Our official comment on the FDA’s FSMA proposed produce rule

The Food & Drug Administration (FDA) was mandated by the Food Safety Modernization Act to provide “science-based” standards for production of safe food. The rule that most concerns our farm is open for comment through this Friday November 15; the rule is known as “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.” We don’t think highly of it, for many reasons including that it does little more than to promote the paranoid Pasteurian paradigm, essentially suggesting that the solution to food safety is to kill more microbes.

See our post from yesterday for some “highlights” of the proposed rule, as well as websites of organizations that provide good advice on how to comment.

The text of our official comment to the FDA follows:

Comment on “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption”
Docket ID: FDA-2011-N-0921, RIN: 0910-AG35

We are professional diversified farmers in our mid-30s, both scientifically trained and holding masters’ degrees, who pursued this business as a way to provide healthy & high-quality food to our community and ourselves, to improve our rural environment and economy through sustainable agriculture, to challenge ourselves intellectually and physically, and to pursue the American dream of independence. Our produce has been certified organic for 5 years, on a 7-year-old farm that integrates annual vegetables, perennial fruits & vegetables, log-grown mushrooms, dairy & meat animals, poultry, and timber. Our opinion is that the proposed Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (henceforth referred to as the “produce rule” or just “the rule”) would do much to discourage independent small farms such as ours. We are not convinced that the rule would actually achieve its goal of reducing outbreaks of pathogenic illnesses from produce. We lay out a series of criticisms of the proposed rule in the following pages. This is not a comprehensive list of concerns on our part, but it is all we have had time to compile, as full-time farmers attempting to review a complex set of regulations in what little spare time our business allows.

Proposed regulations are not scientific

The FDA was mandated by the FSMA to develop “science-based” rules for produce production. By our assessment, the produce rule fails to be science based on multiple counts.

— Science and paradigm shifts

Science doesn’t simply march forward, increment by increment, every time a new peer-reviewed study is published. A considerable number of peer-reviewed studies are bogus, as an excellent recent piece in The Economist points out: http://www.economist.com/news/briefing/21588057-scientists-think-science-self-correcting-alarming-degree-it-not-trouble. We are somewhat troubled by the FDA’s definition of “scientifically valid,” which includes the idea that anything peer-reviewed must be true: “we use the term ‘scientifically valid’ to mean using an approach that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research” (from the proposed rule).

Scientific understanding often lurches in a different direction when new data and ideas start to crystallize in such a way to make better sense of the world around us. Such a paradigm shift is happening right now in the realm of microbial science. Since the time of Pasteur, there’s been a considerable amount of “microbial phobia,” assuming that all microbes are inherently dangerous, and this is precisely what the proposed produce rule emphasizes. The word “microbe” is effectively synonymous with “pathogen” by the FDA’s use in the proposed rule. It is assumed implicitly in the proposed rule that it is possible & desirable to eradicate all microbes; thus, the solution to food-borne illness put forward in the proposed rule is to sanitize everything: our soil amendments, our packing sheds, our tools, etc. Wash your hands…kill the germs…sanitize everything….clean, clean, clean.

The FDA is stuck in this existing paradigm of microbial phobia. The new paradigm recognizes a complex microbial ecology, acknowledging that microbes are ubiquitous, important to human health, and subject to ecological principles and interactions. The ubiquity of microbes on produce is demonstrated, for example, by this research paper: http://www.plosone.org/article/info:doi/10.1371/journal.pone.0059310. Only a small subset of the total microbial population is pathogenic to humans.  Strategies to control pathogens need to be more intelligent than the “kill all the microbes” mentality that the proposed rule espouses. While a certain amount of cleanliness is plenty sensible, sanitization is not the be all and end all of microbial management. Sanitizing doesn’t eliminate microbes; biofilms and resilient dormant phases allow microbes to resist all sorts of assaults. The FDA basically assumes that a series of microbial-kill steps will protect produce from pathogens. This is an assertion based on the Pasteurian paradigm, and it is one that looks dubious when viewed through the lens of the microbial ecology paradigm.

The emerging field of microbial ecology leads to a more nuanced and complex view of human interactions with microbes. Achieving optimal human health is far more complex than simply eliminating pathogens; exposure to diverse microbes may be necessary. For example, Jeff Leach, who studies microbes in an anthropologic context, writes: “Increasing evidence suggests that the alarming rise in allergic and autoimmune disorders during the past few decades is at least partly attributable to our lack of exposure to microorganisms that once covered our food and us…. As we move deeper into a ‘postmodern’ era of squeaky-clean food and hand sanitizers at every turn, we should probably hug our local farmers’ markets a little tighter. They may represent our only connection with some ‘old friends’ we cannot afford to ignore.” http://www.nytimes.com/2012/06/21/opinion/lets-add-a-little-dirt-to-our-diet.html?_r=0

And a quote from Michael Pollan: “Such a paradigm shift comes not a moment too soon, because as a civilization, we’ve just spent the better part of a century doing our unwitting best to wreck the human-associated microbiota with a multifronted war on bacteria and a diet notably detrimental to its well-being. Researchers now speak of an impoverished ‘Westernized microbiome’ and ask whether the time has come to embark on a project of ‘restoration ecology’ — not in the rain forest or on the prairie but right here at home, in the human gut.”  http://www.nytimes.com/2013/05/19/magazine/say-hello-to-the-100-trillion-bacteria-that-make-up-your-microbiome.html?pagewanted=all&_r=0

In light of new findings and hypotheses, the potential that excessive sanitation could actually be detrimental to our health in the long run should definitely be on the table. Microbial ecology may offer more effective solutions to pathogen management than simple attempts to destroy all microbes. For example, does competition among microbes in highly diverse soil communities prevent pathogens from reaching problematic levels? Do beneficial “effective microbes” (such as those offered for sale by SCD Probiotics or TeraGanix) offer protection from pathogens through competitive ecological means? Does excessive sanitation lead to open niche space that allows pathogens to colonize and proliferate, a process well-understood in many macro-scale ecological settings? To what extent is microbial diversity necessary for proper plant nutrient uptake, which in turn affects the health of the people that eat the plants? There are more questions than answers, and any rules should account for the fact that our understanding of microbial ecology is bound to change over time. Codifying the out-dated paranoid Pasteurian paradigm into the rules of Food Safety “Modernization Act is not a way for it to live up to its name. A re-write is needed to bring the proposed rules in line with the modern microbial ecology paradigm.

— Scientists are picky about terminology

My reading of the proposed rule suggests that the FDA is a bit unclear about the fact that insects (and a whole bunch of other critters) are biologically classified as animals. Most references to “animals” make more sense if the word “vertebrates” is substituted instead.

Take these examples:

  • “Pest means any objectionable animals or insects including birds, rodents, flies, and larvae.” Animals OR insects? This implies that FDA is either unfamiliar with basic conventions of the English language, or the FDA is not clear that insects are, in fact, animals. “Vertebrates or insects” would make a lot more grammatical sense, though still not a lot of biologic sense since all the non-insect arthropods and other invertebrates would be omitted.
  • The FDA proposed rule regarding harvest requires: “Avoiding contact with animals other than working animals…” That’s really hard to do, given that animals including eyelash mites live on us, and other animals such as mosquitoes, horseflies, ticks, and chiggers are unlikely to cooperate with this provision. At times, various invertebrates (mostly insects) need to be removed from the produce at harvest time (think squash bugs on squash or cabbage worms on brassicas); we must come in contact with these in order to remove them. Vertebrates are usually much more practical to avoid.
  • Furthermore, the FDA defines yard trimmings as “purely vegetative matter.” All yard trimmings that I’m familiar with contain at least some arthropods if not other animals. The existence of “purely vegetative matter” is probably purely speculative. The intent seems to be to avoid vertebrate manure (or other vertebrate bits). In this context, it might be helpful to be cognizant of the fact that grass clipping from domestic yards may well be contaminated by dog feces.

We expect regulations to be precisely worded to say what they mean and mean what they say, as we know by experience that bureaucrats make irrational rulings by taking words out of context and interpreting them literally. For example, the Missouri Department of Agriculture interpreted a garbage-feeding law literally to mean that we can’t feed vegetables to our pigs, as discussed on our blog here: http://cherthollowfarm.com/2011/04/yes-missouri-deems-it-illegal-to-feed-vegetables-to-pigs/.

If the intent is to avoid vertebrate animals, then that’s what needs to be said. The existing level of sloppiness in the wording is completely unacceptable. As currently worded, a farm could be deemed in violation of the rule just because eyelash mites are coming along for the ride for harvest. If, on the other hand, these statements really are meant to encompass all animals, then the proposed produce rule needs a really big dose of reality infused into it.

— Dubious statistics, dubious assumptions

The cost-benefit analysis of the proposed rule is not something that we have had time to peruse in depth, but it seems to be based on some wild extrapolation. We are concerned over improper use of significant figures and the routine omission of uncertainty estimates. The disconnect between the number of confirmed illnesses associated with produce and the number of illnesses that the FDA estimates this rule will prevent is of particular concern.

A couple of key statistics & quotes from the proposed rule:

  • “Of the total reported outbreaks and outbreak-related illnesses linked to FDA-regulated foods between 1996 and 2010, in the FDA database, produce accounted for 23.3% and 42.3%, respectively. Both domestic produce and imported produce were identified as vehicles in these outbreaks. From 1996 to 2010, approximately 131 produce-related reported outbreaks occurred, resulting in 14,132 outbreak-related illnesses, 1,360 hospitalizations and 27 deaths.” For the 15 year period, that’s an average of 942 illnesses per year, 91 hospitalizations per year, and 1.8 deaths per year.
  • “We estimate the number of foodborne illness prevented by this regulation to be 1.75 million, with an associated benefit of $1.04 billion, annually.”

So, there have been an average of about 1,000 documented illnesses per year associated with produce, but the FDA contends that an estimated 1,750,000 illnesses will be prevented by the FSMA produce rule. That’s a difference of three orders of magnitude! This is a rather extraordinary claim, which in science requires extraordinary evidence. This just looks like extraordinary extrapolation. Making this claim would require sound evidence that the number of illnesses is remotely reasonable, as well as a solid case that the proposed rule will actually prevent illnesses.

This extreme slush in numbers also raises doubts about whether any impact of the produce rule will even be detectable. How can the effectiveness of the rule be assessed when the ability to measure produce-borne illness occurrence is so poor? How can we have any way of knowing whether the produce rule is doing either harm or good, when existing numbers apparently vary so wildly? The FDA’s case for the proposed rule needs to be based on sound economic cost-benefit arguments. If the numbers of prevented illnesses are brought remotely into line with existing data on such illnesses, as cited above, the cost/benefit calculation changes drastically to the detriment of the rule’s worthiness. In our view, the proposed rule imposes a very expensive and problematic set of solutions to a problem whose statistical extent doesn’t warrant such a sweeping intervention.

In addition, the question of the role of small farms in causing illness is an important one. The exemption threshold seems to be based on the following assumption: “Assuming that the likelihood of a farm causing illness is proportional revenues [sic] and that smaller farms are not relatively riskier than larger farms…” (from the OMB’s Preliminary Regulatory Impact Analysis). Presumably that should read “proportional to revenues.” This assumption requires substantiation. We would put forth the hypothesis that small farms are considerably less risky than larger ones for multiple reasons, including: smaller harvest batches, potential for quick turnaround from harvest to consumption, short & local supply chains, farmers who know and care about their customers, greater consumer involvement and awareness in the production & handling methods, and so on.

Keeping in mind the 15-year average of ~1,000 documented produce-related illnesses a year, and the highly questionable assumptions used to justify regulation of small farms, the following statement from the OMB’s Preliminary Regulatory Impact Analysis regarding the threshold level to exempt farms appears completely ludicrous:

“The proposed limit of $25,000 accounts for only 1.3 percent of covered produce, representing an estimated 26,000 illnesses per year, increasing the threshold to $50,000 would represent substantial public health impact, nearly doubling the number of preventable illnesses that would not be avoided.” Add to the absurdity of this statement the fact that those businesses grossing under $50,000 would generally be subject to the qualified exemption anyway, so they would not be required to substantively change their farming practices until and unless FDA takes away their exemption. The cost-benefit analysis used to justify the regulations is astoundingly weak and flawed.

Qualified exemption is inadequate protection

Our farm falls at the small end of the very small business definition, meaning we would fall in the “qualified exemption” category of the proposed rule. The provisions for withdrawal of the qualified exemption provide inadequate protection from potentially flawed decisions of a small number of bureaucrats. The conditions that allow a farm’s qualified exemption to be withdrawn are vague and broad. The lack of guarantee of a hearing is unacceptable. The lack of a process to reinstate the qualified exemption is unacceptable. For farms like ours, removal of the qualified exemption is an immediate death sentence to the business; independent farmers like us cannot simultaneously run a full-time business while drawing on the time and resources needed to defend ourselves against the FDA. Initial compliance timelines for the implementation of this law are given on the time-scale of years. Yet it is mandated for a farm to comply with all requirements in 60 days if a qualified exemption has been withdrawn. That is completely infeasible, given that our growing methods and composting procedures, some of which would be deemed out of compliance with the proposed rule, have been developed and are executed over the course of years on a rolling and ongoing basis. Farming is not a factory production line which can be shut down & restarted on demand.

We sell to CSA members and restaurants within about a 20 mile radius of us. All of our customers have had multiple opportunities to come to the farm; most have visited. All regular workers eat some of what is produced here. Many of our customers are friends. If something happens on our farm that results in illness, our customers will know about it. In such circumstances, we believe it should be up to our customers, not federal bureaucrats, to decide whether our farm is worth continuing to support or not. Indeed, this is in the spirit of the Tester-Hagan amendment. We feel strongly that the intent of the Tester-Hagan amendment–to exempt small farms like ours that do a high percentage of their business selling direct to consumers–should be upheld in the rule.

The current complete exemption to farms grossing (not netting) less than $25,000 will solely exempt small hobby farms, not small professional farms. We disagree with the FDA’s statement that “we have tentatively concluded that farms with $25,000 or less in sales do not contribute significantly to the produce market.” (The word “significant” has a very particular scientific & statistical meaning, yet is used repeatedly by the FDA as a vague and undefined term to indicate general importance.)  By our assessment and experience, hobby farms bringing in less than $25,000 do make up a high percentage of farmers market vendors in some regions. Such farms are and should be subject to the Tester-Hagan amendment. However, if hobby farms are worth exempting, then small professional farms are too. Small professional farmers have every incentive to sell and distribute safe food; for professional farmers, unlike hobbyists, our full livelihood is at stake. The FDA should have every desire to support the stability and success of professional farms, not just to exempt our part-time competition.

In the proposed rule, the mention of the $25,000 threshold for full exemption does not specify that it will be adjusted for inflation. Allowing for adjustment for inflation is critical for all income thresholds. To protect small, responsible professional farms, it is essential to increase the full exemption threshold and to specify that the level will be adjusted for inflation.

More on compost & manure

In FDA’s order of “safest” to “least safe” based on the application interval:

  • Manure from overcrowded, antibiotic-fed, unhealthy animals that has been heated and treated with ammonia–and that is at least momentarily a microbial blank slate waiting for opportunists of unknown origin to colonize it–can be applied to produce crops with no time restrictions whatsoever.
  • Treated human feces (and all the medications and other sketchy stuff that comes along with the sewage) can be applied to produce as close as month prior to harvest, a fact that is swept under the rug by using the euphemism “sewage sludge biosolids” and outsourcing the time requirements to another bit of regulation, but here it is: “Food crops, feed crops, and fiber crops shall not be harvested for 30 days after application of sewage sludge.”  http://www.ecfr.gov/cgi-bin/text-idx?SID=9456682f3f7fe0657a03b7aa6f4d29e0&node=40: The FDA offers no further restrictions.
  • Compost made from bedding from our pastured chickens and goats would require a 45 day waiting period (if we weren’t covered by the qualified exemption). Compost made with manure from the filthiest, most antibiotic-laced feedlot in existence would have the same 45 day waiting period.

Note that the CDC recognizes the hazards of using manure from animals routinely treated with antibiotics; see the Cycle of Resistance Infographic, p. 14 of the 2013 CDC Threat Report,  http://www.cdc.gov/drugresistance/threat-report-2013/

Produce farms have been using compost produced according to organic rules for decades. If compost use contaminates produce, one might think that there would be a pretty good list of documented cases of this happening. Though you can’t prove a negative, an absence of such data suggests to me that there is NOT a “reasonable probability” that compost handled according to NOP guidelines will contaminate produce or make people sick. That organic rules allow feedlot manure to be used for making organic-compliant compost—an allowance that we personally find despicable—suggests to that the proliferation of diverse microbes within a compost pile provides some degree of protection from pathogens.

Questioning the safety of compost, FDA repeatedly cites a single paper, reference # 174 (the journal name in the citation is incorrect in the FDA reference list, by the way, which made the abstract more difficult to find). As this is not an open-source journal, I have not been able to read the paper. I have no doubt that pathogens CAN make it through a compost pile, but are the circumstances addressed in these studies realistic for real world situations? What about the “reasonable probabilities”? What about a cost-benefit analysis of compost, as the extraordinary benefits of compost are completely ignored?

The importance of compost on an organic farm should not be underestimated. Freedom to use compost as our professional judgment deems appropriate is essential to our ability to grow high quality produce. The response of tomato plants, for example, to a mid-season side-dressing of high quality compost is something that must be seen to be appreciated. The diverse microbes present in good compost play a role in plant health in a way that is analogous to microbes in our gut being essential to human health.

That FDA considers compost of questionable safety has serious ramifications. That FDA’s preferred method of manure treatment requires massive amounts of energy inputs, while compost just heats up of its own accord, also has serious ramifications. Over-regulation of biological soil amendments is likely to drive some farmers to use chemical ones instead. The economic, agricultural, environmental, and health consequences of this should not be ignored.

The requirement for “around one foot thick of insulating material” on compost piles during the curing process is highly impractical for small-farm methods of composting. Our compost cycle is driven by the monthly movement of the mobile shelter for our pastured goats, which is in turn driven by the timing of the goat-specific parasite cycles that this rotation is designed to interrupt. Due to the small-scale nature of our composting, the volume of insulating material we would need would EXCEED the amount of compost in the smaller piles that we produce. For example, for a 4x4x4 ft pile, containing ~64 cubic ft of compost, we would need ~116 cubic ft of insulating material. If, as suggested, that material is straw or hay, then we would be reintroducing fresh weed seeds back into the pile which otherwise is designed to heat itself sufficiently to kill weed seeds. If we used finished compost for insulation, we would need nearly two piles worth of compost to cover every one pile in the curing stage. That couldn’t work, because cured compost needs to go to the vegetable plants as intended. Plus, we don’t like to mix our compost batches, because we want to know exactly what has gone into each one. I have seen no science that convinces me of the necessity of such inconvenient & expensive measures.

The proposed 9 month rule for manure application is truly excessive. Organic agriculture has been operating under the 90/120 day rule for years, and I know of no food safety problems from organics associated with this. Imagine a diversified orchard, one with mixed apples, pears, cherries, peaches, etc., that bears from June to October. Chickens would NEVER be allowed to forage is such an orchard according to a strict interpretation of this rule, even post-harvest when their presence can be instrumental to cleaning up dropped & rotten fruit while helping control pest cycles.

Miscellaneous points

  • Regarding the qualified exemption, we think that labeling produce with the farm name is acceptable, but we are not convinced of the need to disclose the complete business address. If the purpose of the address is to provide a rapid means of contact in case of a concern regarding the product, then a phone number, functioning website, and/or email address would be of considerably more use than a postal address. We have made a conscious choice to avoid advertising our physical address, partly as a biosecurity measure, and partly because we simply don’t have time to handle unplanned visitors. The proposed rule makes it clear that the FDA considers visitors a liability, as the proposed rule has specific provisions for protecting produce from visitors. If that’s the case, then why create a situation that will inevitably result in visitors showing up at small farms unannounced? Or are we all expected to pay for post office boxes, something that is not in our tight farm budget? How about making an option to include a choice of postal address, phone number, website, or email address?
  • We find the raw vs. cooked distinction for determining what produce is “covered” to be illogical and arbitrary. Kale is considered a “rarely consumed raw” vegetable, yet Google comes up with well over a million results for the search “’raw kale salad’ recipe.” Indeed, one of our restaurant customers offers a raw kale salad. Furthermore, if the “rarely consumed raw” list is going to be declared exhaustive, then it needs to be more logically complete; for example, why are black-eyed peas listed but not other cowpeas (species Vigna unguiculata) of which there are numerous varieties, many without a black eye (for example: http://www.rareseeds.com/store/vegetables/cowpeas/)? What makes kidney beans and pinto beans special, but not black beans or white beans or the multitude of other varieties of common dry beans of the species Phaseolus vulgaris? Are acorn and butternut squash the only exempted winter squash? What about delicata? Or hubbard? Or kabocha? Or cushaw? Or any other of a multitude of varieties of the four species of winter squash? The “rarely consumed raw” distinction is one that can’t be made cleanly, and is subject to change with future cooking trends and fads. By extension of logic that foods that are rarely consumed raw need less regulation, then FDA should give up its war against raw milk, since milk, after all, is rarely consumed raw, and so it need not be paid attention to. It seems clear that such rules are written by people who understand neither food nor farming.
  • Exempting produce that goes through processing steps will likely have the unintended consequence of making processed foods seem even cheaper relative to fresh, unprocessed whole foods. This has consequences for the health of our population overall. Overall consequences of this rule on the price of produce and implications for the American diet should have been considered as part of the cost-benefit analysis.
  • The no-drops rule is a good example of uninformed bureaucrats generalizing too far. Chestnuts are a good example, as they are harvested off of the ground, period. The standard harvesting suggestions for ground cherries (which are cloaked in a protective husk) is to harvest them when they drop. Tomatillos, like ground cherries, have a protective husk and many that drop to the ground are completely usable.
  • The rule deals only with short-term health issues of a pathogenic nature, with no consideration of farm practices that contribute to nutrient dense foods, or for the consequences of the rule for long term health or the environment.
  • The FSMA mandates the FDA to deal with concerns other than just pathogens, including chemical hazards. Thus we fundamentally disagree with the exclusive focus on biological hazards. Just because pesticides, etc., don’t cause immediate and deadly impacts doesn’t mean that they’re safe. Plus, the unfortunate situation in India this past summer shows that pesticides CAN cause immediate & deadly impacts, yet the FDA ignores chemical concerns.
  • The FSMA mandates the FDA to deal with concerns other than just pathogens: “including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism.” Small farms dispersed across the landscape and serving customers directly are inherently more resilient to terrorism or other forms of intentionally introduced hazards, by the sheer scope of their diversity, independence, and geographic decentralization. Large centralized farms that distribute products reaching large numbers of people in multiple states are inherently more vulnerable to any given problem or attack. If the proposed rule negatively affects viability of diverse small farms, in favor of large centralized farms which can better afford to comply with intrusive and expensive regulation, then the net result may be an increase in vulnerability of the American food system, not a desirable outcome.
  • The proposed produce rule is full of vague language. What constitutes “significant quantities of animals”? What does it mean to “adequately clean”? What is “as frequently as reasonably necessary”? In the event of alleged contamination of produce, farmers will ALWAYS be judged wrong with wishy-washy phrasing such as “reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards.” For example, the term “reasonably foreseeable hazard” is even defined to mean “a potential hazard that may be associated with the farm or food.” To me, a potential hazard includes hazards that are highly improbable but possible, while reasonably foreseeable hazard includes those that have a high probability of occurring. Why use the word “reasonably” if its meaning is discounted in the very definitions of the rule? Take out the word “reasonably” and farms are on the hook to do whatever is “necessary to prevent introduction of hazards.” Furthermore, assessment of what hazards are reasonably likely cannot be made in retrospect with 20:20 hindsight. Managing farms to mitigate that risk of pathogen contamination is a matter of working with an incompletely understood and thus unpredictable biological system. No farm can absolutely guarantee with 100% certainty that produce will never become contaminated with something that is problematic to someone’s immune system. Causes for pathogenic contamination may range from gross negligence to really bad luck, and the problems may originate on the farm through processes controllable to the farmer or off of it due to circumstances beyond the farmer’s knowledge or control. This rule inherently set up an antagonistic relationship between farms and the FDA that will not in our opinion lead to cooperative and productive efforts to better understand the mechanisms of contamination. Too much emphasis is placed on assigning blame. More emphasis should be placed on gaining knowledge that is key to preventing future outbreaks. A system that approaches food safety with the foregone conclusion that the farmer is wrong is not a system that is likely to promote innovative, intelligent, successful farming.


If the proposed produce rule is implemented in its current form, we will be put in a difficult place to decide whether and how long to continue offering our high quality produce for sale to our community. In our cost-benefit assessment of farming, the added risk of being at the whim of FDA bureaucrats is a concern that we do not take lightly. Though a low probability occurrence, the consequences of coming under FDA scrutiny are high. Our distrust of the FDA is rooted in the case of Morningland Dairy, in which a thriving business was shut down due to purported pathogen contamination, in spite of no evidence whatsoever of customer illness and in spite of dubious evidence of actual pathogen presence. We don’t desire to find ourselves in a similar situation, losing our business to a nightmare of selectively enforced yet poorly defined rules and penalties.

For a rule that is supposedly “science-based”, there is little respect shown for good science. The rule is based in lousy use of statistics and insufficiently supported assumptions. Use of terminology is sloppy. And the rule ignores a major scientific paradigm shift that is changing fundamental understanding of how humans interact with microbes. We consider the proposed rule as written to be deeply flawed. We hope, at a minimum, that the rule is re-written to leave small and direct-market farms alone in the spirit of the Tester-Hagan amendment.

3 thoughts on “Our official comment on the FDA’s FSMA proposed produce rule

  1. Thanks for this smart factual critique of the FSMA. How did you make the time during your season to actually read and analyze this sprawling dense proposal? My wife and I also run an organic produce farm near Madison, Wisconsin, but somewhat larger than Chert Hollow (about $800,000 yearly sales). My gloss reading of the draft rule set off many instinctive alarms; here you have expanded and clarified what I’ve been feeling. The FDA has my comment, and several from our CSA members. Your effort is appreciated.
    Steve Pincus/Tipi Produce

    • I read what I could find time for on cold winter days (when the original deadline was May 15) and hot summer afternoons (when the revised deadline was August 15), then finally did most of the writing during recent rainy &/or cold November days (grateful for the again-revised deadline of November 15). Way more time than I would have liked to spend on a non-income generating activity, but I thought it was important. I didn’t do a detailed read of all of the hundreds of pages from the FDA, but printed out & scribbled all over the actual proposed rule (~19 pages in the single-spaced Federal Register version), then went back and read parts of the background that seemed most relevant to my concerns. Didn’t need to read every word to have more than enough to comment on….

      I don’t know of any produce farms around here that wouldn’t fit under the Tester amendment, but it is a good reminder that farms like yours are out there. I’ve been wondering if the private food club precedent being set in the raw milk world may be needed in the realm of produce soon; it seems well suited for those of us who are selling direct to CSA customers anyway. Hoping the final rule has some sensibility infused into it for all our sakes.

      By the way, Eric is a Beloit grad & loves southern Wisconsin.

  2. The Reuters drop the hammer! Seriously, well done. There’s a lot of powerful points in your comment on the proposed rule changes. I hope someone at the FDA reads it and forwards it to the people who have a say in these decisions. Thanks for doing this and for looking out for us.