FSMA: slow, steady progress

by Bernard Shire
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While there’s been criticism of the Food and Drug Administration over how much of the Food Safety and Modernization Act (FSMA) the agency has put into the practice, FDA officials are defending what they’ve done so far. But they acknowledge there’s still a way to go before all the food-safety improvements spelled out under the FSMA are into effect and working. Doing most of the defending for FDA, as well as admitting there’s more to be done, is Mike Taylor, Deputy Commissioner for Foods at FDA.

If the name Mike Taylor sounds familiar to meat and poultry processors, there’s a good reason. He was the guy in charge of the US Dept. of Agriculture when mandatory HACCP was put into effect. In fact, he was the administrator of the Food Safety and Inspection Service between 1994 and 1996, and he can get the credit, or the blame – depending on how you look at it, for implementing the new scientifically based approach for raising safety standards for meat and poultry production. At the time, he did it over the protests of industry, and again received credit or blame for which either way would be considered a heroic accomplishment. Sixteen years later, most parties, even in the industry, think HACCP turned out to be a pretty good thing for meat and poultry processing.

Food safety Déjà Vu

Regardless, in what could be considered Déjà Vu all over again, Taylor is back doing almost the same thing, only this time for the FDA, an agency which also has a few things to say about meat and poultry safety. He has the job, among other things, of converting a big food-safety law into food-safety regulations to be carried out by regulating agencies. The first step FDA is taking is converting its food-safety efforts from catching processors when they’re not doing what they’re supposed to be doing, or even doing something wrong, to a modern, prevention-oriented, food-safety system to work better for both the food industry and for consumers.

Taylor says accomplishments have taken place in the 19 months since FSMA was passed, including the passage of three final regulations; nine draft and final guidance documents published in the Federal Register, with two more in the process of clearance right now; five reports made to Congress; notices published on state and local food-defense capacity from sabotage and other crimes, and implementation of FSMA re-inspection fees; and anti-smuggling strategy published with the Department of Homeland Security.

He also points to proposed rules establishing an accredited, third-party certification program and transportation safety standards, as well as an advanced notice of proposed rulemaking on intentional adulteration of food products. There are other areas still being worked on at this point, Taylor says, including both strategies and system-building for inspection and compliance with regulations, risk-based priority setting and resource allocation; a new import safety system to prevent some of the problems experienced in the past; science and research, and outbreak response.

“We’ve known from the start we can’t implement FSMA on our own,” Taylor admits. He says the agency wants to improve food safety by visiting food-processing facilities in 14 states. “We also opened two-dozen dockets for written public comment, and convened five formal public meetings. We participated in several hundred presentations, individual meetings, webinars and teleconferences with industries and consumer groups, and our partners in other federal and state agencies. This will improve every aspect of how we implement the FSMA,” Taylor said.

Anticipation

It will be interesting to see the effect the massive but gradual implementation of the Food Safety Modernization Act has on food safety. One of the great criticisms of the food-safety system in the US is the lack of a single, powerful food-safety agency, but the chances of that ever happening are slim to none.

Beyond that, great criticism has always existed of the differences between USDA food-safety activities and those at FDA. Some critics voice concern about the strength of the FDA on the drug and pharmaceutical side vs. its weakness on the food side and use that comparison to argue again for a single food-safety agency.

But barring that, there is support for making FDA more like USDA in food safety, one of the major arguments for passage of the Food Safety Modernization Act. Critics of the current operation ask questions like: Why are plants operating under USDA inspection subject to inspection virtually every day, or every day they operate, when on the FDA side, years can go by between inspection visits? Why does FDA delegate some of its inspections to the state level?

A difference in money used to be the answer. With the passage and the gradual implementation of FSMA, that may be changing.

Bernard Shire is a contributing editor based in Lancaster, Pa. Shire also works as a food safety consultant with Shire & Associates LLC.

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