Avoid Your Next FSA By Staying Off FSIS’ Radar

Posted in Regulatory Compliance

Although most readers of this post will conduct their business under the watchful eye of continuous federal inspection, there is something far more distracting and onerous than having to manage the daily criticism of FSIS onsite inspectors. Indeed, every so often, a team of FSIS Enforcement, Investigations and Analysis Officers (EIAOs) will enter an establishment, present their federal credentials and insist on unimpeded access to conduct a seemingly endless and penetrating inspection. While many in the industry describe the experience as something akin to an unnerving and long-lasting headache, FSIS likes to characterize the exercise as a comprehensive Food Safety Assessment (FSA).

When FSIS conducts a comprehensive FSA, the agency methodically reviews and critiques virtually every aspect of an establishment’s operations, and the EIAOs take their time. Historically, EIAOs have spent an average of about 38 days conducting each assessment. And, although FSIS likes to conduct a FSA in each federally-regulated establishment every few years or so, in light of the overall distraction a FSA can cause, industry has been asking whether there is any way to simply make the agency go away.

Well, according to FSIS, industry’s fate is now in industry’s own hands. Rather than simply performing a FSA for the sole purpose of performing a FSA, the agency has begun using the FSA process as a tool to specifically target “at risk” companies.

What does this mean for industry? It means that, if you are a federally-regulated establishment, you can avoid your next FSA (perhaps indefinitely) by staying off the agency’s radar.

Every month, under the new approach, FSIS Headquarters will now provide each District with a list of establishments that the agency wants assessed. This monthly “hit list” will be created using a Public Health Risk Evaluation (PHRE). The agency will consider a number of risk factors, including whether the establishment produced any product linked to illness, whether any products were associated with any positive pathogenic findings, whether the establishment had any recalls, or whether the establishment has a persistent noncompliance problem.

Although FSIS will not generally allow establishments to review the PHRE, the agency will use its findings to direct the scope of the FSA. And, under the new, more focused approach, where the assessment will be concentrated on the highest-risk areas within the establishment, the agency is claiming the entire process should only last about 5 to 7 days. At the end of the FSA, the EIAOs will recommend whether additional regulatory action, such as the issuance of NRs or notices of intended enforcement or suspension, is appropriate.

So, can your company avoid your next FSA? The answer is likely yes. Looking for ways to enhance food safety within your facility will help you stay off of FSIS’ radar and, ideally, avoid your next FSA.