There has been a great deal of noise in the media recently about “plants running without inspection” and the significance to both the establishment and to FSIS.
It is important to remember that no operations requiring inspection shall be conducted “except under the supervision of a program employee.” FSIS provides that supervision in a variety of ways during the plant’s approved hours of operation, either through continuous on-site inspection or by a patrol inspector who is assigned to one or more establishments within a geographic area. With a patrol inspector, FSIS is “constructively present” at all establishments within the patrol because the inspector could appear at any individual establishment at any time. FSIS does require that the inspector also be physically present at each establishment at least once per shift.
The question arises, what, if during the day, the establishment determines it needs to run outside of the approved hours of operation? The establishment officials must notify FSIS as soon as they are aware they need to run overtime to make arrangements for inspection coverage. There are certain activities that must be conducted under inspection. The establishment should not perform these activities without reaching the inspector to have the overtime approved. The plant should have a documented procedure for requesting overtime and make sure it is current (given the periodic inspector rotation). The most common reason for a plant running without inspection is that it is an infrequent occurrence and the personnel simply forgot the process for notifying FSIS. Who do we call? What is the correct after hours number? If the Consumer Safety Inspector is not available, who do we call next? What is the number for that person? Where are these numbers accessible at the plant? FSIS maintains the phone numbers for the District Offices on the FSIS website. The phone numbers for the in-plant inspection personnel will have to be obtained at the local level.
Additionally, many establishments do not have a clear sense of the specific activities that FSIS has outlined as requiring inspection. FSIS Directive 12,600.2, Rev. 1 provides the specific details on the activities that require FSIS inspection presence. For example, the obvious activities of preparing meat and poultry products for packaging or for further processing into meat or poultry food products require inspection. The example activities include: slaughtering, boning, cutting, slicing, grinding, injecting, pumping, adding ingredients through other mechanical means, formulating, assembling, packaging or labeling meat or poultry components of meat or poultry food products.
FSIS has also defined verification activity of direct observations of its monitoring activities at CCPs as requiring inspection, as well as applying the mark of inspection.
FSIS distinguishes these activities from those which the Agency would consider as not requiring inspection (and which accordingly would not require overtime inspection services), including:
- Receiving meat and non-meat ingredients;
- Receiving and sorting returned goods;
- Shipping inspected and passed products;
- Moving products within the facility;
- Performing sanitation procedures and monitoring procedures outlined in the SSOP;
- Performing monitoring or verification (e.g., calibration or records review) associated with HACCP;
- Performing corrective actions;
- Performing pre-shipment review;
- Cooking, drying or smoking – as long as the establishment does not conduct verification during the time period. For example, cooking with continuous monitoring overnight, with the verification done the next morning when inspection is present.
- Chilling as long as verification is not conducted during the time period. For example, carcasses may be chilled overnight. The establishment may monitor during the chilling process, but the verification would take place the next morning when inspection was present.
- Collecting and testing samples of product.
FSIS has provided these as examples of activities that can be conducted without overtime inspection presence. The key to the activities is that there are adequate records for inspection verification.
Why FSIS has made the differentiation for verification requiring inspection compared to other activities is not clear. What is very clear is that products produced without “inspection” will be subject to voluntary recall if it is already in commerce. All products will be required to be diverted into inedible rendering or denatured and sent to landfills. Finally, FSIS can initiate a suspension of inspection without prior notice.
FSIS response to products being produced without inspection is covered in FSIS Directive 12,700.1, Rev.1.
This is a totally preventable situation! Understand what activities require inspection during overtime. Know who to ask and how to reach them. Have a documented procedure for reaching them, and follow it! If ever in doubt, reach out!
About “Dr. Doom”
Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator. During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations. While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health. Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.
Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations. She was the lead of the FSIS HACCP Hotline. In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation. She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities. She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.