FDA’s Non Solution

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Imagine hiring a contractor who submits a report saying, “The solution is that you need to study the problem, produce a report identifying the issues, and then fix them. We’ll be happy to oversee your progress.”

In 2010, at the urging of former FDA officials, Congress passed the Food Safety Modernization Act – FSMA. It required everyone in the food industry to use the same processing safety procedures. It was invented 40 years prior to the law by the food industry for its own use. It’s called Hazard Analysis, Critical Control Points, or HACCP, and involves a lot of monitoring and recordkeeping.

Pillsbury invented HACCP in conjunction with the National Aeronautics and Space Administration (NASA) in the 1960s, and was used by the Apollo Space Program. In 1971, it was introduced to the food industry, and many companies subsequently found it useful for their food safety programs.

HACCP is a system whereby each company analyzes how foods in their own plants might become contaminated, monitoring points in the processing system where that might happen, and requires remedial action where contamination might happen. It has worked for some processing plants, particularly those where cooking or freezing might fail. But when the FDA tried to impose it for seafood in the 1990s, it didn’t work,because the main problem with seafood is found in eating shellfish, like oysters, raw. Because they are not processed, there is no place to prevent contamination. They also tried to do it for fresh (raw) juices but the real solution was to pasteurize (cook) the juice – requiring HACCP monitoring and recordkeeping which didn’t make an impact. Nevertheless, the FSMA now requires every food producer to use HACCP and the FDA is now trying to impose the theory, imperfectly, on produce.

The latest iteration of the FSMA rule is new requirements for farmers to make their irrigation water safer. In 2015, the FDA passed a rule that required farmers to test their irrigation water using FDA standards for underground or surface water. The proposed requirements for testing for microbial pathogens in water included requirements such as calculating:

two numerical values of generic E. coli in their water samples: A geometric mean (GM) (a measure of central tendency of a water quality distribution) and a statistical threshold value (STV) (a measure of variability of a water quality distribution, derived as a model-based calculation approximating the 90th percentile using the lognormal distribution). 

Although farmers objected, one commenter recently found it “quite alarming that key players in the agricultural sector” found it hard to abide by such rules. This obviously raises a point not about the key players in the agricultural sector but the efficacy of the rules themselves. Nevertheless, the FDA convened multiple outreach efforts, coalition meetings, speaking engagements, conferences and educational programs. Unsurprisingly, the result of all of FDA’s meetings, conferences, and education efforts was that they discovered that numerous farmers found it “difficult to understand, translate and implement in their operations.”

So, FDA regulators went back to the drawing board to see if they could come up with something better. They now have a proposed rule that would require that farmers do an Agricultural Water Assessment that includes whether their neighbors have pigs, cows, or chickens, whether there are wildlife in their area (e.g., deer or birds), and other factors that might contaminate their water sources. If they find there are potential problems, they must “expedite mitigation measures” to protect their crops, i.e., solve the problem.

To estimate the costs and benefits of this new rule, the FDA compared the additional costs and benefits to the 2015 testing rules. Their guesses as to the benefits of the new requirement came from unidentified experts. The experts concluded that the new rule would probably be worse because the loss of the mandatory testing benefits would outweigh any cost savings with the new rules. In particular, they speculated that the new proposed provisions would generate fewer benefits if farmers failed to identify the hazards or “properly mitigated identified hazards.” 

One commenter wondered exactly what they were supposed to do about mitigating identified hazards, as there wasn’t a lot an individual farmer could do about his neighbors’ farm animals or wildlife in the area. 

Another commenter explained that the proposed rule would require farmers to do a new risk assessment every time they changed commodities – adding a lot of paperwork. They added that treating ground or surface water (with chemicals, filtration, or ultraviolet light), or using municipal water (not available), would put small to medium size farms out of business.

On the side of favoring the FDA’s approach, one commenter just liked the idea of giving the FDA “the ability to take charge.” But one might question exactly what the FDA has done by taking charge. The FDA describes their most recent proposal as being “workable, flexible, and adaptable.” While this solves the FDA’s problem of being shown to be addressing a problem, it actually just tosses it back to farmers to solve. Imagine hiring a contractor who submits their report saying, “The solution is that you need to study the problem, produce a report identifying the issues, and then fix them. We’ll be happy to oversee your progress.”  

The USDA and the FDA have been working on the water safety issue since the publication of their 1998 Good Agricultural Practices, as well as a more recent alignment of the USDA’s volunteer audit program and the FDA’s FSMA. But farmers already had market incentives to find solutions for produce safety and have had an international organization looking for solutions for over two decades. In fact, contamination of water with microbes has been understood since John Snow discovered a cholera-infected pump in London in 1854. The FDA’s new regulation solves nothing; it is not only irrelevant, but may distract the industry from finding real solutions. 

One thing is almost certain, no one will follow up to see if the regulation has worked. Even though it is required, the FDA most likely will never conduct a retrospective review. There may be a slight decline or even an increase in food poisonings, but there also probably won’t be any congressional hearings to ask why it hasn’t worked. One thing that will happen is that the price of produce will increase, and consumers will eat fewer fruits and vegetables (perhaps putting them at greater risk).

HACCP is not a solution; it’s an instruction to find a solution. In this case, water contamination on farms, the FDA should admit it doesn’t have a solution. Sometimes, that’s the answer and the best possible thing they can do is to do nothing. The real solutions lie in more research into finding safer ways to grow fruits and vegetables. For example, we have smart packaging to alert us to microbial contamination in food packaging using nanotechnology. Could something like that, such as plant diagnostic sensors, be incorporated into precision agriculture?

Either way, the FDA is proposing a non-solution solution and having alerted the public to the problem, should stop, and wait for technological solutions.