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.
FSIS
Impact of Government Shutdown on Scope of FDA, FSIS, and CSPC Activities
By Joe Levitt & Samantha Dietle on
On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), and the Consumer Product Safety Commission (CPSC). These agencies will be operating under significantly reduced functions until the shutdown ends, i.e., until Congress passes a new appropriations bill providing funding for these agencies. This post provides a summary of the scope of each of these agencies’ operations during the shutdown, as well as the implications for the food and other consumer product industries.
USDA and FDA Announce Joint Oversight Over Cell Cultured Products
By Gary Kushner, Brian Eyink & Mary Lancaster on
On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured products. Under the proposed framework, FDA plans to oversee cell collection, cell banks, cell growth, and cell differentiation. USDA will oversee cell harvest, production, and labeling of food products derived from the cells of livestock and poultry. While the technical details of the framework remain undefined, the agencies have expressed their view that no legislation on the topic is necessary because the agencies have statutory authority to regulate cell cultured food products derived from livestock and poultry.
This announcement comes three weeks after USDA and FDA hosted a joint public meeting on the topic, and before comments on the meeting are due. The agencies also announced they continue to seek public comment on the issue and will extend the deadline to submit comments until December 26, 2018.
FSIS Issues Guidance on Retailer and Restaurant Exemptions from Inspection Under the Federal Meat Inspection Act
By Gary Kushner, Brian Eyink & Samantha Dietle on
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) recently released a guidance document to help companies determine whether their operations are exempt from the inspection requirements of the Federal Meat Inspection Act (FMIA). This guidance marks FSIS’s first significant attempt to articulate policy addressing the applicability of its retailer and restaurant exemptions to newer food distribution models, such as online retailers and home delivered meal services. In particular, the guidance confirms that online-only grocery stores and home delivery meal kit services are eligible for the retailer exemption from FSIS inspection.
This post focuses on new aspects of FSIS’s guidance that apply to operations such as online grocery stores, online markets, meal kit delivery services, and restaurants, although the guidance addresses other exemptions including custom slaughter operations.
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.
US Cattleman’s Association Submits Petition Regarding Labeling of Synthetic and Lab-Grown Meat
By Gary Kushner, Brian Eyink & Christine Forgues on
On February 9, 2018, the U.S. Cattlemen’s Association (USCA) submitted a petition requesting the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) to establish labeling requirements that would exclude synthetic products made from alternative proteins and lab-grown meat from animal cells from being marketed as “beef” and/or “meat.” The petition requests that new regulations be adopted limiting the term “beef” to describe the tissue or flesh from animals born raised, harvested, and processed in the “traditional” way, and limiting the term “meat” to the tissue or flesh of animals that have been harvested in the “traditional” manner.
FSIS Releases Fiscal Year 2018 Annual Plan
By Gary Kushner, Brian Eyink & Christine Forgues on
Posted in Food Safety, FSIS
On December 1, 2017, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS or the agency) issued its Fiscal Year 2018 Annual Plan. The Annual Plan, which is directly aligned with the agency’s 2017 – 2021 Strategic Plan, outlines the ways FSIS plans to achieve its strategic goals over the next fiscal year. It serves as an operational guide for FSIS, where the agency explains the progression of activities from the key milestones the agency achieved in FY 2017, outlines what it plans to achieve in FY 2018 and why, and describes how it will assess progress by using Strategic and Annual Plan measures and targets.
Overall, the agency anticipates focusing on prevention of product contamination and foodborne illness, modernizing systems and approaches, and streamlining to enhance business. Continuing priorities for FY 2018 include further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, effectively using Public Health Risk Evaluations (PHREs) and pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The agency plans to continue increasing use of whole genome sequencing, further develop key informational tools and resources for inspection personnel, and work with public health partners to prevent Listeria monocytogenes in retail delicatessens. The agency will also encourage industry continued adoption of food defense and humane handling practices, and consumer adoption of safe food-handling practices.
FSMA Implementation Update
By Joe Levitt, Elizabeth Fawell & Maile Hermida on
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:
- Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign Supplier Verification Programs (FSVP) rule for animal food importers;
- Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
- Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
- Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
- Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.
Click here to read our update.
President Trump’s Budget Proposes Reduced Funding for FDA & USDA
By Joe Levitt & Brian Eyink on
The Trump Administration recently released its Fiscal Year (FY) 2018 budget request. The FY 2018 budget request is notable because it proposes dramatic cuts to both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), among other agencies. Presidential budget proposals are at most a starting point – with Congress ultimately responsible for deciding what funds to appropriate – but often provide valuable insight into an administration’s priorities.
The FY 2018 budget request earmarks a total of $5.1 billion for FDA as a whole – an increase of $456 million or 10 percent above the funding provided by Congress in the FY 2017 Continuing Resolution. This increase, however, would consist of reducing FDA’s total budget authority by $854 million, while proposing an increase in user fees of $1.3 billion in non-food programs (which are unlikely to pass, as explained below).
The FY 2018 budget request proposes $137 billion to USDA, a decrease of $12 billion or 8 percent from an estimated $149 billion in FY 2017, and outlines plans to lower spending on USDA programs by roughly $230 billion over a decade. This memorandum discusses FDA and USDA’s plans for reducing expenditures as they relate to food safety.
As described in more detail below, the proposed FY 2018 budget calls for a sizeable reduction ($82.8 million) in FDA’s food safety program and a modest increase ($25 million) in the Food Safety and Inspection Services (FSIS) food safety program at USDA. Notably, no new user fees are proposed for either FDA or FSIS food safety budgets, although the USDA budget alludes to a desire for legislation authorizing user fees, as have past budgets.
FSIS Instructing Inspectors to Survey Establishments Making Antibiotic, Hormone, and Soy Claims
By Steve Steinborn, Brian Eyink & Samantha Dietle on
Posted in FSIS
The Food Safety and Inspection Service (FSIS) recently issued a notice instructing inspectors in establishments to collect data on the use of certain raising and other claims as a prelude to developing a field compliance testing program to verify that various approved claims are accurate based on product testing. The survey covers establishments that produce raw ground beef products, raw chicken parts, and ready-to-eat (RTE) products. Inspectors will complete a “Labeling Claims Questionnaire” to collect information on three types of labeling claims: 1) claims on raw ground beef products that hormones were not administered to the cattle; 2) claims for raw chicken parts that antibiotics were not used in the chicken production; and 3) soy-free claims on RTE products. Claims of limited use of antibiotics for raw chicken parts are not included in the survey.
FSIS intends to use the information collected to conduct an exploratory sampling program to verify that such claims are accurate based on actual product testing. This notice also provides some insight on the types of claims FSIS has reviewed and approved for each of the categories of claims itis evaluating under this notice, as discussed further below.
Click here to read more.