Building an Integrated Food Safety System One Brick at a Time
Abraham Lincoln was once quoted as saying, “Things may come to those who wait, but only the things left by those who hustle.” You must be wondering how long you have to wait before you begin to see the integrated food safety
system that government agencies have been promoting. Are there target dates, timelines and plans? Who are the ones who “hustle” while we wait?
Actually, food safety stakeholders should now be able to recognize with some clarity that the vision of an integrated food safety system (IFSS) is currently being implemented, and it is beginning to illustrate great promise. An IFSS really isn’t anything new, as it has been employed for some time now. Let’s look back to 1937.
The Elixir Sulfanilamide
Government’s response to the sulfanilamide episode in 1937 may have been the first truly integrated effort in food and drug safety control efforts. It was an exceptional effort that clearly saved lives. Not only were federal, state and local agencies involved, but doctors, pharmacists and the news media played roles as well.
During September and October 1937, sulfanilamide was responsible for the deaths of more than 100 people in 15 states, many of whom were children. This incident led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act), which increased the authority of the U.S. Food and Drug Administration (FDA) to regulate drugs.
Sulfanilamide was used to treat streptococcal infections and had been used safely for some time in tablet and powder form. In June 1937, S.E. Massengill Co. found that sulfanilamide would dissolve in diethylene glycol, and after testing it for flavor and appearance, began to market the product in liquid form. The company sent 633 shipments all over the country.
When deaths started to be reported, FDA set out to retrieve all shipments of the drug by utilizing their entire field staff of 239 inspectors and chemists. State and local health officials joined in the search as well.
This was not the easiest task as FDA had to track down the company’s 200 salesmen and review approximately 20,000 sales slips.
Without anyone really recognizing it, this entire response effort was, perhaps, the first instance of a fully national integrated system that included the coordination and persistence of multi-jurisdictional health agencies, along with the effective actions of the medical community and the news media. As a result, most of the elixir was recovered. Of 240 gallons manufactured and distributed, 234 gallons and 1 pint were retrieved; the remainder that had been consumed caused the deaths of the victims. Imagine how many lives would have been lost without an integrated response.
This event did more than hasten enactment of the FD&C Act. It also clearly demonstrated how food and drug safety is a national concern best addressed through a nationally recognized rule and a nationally integrated system designed to prevent such tragedies.
Early Efforts in Federal-State Coordination
Early efforts to improve federal and state coordination are marked by clear intentions. Seldom would anyone use the term “integration,” instead referring to “contracts,” “partnership” and “leveraging.” There were plenty of milestones that expanded the idea of the need for closer federal, state and local collaboration. Some of those milestones can be seen in the illustrated timeline.
While many federal statutes and regulations preceded the creation of the Food Safety Modernization Act (FSMA), it was this act that directed FDA to better coordinate food safety resources with its partners at the state, local, territorial and tribal levels. FSMA has had a huge impact on the IFSS effort. All previous visions and hopes of an IFSS were weakened and difficult to advance without the strength of a congressional mandate. Because of FSMA, the country could now truly begin to develop that IFSS aspired to by so many for so long.
Partnership for Food Protection (PFP)
The PFP is a group of dedicated professionals from federal, state and local governments with roles in protecting the food supply and public health. It is the structure used to coordinate activities by representatives with expertise in food, feed, epidemiology, laboratory science, animal health, environment and public health, and helps develop and implement the IFSS.
The PFP is a volunteer organization; its members dedicate their expertise, in addition to their regular job duties, because of their belief and support for an IFSS. Members enjoy the opportunity to work on collaborative public health projects with multi-jurisdictional officials and with representatives of the Association of Food & Drug Officials (AFDO), the National Association of State Departments of Agriculture, the National Environmental Health Association, the Association of State and Territorial Health Officials and the Association of Public Health Laboratories. Many working relationships have developed within the PFP, and they have been helpful when responding to a foodborne outbreak investigation, or simply in obtaining input on inspections, work planning or training activities.
Since its establishment, the PFP has utilized its workgroup structure to develop and implement procedures, best practices and other work products that would advance an IFSS. There are seven PFP workgroups: Compliance and Enforcement, Information Technology, Laboratory Science, Outreach, Surveillance, Response and Post-Response Training and Certification, Work Planning and Inspections.
The PFP has also established a strategic plan covering a 6-year period from fiscal year (FY) 2015 through FY2020. The plan focuses primarily on integrating functions related to domestically manufactured human and animal food. It is reviewed every 2 years to allow for adjustments. Although the focus for an IFSS is currently domestic, PFP principles and resource documents may be shared with foreign government partners to promote a global approach.
Collaboration Timeline
1913 The formation of the Federal Office of State Cooperation resulted from a formal request of the Association of Food & Drug Officials (AFDO). This new office eventually would become the U.S. Food and Drug Administration (FDA)’s Division of Federal State Relations and today is known as FDA’s Office of Partnerships.
1927 AFDO’s adoption of a Model Uniform Food Law provided a basic food law for the states that most all would adopt.
1968 The reorganization of federal health programs placed FDA into the U.S. Public Health Service (PHS).
1969 FDA begins administering sanitation programs for milk, shellfish, foodservice and interstate travel facilities to prevent poisoning and accidents. These responsibilities were transferred to FDA from other units of the PHS.
1997 AFDO President Dan Smyly, Florida Department of Agriculture & Consumer Services, addresses the Regulatory Affairs Professional Society Annual Conference held in Washington, DC, and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service Annual Federal/State Conference on Food Safety in Sacramento, CA, where he advises attendees of AFDO’s vision of a national IFSS. Furthermore, Smyly requests support from USDA and FDA to convene a meeting of a select group to develop the blueprint for a vertically integrated national food regulatory system.
1998 The National Food Safety System is formed following a 50-state meeting. Workgroups consisting of federal, state and local government officials begin developing projects to advance the vision of an integrated system.
2009 The PFP is established to help implement the recommendations from the 2008 50-State Workshop. The PFP will be designated the primary group to advance and build the IFSS.
2011 FSMA is passed. It provides FDA with new enforcement authority related to food safety standards, gives the agency tools to hold imported foods to the same standards as domestic foods and directs FDA to build an IFSS in partnership with state and local authorities.