F.D.A. issues criteria for inspections
March 27, 2012
by Jay Sjerven
The Food and Drug Administration on March 9 issued criteria it will use in categorizing domestic food facilities as “high risk” or “non-high risk.” Under the Food Safety Modernization Act, frequency of routine or regular F.D.A. inspections of food facilities will be based on risk. Food facilities designated as high risk must be inspected at least once every three years, and facilities designated as non-high risk must be inspected at least once every five years. The inspection frequencies are minimums, and some facilities may be inspected more often.
The F.D.A. estimated the total inventory of domestic food facilities at 82,300. Of these, the F.D.A. said an estimated 22,325 facilities currently were in the high-risk category with the remainder in the non-high-risk category.
The F.D.A. said its goal was to complete the initial cycle of high-risk facility inspections in a three-year period (fiscal years 2011-2013), even though Congress required only that the initial cycle of inspections be completed in five years after enactment of the F.S.M.A. and that the mandated three-year inspection cycle regimen for high-risk facilities begin thereafter. The agency said it would complete the initial cycle of inspections of non-high-risk facilities in seven years as allowed by F.S.M.A. (fiscal years 2011-17) and begin the mandated five-year cycle regimen for inspections of such facilities in fiscal 2018.
The F.D.A. said for fiscal year 2012, it planned to inspect approximately 7,400 high-risk and 8,600 non-high-risk facilities.
The F.D.A. said its method for determining high-risk and non-high-risk facilities was likely to evolve for the fiscal 2014 planning cycle as better data become available and other “risk defining” sections of the F.S.M.A. continue to progress. But for the initial cycles of inspection, the F.D.A. primarily was considering two criteria for designating a food facility as high risk or non-high risk.
The first criterion was the known safety risks of the food manufactured, processed, packed, or held at the facility. The F.D.A. said “known safety risks” of a food “are based on broad, industry-level food commodity categories, e.g. bakery, leafy vegetables, spices. If a facility manufactures food commodity categories associated with foodborne outbreaks and class I recalls, then they are placed in the high-risk facility category. If a facility manufactures food commodities associated with foodborne outbreaks or class I recalls, and they have not been inspected within the previous five fiscal years, then they are placed in the high-risk facility category.”
The second criterion was the compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of safety standards. The F.D.A. explained, “The facility-specific factor of ‘compliance history’ is based on inspection results for a facility from the previous five years. Facilities with a history of noncompliance with safety requirements and those with food safety violations of regulatory significance are placed in the high-risk facility category.”
In subsequent inspection cycles, other criteria may be considered. Among these would be a facility’s hazard analysis and risk-based preventive controls for which adequate data are not yet available. Such data will become available as more companies establish the required programs.
Joe Levitt, partner in the law firm of Hogan Lovells, which provides counsel to the Grocery Manufacturers Association, noted if a food facility is categorized as a high-risk facility, there may be absolutely nothing at all wrong with that facility.
“In the vast majority of cases, that is going to be true,” he said. “It is simply more likely that they make a product that when made by some other company at some other time, caused a problem.”
Asked whether the F.D.A. necessarily will inform a facility’s management whether the facility is in the high-risk or non-high-risk category, Mr. Levitt observed, “The F.D.A. is entitled to inspect any facility at any time. They don’t have to say whether the facility is in this category or that category. All they usually do is say they are there for a routine inspection, which would apply to both categories, or they were there to investigate a known problem.”
Mr. Levitt said the F.D.A. is required to provide an annual report to Congress in which it must indicate in the aggregate how many inspections it conducted in the past year and how many of the facilities inspected were in the high-risk category and how many were in the non-high-risk category.
Mr. Levitt said the F.D.A. seemed to be looking at five-year windows. He said if there hasn’t been an outbreak associated with a food sector in the past five years, but there may have been one 10 years ago, there may be a point when the F.D.A. decides that sector seems to have things under greater control and the agency should concentrate on areas where there may have been more recent injury. In other words, the categories and the facilities assigned to them were not expected to remain static.
Mr. Levitt emphasized, “Every food processor needs to be ready for an F.D.A. inspection at any time, and make certain they’re always adhering to high safety standards.”