Dick Groves
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Is The FSMA Too Big And Complex To Succeed?

When it was signed into law more than three years ago, the Food Safety Modernization Act was widely described as the most sweeping food safety law passed in the US in over 70 years.

Based on what’s happened since then, and, more importantly, what’s going to be happening over the next couple of years, we’re beginning to think the FSMA was a little too “sweeping” for both the Food and Drug Administration and for the regulated food industry. This is one huge, complex, and expensive food safety regulatory reform initiative.

The complexity of the FSMA can be seen in several different ways. For example, it took Congress several years to finally pass a food safety bill of any significance. That meant years of legislative discussion drafts, actual bills and public hearings, not to mention recommendations from government and outside organizations, before the FSMA was finally passed into law in late 2010 and signed into law by President Obama in the first week of 2011.

Also, this is a pretty detailed law, running some 236 pages in length and including four separate titles (improving capacity to prevent food safety problems, improving capacity to detect and respond to food safety problems, improving the safety of imported foods, and miscellaneous provisions).

To put that in a bit of perspective, the recently signed 2014 farm bill runs a grand total of 949 pages, the first 13 of which are just a listing of titles (there are 12 of them, dealing with commodities, conservation, trade, energy and various other topics), not to mention subtitles too numerous to count.

Another illustration of the complexity of the FSMA can be seen in how long it’s taken FDA to implement the law. Depending on your perspective, the length of time it’s taken FDA to implement certain key provisions of the FSMA ranges from “too long” to “not long enough.”

Falling into that “too long” category was the Center for Food Safety, which filed a lawsuit against FDA in August of 2012, alleging that FDA had violated FSMA and something called the Administrative Procedure Act by unlawfully withholding the FSMA regulations beyond the required statutory deadlines.

Frankly, the food industry should probably be thankful that FDA dragged its feet in implementing the FSMA. After all, some of the final rules, such as those dealing with preventive controls for human food, were supposed to be effective 18 months after the FSMA was signed into law, or in July of 2012.

Well, it wasn’t until January of 2013 that FDA finally got around to publishing just a proposal to implement the preventive controls rule. And the complexity of just that single section of the FSMA (this was Section 103 of Title I of the law) can be seen from the fact that FDA extended the period just for submitting comments at least twice.

The initial comment period of 120 days was later extended by another 120 days, and then again, meaning that FDA accepted comments just on this single section of the FSMA from January 16 until November 22, 2013, a period of more than 10 months.

In the end, the Center for Food Safety prevailed in its lawsuit against FDA, and the agency (as we reported back on February 21st) now has firm deadlines for publishing final FSMA rules.

So, for example, the final rule for preventive controls for human food has to be released by August 30, 2015, or more than three years after FDA was supposed to have published a final preventive controls rule. While the three-year delay was certainly nice, based on the facts that the proposed rule had a comment period that ended up running more than 300 days, and that the agency received more than 8,000 comments on the proposal, a further delay in implementation wouldn’t have been such a bad idea.

Did we mention that, while the preventive controls rule is just one section of one of the four titles of the FSMA, just the proposed rule ran almost 180 pages in the Federal Register (single-spaced, three columns per page)? The food industry will have to comply with the final version of this rule after it’s published in less than 16 months.

But that’s hardly the end of FSMA implementation for the food industry. Among other things, under the consent decree FDA reached with the Center for Food Safety, the agency will be issuing its final rule on the sanitary transport of food and feed by March 31, 2016; and its final rule on the intentional contamination of food (food defense) by May 31, 2016.

FDA had published its proposed rule on food defense plans in December of 2013, and then published its proposed rule on the sanitary transport of food and feed earlier this year. Comment periods for both of these proposed rules are still open.

And if all of those FSMA final rules aren’t enough, FDA also, less than two months ago, published a proposal to update the “Nutrition Facts” label that’s found on most food packages.

So food companies in the next several years will have the pleasure of not only complying with the most sweeping overhaul of food safety regulations in over 70 years, but also tossing out their current food labels and applying new ones.

We can’t help but think that maybe the food industry (as well as FDA and consumers) might have been better off if Congress had passed less-sweeping food safety legislation.

Hopefully the FSMA will result in safer foods for consumers, but in adhering to the upcoming final rules, many food companies might find themselves developing some pretty nasty indigestion. DG

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