration (OSHA) has issued an interim final rule to establish procedures for handling retaliation complaints brought by whistleblowers who gained new protections under section 402 of the Food Safety Modernization Act (FSMA). Effective on February 13, 2014, the interim rule establishes procedures and time frames applicable to retaliation complaints, including rocedures and time frames for employee complaints to OSHA, OSHA investigations, appeals from OSHA determinations, administrative aw judge (ALJ) hearings, Administrative Review Board review of ALJ decisions, and judicial review of the labor secretary’s final decision. omments on the interim final rule are requested by April 14, 2014. FSMA protects employees from retaliation “by an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food,” if the employees either provided or are about to provide their employer, the federal government or a state attorney general with information about Food,…
The U.S. Food and Drug Administration (FDA) has issued a request for comments, scientific data and other information to help the agency develop its process for designating high-risk foods. Required under the Food Safety Modernization Act to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to “rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event,” FDA specifically seeks information on (i) alternative approaches for identifying high risk foods; (ii) whether the criteria should be weighted equally; (iii) changes in the scoring system; and (iv) how foods should be categorized. Comments will be accepted until April 7, 2014. See Federal Register, February 4, 2014. Issue 512
The U.S. Food and Drug Administration (FDA) has announced two additional public meetings, February 27, 2014, in Chicago, Illinois, and March 13 in Anaheim, California, to discuss the Food Safety Modernization Act (FSMA) proposed rule for “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.” The meetings are the second and third in a series announced in the December 20, 2013, Federal Register and on FDA’s FSMA website. The first meeting is slated for February 20 in College Park, Maryland.
According to U.S. Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor, the agency will revise proposed rules under the Food Safety Modernization Act (FSMA) “affecting farmers,” who have apparently expressed concern about the potential impact on their livelihoods. Among provisions to be revised and re-published for public comment in early summer 2014 are (i) “sections covering water quality standards and testing,” (ii) “standards for using raw manure and compost,” (iii) those “affecting mixed-use facilities (such as a farm that has a food-processing operation),” and (iv) “procedures used to withdraw the qualified exemption to these requirements for certain farms.” Taylor also noted that the agency continues to review the comments already submitted to the rulemaking docket and may decide to include other changes for public comment. See FDA Voice, December 19, 2013. Issue 508
The U.S. Department of Agriculture (USDA) has terminated proceedings on a proposed marketing agreement that sought to regulate the handling of fresh leafy green vegetables in the United States. Modeled after a 2006 initiative pioneered by California growers in the wake of an E. coli outbreak linked to fresh spinach, the National Leafy Green Marketing Agreement (NLGMA) would have authorized “the development and implementation of handling regulations (audit metrics) to reflect the United States Food and Drug Administration’s (FDA) Good Agricultural Practices, Good Handling Practices, and Good Manufacturing Practices.” According to the California LGMA, which participated in the NLGMA effort, the proposed program became redundant under the Food Safety Modernization Act (FSMA), which requires FDA to regulate produce farmers “to ensure their products are safe.” To this end, the California LGMA recently submitted comments on FSMA’s proposed Produce Safety Rule, asking the FDA to consider certified LGMA members as compliant…
Due to the recent government shutdown, the U.S. Food and Drug Administration (FDA) has extended the public comment period for several proposed rules related to the implementation of the Food Safety Modernization Act (FSMA). FDA has extended the deadline for comments on (i) “Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” until March 15, 2014; and (ii) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,” until January 27.
While the Ninth Circuit Court of Appeals has granted the Food and Drug Administration’s (FDA’s) motion for expedited consideration of its emergency motion to stay a district court order establishing rulemaking deadlines under the Food Safety Modernization Act, it denied the stay pending appeal. Ctr. for Food Safety v. Hamburg, No. 13-16841 (9th Cir., order entered November 4, 2013). Details about the motion appear in Issue 501 of this Update. The Ninth Circuit has, however, deemed “the period of compliance established by the district court tolled” due to the “government shutdown.” It extended until December 20, 2013, the date on which FDA will be required to publish a notice of proposed rulemaking addressing novel requirements for preventing the intentional adulteration of food. The Ninth Circuit also granted FDA’s motion to expedite the hearing of its appeal. Thus, the opening brief must be filed by December 23, the answering brief is due…
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would establish current good manufacturing practice (CGMP), hazard analysis and risk-based preventative controls for animal food. According to an October 29, 2013, Federal Register notice, FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.” Billed as “part of the Food Safety Modernization Act’s larger effort to modernize the food safety system for the 21st century,” the proposed rule would require domestic and foreign animal-food manufacturing facilities registered under the Federal Food, Drug, and Cosmetic Act to develop a formal plan to prevent foodborne illness as well as respond to “any…
Three days after the U.S. Food and Drug Administration (FDA) filed a motion for emergency stay pending appeal before the Ninth Circuit, the federal district court that had established November 30, 2013, as the deadline for the agency to publish notices of proposed rulemaking (NPRM) for specific food safety rules under the Food Safety Modernization Act denied the motion for stay pending appeal that FDA filed before it in September. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered October 21, 2013). Details about the emergency stay request based on delays attributable to the federal government shutdown appear in Issue 501 of this Update. According to the district court, FDA failed to show that it would be irreparably injured absent a stay. The court recognized that the agency was unprepared to issue a final rule on the intentional adulteration of food by the November 2013 deadline, “But…
