Subtitle: Further Exposing the “Smoking Gun” of the Food Safety Modernization Act
The past week brought news that the comment period for proposed rules implementing the Food Safety Modernization Act (FSMA) has been extended another 120 days beyond the original May 16 deadline. Oddly, the word on that is not yet official, though was confirmed by FDA Commissioner Hamburg around midweek. Given the odd way the news leaked out, one wonders if there is trouble in food safety paradise these days.
So now we apparently have more time to study the issues and sharpen our messages about what truly constitutes a safe – and secure – food system. This gives me a chance to reflect on an issue I’ve written about before, i.e. the circumstances involving some of the limited exemptions included in the new law. As I explained in my previous post, The Food Safety Saga and Why It Matters (3/19/13), the so-called Tester-Hagan Amendment (THA) in FSMA allows for qualified exemptions of produce farms, processing plants and mixed-type facilities that gross under $500K per year and sell more than half of their food to qualified end users, which includes consumers, restaurants and retailers within the same state or a 275-mile radius.
The THA contains some aspects of brilliance, particularly in the way it begins to break down state boundaries as the unreliable arbiters of food safety that they are. But there is also some arbitrariness, e.g. why would a farm that sells $501K each year be considered somehow less safe than another achieving only $499K? And there’s some real ugliness too, especially when you consider that the various sales calculations reflect all food sold from the farm or facility in question, including conventional grain, milk for processing, animal feed and even livestock. This means that even farms grossing well under $500K, with over half of that being conventional commodities, will not qualify for an exemption on the bit of produce and processed food they sell locally on the side. Don’t look now, but many – very many actually – existing farms will face the full brunt of FDA regulation when they put in their first little patch of zucchini or make their first batch of pickles to sell through local channels . . . you know, that common practice found in rural areas for buying Christmas gifts, a family vacation or even new braces for Johnny?
In other words, we have some work left to do. It would be nice if all we had to do would be to convince Congress that the “all food” part of the rule should read “all food covered by this rule.” Yet there is an even more troublesome aspect to the rules emanating from the THA provisions. Specifically, the limited exemptions can be withdrawn if a foodborne illness is traced to a farm (which makes perfect sense), or if
…the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm.
This is what I have called the “material conditions” clause, and it is problematic, not only in terms of insufficient definitions, but also the conditions under which it can be invoked, and especially for the procedures, which are so far nonexistent, by which it can be regained by a qualifying farm or facility.
It makes sense that the FDA, or any health authority for that matter, should have procedures that can be used to prevent foodborne illness outbreaks, rather than just responding after the fact. This is especially important if a threat does indeed seem imminent based on the best science available and actual detection of pathogens. However, the material conditions clause does not say that. Instead, it is so general as to invite outright abuse, including punitive action based on an individual inspector’s opinion, the preconceptions and prejudice of FDA personnel in any given situation, or even a decision from above that some class of farms or farmers are inherently unsafe.
Furthermore, if an exemption is lost, the currently proposed rules establish that as a permanent condition, and there is total lack of clarity as to whether the permanent loss of exemption applies to the farm, the farmer (who might move to another farm), a business the farmer may later sell, or all three. This combination of vague reasoning for withdrawing an exemption, lack of clarity as to whom or what entity the withdrawal accrues, and absence of any procedures for redressing the situation, is an entirely lethal mix in terms of failing to build trust or achieve the ultimate goal of increased food safety. Either these things get fixed in the rules, or FSMA will fail.
Although FSMA just may fail in any case. As I have also described before (New Food Safety Regulations Miss the Point, 4/8/13), the approach taken here to improving food safety does not adequately account for the full breadth of biological systems involved. The rules seem not to be working with nature so much as they try to discern between good and evil aspects of the natural system and then prescribe actions for pursuing the bad guys. To suggest a crude analogy, it’s clear that anyone can be cured of the common cold if a hammer is used, and used hard enough.
What we really need is a system for achieving food safety that takes advantage of the most fundamental precautions that are inherent in nature, namely that we produce food without unnecessary adulterants, for consumption as close to its source as possible, with minimal handling, processing, storage and trucking. Beyond that, we also need to pay attention to the health of the environment within which food is being grown and consumers live.
Making space to realize this latter vision of food safety and security is exactly what the Tester-Hagan amendment was all about. But perhaps, as some philosopher once pointed out, you cannot get where you want to go by proceeding more urgently and forthrightly down the wrong road.
Farmers who understand all of this have no interest at all in being exempt from responsibility to feed their customers as safely and healthfully as possible; they only wish to have the latitude to choose the correct path that will get them to that goal.
For more information about the Food Safety Modernization Act (FSMA), please consult the FSMA Action Center maintained by the National Sustainable Agriculture Coalition at http://sustainableagriculture.net/fsma/.