The Appointment of Michael R. Taylor
The FDA has created a new position, Deputy Commissioner of Food, and has appointed Michael R. Taylor to fill it. The new office is supposed to unify a focus on food safety among the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the foods-related activities of the Office of Regulatory Affairs (ORA), plus other staff offices that support them.
This is a significant consolidation of FDA resources toward a mission focused on food safety. The idea has been out there for a while—for example, in May of 2009 the group Trust for America’s Health released a report advocating precisely this move, arguing it is an important interim step in the creation of a single food safety agency. Yet even if all goes well this is going to take a year to bear significant fruit. The several food-related units within FDA have many items on their now-shared plate: inspection and ensuring compliance with rules, coordination with state and local agencies who do much of the work of food safety, responses to “incidents” that hurt people, getting a handle on imported items that find their way into food, sponsoring and organizing the scientific and technical research needed to design a safe food system, including animal feed and veterinary care, and building the information network that helps to knit all of these together. The new Deputy Commissioner’s office is supposed to employ risk-based criteria for the difficult budget and other resources decisions to make all of this happen.
It will be a difficult job.
Mr. Taylor clearly has the experience to take on this job, and some of the most knowledgeable people in the food safety world (like Marion Nestle and Steven Grossman) are saying this is very good news. Mr. Taylor’s published writing and congressional testimony may tell us what to expect—these will be the subject of a subsequent note.
This is all good news. But do not read too much into it. I have two reservations. First, we still have the split responsibility for food between the FDA and USDA. The FDA mission includes much less of the industry cheerleader responsibilities shouldered by USDA, but there is enough wiggle room in the mission language to let a pro-business conservative appointee take the agency in a very different direction. This is the second reservation. A food safety system should not depend on a particular party winning an election. A subsequent blog will compare different models of locking in a mission at an institution like FDA.
Mr. Taylor has written and testified about food safety issues, which provides a record that may tell us what to expect.
During his time at Resources for the Future (RFF) he co-edited (with Sandra A. Hoffmann) Toward Safer Food: Perspectives on Risk and Priority Setting (RFF, 2005), and contributed a short summary chapter. The topic of risk analysis is inherently contentious—in general, advocates of a precautionary approach, as found in several western European countries, do not like it, and advocates of using the business bottom line as a factor in safety issues endorse it. [Disclosure: I personally advocate the use of risk analysis, and am convinced it needs to be part of a precautionary approach—but now seldom is.]
It makes sense to go after the biggest threats to human well-being, and to pursue the policies that produce the most improvement for scarce available dollars. Yet risk analysis comes with a technical vocabulary and measurement techniques that tend to limit participation in debates to those with the skills and experience to speak about and decipher the approach. What I saw throughout Toward Safer Food was a model of analysis that treated technical innovations as mostly exogenous variables, as the economists call them, which respond to market forces. Take the example of concentrated animal feeding operations (CAFOs). They produce meat that costs less per pound and brings animals to slaughter many days faster. Markets gave us CAFOs. And yet, they produced public health consequences that have to be paid for through public policy and increased consumer caution—they have killed people. One of the things markets do is to allow some folks to seize the benefits of new technologies while avoiding the costs the new practices impose on others (indeed, many are created for precisely this reason). Risk analysis should include the likely effects of proposed food system technologies to vet them for things like the production of new super-germs, the need for more drugs in animals during production, and so on. None of the authors of the chapters in Toward Safer Food appear to embrace the more robust modeling needed to make risk analysis vigorously support public health.
Another important piece by Mr. Taylor is the 2007 report from Harnessing Knowledge to Ensure Food Safety, coauthored with Michael Batz (Food Safety Research Consortium, 2008). The report focuses on the food safety information infrastructure needed right now. [The 9-page executive summary is available at http://www.thefsrc.org/FSII/Documents/FSII_Exec_Summary.pdf. It is worth reading.] Briefly, we now have a chaotic cloud of food safety information, no widely shared standards for how to develop research, or how to test ideas about food safety, how to collect information at state and local government, in private industry, and in a dozen national government entities. We have to build an information system that supports public health. There are many good ideas in here, as you can see in the executive summary. One key feature of the approach advocated by Mr. Taylor is “the stakeholder model,” (TSM) in which the interested parties discuss challenges and prospects and develop approaches for improvement. Representatives from government, industry, consumer groups, and anyone else with a recognized stake get together (in this report, the gathering will be called a council) to seek consensus among their perspectives. Like the topic of risk analysis, this is a highly contentious idea. TSM has been widely adopted by state and local governments in environmental policy, to cite one example example, because of the political pressures against regulation. Plans that emerge from stakeholder committees or councils emphasize self-financing elements and voluntary compliance. Sometimes a stakeholder has a perspective that harms public health. This fact needs to be part of the institutional design. [Another disclosure: my view on this is probably influenced by personal experience, as described in http://www.plu.edu/~olufsdw/unpleasant.htm.%5D
A third publication, Stronger Partnerships for Safer Food (coauthored with Stephanie D. David, from GWU School of Public Health and Health Services, 2009) describes the intergovernmental maze of food safety organizations we will have to integrate into an effective system. Nineteen recommendations describe the needed changes, and it is a compelling case (see the executive summary at http://www.rwjf.org/files/research/20090417foodsafetysummary.pdf).
Among the more difficult features are a clear congressional mandate to the Dept. of Health and Human Services (HHS), a HHS secretary committed to food safety as a main agency priority, and a significant increase in intergovernmental funding. One frequently mentioned feature of the current system is the required visual inspection of all animal carcasses, which do not detect the most dangerous sources of contamination. If they were cut out, perhaps $200 million or so could be saved—at some cost to public health. But this goes at most halfway toward funding the required changes needed at FDA alone, which needs to be supplemented by large increases in intergovernmental funding for state and local food agencies. (The budget estimates I refer to here come from sources like the Congressional Research Service and Congressional Budget Office, not the publications mentioned above.)
Observers of the health care debate over the last half year must be forgiven for their profound skepticism that these obstacles can be overcome.
I don’t wish to sound entirely negative. There is much in the latter two documents that need to be put into an effective food safety agency. But more is needed, in my view. To repeat: A food safety system should not depend on a particular party winning an election. The reservations noted above are all things that can be dramatically altered by a shift in party control of Congress or the White House. A subsequent blog will compare different models of locking in a mission at an institution like FDA.