As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding the scope of FDA food facility inspections during the government shutdown, which is summarized in this memorandum. We will continue to monitor major developments related to the scope of FDA’s food safety activities during the government shutdown; food companies may also wish to follow Commissioner Gottlieb’s Twitter account for the most recent developments on this issue. In a related update, we understand that FSIS is now in the process of reviewing label submissions in a limited capacity.
FSMA
Intentional Adulteration Rule under FSMA Training Requirements and Course Availability
By Joe Levitt, Elizabeth Fawell & Maile Hermida on
This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) to conduct a vulnerability assessment if using the Key Activity Types method. Below, we review the requirements for “qualified individuals” in the IA rule and provide additional details on the training courses available now and forthcoming from FSPCA.
FDA Issues Final Guidance on Mandatory Recall Authority under FSMA
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in cases where FDA has to intervene quickly to help protect consumers from unsafe foods.
The Guidance outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It also offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food a serious health risk. Commissioner Gottlieb’s statement explains that providing this additional clarity can enable the FDA to make more robust use of the mandatory recall authority.
FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first document is for farms covered by the Produce Safety Rule (PSR). The second document is for facilities subject to FDA’s Preventive Controls for Human Food (PCHF) rule and that manufacture, process, pack, or hold fresh-cut produce. The deadline for comments on both guidance documents is April 22, 2019.
Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth additional traceability record keeping requirements for facilities that manufacture, process, pack, or hold those foods. The lawsuit was brought in the U.S. District Court for the Northern District of California by the Center for Food Safety (CFS) and Center for Environmental Health (CEH).
FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in two-tier inspections. FDA plans to limit initial participation in the program to five businesses. FDA will consider the results of the two-tier inspections pilot to determine the feasibility of employing the two-tier approach to inspections on a broader scale. This post summarizes the program and FDA’s criteria for participation. Interested companies must notify FDA of their desire to participate no later than October 31, 2018.
USDA Sends National Bioengineered Food Disclosure Standard to OMB While Facing Lawsuit for Failing to Meet Statutory Deadline
By Martin Hahn, Veronica Colas & Leigh Barcham on
On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory rulemaking deadlines for the National Bioengineered Food Disclosure Standard (NBFDS). The suit was filed by the Center for Food Safety (CFS) and Center for Environmental Health in the United States District Court for the Northern District of California. 1/ On September 6, 2018, the plaintiffs filed a motion for summary judgment requesting that the court order USDA to issue the rule within 60 days.
FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working. This first installment includes the first four chapters of the Draft Guidance, which provide FDA’s recommendations on how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps, developing mitigation strategies for actionable process steps, and monitoring mitigation strategies. It also contains templates for various components of a food defense plan.
FSMA Implementation Update: FDA Releases New Supplier Verification Tool to Assist with FSMA Compliance and Provides Update on VQIP
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Erika Ward on
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier verification requirements under FSMA. A new section of the FDA’s Data Dashboard will help companies that perform supplier verification under FSMA by functioning as a “one stop shop” for identifying compliance and enforcement information related to specific suppliers. Second, FDA announced that the Voluntary Qualified Importer Program (VQIP) will not launch until the Fiscal Year (FY) 2020 benefit year—i.e., October 1, 2019. VQIP is a voluntary, fee-based program that offers expedited review and entry of food into the United States.
OMB Releases Spring 2018 Unified Agenda of Regulatory Actions
By Maile Hermida, Leigh Barcham & Erika Ward on
The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency. This post summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans.