On July 19, 2024, the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS), and state public health regulatory officials announced an investigation into a multistate outbreak of Listeria, also known as listeriosis or listeria infection. As part of that investigation, an unopened Boar's Head brand liverwurst product collected from a retail store tested positive for Listeria monocytogenes, the species of bacteria that causes Listeria. That product's manufacturer, Boar's Head Provisions Co., Inc., issued a voluntary recall on July 26, 2024, of over 200,000 pounds of liverwurst products produced at its plant in Jarratt, VA. Four days later, Boar's Head expanded its recall by including 7 million pounds of additional ready-to-eat meat and poultry products. On September 13, 2024, Boar's Head announced an indefinite closure of the Jarratt establishment. By September 30, 2024, 10 people had died and 59 others across 19 states were hospitalized, representing the largest foodborne listeria outbreak since an incident in 2011 involving cantaloupes in Colorado.
Listeria can survive and grow in refrigerated conditions and has a high resistance to common preservative methods, such as the addition of salt, smoke, or acids to food. It also thrives in moist environments. Reports that conditions ideal for the prolific growth of Listeria were present in the Boar's Head facility have led to congressional interest in the effectiveness of U.S. food safety laws and regulations. This In Focus summarizes FSIS's role in ensuring that meat, poultry, and egg products are safe, wholesome, and properly labeled.
Background
FSIS derives its inspection authority from the Federal Meat Inspection Act (21 U.S.C. §§601 et seq.), the Poultry Products Inspection Act (21 U.S.C. §§451 et seq.), the Egg Products Inspection Act (21 U.S.C. §§1031 et seq.), and the Humane Methods of Slaughter Act (7 U.S.C. §§1901 et seq.).
The agency's field staff conducts inspection tasks in 6,900 federally regulated establishments. FSIS also supports state meat and poultry inspection programs across the 29 states with which it has cooperative agreements. These 1,450 state-inspected establishments are restricted to intrastate commerce, unless they are located in one of the 10 states that have opted in to the Cooperative Interstate Shipment program. FSIS may also enter into cooperative agreements that allow state inspectors to conduct federal inspections. Approximately 360 establishments in nine states, including the Boar's Head facility, are overseen by the Talmadge-Aiken Cooperative Inspection program (Talmadge-Aiken; 7 U.S.C. §1633).
Inspection Activities
All meat, poultry, and egg products must undergo federal inspection before entering commerce. Federal oversight begins when an animal enters the regulated establishment. Inspectors are to verify that all livestock offered for slaughter are handled humanely, including during on-site transportation and unloading, and that each animal is free from disease or injury that may render it unfit for human consumption. Following slaughter, carcasses deemed "sound, healthful, wholesome, and otherwise unadulterated" by the inspectors are stamped with the official mark of inspection.
FSIS requires establishments to use the science-based Hazard Analysis and Critical Control Points (HACCP; 9 C.F.R. §§417 et seq.) system to identify possible points of contamination and implement measures to control those points. This method of preventative control is to reduce or eliminate microbial pathogens on raw products that may cause foodborne illness. Establishments must also implement sanitation performance standards (SPS; 9 C.F.R. §§416.1-416.5) and sanitation standard operating procedures (SSOPs; 9 C.F.R. §§416.11-416.17).
One or more inspectors is required to be present during slaughter. In processing facilities, an inspector performs daily inspection tasks at least once per each eight-hour shift. Establishments adequately implementing HACCP, SPS, and SSOPs are deemed by FSIS to be producing products that are not adulterated or misbranded. Inspectors review the establishment's sampling and testing records for certain microorganism contamination. Results of inspection tasks are recorded in FSIS's Public Health Information System and discussed weekly with establishment management.
Enforcement Actions
An establishment's failure to meet regulatory requirements is documented as a noncompliance record (NR). An NR addresses a specific issue observed at a specific time for which the establishment must resolve and prevent its recurrence (Table 1).
|
FY2023 |
Tasks Performed |
NRs |
Compliance Rate |
|
Q1 |
1,850,466 |
22,036 |
98.8% |
|
Q2 |
1,913,158 |
23,984 |
98.7% |
|
Q3 |
1,922,448 |
22,952 |
98.8% |
|
Q4 |
1,921,401 |
24,814 |
98.7% |
|
Total |
7,607,473 |
93,786 |
98.8% |
The accumulation of NRs, especially those occurring repeatedly, may result in FSIS taking enforcement action against an establishment. FSIS publishes quarterly enforcement reports outlining actions it has taken against establishments.
The decision to pursue enforcement is recommended by the on-site inspector, through their supervisor, to the FSIS district office (DO). If the DO finds cause for further evaluation of the establishment, an FSIS enforcement, investigation, and analysis officer will conduct an investigation in which they will recommend one of three outcomes: (1) no further action, (2) issuance of additional NRs by the on-site team, or (3) enforcement action. Enforcement actions include the following:
Establishments may appeal any NR or enforcement action within 30 calendar days of receiving written notice of the inspection decision or action.
Recalls
A recall is a voluntary action by an establishment to remove its products from commerce. When the establishment or on-site inspector has reason to believe that products may be adulterated or misbranded, FSIS must be notified within 24 hours. Following notification, FSIS forms a committee with representatives from various program areas to decide whether to recommend a recall, consider recovery actions already planned or initiated by the establishment, issue a public health alert, or recommend other appropriate actions. If the committee and the establishment agree to a voluntary recall, FSIS will issue a recall press release and work with the company to ensure it has properly identified and removed recalled products from commerce. If the company does not agree with the committee's recommendation, FSIS has the authority to detain the adulterated or misbranded product for a period not to exceed 20 days or to petition the U.S. Department of Justice (DOJ) to seize and condemn the product.
In 2023, there were 65 recalls totaling 4,005,384 pounds of meat and poultry products (see Figure 1). Fifty-eight recalls were Class I (reasonable probability that eating the food will cause serious adverse health consequences or death) and seven were Class II (remote probability of adverse health consequences from eating the food). There were no Class III recalls (use of the product will not cause adverse health consequences).
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Source: FSIS, Summary of Recall and PHA Cases in Calendar Year 2023. |
Funding
USDA's FY2025 budget request proposes a 4.5% increase in discretionary funding (Table 2). The House- and Senate-reported FY2025 appropriations bills would provide increases for FSIS, but less than the request. The House-reported bill proposes a 2.8% increase (H.R. 9027), and the Senate-reported bill proposes a 3.6% increase (S. 4690).
|
FY2023 |
FY2024 |
FY2025 Request |
|
|
Federal Inspection |
1,037 |
1,066 |
1,116 |
|
State Inspection |
67 |
68 |
71 |
|
International Inspection |
19 |
21 |
22 |
|
PHD Communications Infrastructure System |
35 |
35 |
35 |
|
Total |
$1,158 |
$1,190 |
$1,244 |
Source: P.L. 117-328, Div. A; P.L. 118-42, Div. B; and USDA, FY 2025 Budget Summary. PHD = Public Health Data.
Issues for Congress
Congressional interest in the safety of meat and poultry products intensified following the Boar's Head recall notices. For example, one Member sent a letter to Boar's Head executives asking why recurring NRs were not resolved sooner and permanently. Two Members sent a letter to USDA and the U.S. Attorney General calling for "immediate justice" and urging USDA and DOJ to determine whether to bring criminal charges against Boar's Head. Twenty-six Members sent a letter to FSIS officials asking how to prevent future deadly outbreaks.
Policy options of potential interest to Congress include investigating the robustness and efficacy of current pathogen sampling and testing; examining implementation of the Talmadge-Aiken program; and considering whether to provide FSIS mandatory recall authority similar to that given to the Food and Drug Administration by the Food Safety Modernization Act (P.L. 111-353).
Document ID: IF12784