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FDA Unveils New Strategy for Imported Food

Food and Drug Administration Commissioner Scott Gottlieb announced on 25 February changes to his agency’s strategy for ensuring the safety of food imported into the United States. Gottlieb’s statement referenced the growing importance of imported food in the U.S. marketplace, noting that the United States now imports 15 percent of its food from more than 200 countries or territories. Some 125,000 foreign food facilities and farms supply about 32 percent of fresh vegetables, 55 percent of fresh fruit and 94 percent of seafood consumed in the United States. Moreover, between 14 and 15 million shipments of imported food are expected to enter the United States in 2019 alone.

More complex and globalised supply chains and increased specialisation mean that a single ingredient can be used in many different finished products, posing a singular challenge to the U.S. food safety system. In response, the FDA Food Safety Modernization Act enacted in 2011 gave the FDA expanded authority to mandate additional preventive controls as well as new and supplementary oversight and enforcement authorities. Among other things, FSMA shifted the focus of federal regulations from responding to contamination to preventing it while specifying distinct roles for importers, manufacturers, third-party auditors, foreign regulatory bodies and others. In addition to establishing food safety standards, FSMA granted the FDA new and supplementary oversight and enforcement authorities to ensure industry is meeting these standards.

The FDA believes that optimising its FSMA implementation activities as well as its long-standing tools and authorities “will provide for an even more comprehensive approach” to help ensure the safety of imported food. In this regard, the agency’s new strategy aims to help determine the best way to use available tools across the different segments of the international food supply chain in ways that decrease public health risks while maintaining a level playing field for domestic and foreign producers. Its goals are to prevent food safety problems in the foreign supply chain prior to entry into the United States, effectively detect and refuse entry of unsafe foods at the border, and rapidly respond to unsafe imported foods. More broadly, the strategy seeks to create an effective and efficient food import programme.

The strategy outlines several methods the FDA plans to use to accomplish these goals, including strategies for each of the following objectives.

  • optimise the use of foreign facility inspections (e.g., use FDA foreign offices to perform and facilitate more inspections)
  • ensure the use by importers of verified foreign suppliers through effective implementation of the Foreign Supplier Verification Program rule (e.g., strategic enforcement of verification programmes and supply chain controls requirements)
  • utilise reliable audits, such as those issued under the accredited third-party certification programme
  • incentivise importers to use verified suppliers of safe food through the Voluntary Qualified Importer Program
  • leverage the oversight efforts of regulatory counterparts with strong food safety systems
  • increase awareness of and training on food safety requirements and strengthen the capacity of foreign suppliers to produce safe food
  • continue to enhance and refine the FDA’s import screening and entry review processes (e.g., use screening to prevent entry of food shipments by importers lacking adequate foreign supplier verification programmes)
  • optimise the use of physical examination and sampling of imported food (e.g., focus on highest-risk products)
  • strategically utilise import alerts and import certifications (e.g., detain and refuse admission of food from a foreign facility that refuses FDA inspection)
  • improve testing methodologies and tools used to determine admissibility of food offered for import
  • maximise the benefit to border surveillance from state and other partnerships
  • maximise the effectiveness of FDA responses to events involving imported food
  • enhance the efficiency and effectiveness of imported food safety recalls
  • use information-sharing opportunities to prepare for and respond to the entry of unsafe imported food
  • optimise resource allocation by developing a comprehensive global inventory of food facilities and farms and assessing the cumulative oversight applied to the global inventory
  • ensure effectiveness of import activities through performance assessment and continuous improvement (e.g., publish meaningful data related to imported food, foreign food suppliers and FSVP importers)

One of the objectives outlined above encourages the use of VQIP, a fee-based programme that allows importers to enter qualified imports much more rapidly. Participants are eligible, if, among other criteria, they import food from suppliers certified by an accredited third-party auditor as producing the audited product in accordance with applicable FDA food safety requirements, including the preventive controls and produce safety rules. Moving forward, the agency intends to promote the production of safe food through this programme and protect the integrity of VQIP through continued monitoring and transparency.

Meanwhile, efforts to ensure that importers use verified foreign suppliers will be stepped up by (i) providing education and technical assistance to increase awareness of, and compliance with, foreign supplier verification programmes; (ii) deepening the importer and foreign food facilities and farms inventory knowledge base to enable the FDA to evaluate the extent of agency oversight of the foreign inventory through FSVP and to inform work plan determinations as to type and frequency of inspection; and (iii) deterring non-compliance through strategic enforcement of foreign supplier verification programmes and supply chain controls requirements.

The FDA is also seeking to optimise import screening by incorporating new sources of intelligence with current data and preventing entry of food shipments by importers lacking adequate foreign supplier verification programmes. Currently, the agency uses an automated import screening tool – known as the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) –  to identify higher-risk shipments of food offered for import. Concurrently, the FDA intends to develop and execute strategic and targeted physical examination and sampling based on advanced analyses of data from multiple sources and utilise data and information from oversight activities, regulatory co-operation and other reliable sources to enhance the effectiveness and efficiency of import alerts.

During the recent partial U.S. government shutdown, one of the concerns expressed most frequently in U.S. media outlets was whether the FDA was continuing to inspect food, both imported and produced domestically. Since its return to full operation the FDA has announced numerous enforcement actions and strategic changes, including the new strategy for imported food.

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