Will we wake up to a federal government shutdown on October 1st? Many of the ingredients required for a shutdown are present. There may be a breakthrough that will allow Congress to coalesce around an approach to appropriations. However, Congress may not get on track to pass all of the appropriations packages by the end of the fiscal year – September 30, 2023.
First, a quick primer on categories of government program funding:
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- Discretionary funding – these are programs that are paid for with funds from Congressional appropriations bills;
- Mandatory funding – mandatory programs, such as the National School Lunch Program, are funded through other statues; and
- User fees – user fees are fees paid by regulated industries to fund government programs. Many medical products and voluntary inspection activities are paid for by user fees.
A government shutdown would affect all federal activities covered by discretionary funding. Much of the funding USDA and FDA receives for food safety and enforcement is in the form of discretionary funding. So, what does that mean if the government shuts down?
Since the U.S. government occasionally deals with lapses in funding, there are contingency plans in place to avoid disruption of critical services. The Office of Management and Budget (OMB) maintains a list of contingency programs for each agency. Below, we highlight the contingency plans for FDA and USDA in the event of a government shutdown.
FDA’s Contingency Plan
FDA’s FY 2023 contingency plan was last reviewed by the U.S. Department of Health and Human Services (HHS) on September 30, 2022. The contingency plan covers activities and staff planning to ensure the Agency is able to operate, albeit in a limited capacity, should Congress not meet its midnight deadline on September 30. Importantly, FDA will continue its domestic and border enforcement activities as described below.
- FDA Activities
FDA activities that will continue include those funded through user fees, activities in response to COVID-19, and vital activities related to imminent threats to human health or life.
Activities funded through user fees include the regulation and testing of human and animal drugs, biosimilars, medical devices, and tobacco products. FDA may only use carryover user fee balances since FDA cannot collect user fees during a shutdown. In the context of COVID-19, continuing activities include emergency use authorizations to respond to the COVID-19 pandemic.
In addition, all vital FDA activities related to imminent threats to human health or life will also continue. This includes:
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- Detecting and responding to public health emergencies,
- Continuing to address existing critical public health challenges, and
- Managing recalls, including drug shortages, and outbreaks related to foodborne illness and infectious diseases.
FDA also categorizes surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, determining and conducting systems for cause and surveillance inspections of regulated facilities, and criminal enforcement work and certain civil investigations as vital activities.
- FDA Staffing Plan
FDA will retain 81% of staff that are exempt or excepted from the impact of a government shutdown.
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- 64% of the retained staff are exempt because their activities or positions are already funded or otherwise exempted; and
- The remaining 17% are excepted because their activities are deemed necessary by implication, or for the safety of human life or protection of property.
Excepted staff can legally continue their activities in the absence of appropriations. These staff fall into three categories:
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- Those whose work is necessary for the safety of human life,
- Those whose work is necessary for the protection of property, and
- Those whose work is “necessarily implied” from the authorized continuation of other activities.
Excepted FDA staff will continue in the following tasks and activities:
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- Perform vital tasks related to imminent threats to human life including detecting and responding to emergencies, managing recalls, pursuing criminal enforcement work and certain civil investigations, reviewing import entries to determine potential risks to human health, conducting for cause and surveillance inspections of regulated facilities, conducting surveillance of adverse events reports for issues that could cause human harm, and other critical public health issues as appropriate. These excepted staff will also be responsible for continuing efforts to address other serious public health challenges, including drug shortages, and outbreaks related to foodborne illness and infectious diseases.
- Activities ensuring the protection of government research property, animals, and inanimate property. Examples include the care and feeding of any animals associated with research activities and maintaining research property used for regulatory science research such as high-performance computational equipment.
Additionally, 245 Public Health Service Commissioned Corps Officers are excepted because their duties are necessary to ensure the ongoing support and operations of funded activities or are needed for the orderly phase down and suspension of non-funded activities. They will continue to provide the necessary operational support to ensure the centers and offices can continue authorized and funded activities.
USDA’s Contingency Plan
USDA has not yet released any recently updated information regarding its plans in the event of a shutdown. However, the USDA Website provides a blueprint of plans and procedures developed previously for use in the event of a shutdown. This blog will focus on only the following agencies within USDA: FSIS and certain Farm Service Agency (FSA) plans. Most likely, any new plans/procedures will likely be similar, if not identical, to those previously developed.
- FSIS’ Plan
FSIS’s Contingency Plan was last updated in August 2020. The following are FSIS’s “excepted activities” – meaning they will continue in the event of a shutdown. They include:
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- Appropriated Activities – Functions expected to ensure that the U.S. commercial supply of meat, poultry, and processed eggs is maintained safely. For example, daily on-site inspection presence, regulatory enforcement, food safety surveillance, investigations, and product testing.
- Reimbursable Work for Industry (i.e., Non-Federal Partners) – Reimbursable work, not funded by appropriations, as authorized under the Agricultural Market Act (AMA), Federal Meat, Poultry, and Egg Products Inspection Act’s (FMIA, PPIA, and EPIA). This includes overtime inspection activities and voluntary inspection (e.g., export certification, exotic species)
- Additional Supported Activities – In addition to inspection, some critical support staff will continue to work because they are necessary to support expected activities. Including certain functions within senior level management and coordination, Office of Public Health Science (OPHS), Office of Management (OM), Office of Chief Financial Officer (OCFO), Office of Chief Information Officer (OCIO), Office of Public Affairs and Consumer Education (OPACE), Office of Planning, Analysis and Risk Management (OPARM), Office of Employee Experience and Development (OEED), Office of Policy and Program Development (OPPD), Office of International Coordination (OIC), Significant Incident and Preparedness Staff (SIPRS); and Internal Affairs (IA).
Generally, the shutdown will impact:
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- Excepted Staff – Missing or delayed payments, potential funding issues, and travel issues.
- Expired Contracts – Contracts expire at various points during FY and those that expire during shutdown may result in a lapse that will take longer to replace.
- Cooperative Agreements for Inspection – States may run out of funds for inspection services (i.e., State-run Meat and Poultry Inspection (MPI)).
- Regulations – Stall of policy priorities and initiatives.
Once OMB notifies USDA and USDA notifies FSIS, FSIS will prepare as much as possible to implement the Contingency Plan. FSIS is aware that the Contingency Plan may change based and OMB and USDA Guidance. Preparation includes the steps presented for an orderly shutdown and those for seven (7), three (3), two (2), and one (1) calendar day(s) and the hours leading up to the shutdown.
- FSA’s Plan
FSA’s Contingency Plan was last updated in 2021. FSA provides relatively detailed procedures, guidance, financial management, and the like in the event of a shutdown. This includes, but is not limited to logistical preparations, specific program activities that will continue, and the employees that will be necessary to continue operations. Notably, certain programs will continue in the Office of the Administrator (OA), Business Operations (BizOps), Trade Policy and Geographic Affairs (TPGA), Foreign Affairs, Global Market Analysis (GMA), and Global Programs (GP). For example, activities funded via resources outside of FSA appropriations, such as export credit guarantee activities, will continue.
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