FDA’s Proposed Produce Rule

By Daniel B. Cohen on November 13, 2013

The deadline for comments on the U.S. Food and Drug Administration’s Produce Safety Rule is Nov. 15, 2013. This was probably supposed to be the easiest and most straightforward of the rules to implement the Food Safety Modernization Act (FSMA). It may be that FDA fell into the trap of a well-worn groove in designing the Produce Rule.

There are precedents for their approach from both Democratic and Republican administrations. However, this is the fourth time that manufacturers, processors and larger handlers of produce have attempted to use, or successfully used, food-safety legislation or state power to achieve multiple economic agendas – even when this would seem unnecessary, given their tremendous economic strength in the marketplace. In commenting on one of those attempts, I wrote: “It doesn’t take much time or experience to realize that Democrats act as they have never met a regulation that they didn’t like, and, if the regulation is ineffective, dysfunctional and complicated, they may like it even more. The Republicans claim they have never met a regulation they liked, except in practice, when it is demanded by industry to give a gloss of procedural protection (biotech for example) or provides a barrier to competition protecting the largest companies in the industry from competition.”

My view in this article is a plague on both their corporatist houses. Different strands were contributed for different political reasons, but they were woven into a political, not a science-based, approach, which said that farmers are ultimately responsible for all produce safety problems; therefore, food safety is achieved by telling farmers what to do. Furthermore, that a farm can be treated in exactly the same way as an individual closed-system manufacturing plant, rather than recognizing the reality of farms being open to, and part of, both a larger polluted environment and a natural ecosystem – and often cooperating with other farms in a social agricultural community, or human ecosystem, if you like.

It’s like blaming shellfish harvesters for the pollution entering Puget Sound, as well as the trucker who did not maintain a cold chain, the chain of stores that improperly stored the shellfish and the ill restaurant worker who accidentally contaminated a seafood salad bar. What is more appropriate for regulating shellfish seems to be discourage harvesting during the warmer months (those not spelled with Rs) , or when public health agencies detect concentrations of human pathogens. The three previous attempts to regulate produce, in this manner, were: (1) Use state power.

This includes (a) the Leafy Green Marketing Agreements (first California, then Arizona) under the state equivalents of the 1937 Agricultural Marketing Agreement Act, creating industry-run state agencies under the Departments of Agriculture authorities; (b) the use of the federal law for the single-state (California) production of almonds under a mandatory Marketing Order, with a rule issued by the USDA’s Agricultural Marketing Service, and (c) changing a state law to incorporate food-safety practices for a commodity, which the Florida tomato industry did in 2008.(2) Incorporate a national food-safety enabling section for produce marketing agreements and orders in the Farm Bill. (3) Create a national Federal Leafy Greens Marketing Agreement (or even Order), which is dormant but still pending. We are now on version (4), achieving similar goals under FDA’s proposed Produce Rules as an interpretation of FSMA.

I was often quite naive about some of this. When the California Leafy Green Handlers Marketing Agreement was being implemented, the organizing procedures were being run by the chief counsel for the California Department of Food and Agriculture. He was a wonderful man who could have come straight from central casting and had to shepherd food corporation vice presidents into acting like a state agency. When I was trying to challenge him about the misuse and potentially illegitimate use of a progressive-era law to enable processors and handlers to regulate farmers (and not themselves) on food safety, he cut me off before I could finish the question because he thought he knew where I was going and said, “It’s not a problem.

They are exempt from anti-trust under the specific language of the Act.” I hadn’t even considered anti-trust issues, but, sure enough, both the federal and state versions of the 1937 Acts (as amended) specifically exempt Market Orders and Market Agreements from anti-trust legislation and actions. What a deal! I found the food-safety theater aspects of FDA’s proposed Produce Rule on irrigation water quality, using indicator bacteria, to be an abysmal misuse of regulatory authority that would fail to enhance food safety except by accident, but would wipe out farms or eliminate major crops as options to be grown by many farmers.

However, similar rules in the state programs also have a genuine legal and functional role. It shows a kind of science-inflected good will, which calms down the large buyers. It does not present the liability problems of having detected actual human pathogens like pathogenic Salmonella, O157:H7 and other pathogens in water (or other inputs) and, having documented this, potentially used the water (or other inputs). It’s better to be regulated by food-safety theater and not document intentional decision-making informed by genuine hazards; these may be dealt with in private. Here is another strand of the rope to hang farmers with:The so-called Good Agricultural Practices, or GAPs, came in under the Clinton administration. I may be the only commenter who actively dislikes them.

They were the soft-sell for “improving food safety on farms” by telling farmers what to do – without quite ordering them to follow other people’s guesses. As checklists of concerns, they can be useful. As specific demands for detailed practices, they can be worse than useless by giving a false sense of security to everyone. GAPs are not guarantees, even if they are treated roughly as guarantees in the marketing of produce. Global GAP Certification is a more rigorous and certified version of voluntary Good Agricultural Practices. A former secretary of the California Department of Food and Agriculture found his family-owned produce operation subject to a Salmonella detection recall (on peppers).

The month before, they had been Global GAP Certified. The farm involved in the cantaloupe Listeria 2011 outbreak had received an extremely high rating from their third-party food-safety inspection. Litigation, liability, and now criminal liability adhere to actual contamination of food in commerce. How much of GAPs and certifications and inspections are just more food-safety theater? USDA and private groups did come up with a farm self-assessment food-safety software program, available from the USDA or FamilyFarmed.org, that may be more useful to some farmers than GAPs. A science-based question: Are there any studies documenting an improvement of safety after the implementation of the California LGMA? Answer: No. All right, then, are there any studies documenting that farms following GAPs and FDA Guidances improve food safety? Answer: No. FDA Guidances are hybrid animals. They are not regulations; farmers are not required to follow them, but not following them may increase potential liability.

It’s not that GAPs and Guidances may not ever help. But the assumption behind assuming they will help is that farmers are not taking food safety seriously in the first place. Furthermore, the farmers who have already adopted following GAPs and Guidances may have done so to document food-safety practices they were already using in order to sell their produce to end-users. The difference in their food-safety concerns and practices before and after becoming GAP-certified may be nonexistent.

Their ability to sell their produce, not their ability to implement food safety, may be the only change.The assumptions behind the economic benefits to be derived from the FDA’s proposed Produce Rule are (approximately): “Farmers are idiots. Following the proposed Produce Rule will force them to improve their food-safety practices over an incompetent base level of inadequate food safety. Therefore, all food-safety practices, including those already used, including actual competent existing food-safety programs, can be counted as an economic benefit solely due to the proposed rule being implemented and to the supposed reduction in illnesses, all of which are accounted for as due to compliance with the Produce Rule.” Checklists are fine.

Let’s recall that it was Curtis Lemay and a few other surviving top pilots who developed the aviation checklist so that the experimental planes that became the B-17 could safely be flown. Four of the best pilots in the Army Air Corps had just been killed or maimed in test flights. Safety checklists were developed by expert pilots that could protect every plane and crew before flight. Some 60 years later, similar checklists were developed by some hospitals for preventing respiratory infections in patients at risk after surgery, using the aviation industry as a model. I have never heard of a farm GAP or a produce Guidance whose development follows this model – where the persons with the greatest experience and competence, who have to implement, live with, and work with a safety program, design the program, hitting everything essential for survival. In this case, farmers with demonstrated expertise in both farming and delivering safe produce.

There are major corporations that do this and small truck-farms that do this. Farmers have never run the farm food-safety agenda. You would think someone would notice, even as an academic observation. Enter the FDA, writing a Produce Rule implementing FSMA against this background. There seemed to be models, all of which claimed to be science-based produce-safety programs. Along with the models they were using, defective as these may or not be, they picked up some of the baggage that informed those models and came along for the ride.

Briefly, this baggage includes: (a) the war on organics (still a cultural factor after all this time); (b) fear of competition from local production; (c) protection of the largest processors and handlers; (d) offloading as much liability and regulation as possible onto produce farmers; (e) disregarding systemic off-farm issues that affect farm safety, particularly urban waste streams and CAFOs. Therefore the proposed rules:(a) Violate the specific language of FSMA, overriding the Organic Farming Production Act on compost and manure use and disregarding microbial ecological control of pathogenic micro-organisms. (b) Impose regulatory costs that will impact all farmers’ profits, but the largest farms the least harmfully, and, according to FDA’s own analysis, drive many farms out of business with complex facilities rules that will destroy food hubs and CSAs as common practices; (c) Neither regulate fresh-cut under the Produce Rule nor specifically regulate fresh-cut under any other rule (unlike sprout production); (d) Completely misuse food-safety statistics to imply, for example, that farming practices cause human-transmitted norovirus outbreaks or that amoebic contamination only found in foreign imports are due to U.S. farmers; (e) Fail to regulate inputs to farms from CAFOs, urban greenwaste, sewage sludge or ash, etc., according to their health hazards or risk before farm purchase.

Some of the worst outbreaks in U.S. history have been the direct result of farmers or processors trying to improve food safety in handling on-farm or processing after delivery of raw produce. The farms and processors involved followed the advice of “the best and the brightest” to make their operations safer and ended up in disasters. Trying to improve food safety led to a food-safety failure. I am alone, perhaps, in finding that acquiring new equipment, including for specific food-safety reasons, or taking over old equipment new to a farmer or processor, is a specific hazard point that has to be controlled for.

This can be made more dangerous when a farm or processor is expanding production and under market pressure to meet higher production levels. It seems to me to be obvious in the outbreak record. You might think that this record would result in a certain humility or caution in telling farmers exactly what to do, especially in those areas on which FDA’s expertise is most lacking, from planting to harvest. Yet this is exactly the area that the proposed Produce Rules spend most of their time on, with the greatest negative impact on farming and the fewest potential returns in actual improvement of food safety.

The errors in the drafting of the Produce Rule propagate, populate and intensify in the other proposed rules implementing FSMA, including preventive control rules, foreign facilities, foreign imports, intentional contamination, third-party inspections, and others. Who among the congressional drafters of the legislation anticipated that the exceptions and exemptions for U.S. farmers under FSMA, such as the Tester amendment, would apply across borders to foreign producers with the same dollar values and distances? Yet that seems to be the interpretation.Or that FDA would have no problem with sewage sludge for growing produce, so long as EPA’s complicated calculations on cumulative use are followed, and that this would open the door for importing foreign produce grown with sewage sludge for U.S. consumption (even if not legal for their own consumption)?

Or that the failure to specify produce-caused outbreaks shall be a guide to drafting the Produce Rules would open the door to conflating outbreaks caused by farming practices (minimal in the record used), with handling and processing contamination (large), point of consumption (largest) and human-to-human transmission, all under the rubric of “FDA-regulated produce”? Most of the food processors I have met and worked with over the past 30 years are far more negative than I am about FDA’s role.

One of my all-time favorite clients, a major West Coast food processor, could never refer to a former FDA commissioner – whom I liked – by his name, only by his full title: “That idiot, David Kessler, who thinks he knows more about running my business than I do.” It goes downhill from there. Actually, way downhill. Most farmers I have worked with are even more caustic about regulators. Some of them voted out the then-Speaker of the House when the Republicans gained control of the House. It goes downhill from there. And this is just the background farm culture. Few of them have had the pleasure of a uniformed FDA inspection by someone trained in regulating medical devices.

Therefore, in my view, it is in FDA’s own interest to tear up the proposed Produce Rule and start again, aiming for statistical improvement in food safety by a few clear and simple rules that are not based on food-safety theater or corporatist favoritism, but instead follow FSMA’s direction in being actually science-based, that build on FDA’s existing strengths and competence, and are open to change with new information.

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