The opening paragraph of the executive summary of the proposed produce safety rule reads as folows: “The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) requires FDA to publish a notice of proposed rule making to establish science-based minimum standards for the safe production and harvesting…” etc.
“Science based” is another term you’ll have heard a lot if you’ve been following the roll-out of this law. The FDA uses it a lot. Thus, the media repeats it a lot. But I have yet to see anyone look into the phrase. If the new system will be “science based”, on what is the current system based? Looking into this question too deeply will lead you to information that will make you ill. Instead let’s stay focused on the new food safety regime and its “science”.
The FDA’s hopes for the FSMA are pinned, in large part, to something called Good Agricultural Practices (GAP). GAP is an already existent certification program currently overseen by the USDA, Agricultural Marketing Service, Fruit and Vegetable Program, Specialty Crops Inspection (SCI) Division. Currently, GAP is voluntary, though most supermarkets, restaurants, hospitals and other businesses known as ‘institutional buyers’ require GAP compliance by farmers and others from whom they purchase food. The FDA is looking to make GAP universal, mandatory and take over enforcement. While the name sounds wholesome (Good Agricultural Practices must be good right?), one should investigate the results of the program before assigning it a warm, gushy feeling. Let’s take just one example out of, oh 48 million (yes this is an exaggeration…but not a very big one.).
In early November 2012, nearly two years after President Obama signed the FSMA into law, Wegmans Food Markets Inc. recalled organic spinach and spring mix due to an outbreak of e-coli O157-H7 during which the CDC reported 33 people in 5 northeastern states were infected, nearly half of them hospitalized and two suffering kidney failure. The greens in question were sourced from State Garden Inc., which is required by Wegman’s to meet GAP specifications. According to the USDA’s GAP website, in 2011 the SCI performed 3000 audits across 46 states and Canada. According to Food Safety News the agency has been missing a few more cases than just that of State Garden Inc. It is relevant to note that while the USDA has overseen compliance with GAP, the certification was actually created by (drum roll please) you guessed it, the FDA in consultation with the food industry.
The point here is that State Garden Inc. is a certified organic, GAP certified processor. That’s supposed to be the gold standard. Organic and GAP? That’s supposed to be the best insurance you can buy as far as food safety goes. Incidentally, State Garden Inc. is not a first time offender. They’ve had multiple food safety problems over the years. This is actually one of the biggest arguments against the FSMA. If produce from my farm had caused kidney failure in two people do you think I would be in business the next day? Of course not. FSMA is shoring up a system in which huge corporations, which can afford to eat the financial costs of compliance and failure will sicken or kill again and again. Meanwhile, as discussed in my last post, the small farms will be driven out of business because compliance with a law based on ineffective GAP is too costly.
The problem with the FDA continually using the phrase “science based” to describe it’s approach to the FSMA is that “science” is a defined term. In order for it to apply there has to have been a hypothesis and a set of varied experiments either proving or disproving it. I can disprove that the new produce rules are ‘science based’ with one word. “Adequate”. Ok, actually it’s one word two hundred twenty one times over. That’s how many times the word ‘adequate’ appears in the proposed rule. Adequate, is subjective. What is adequate to one person may be inadequate to another. “Hi, I’m an inspector from the FDA. I’ve decided there is inadequate window screening in your packing shed. And since I have used the word adequate instead of setting a definitive minimum amount of screening, it is impossible for you to prove me wrong…or even argue. It also doesn’t matter that your neighbor’s farm has less screening on her packing shed. The day I inspected her farm the amount she had seemed adequate to me.” If you think this is far-fetched you apparently haven’t been on the receiving end of an inspection under regulations with the word ‘adequate’ in them. (Incidentally, this regulatory tool is not by any means unique to the FSMA. The word is used extensively in the composition of regulations because of the very flexibility is provides to inspectors.)
In many cases the FDA’s proposed rules may sound like they make sense to someone who isn’t thinking very hard about a particular issue. Let’s just pick at random.
Biological soil amendments. For the most part this is a fancy euphamism for manure. There are a lot of ‘if-then’ statements in the FDA’s proposed rules. But let’s just pick the first one in their handy chart. If a farmer wants to apply untreated (read ‘fresh’) manure to a field then he or she must, under the new rules, wait 9 months to harvest any produce (covered by the rule) from that field. Now, at some point in the future I will rant about the practice of applying raw manure to a field. But for the sake of discussion let’s say it’s a necessary practice and a great way of adding nutrients back to the soil. Under the auspices of science, there must be a lot of experiments showing that the microbiological pathogens that might be present will disappear or be rendered harmless after 9 months, and not a moment sooner. I bet you can’t even find one scientific study showing this. Want to know why? Because it’s ridiculous.
Nine months is roughly 280 days. What a nice round number. Question. Is that 280 days in southern California or central Maine? Are we talking about nine months in Seatle or Talahasee? Here is a hypothesis for you. You could spread fresh manure on a field and find zero deadly pathogens in it after just three days during a typical Maine Spring or Autumn in which a pathogen could be subjected to temperature swings greater than seventy degrees, horizontal snow, sleet, ice, foot deep puddles, blazing sunshine and drying, sustained winds of over thirty miles per hour.
I am not in any way suggesting we have a rule that says three days. In fact I don’t think we should be spreading fresh manure on fields at all (though for reasons that have little to do with the consumption of produce) though the agency also has new rules for compost and composted manure. But I am suggesting we don’t use the word science to describe what we’re doing if it is arbitrary and one-size-fits-all instead of scientific. Currently, my three days in the spring idea is just a hypothesis. But if I want to make it into a universal law of the land and call it ‘scientific’, then I need to prove it. This is just one example. There are dozens, if not hundreds, of similar cases of universally applied, arbitrary standards that do not take into account such things as local climate, micro-climates, sources, scale, methodology nor historical context. Simply saying something is based in science does not make it true. In order for the FDA’s proposed rules to be scientific, they would have had to have been created using the scientific method. At the very least they would have to hold up under its scrutiny. In both cases the FDA has failed.
The FSMA and the FDA’s proposed response to it, based largely on the ‘science’ behind GAP, will not make the food system any safer. To be clear, I am not saying GAP is useless. Many of the practices in GAP are indeed intelligent, good ideas that should be practiced in order to ensure the safety of food. But GAP, required by many grocery and restaurant chains, hospitals and other large institutional buyers, is already widely practiced by many farms and other players in the food system. Here is another hypothesis which will be tested repeatedly in the coming decade. Forcing farmers and processors (that are producing safe, healthy food using age old wisdom and new technologies) to adhere to a new mandatory version of a failed safety protocol under a system that will see the most dangerous, centrally controlled producers (serving millions each) survive and the safest, most diversified producers (serving dozens or at most hundreds each) disappear will lead to a food system which is less safe than that currently in existence. The experiment is about to commence.
There is so much more to say about the FSMA and I intend to get to it. But I’m going to take a break from it for several posts in an effort to help my readers better understand what they can do about it, what they can do to avoid the dangerous ‘food’ available under the FDA’s pride and joy (GAP) and how to strengthen the alternative food system. Here’s a hint. Local food. Eat well – be well.