There are two separate but related issues here: The first is how to structure an investigation to be more effective. Our interview with Dr. Michael T. Osterholm, pioneer in the investigation outbreaks in produce, made that clear:
- We need a defined chain of command. Right now, CDC passes the ball to FDA, which passes it back and they both blame the state health departments — or hesitate to when they should place blame on the states. You can’t run an outbreak investigation by committee.
- Control cases must be traced back. It is now clear, even to a layman, that it is not sufficient to trace back the cases of ill people alone on complicated bulk product outbreaks. Only case/control traceback — meaning traceback both of the tomatoes reported purchased by sick people and well people — will produce a picture of the outbreak with sufficient clarity to rapidly “solve” an outbreak.
- Stop hoarding information. The CDC can’t do this all itself. There are many intelligent people who can contribute to this process if they are given the data to do so. Posting on its web site simple data such as how many people have, so far, reported each event such as the date of onset of their illness, would be very valuable.
- Engage with the industry. The “Not associated with this outbreak” list was a good idea but was ruined by FDA’s ad hoc method of producing the list, which placed the onus on growers to beg their politicians to plead their case before FDA.
- Emphasize the mathematical risks. Every time CDC mentions a numerator — 50 people hospitalized, it must mention a denominator — out of a population of 305 million. When talking about risk, it would be helpful to make comparisons that consumers could relate to. Just as a good writer will write that the ship is 300 yards long, the length of three football fields, so that a reader can conceptualize the distance, CDC and FDA have a responsibility rather than just screaming “danger, danger” to put that danger in perspective. How do the risks compare with getting hit by lightening or being in a car accident?
The second issue that needs to be addressed is the need to make sure CDC and FDA have some checks and balances before they destroy an industry and make consumers spend hundreds of millions of dollars replacing food. A few key ideas:
- Decisions must be signed. People must be held responsible for their mistakes. In other words, you want at least three epidemiologists to sign a statement saying that with a high degree of confidence they can state that product XX or company X is the cause of an outbreak. There has to be a downside to these people for being wrong.
- Every outbreak should have a ”Team B”. Team B was an exercise in competitive analysis conducted by the CIA under its then-Director, George H. W. Bush. The idea was that every time the CIA analysts came up with an intelligence estimate regarding the Soviet Union, a group of outside intelligence experts were brought in to challenge the CIA’s internal analysts — though the question of who was right remains controversial to this day. The very fact that CIA analysts knew that their opinions would be challenged probably improved the quality of their analysis. Before the FDA issues recommendations, we need to make sure those recommendations have been challenged by competent personnel.
- The ”Zero Tolerence” standard must be junked. If we could test every single tomato, cantaloupe or other item, we would probably find some baseline level of Salmonella out there. This means that this is part of life and not a cause for hysteria. The FDA needs to establish realistic baselines that we can then work to improve year by year. To simply pretend pathogens don’t exist, ever, in products grown in the dirt, rained on and in contact with man and beast makes FDA irrelevant rather than a partner in advancing food safety.
- Recommendations should only be issued after a finding that it will enhance public health. During our discussions of the Honduras Cantaloupe situation, we pointed out that the farm implicated was a top quality, fully certified one. We questioned the logic of banning their product from America while allowing the completely unaudited farm next door to ship freely. Equally, in this tomato outbreak, we pointed out that many buyers who had cultivated food safety partnerships had to abandon their fully vetted sources and buy from strangers. We questioned how this could possibly help enhance public health. Before they issue a recommendation or import alert or anything that blocks product, FDA should be required to issue a finding that the alternatives available will be more likely to be safe.
- Give credit for food safety efforts. One of the saddest parts of all this is that its mode of operating discourages investments in food safety. As we discussed here, FDA cannot treat equally the grower who is fully certified by customers and third parties as one that does nothing to enhance food safety. Perhaps FDA should establish its own food safety standards for growers. Those growers that are third-party audited to the standard FDA approves by auditors FDA has approved would be deemed ‘innocent’ in the absence of specific evidence implicating those growers. These massive bans and recommendations should only apply to unaudited product.
These are ten specific changes that need to be made. What the industry should call for is a formal investigation of this outbreak with the goal being the production of a report urging these and other necessary changes in the outbreak management and public health system.
