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.
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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 email@example.com or (414) 224-7784.