Historically the FDA and FSIS have not been really cooperative when it comes to food safety: Each Agency has a separate funding stream and is under separate departments, and, in a variety of ways, they are inherently competitive.
While this may seem like a platform statement for a missive on a single food safety agency, that is not what this newsletter is about. Recently, the GAO issued a report onFederal Food Safety Oversight which, at least in principle, set out to explore how to better manage overall food safety oversight.
In general, the report may have the right idea on its “findings” that broad-based, centralized collaboration between FDA and FSIS would provide for a more unified food safety system. As I was a part of this process, I know that GAO spoke with people with personal experience of federal food safety dysfunction.
However, the final report appears to have focused more on using the strategic planning reports of the parent departments " Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) " as the basis of a food safety collaboration assessment.
As stated in the report’s summary section, What GAO Found, in their strategic and performance planning reports, “HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts. In addition, they do not include several relevant crosscutting efforts, such as the National Antimicrobial Resistance Monitoring Systems.” Does it really take a GAO report to figure that out?!
The original mission of this report as stated to me was solid " GAO was looking at ways to improve overall collaboration and integration of food safety at a federal level. There is no question that we certainly need that. But the issue we see is that the report seems to be fairly useless in that it is not really assessing the interagency collaboration as much it is assessing the quality of the strategic reports.
Just because an activity is not specifically detailed in the strategic plans doesn’t mean these don’t exist " GAO acknowledges this itself in noting NARMS (above). Since there are a number of areas in which the agencies have collaborated such as NARMS, PulseNet, Whole Genome Sequencing, etc. (as we detail below), what is the point of writing a 46-page report on what is or isn’t detailed in the departmental strategic plan? Wouldn’t the time have been better spent and the report more useful if it actually assessed the agencies’ collaboration?
HHS has 11 operating divisions, including eight health and three human services agencies, each of which then includes a variety of offices and centers whose responsibilities are further divided. For example, the FDA, itself, is responsible not only for food safety, but also for medical products, tobacco, veterinary medicine, and global regulations.
So to expect a department to write a strategic plan that details every initiative that every division, center and office operating has taken " and to assess the actions of a single center [i.e., the Center for Food Safety and Applied Nutrition (CFSAN) of FDA of HHS] based on that general report seems to us to be an exercise in futility and, to be blunt, a waste of time. The same is true for USDA which has seven agencies, under which FSIS is just one of 18 services.
To take it a step further, the report also said, “In 2011, GAO recommended that the Office of Management and Budget (OMB), in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not acted on that recommendation.”
So now we are going even further upward in the hierarchy for responsibility, but as we saw so many times with the FSMA rules, OMB has so many responsibilities that an FDA-initiated action can sit on its desk for months awaiting approval. So again, assessing CFSAN and FSIS collaboration by OMB lack of movement is unfair at best.
Now, this is not to say that the agencies shouldn’t have a strategic plan, nor that GAO shouldn’t assess it. We just don’t believe that developing a “Federal Food Safety Oversight” report from these upper level (HHS/USDA) strategic documents is really all that helpful. Concluding that food safety collaboration is poor and “Additional Actions Needed to Improve Planning and Collaboration” (as the report is titled) is an accurate assessment of our food safety system is undoubtedly correct " but we knew that going in. What is key is how to improve the system.
In actuality, there are numerous areas in which FSIS and FDA, along with the Centers for Disease Control and Prevention (CDC), are collaborating " so it can be done. The examples below are, for the most part, science based; but where the systems fall apart is alignments on policy and oversight. Yet, we should acknowledge some good collaborative efforts, just a few of which are:
- National Antimicrobial Resistance Monitoring System " FDA, FSIS, CDC collaboration in a national public health surveillance system that tracks changes in the antimicrobial susceptibility of certain enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the U.S.
- Interagency Food Safety Analytics Collaboration " FDA, FSIS, CDC collaboration to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use. Projects and studies aim to identify foods that are important sources of illnesses. The current focus of IFSAC’s activities is foodborne illness source attribution, defined as the process of estimating the most common food sources responsible for specific foodborne illnesses.
- PulseNet - FDA, FSIS, CDC collaboration to connect cases of foodborne illness to potential outbreaks and find immediate (such as a food recall) and long-term (such as a new production practice) solutions to the problems that cause outbreaks.
- Whole Genome Sequencing " FDA, FSIS, CDC and NIH collaboration designed to showcase the capacity to revolutionize foodborne disease tracking through such goals as further development and roll out of the open database,GenomeTrakr, a pathogen detection network which would store genomic data of bacteria that have been responsible for foodborne illnesses outbreaks around the world.
- Food Defense " FSIS/FDA participation in interagency discussions and reviews on the FSMA food defense tools to continue federal partnership on food defense and help ensure continued FSIS-FDA consistency in food defense principles.
Perhaps there are more awaiting approval at the upper levels of HHS, USDA or OMB?
We also see it as no great revelation that, as GAO asserts, “a government-wide performance plan for food safety is necessary.” But, we would take that a step further to say that perhaps it is a single, united, government-wide food safety agency that is needed, and GAO has supported that assertion in the past.
A single FDA/USDA that is responsible for all food safety, reports up to the same department, and has the same Congressional mandates. Then collaboration would truly be enabled. Then we could truly make system-wide improvements in food safety. However, we should not forget the critical importance of other agencies involved in food safety (e.g., EPA) that are listed in the GAO report. These, too, have to be part of the total collaborative effort as do both state and local regulatory bodies.
Fundamentally no one wants to give up turf or power, and to date there has not been a big enough disaster to drive change from either the White House or Congress. As with all things food safety, it is sad to say that it will take a major disaster that will likely involve the loss of life for some of these fundamental organizational issues to get addressed in a meaningful way.
Dr. David Acheson is the Founder and CEO of The Acheson Group.
Dr. Acheson brings more than 30 years of medical and food safety research and experience to the firm. www.achesongroup.com
David graduated from the University of London Medical School and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and became an Associate Professor at Tufts University in Boston, studying the molecular pathogenesis of foodborne pathogens.
Prior to forming The Acheson Group, David served as the Chief Medical Officer at the USDA Food Safety and Inspection Service and then in 2002 joined the U.S. Food and Drug Administration as the Chief Medical Officer at the FDA Center for Food Safety and Applied Nutrition (CFSAN). After serving as the Director of CFSAN’s Office of Food Defense, Communication and Emergency Response, David was appointed as the Assistant and then Associate Commissioner for Foods which provided him an agency-wide leadership role for all food and feed issues and the responsibility for the development of the 2007 Food Protection Plan, which served as the basis for many of the authorities granted to FDA by the Food Safety Modernization Act.
Since founding the food safety practice within Leavitt Partners in July 2009, David has used his regulatory insight, food safety knowledge, and expertise in crisis response to advise food industry clients around the globe on how to best manage risk in a global supply chain and evolving regulatory landscape.
David has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. He is a sought after speaker and regular guest on national news programs. He serves on a variety of boards and food safety advisory groups of several major food manufacturers. Additionally, David is a fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America, and a member of the American Society for Microbiology (ASM), Institute of Food Technologists (IFT), and International Association for Food Protection (IAFP).
