This letter is in reference to a recent Letter from the Editor in Food Safety News (“An independent food safety board is far better than anything FDA Commissioner does on his own”), dated January 29, 2023. As some may remember, I had the great privilege of serving as Undersecretary for Food Safety at the U.S. Department of Agriculture from 2001 to 2004. During that time, we faced several foodborne illness events and meat recalls due to contamination with E. coli O157:H7 (ground beef patties) and Listeria monocytogenes (ready-to-eat cold cuts), among others. To address these and other issues, we focused on ensuring that our inspectors were well trained in the science of the Hazard Analysis Critical Control Points system (HACCP), forming teams of auditors to ensure that plans were not only in effect at meat processing plants, but that they had been developed in a science-based manner. In fact, we made sure that all regulations we would issue would be based strictly on science and evidence, not speculation. As a result of our activities, the rate of contamination of ready-to-eat meat and poultry with L. monocytogenes dropped from 0.64% in 2005 to 0.33% in 2017 (Mamber, S.W., et al, 2020 J. Food Prot. 83(9):1598-1606), and illnesses due to E. coli O157:H7 decreased by 42%, reaching the CDC’s Healthy People 2010 Goals for foodborne illnesses due to this organism ahead of schedule (cdc.gov/mmwr, April 15, 2010).
During that time, there had been calls from various groups urging the formation of a single food safety agency, to include both the Food Safety Inspection Service (FSIS) which was under my authority, and the Food and Drug Administration (FDA), which was under the authority of the Commissioner of FDA. As Undersecretary, I was most proud of the fact that FSIS worked well with other agencies within USDA, such as the Animal and Plant Health Inspection Service (APHIS) and the Food and Nutrition Service (FNS), both of which had relevance to food safety. In addition, FSIS worked well with FDA, with then Deputy Commissioner Dr. Lester Crawford and I interacting frequently, as we were not only facing unintentional food contamination, but also the potential for bioterrorism acts in the wake of September 11th. It became evident that each agency served its purpose, as per the mandates that specific laws had provided, such as the Federal Meat Inspection Act for FSIS, and the Food, Drug & Cosmetic Act for FDA. It was also very evident that given the very unique authorities of each agency through very different laws, that we all needed to work well together. This was in fact what followed, with Dr. Crawford and I ensuring that the agencies we oversaw were well staffed with knowledgeable professionals, but also empowered to carry out their duties, obviating the need for a single food safety agency.
I think we can all agree that ensuring the safety of our food supply is an incredibly important activity that cannot be underestimated. It requires that the regulations that federal agencies like FSIS and FDA promulgate be based on science, and that these agencies be led through a structure that ensures proper supervision of the right number of well-trained staff so that said regulations can be rigorously enforced. Evidence shows that there have been some issues related to enforcement in the “food” portion of FDA, most recently demonstrated by the Abbott Labs infant formula incident. However, what we don’t need is the unnecessary upheaval of federal agencies, but rather to concentrate where the problems are, and then fix them.
This brings me to the point of this letter: that FDA does not need to be removed from the Department of Health & Human Services. Rather, that we should look to follow the FSIS model, an agency that is within USDA, with great connectivity to other agencies within that department, fully independent, fully empowered, yet well connected. Similarly, FDA needs to be split into two agencies, one for foods, and one for drugs and cosmetics, both remaining within the Department of Health & Human Services. Each agency would then be led by a presidentially appointed Commissioner. By remaining within HHS, both agencies would then be able to continue to work closely with each other, as they are both provided with authority from the same law, the FD&C Act, as well as with other entities within HHS such as the Centers for Disease Control. Importantly, the new “Foods Agency” would then be empowered to have its own structure, focused entirely on foods under its jurisdiction, just like FSIS has within USDA. This should translate into a better managed agency, able to respond to whistleblowers and to surveillance data much more quickly. Of course, adequate funding for such an agency is of primary importance, as long as it is efficiently designed as to avoid bureaucratic delays in developing, monitoring, and enforcement of its regulations.
Dr. Elsa A. Murano, Former Undersecretary for Food Safety at USDA
Director of the Norman Borlaug Institute for International Agriculture
President Emerita and Professor of Food Science & Technology
Texas A&M University