In Response to: “Blue Bell and the Very Real Impact of the Food Safety Modernization Act” at Food Safety news

I appreciate Michael Taylor’s comments in the above article posted on Food Safety News and also believe that FSMA is a step in the right direction. The fact, however, is that companies around the globe have already adopted food safety systems! This article makes it sound like preventative controls are something new and that such programs will be brought about by new federal law. The fact is in most major operations the preventative controls are in place right now. There are firms that have not adopted such in their operations, and FSMA may help to address this, but by and large, the large food borne illness outbreaks we have seen are not the result not having a prevention program, but the failure of the program to prevent the hazard from occurring.

Breaking a law, however, comes with a high cost for non-compliance, and that hammer is needed for some. But for most operators, this is not the answer to the microbial contamination control problem in their facilities. Our overarching goal in industry should be to be in compliance with FDA’s new laws, however, we need effective food safety management systems and we do not always have them. This is illustrated by the findings of serious sanitation issues, after the fact, in the investigation of the Blue Bell ice cream plant outbreak and many others.

As a regulator, consultant, auditor and investigator for almost 40 years, I am painfully aware of the difficulties in the implementation of complicated quality assurance and safety programs. In light of this, I feel simply more or different “preventative controls” are not likely to improve the situation much, by themselves.

Still, we look to FDA to help us, and I am still wondering if we will get what we need from the agency. We need consistent application and enforcement of the rules, and FDA has to get agents into the field, but most importantly, firms must organize their companies around food safety. This means establishing active and effective committees, appointing dedicated food safety staff, and a planned approach to assuring the safety of products. Companies must also effectively train and educate everyone in the organization, and maybe most importantly, apply the available science and technology to the food safety problem.

A lack of commitment within companies is a root cause of much of the failures of the existing programs, along with a lack of resources. We waste tons of money on audits, manuals, record keeping etc, etc, when we should be investing in educating our employees, improving our  infrastructures and applying technology. These applications should include onsite laboratory capability, remote monitoring of critical processes, and sophisticated traceability and recall programs.

I totally support what FDA is doing with FSMA, but we should recognize that a new system of preventative controls is only a solution if our food safety management systems are working effectively.