With the passage of the FSMA, FDA received new authority to enhance its oversight of food imports. That includes the authority to establish a system for accrediting third parties, including foreign governments and private auditing firms, to certify foreign foods facilities’ compliance with US food safety requirements. FDA has also begun to assess selected foreign food safety systems to determine if these systems provide the same level of public health protection, among other things.

The Government Accountability Office (GAO) was asked to identify major actions FDA should take to implement a system for accrediting third parties and challenges it and others report with these actions. The GAO was also tasked to examine FDA’s approach for using comparability assessments to leverage other countries’ oversight capacity and enforcement authority.

In its report, FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources, GAO reviewed FDA documents and interviewed officials from FDA and other agencies and stakeholders, such as consumer groups and industry representatives. GAO recommends FDA revise its comparability approach to one that also includes assessing foreign food safety systems for particular food products, such as seafood.

The GAO identified five major actions FDA is to complete under FSMA to establish a reliable system that uses third-party audits conducted by these foreign governments or other third parties to help insure food safety. FDA officials and others report each of these actions presents challenges that must be addressed. They include:

1. FDA is to develop new preventive controls and related guidance for all of the foods under its jurisdiction, such as milk, produce, cheese, spices, etc. FDA will need to develop appropriate training for foreign producers and processors.
2. FDA is to establish a voluntary user fee program for importers that encourages the use of third-party certifications, and it faces a challenge in developing such a program.
3. FDA has to develop a system for recognizing accreditation bodies that can accredit third parties to certify foreign food facilities. There is a concern that foreign governments may not approve of audits unless they’re conducted by FDA.
4. FDA is to develop model standards for accreditation bodies to use in evaluating and accrediting third parties, and faces challenges in, for example, determining the competency of third-party auditors.
5. FDA is to oversee the third-party accreditation system, including periodically evaluating accreditation bodies and third parties, and faces a challenge in deciding the level of oversight that is required to accomplish the task.

According to GAO, FDA’s approach for using comparability assessments can enable the agency to leverage other countries’ oversight capacity and enforcement authority. This could result in some of the same advantages as the equivalence approach used by USDA’s FSIS and the European Union before specific food products can be imported. These advantages include having a foreign competent authority address any identified problems and take regulatory actions across the supply chain as necessary.

However, according to FDA officials, the agency expects few countries to seek comparability with the US because, in part, most countries will not meet the FDA requirement that a foreign government’s domestic and export food safety systems be comparable to the US system under FDA’s jurisdiction.

For more information, read the GAO report, FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources.