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From: Food Quality & Safety magazine, June/July 2011

Put Your Stamp on Food Safety

Think you have an adequate plan? Now’s your chance to prove it to the FDA and help shape enforcement of the FSMA

by Shawn K. Stevens

Put Your Stamp on Food Safety

The passage of any new legislation is bound to bring on a lengthy period of adjustment. When that legislation is as broad and sweeping as the Food Safety Modernization Act (FSMA), the period of adjustment can last years. In our last column, we addressed the new federal requirement, which begins in June 2012, that food companies adopt written food safety plans, alternatively referred to as Hazard Analysis and Critical Control Point (HACCP) plans. While the initiative may appear relatively simple and straightforward, in practice it may prove difficult for the Food and Drug Administration (FDA) to enforce the new requirements uniformly and fairly. We wanted to take a moment to highlight some of the momentous challenges associated with the eventual implementation of the FDA’s new food safety rules.

The concept of HACCP was developed in the 1960s by Pillsbury and NASA in a project aimed at keeping astronauts’ food pathogen-free. Microbiological testing, they knew, was only effective to a point. So, they collaborated on a program aimed at understanding where and how failures in food safety occur. The result was HACCP, a program designed to seek out and identify the processing points where food safety risks could be reduced to the greatest extent possible. In the 1990s, the FDA mandated HACCP for seafood production, and the program was eventually required in meat and poultry establishments by the Department of Agriculture’s Food Safety and Inspection Service.

The program has been largely successful in the meat industry and has led to a pronounced reduction in the number of foodborne illness outbreaks. As with any regulatory initiative, however, HACCP requires continuous refinement as science, technology, and consumer attitudes mature. And, while recognizing HACCP’s far-reaching success in the meat industry, it is important to note that the meat industry produces a fairly limited set of distinct products and that all beef slaughter operations, by nature of the processes used, follow relatively similar HACCP programs. The risks are finite and can be addressed from one plant to another with identical—or at least similar—interventions. Thus, within the meat industry, establishing uniformity in enforcement and compliance, while never easy, has at least proven somewhat manageable.

The FDA, unfortunately, has a much more complicated scenario to manage. Under the new requirements, every food processor will have to identify, categorize, then formally address a unique set of hazards. In other words, the HACCP program at a factory that makes frozen waffles is going to be fundamentally different than the one for a processor making yogurt, crackers, seasonings, or egg salad sandwiches. There are tens of thousands of food processors in the U.S. making hundreds of thousands of products.

So, how will the FDA ultimately approach the development and implementation of an inspection apparatus that deals uniformly and fairly with tens of thousands of companies producing hundreds of thousands of distinct food products? This, of course, is the million- (or, perhaps, billion-) dollar question, a question that should be flagged and debated today, as opposed to next year when compliance—however that term is ultimately defined by the FDA—will be required.

The FDA and the food industry have time to address many of the challenges of reaching the FSMA’s goals, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.

In a perfect world, the FDA could simply publish guidance materials outlining a single HACCP methodology, with a single set of compliance standards that could be applied uniformly to every manufacturing facility and food product. This scenario would prove impossible, however. As noted, there are simply too many different food companies producing too many dissimilar food products, and there is no such thing as a one-size-fits-all science-based HACCP program.

Additionally, even if a uniform set of compliance benchmarks could be adopted and understood by all, it remains unclear how the FDA would uniformly enforce those standards throughout its many districts. In each of the FDA’s jurisdictional districts, there will be many different inspectors, each with different qualifications. Thus, the follow-on dilemma for the FDA will be how to ensure that the cookie producer in New York is being judged by the same standards as the one in California.

That, of course, presumes that FDA inspectors will be adequately trained in HACCP. Indeed, before the FDA can determine whether any company is in compliance, FDA inspectors will need to gain significant expertise in HACCP. Ideally, an FDA inspector should hold a degree in food science and have a clear understanding of the risks that exist in all the specific products he or she oversees, which, as noted, could number in the thousands. As of today, however, many FDA and other public health inspectors lack the appropriate food science background. Thus, there is and will continue to be a shortfall in the number of qualified inspectors needed to build an inspection apparatus of the size and scope necessary to visit, even on a rotating basis, each of the food processing plants in the country.

And, that’s just here at home. Many food products in our grocery stores, gas stations, drug stores, and specialty shops contain imported ingredients. From salt and pepper to noodles, brownies, and whipped cream, the things we consume often contain ingredients from faraway places. It remains to be seen who, if anyone, will oversee these products.

It stands to reason that the FDA will have to substantially increase the number and qualifications of its inspectors, not only in the United States but also possibly abroad, to meet the goals of the FSMA. The FDA must also recognize, however, that enforcement will be complicated tremendously if the inspectors who are tasked to ensure compliance lack the basic experience and training needed to oversee a science-based system that, while it appears simple on paper, can be extremely complex in practice.

Fortunately, the FDA and the food industry have time to address many of these challenges, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.

The new legislation presents a unique opportunity for industry to partner with the FDA to prepare for and streamline the implementation of the FSMA. In advance of each pending deadline, the FDA will invite industry to comment on its proposed rules and regulations. Industry needs to offer written suggestions and ask the FDA to define, as precisely as possible, what its expectations will be. Companies should take maximum advantage of these opportunities, which represent their best chance to play a role in developing the rules—and, by extension, the expectations—that will one day govern their food safety programs.

As with any large undertaking, active engagement, along with preparation and planning, will make all the difference between success and failure. Use the time you have now to prepare for the sweeping changes that will soon be at your doorstep. Lastly, if you do nothing else, work alongside and communicate with the FDA as these changes are instituted. How exactly your food safety plan is enforced might eventually be up to you.

Shawn Stevens, an attorney at Gass Weber Mullins LLC in Milwaukee, Wis., counsels food industry clients nationally on food safety regulatory and liability issues. He can be reached at or (414) 224-7784.



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