For a long time, a simple question about government food-safety efforts has been asked: Why is the US Dept. of Agriculture’s Food Safety and Inspection Service so much tougher than inspection by the Food and Drug Administration, which has food-safety authority over most non-meat food? There are a lot of possible answers to the question, but the reason always seems to come down to money and employees at the FSIS, compared to its counterpart at the Dept. of Health and Human Services.
One of the goals of the Food Safety Modernization Act (FSMA) is to make the FDA’s food inspection tougher than it’s been in the past, and agency officials say that process began even before FSMA became law. They claim there are more warning letters being issued to company violators, more inspection reports given to processors, based for the most part on what the agency’s had to operate with in the past: its good manufacturing practices regulations regarding pest and sanitation control, and other basics of food safety.
But the question remains: Why does USDA inspect plants every day, or at least require plants to be available for inspection every day they’re operating, while years can pass between inspections of FDA-regulated plants? Again, the answer has come down to the number of inspectors, the money to be spent on the job and the requirements of the regulations themselves, which differ a great deal between the two agencies. But one of the themes of the FSMA is to make the FDA more “USDA-like” in its approach to food safety and inspection of processing and manufacturing facilities.
The implementation of a HACCP food-safety process system, adopted by the poultry and meat industry for the past 15 years, into plants inspected by FDA will make a difference. So will the introduction of stricter controls to prevent food-safety problems, as required by FSMA regulations. These will include expanded recordkeeping requirements by FDA.
This can be seen by looking at how the two agencies operate. USDA is always fine-tuning its HACCP requirements. The agency did this just recently by publishing a notice requiring meat and poultry inspectors to occasionally watch company employees do a pre-shipment review when the inspectors are carrying out review and observation. Inspectors are supposed to determine whether the employees have reviewed all records associated with the company HACCP system, including records associated with pre-requisite programs and disposition, associated with the production of a specific product as part of the HACCP plan pre-shipment review. The review of what the company did or carried out as part of its pre-requisite programs can also be particularly important because the company may use its pre-requisite programs to prevent food-safety problems during its manufacturing or processing. In fact, the pre-requisite programs may be used to eliminate hazards found during the company’s hazard analysis, and is really considered part of the company’s HACCP system. The idea is for the establishment to review all records that pertain to hazard analysis, its critical limits, the corrective actions it takes – in other words, basic HACCP.
A fundamental element
Recordkeeping and records review are fundamental elements of the USDA’s HACCP programs. Now, under FSMA, FDA will get the chance to take a closer look at processors’ records. Companies under FDA inspection that haven’t operated under FDA HACCP programs that were previously required for seafood and juice production will experience FDA’s now-much-closer look at how they carry out the food-safety aspects of their product manufacturing. While FDA has traditionally looked at what kind of basic programs a company has in place, including its good manufacturing practices, the agency has been much more lax in watching what kinds of control programs a company has in place to prevent pathogens and adulterated products.
Under the Food Safety and Modernization Act and the regulations that are springing from the new law, FDA will place more emphasis on making sure companies are ensuring their products are being made safely under HACCP. With these requirements, there will be a lot of company history for the agency to look at, history springing from a wealth of records generated as a result of the HACCP food-safety requirements the companies will now be creating and carrying out.
Bernard Shire is a contributing editor based in Lancaster, Pa. Shire also works as a food safety consultant and writer for Shire & Associates LLC.