The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). "In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health," the constituent update states. "As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance." Affected rules include: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food; Foreign Supplier Verification Program; Produce Safety; and Intentional Adulteration.
Tag Archives FSMA
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) announced a number of developments in their work on organic food, poultry and food safety. FDA released an update on the implementation of the Food Safety Modernization Act (FSMA), announcing it will track outcomes for FSMA rules for inspections and recalls via the Food Safety Dashboard. One metric the agency will track is how quickly a company issues a public notice for a Class 1 recall for human and animal food. FDA has also released guidance on recall plans for its multipart guidance on “how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’” USDA updated the National Poultry Improvement Plan (NPIP) Program Standards to incorporate proposed changes published in April 2019, including the amendment of the testing…
The Center for Food Safety and Center for Environmental Health have filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to promulgate rules for a program to improve foodborne-illness detection as required under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Azar, No. 19-5168 (N.D. Cal., filed August 19, 2019). The organizations allege that FDA failed to create a laboratory accreditation program "whereby an increased number of accredited laboratories following model standards developed by the agency would be in place 'to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards.'" "FDA’s failure to implement FSMA’s laboratory accreditation provisions by their statutory deadlines is an abdication of the agency’s fundamental responsibilities," the complaint asserts. "Moreover, the agency’s unlawful withholding and unreasonable delay is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’s commands. This lawsuit therefore…
A California federal court has entered a consent decree compelling the U.S. Food and Drug Administration (FDA) to designate a list of high-risk foods as required by the Food Safety Modernization Act. Ctr. for Food Safety v. Azar, No. 18-6299 (N.D. Cal., entered June 7, 2019). The decree is the result of a lawsuit brought by the Center for Food Safety and Center for Environmental Health seeking to compel the agency to promulgate a list of "high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health" as well as host the list on the FDA website. The decree lists deadlines for FDA to meet—including September 8, 2020, for the designation—but allows the agency to seek extensions if it needs one "despite FDA's best efforts (meaning commitment of agency time, money, energy, and resources that FDA reasonably anticipates will result in meeting the schedule in…
Class action litigation, the legal landscape for cannabis and the evolving implementation of the Food Safety Modernization Act (FSMA) were trending topics at the 2019 Grocery Manufacturers Association (GMA) Legal Conference. Numerous panels at the conference focused on emerging issues affecting the industry and anticipated trends moving forward, including implications of whole genome sequencing; how courts view the confluence of First Amendment rights and mandated advertising content; and standards-of-identity issues related to non-dairy milks, non-animal meats and cell-grown meats. Shook Partners Katie Gates Calderon, Phil Goldberg and Jim Muehlberger presented with Courtney Ozer, Assistant General Counsel – Litigation for Unilever United States, and Suzanne Werner, Litigation Counsel – The Coca-Cola Company, on strategies for avoiding and defending against claims involving product testing. The panel discussed (i) assembling a crisis-management team, which should include key company stakeholders, inside counsel, public-relations and governmental-relations personnel; (ii) understanding the pending lawsuit, which involves robustly…
The Center for Food Safety and the Center for Environmental Health have filed a lawsuit asserting that the U.S. Food and Drug Administration (FDA) has failed "to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA)." Ctr. for Food Safety v. Azar, No. 18-6299 (N.D. Cal., filed October 15, 2018). The organizations assert that FDA has failed to "classify and designate which foods that are classified as 'high-risk' for foodborne illness purposes" and "to create additional record keeping requirements for facilities handling such foods." The complaint argues that "retailers now have the available technology (e.g., blockchain) to 'identify the origin of certain produce shipments in as little as 2.2 seconds.' … In light of these advances in technology, FDA can no longer shirk the mandatory actions required of it by Congress to designate high-risk foods and issue a…
