Gottlieb's FDA Should Focus on Food Safety Policy
Some observers have expressed concern about the recent appointment of Scott Gottlieb as head of the Food and Drug Administration because of his past work with pharmaceutical companies. However, it’s important to remember that the FDA handles a lot more than drugs and biologics. In fact, addressing the Food Safety Modernization Act (FSMA) regulations will be a critical issue for Dr. Gottlieb.
A review of economic analyses written by the FDA to support many of its regulatory decisions in implementing FSMA shows that there were much better options on the table than those selected — options that would have lowered the cost of these regulations. To take just one example, the FDA chose to target all produce with a food safety rule using FSMA. Had FDA regulators focused instead on only those fruits and vegetables that have demonstrable risk, the resulting regulations would have been less burdensome and less costly.
It’s important to understand what “modernization” means in the context of the Food Safety Modernization Act. One of the major components of the FSMA is a requirement that every food manufacturer follow a ramped-up series of process controls invented by the food industry over 60 years ago for NASA’s Mercury program called Hazard Analysis Critical Control Points (HACCP). It directs companies to look for points in the production process in which hazards can either become a problem or be mitigated, and monitor those points, making adjustments where necessary.
The HACCP process was initially applied to canned foods. Next, in 1996, the FDA required the seafood industry to implement HACCP, primarily to reduce the risk of raw oysters. the FDA predicted that this change would prevent 50 percent of related pathogen poisoning cases. But by 2011, those poisonings had doubled. Despite HACCP implementation spreading to meat, poultry, and fruit and vegetable juices, one USDA investigator found no real decline in reported foodborne illness between 1996 and 2013.
In expanding HACCP implementation to all packaged food, FDA regulators acknowledged they have no idea how many cases of foodborne illness might be due to “handling or storage at retail establishments, restaurants or homes.” Although no one knows the exact proportion of foodborne disease outbreaks that are caused by mishandling, one estimate suggests that 52 percent are associated with restaurants (including cafeterias and hotels). Restaurant practices and home preparation are not covered by FSMA, so the FDA has no idea whether spending billions of additional dollars on this technology will improve the food safety picture.
Further evidence of high costs without safety improvement comes from the produce industry. Rather than simply focusing their efforts on produce that has been actually implicated in an outbreak, the FDA has chosen to cover all produce. Why? Because, as they put it, “It is likely that at least some commodities that currently have never been implicated in an outbreak have a positive probability of being implicated in a future outbreak.”
By that logic, there is no reason not to cover every type of food since there is always some extremely low probability of something bad happening. The FDA did the same thing with animal feed, too, significantly raising costs when the problem could have been solved by simply targeting pet food.
Food safety is an extremely important public health problem. One out of six people becomes ill from foodborne disease each year, leading to 128,000 hospitalizations and 3,000 deaths. Dr. Gottlieb could more do more good by turning the FDA’s attention away from command-and-control regulation and toward incentivizing the food industry, including restaurants, to be more diligent when handling food. No food provider wants to be responsible for a food-related disease outbreak.
With the FDA’s attention re-focused on tracking down outbreaks, identifying the causes and drawing attention to failures of private facilities, producers would have stronger incentives to get food safety right. Empowering producers to focus on solving problems — rather than adhering to a 60-year-old technology — would be a huge step forward in preventing foodborne disease.