FDA’s framework for identifying high-risk and non-high-risk facilities involved in producing food for human consumption is based on the following factors:
- The known safety risks of the food manufactured, processed, packed, or held at the facility;
- The facility’s compliance history including food recalls, outbreaks of foodborne illness, and violations of food safety standards;
- The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls;
- Whether the food manufactured, processed, packed, or held at the facility meets the criteria for prioritization to detect intentional adulteration;
- Whether the food or the facility that manufactured, processed, packed, or held such food has received certification under the Voluntary Qualified Importer Program; and
- Any other criteria deemed necessary and appropriate for allocating inspection resources
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According to FDA’s FSMA Domestic Facility Risk Categorization (FY 2012), the decision-making process for domestic facilities during Fiscal 2011-13 was based mainly on the first two factors. Data were not available to characterize the third factor for all industry types and will be incorporated as the Preventive Controls rule and data collection develop. The fourth factor applies only to foreign facilities. The fifth factor may apply to some domestic facilities, but the relevant certification programs have not yet been established.
Craig Henry, a director at Deloitte & Touche LLP, says FDA needs to be more transparent in deciding how it will calculate facility risk levels. “Let’s say you have a facility that mostly processes lemons but also produces a small amount of bean sprouts. Is that facility high-risk or low-risk? What is the weighted average of risk? FDA will have to fall back on whether there has ever been a recall or foodborne illness, and the agency has a ways to go in terms of transparency with industry,” Henry tells Food Quality & Safety.
According to the FDA, inspection costs are not determined by risk level alone. Rather, risk level is one of many elements with others including the facility’s size (both number of people and square footage), the complexity or level of automation of the manufacturing process, and the volume of products (both in terms of the quantity produced and the number of different types of products).
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“Congress included so many mandates in the new law, including the inspection mandates that, as a practical matter, the agency just can’t get out there and look at all these facilities; it’s a physical impossibility given the resource constraints,” says Arnold Friede, senior food and drug law attorney at Sandler, Travis & Rosenberg in Miami and a former associate chief counsel in the FDA’s Office of the Chief Counsel. “It’s all well and good to have the new statutory mandates—hopefully there will be a lot of voluntary compliance—but I’m skeptical FDA will have the needed resources for all the inspections across the areas they have to consider,” Friede tells Food Quality & Safety. “The FDA can ask for more money but let’s be real: In terms of budget cuts, it’s hard to believe they will get a significant amount of increased resources,” he says.
During Fiscal 2011, FDA’s CFSAN identified 22,325 domestic food firms as being high-risk and 11,007 of them were inspected that year. In Fiscal 2012, another 8,023 facilities were inspected (or attempted), bringing the total to 19,030 or 85 percent of the high-risk firm inventory. In addition, another 3,736 firms inspected in FY 2011 were re-inspected (or attempted) in FY 2012.
FDA’s cost to conduct high-risk foreign inspections has risen from $13,900 per facility three years ago to $23,600 in Fiscal 2012.
“When you look at these inspections, it’s a little more than 22,000 high-risk facilities or about 30 percent of the total facilities that would be addressed every three years,” says Henry. According to Association of Food and Drug Officials, the states conduct about 60 percent of all federal food inspections under contract with FDA. In addition, FDA’s cost to conduct high-risk foreign inspections has risen from $13,900 per facility three years ago to $23,600 in Fiscal 2012, Henry says. “The number of foreign food facility inspected per year is limited by budget constraints,” an FDA spokesperson acknowledges. “Certainly, ongoing budget challenges such as sequestration and reductions in funding will have a huge impact on this,” Henry says.
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