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FDA Inspections in 2014: Big Ambitions Hampered by Limited Resources
by Ted Agres
Facing the likelihood of ongoing budget constraints, the FDA will be hard pressed this year to carry out the full range of inspections mandated by the Food Safety Modernization Act (FSMA). Weaknesses and gaps in its internal records systems have also hampered the agency’s ability to identify which food facilities to inspect and even prevented it from determining the number of domestic and foreign facilities that had been scheduled to be inspected but were not.
In its “2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices” released in November 2013, the FDA acknowledges that “data quality challenges” in its so-called Section 415 facility registration database—the registry of firms required by the 2002 Public Health Security and Bioterrorism Preparedness and Response Act—forced the agency to rely instead on its Official Establishment Inventory (OEI) to determine which facilities were inspected in Fiscal 2011-12 and which were scheduled to be inspected in Fiscal 2013.
This is because the 2002 Bioterrorism Act gave FDA only limited authority to collect information from food facilities, such as addresses and the types of food being handled. OEI, on the other hand, is a longstanding database of information about companies under FDA inspection authority. It contains detailed information such as the types of processes and products each firm produces and its place in the supply chain. “The Official Establishment Inventory was used to determine the number of facilities because it contains additional information that was not captured in the [Section 415] facility registration database,” an FDA spokesperson explains.
“For FDA to look across the list of all regulated establishments, the OEI provides more in-depth data and information to help prioritize, rank, and understand the operations going on in those facilities,” says Faye Feldstein, a senior adviser with Deloitte Consulting LLP and former director of the Office of Food Defense, Communication, and Emergency Response in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The Bioterrorism Act required companies to register but not update records unless there had been a major change, such as in ownership or responsible party. However under FSMA, firms must now renew and update their registration information every two years. “The biennial registration requirement under FSMA should improve the accuracy of the information in the registration database and FDA will transition to using the registration database to determine which facilities to inspect for future work planning cycles,” the FDA spokesperson adds. Also, by law, FDA is prohibited from sharing certain information in its registration database with other agencies. Under OEI, however, FDA is able to share that information. “As an external party, I can say that it would be very helpful to have these two lists merged into one at some point in the future,” Feldstein tells Food Quality & Safety.
FSMA was enacted in January 2011. Under the law, all high-risk domestic facilities must be inspected within five years of enactment and no less than every three years afterwards. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. Despite limitations in its records, FDA had been aiming to inspect all foreign and domestic high-risk facilities within three years, two years earlier than directed by FSMA, and is attempting to inspect all non-high-risk facilities within seven years (by Fiscal 2017), according to the agency’s annual report. During Fiscal 2012, the FDA and states under contract with FDA inspected or attempted to inspect 24,462 domestic food facilities while FDA inspected 1,342 foreign food facilities, the report says. The average cost to inspect a domestic non-high-risk facility was $9,200 while the average domestic high-risk facility cost $15,500. Foreign high-risk food facility inspections each averaged $23,600, the report says.
Framework to Identify Risk
After FSMA was enacted, the agency began to develop models for determining risk levels. The agency then retrospectively looked back through the OEI to categorize the inspections that had been made by risk level. “Therefore, the usual sequence of scheduling certain facilities for inspection and then striving to meet that benchmark did not take place,” the report says. Accordingly, the FDA was not able to determine the number of registered foreign and domestic facilities that had been scheduled but were not inspected. The agency does expect to report those numbers for Fiscal 2011-13 in a report later this year and to use the registration database going forward.
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 .
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).
“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.
As in previous years, the FDA in Fiscal 2012 physically examined only about 1.9 percent of imported food lines, in this case 207,839 of the 11,136,599 total. Nevertheless, imports are electronically screened using the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT)—an automated IT system that was installed in all 16 import Districts in September 2009. PREDICT helps inspectors identify which products pose the greatest potential risk and should be physically examined. The system calculates risk scores for every line in an entry based on numerical weights assigned to inherent risk rules, data anomaly rules, data quality, rules and the compliance history of the manufacturer, shipper, and consignee and product associated with the line.
In Fiscal 2012, FDA inspectors electronically screened about 27 million import entry lines and were projected to have screened about 33 million in Fiscal 2013. According to FDA’s annual report, the average cost of physically inspecting or sampling a line of food that is imported or offered for import is about $160 per field exam and about $3,100 per sample analyzed. Reducing the number of physical inspections can also result in cost savings, but the report did not quantify any such savings.
Agres is based in Laurel, Md. Reach him at email@example.com.