Food Safety Must Advance (FSMA, 15 years later)

Not sure where to start with this one, so here are the various thoughts floating in my

head now that we’re 15 years into the Food Safety Modernization Act:

• How many people reading this were even in food safety 15 years ago? Who

would know what I’m referring to if I say S.510? Who remembers the excitement

around FSMA? Who spent their weekends pouring over the proposed rules,

participating in public meetings (in person. Virtual meetings were not a thing),

offering comment, and obsessing over the comments of others? Who wondered

how the heck we’d get everyone on the same page, raising awareness, offering

trainings—especially given the global impact?

• How can I say we haven’t met the vision of FSMA if there’s no quantitative

baseline for comparison, and no good measurement system in place now?

Ultimately, we want to improve public health. For many, many, many, many

reasons tracking changes in rates of foodborne illness is difficult, and even if we

see changes, establishing causality is also difficult. (the recent GAO report

recommends that FDA have a process management system for this, and HHS in

their response pointed to the challenge).

• What’s gone well? One of the best things to happen in the early years was the

collaboration between stakeholders. FDA’s engagement with the industry was

commendable, and I’m of the opinion that most of the industry really embraced

the vision of FSMA. What’s improved? Is there greater visibility through supply

chains owing to the supply chain preventive control in the PC rules, FSVP, and

now the traceability rule? Maybe, but there’s still huge room for improvement. Is

there greater technical expertise and capacity owing to the trainings that have

been developed for the various rules? I’m not sure. In some segments of the

industry I think the answer is yes. Certainly, there’s awareness of FSMA and

awareness of the rules, and the concept of food safety culture seems to have

taken hold as a result. Undoubtedly, FDA’s authority is greatly expanded, which

was needed.

• Has FDA taken full advantage of the authorities bestowed upon them by FSMA?

Probably not. Some companies seem to slip through the cracks, or get off too

easy. But as we’ve seen with all things FSMA, timeliness is not FDAs (or the

governments) forte.

• Have we moved from a reactive to preventive system? When it comes to

regulatory inspections and market access audits, I don’t think we have. It’s much

easier to measure the width of a gap in a dock door than establish if a sanitation

preventive control and the accompanying environmental monitoring program are

adequate to prevent post process contamination. Has industry moved toward

prevention? Maybe- but they still know their auditor will ding them on the dock

door. We see many companies, particularly medium size companies, put

resources toward passing their audits, often at the expense of shoring up their

preventive systems.

I’d love to dig into each of these topics. There’s so much to say when reflecting on

FSMA. As we look toward the future, the idea that Food Safety Must Advance should be

the ‘new FSMA’. We’re not done. We’ll never be done, but I believe we can pick up the

pace if we prioritize those programs that matter most, and actually make food safer.

I fear that this post may come across more negatively than I actually feel. I’m truly

excited by the spark and curiosity I see in some newer food safety professionals. I feel

their frustration when they struggle to move the needle, and share in their joy when

we’re able to move toward a more risk-based system. Their passion, combined with the

technology tools available today, should allow us to surpass the vision of FSMA.