FDA Inspections in 2014

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.