The U.S. Food and Drug Administration (FDA), currently under a district court timeline for completing the implementing regulations required under the Food Safety Modernization Act (FSMA), has filed an emergency stay pending appeal before the Ninth Circuit Court of Appeals, arguing that the 16-day government shutdown in October makes compliance “not only unsound but impossible.” Ctr. for Food Safety v. Hamburg, No. 13-16841 (9th Cir., filed October 18, 2013). Details about the district court’s refusal to amend the deadlines appear in Issue 494 of this Update. FDA specifically requests relief from the November 30 deadline for the publication of a proposed rule “addressing novel requirements for preventing the intentional adulteration of food.” The agency claims that compliance would “threaten[] to waste scarce agency resources and risk results inconsistent with the public interest by requiring FDA to spend the next several weeks completing and publishing a proposal that does not take…
Tag Archives food safety/FSMA
The Food and Drug Administration (FDA) has announced an upcoming public meeting slated for September 19-20, 2013, in Washington, D.C., to discuss regulations proposed under the Food Safety Modernization Act (FSMA) that would establish Food Supplier Verification Programs as well as new rules for accrediting third-party auditors and certification bodies. Intended to ensure “that imported food meets the same safety standards as food produced domestically,” the proposed rules would (i) require importers “to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by [FMSA],” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies currently rely.” FDA will accept advanced registrations from individuals who wish to participate in person by September 10, 2013. Additional details about the proposed rules appear in Issue 492 of this Update. See Federal Register, August 16, 2013.
A federal court in California has determined that the U.S. Food and Drug Administration (FDA) has not met the standard for the court to issue an order amending the deadlines set forth in its June 2013 order for promulgating and finalizing implementing regulations under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered August 13, 2013). Information about the court’s earlier order appears in Issue 489 of this Update. Because the plaintiff agreed that the proposed sanitary transport rule deadline could be extended, however, the court granted FDA’s motion only to this extent. The proposed rule must be published by January 31, 2014, and the court will allow comment on it until May 31. The final rule must be published as originally specified—no later than June 30, 2015. The court rejected FDA’s request to extend the deadline for promulgation of the…
The Center for Food Safety has filed its reply to the Food and Drug Administration’s (FDA’s) request that a federal court in California reconsider the Food Safety Modernization Act implementation rulemaking deadlines it established for the agency. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., filed August 2, 2013). Additional information about FDA’s motion appears in Issue 492 of this Update. While the center argues that FDA is attempting to re-litigate issues the court has already decided, it does not oppose a one-time, 60-day deadline extension for the food transportation rule. Meanwhile, FDA has issued notices extending until November 15, 2013, the comment periods on its proposed “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.” According to FDA, the extension will allow stakeholders to consider the interrelationships between…
The U.S. Food and Drug Administration (FDA) has filed a motion for reconsideration or stay of a court order establishing rulemaking deadlines under the Food Safety Modernization Act. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., Oakland Div., motion filed July 19, 2013). More information about the litigation appears in Issues 481, 487 and 489 of this Update. Scheduled to be heard on August 28, 2013, the motion contends that two of the seven rulemakings at issue, the sanitary transport rule and the intentional adulteration rule, pose challenges that preclude their issuance by the court’s deadline. Requesting that the court reconsider its order largely on the basis of arguments already rejected, the agency also asks the court to stay the order pending the Solicitor General’s determination whether to authorize an appeal and, if an appeal is authorized, while the appeal is pending.
The U.S. Food and Drug Administration (FDA) has proposed two rules under the Food Safety Modernization Act (FSMA) for verifying foreign suppliers and accrediting third-party auditors. Part of the agency’s effort “to ensure that imported food meets the same safety standards as food produced in the United States,” the proposed rules would (i) require importers to verify “that their foreign suppliers are implementing modern, prevention-oriented food safety practices,” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.” In particular, the rules establishing foreign supplier verification programs would hold U.S. importers responsible for ensuring that human and animal food produced abroad meets the safety standards set forth in the Federal Food, Drug, and Cosmetic Act and is neither adulterated nor misbranded “with respect to food allergen labeling.” In addition, FDA has proposed creating…
A recently published law review comment contends that food makers should not be concerned that the Food Safety Modernization Act (FSMA) will increase food borne illness-related litigation or make it easier for plaintiffs to succeed. David Benton, “The Impact of Mandatory Recalls on Negligence and Product Liability Litigation Under the Food Safety Modernization Act,” San Joaquin Agricultural Law Review (2012-2013). The author opines that the FSMA “will likely have little or no impact on negligence and product liability litigation,” but recommends that manufacturers be given limited immunity from civil actions when they comply with a Food and Drug Administration voluntary recall request. He also recommends that the law be amended to expressly preempt state regulation, which would bring the FSMA closer in line with the Food, Drug, and Cosmetic Act as to medical devices.
Finding the Food and Drug Administration’s (FDA’s) proposed “target time-frames” “an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction,” a federal court in California will require the agency to publish all proposed regulations required under the Food Safety Modernization Act by November 30, 2013. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., decided June 21, 2013). The court further ordered FDA to close each comment period no later than March 31, 2014, and to finalize the rules no later than June 30, 2015. The order follows the court’s determination that FDA violated the FSMA and Administrative Procedure Act by failing to comply with the food safety rulemaking deadlines established by Congress. Additional details about the litigation appear in issues 481 and 487 of this Update.
The California Cantaloupe Advisory Board (CCAB) has launched a new food-safety program that requires government audits of all cantaloupe production activities. Described by CCAB as “the only mandatory food-safety program that requires government audits of all cantaloupe production activities,” the program invites government auditors to inspect all aspects of operations including growing, harvesting, packing, and cooling to ensure that a set of “science-based standards is being followed.” Under the program, handlers must be 100 percent compliant with food-safety audits that cover 156 checkpoints. According to California melon producer and CCAB Chair Steve Patricio, CCAB will use inspectors from the California Department of Food and Agriculture instead of private inspection companies to ensure accountability, uniformity and consistency of audits throughout the California cantaloupe industry. Patricio also noted that the new audit program will allow producers to meet or exceed requirements of the Food Safety Modernization Act when it is implemented and that…
The Center for Food Safety and the Food and Drug Administration (FDA) have filed separate proposals to implement a court order requiring the agency to complete its rulemaking under the Food Safety Modernization Act (FSMA) after finding that FDA had violated the law by failing to meet its rulemaking deadlines. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., proposals filed June 10, 2013). Additional information about the court’s order appears in Issue 481 of this Update. According to plaintiff’s proposal for injunctive relief, FDA “utterly fails to comply with the Court’s Order and FSMA,” because the agency has insisted on establishing “a schedule of target timeframes” that the agency “will endeavor to meet” with caveats that could require new timeframes. The Center proposes May 1, 2014, as the date on which seven final implementing rules must be submitted to the Federal Register. It would add an additional year to…
