FDA Announces Risk-Based Data-Driven Approach to Food Imports Oversight

Foods imported from high-risk areas around the world would be subjected to prioritized inspection and border screenings under a new data-driven strategy announced recently by the FDA to modernize oversight of imported food. In its announcement, the FDA noted that the additional authority over food importers granted to the agency under the Food Safety Modernization Act, as well as existing regulatory tools would provide for a more comprehensive approach to help ensure the safety of food imports.

Four Goals

According to the FDA, their new imported food safety strategy is designed to meet four goals:

  • Preventing food safety problems in the foreign supply chain prior to entry into the US;
  • Detecting and refusing entry of unsafe foods at US borders;
  • Responding quickly when becoming aware of unsafe imported foods; and
  • Measuring the agency’s progress to ensure that the imported food safety program remains effective and efficient.

Goal 1: Risk-Based Inspection and Equivalency

As part of the first goal of preventing imported safety problems prior to entry, FDA indicated it would take new steps to ensure that imported foods meet the same standards as domestic foods. One of the tools that the agency intends to use to make this so-called equivalency determination is onsite inspections of foreign food facilities. Because these types of inspections are resource-intensive, FDA explained that these inspections would be prioritized based on risk with decisions informed by data and information from other oversight activities and other agencies.

Achieving this goal also involves ensuring importers are complying with FDA’s Foreign Supplier Verification Programs rule, which requires importers to verify that their suppliers are meeting US food safety standards. To meet this requirement, importers are obligated to conduct hazard analyses, perform evaluations of the risk of the food and foreign suppliers, and conduct safety verification activities based on the identified hazards.

It is clear that FDA is becoming more focused on FSVP enforcement. This past December, the agency released its Inspection Observations data, otherwise known as the results of the agency’s Form 483s that tracks inspection and enforcement activity by FDA’s Office of Regulatory Affairs. According to the data on the FDA spreadsheets, the lack of an FSVP was the top food facility violation during FY 2018.

The focus on preventive measures will include the FDA’s utilization of a systems recognition program, similar to the equivalency determination process at USDA’s Food Safety Inspection Service. Under this program, FDA would recognize that certain countries’ food safety systems and oversight activities provide comparable levels of public health protection to the US system. FDA asserted that leveraging this system would allow them to prioritize inspections and border screenings on foods imported from countries with a higher-risk food safety system.

Goal 2: Detecting and Refusing Unsafe Foods

The FDA uses an automated import screening tool – the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) – to identify high-risk shipments of imported foods. As part of its strategy to detect these unsafe shipments, the FDA intends to optimize the use of PREDICT by incorporating new sources of FSVP data, voluntary importer incentive programs, accredited third-party auditors, foreign regulatory authorities and domestic supply chain activities. The FDA contended that having access to these various data points will allow them to calculate risk more effectively and catch issues before they are made available in the US.

Goal 3: Responding Quickly to Unsafe Foods on the Market and Mandatory Recalls

Recognizing that it is impossible to stop all unsafe foods from being imported, the FDA declared that their ability to respond swiftly to seize these products would be enhanced with the use of data from multiple sources to optimize use of physical examination and targeted surveillance of the highest-risk products. This approach allows regular monitoring and surveillance of imported products, and targeted assignments of facilities to collect data on oversight activities, the FDA explained. The agency also indicated that they would continue working with state and other partners to determine how testing methodologies can be improved and tools used to determine admissibility of food offered for import.

The most notable regulatory tool available to the FDA – mandatory recall authority – was mentioned briefly as a method to capitalize on opportunities for improving the agency’s response to food safety incidents.

Goal 4: Monitoring Progress and Accountability

The final goal for FDA under this strategy is ensuring that the import program remains effective. To achieve this, the FDA noted that they would be developing an improved global inventory of food facilities and farms to help enhance resource allocation for imported food safety oversight to areas of higher risk. The FDA indicated that they would develop performance measures and outcome indicators to assess overall performance of imported food safety activities and make necessary adjustment when warranted. According to the announcement, the agency intends to publish their measures and non-confidential data about imported food, foreign suppliers, FSVP importers and other importers to the public as it becomes available.

In its announcement, the FDA outlined some notable statistics about imported foods. The US imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Other countries now supply about 32 percent of the fresh vegetables, 55 percent of the fresh fruit and 94 percent of the seafood that Americans consume.

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