Status of Regulatory Compliance of Establishments Under USDA FSIS Jurisdiction

By Omar A. Oyarzabal, PhD, EAS Senior Consultant

The U.S. Department of Agriculture’s Food Safety and Inspection Services (USDA FSIS) collects information on compliance under its jurisdiction. The data collected include enforcement actions related to establishments’ food safety regulations including sanitation standard operating procedures, risk-based food safety plans based on the seven principles of the Hazard Analysis and Critical Control Points (HACCP), and sanitation performance standards. USDA FSIS also collect data on the enforcement actions of inhumane treatment/slaughter of animals, interference/assault, other issues (e.g., label noncompliances), and letters of information. These enforcement actions are taken to ensure meat, poultry, and egg products reaching consumers are safe, wholesome, and properly labeled.

USDA FSIS publishes a summary of enforcement actions in its Quarterly Enforcement Report. A summary of the number of verification procedures and noncompliances by quarter/year from October 2021 until March 2023 is provided in Table 1. The table also presents the compliance rates, in percentages, the total actions initiated, and total actions closed.

Using data from the Meat, Poultry and Egg Product Inspection directory, we determined the number of establishments by size (Large, Small, Very Small), and calculated the percentage of administrative actions by establishment size. We also made a comparison of percentages of noncompliances (administrative actions) among establishment sizes using Pearson’s chi-square test in R.

In general, the compliance rate is quite high (98.7%) and the number of actions taken (301) is low for the number of verification activities performed (more than 11.19 million). There was no suspension of inspection of any establishment based on non-compliance with HACCP. Therefore, the noncompliances with HACCP regulations were not considered important enough violations to withhold inspection of the establishments. Among the other administrative actions, large establishments had less sanitation standard operating procedures noncompliances and sanitation performance standards noncompliances than very small establishments. However, large establishments had more inhumane treatment/slaughter of animal noncompliances than very small establishments (Table 2).

Sanitation performance standards are set up to know the expected results from the sanitation practices and are meant to prevent insanitary conditions that may result in product adulteration. Establishments then develop sanitation standard operating procedures, which are the written procedures describing the practices to implement to prevent direct contamination or adulteration of product. Establishments must also maintain daily records to demonstrate the implementation and monitoring of the sanitation standard operating procedures, and any corrective action taken. An explanation of the differences in compliance between large establishments versus small and very small establishments is that setting up the appropriate sanitation performance standard and then writing the appropriate sanitation standard operating procedures require more resources. Therefore, small and very small entablements will have more difficulties complying with these regulatory requirements than large establishments. The more noncompliance to the inhumane treatment/slaughter of animal regulations by large establishments may be related to a lack of training of employees handling live animals before the stunning and processing of the animals.

The results shown in Table 2 have some limitations because we used two different databases. However, the data are good approximations that help us further understand the information provided by USDA FSIS, and the overall regulatory compliance by different establishments under USDA FSIS inspection.

Table 1. Number of verification procedures, noncompliances, compliance rates (%) and actions by USDA FSIS from October 2021 until March 2023.

Table 2. Categorization of establishments by size and number and percentage of administrative actions by size of establishment.

¹ Percentage base on establishment size. SSOP: Sanitation Standard Operating Procedures; HACCP: Hazard Analysis and Critical Control Points; SPS: Sanitation Performance Standards; INH: Inhumane Treatment/Slaughter.
² Number of establishments = 6,049. There are 831 establishment that do not have a size designation (total = 6,880; 6,049 + 831)
³ Large establishments had less noncompliance than very small establishments (p-value = 0.049)
⁴ Large establishments had less noncompliance than very small establishments (p-value = 0.009)
⁵ Large establishments had more noncompliance than very small establishments (p-value = 0.020)