In response to a request from Senators Rockefeller, Snowe, Cantwell, and Inouye, the Government Accountability Office (GAO) released a report yesterday addressing obstacles that FDA may face in implementing certain provisions of the Food Safety Modernization Act (FSMA) designed to ensure the safety of food imports. The report identifies several obstacles to the implementation of a successful third-party accreditation system for foreign facilities and recommends that FDA minimize dependence on third-party accreditation by maximizing use of foreign countries’ existing regulatory and enforcement resources.
The GAO framed the objectives of the report as twofold: (1) identify the major actions FDA is to take to implement a system for accrediting third parties, as directed by FSMA, and the challenges, if any, FDA and others report will be associated with these actions, and (2) examine FDA’s approach for using its comparability assessments to leverage other countries’ oversight capacity and enforcement authority.
With regard to the first objective, GAO identified five major actions that FDA must complete in order to establish a third-party accreditation system to ensure food safety and explained that each action presented unique obstacles that may hinder the effectiveness of the system. For instance, GAO noted that FDA will need to develop new preventive control requirements and supporting guidance and training material and explained that “[d]eveloping guidance with the necessary level of detail on each food industry under its jurisdiction could present a challenge for FDA.”
GAO also noted that FDA would face obstacles in determining when to use its authority to require third-party certification as opposed to simply incentivizing third-party certification under the Voluntary Qualified Importer Program (VQIP). Under FSMA, FDA must establish a program that provides expedited review of imported foods for certain accredited importers and assesses user fees for those importers. Additionally, FDA may require mandatory third-party certification as a condition for importation of certain foods into the United States. The GAO report notes that “FDA faces a challenge in deciding if it should use its authority to mandate third-party certifications” and, to the extent that it does not, “FDA faces a challenge in developing a voluntary program that provides sufficient incentives for expediting the import of food products to warrant the fee that importers will incur to participate in the program.”
In recognition of these obstacles to the third-party certification program, GAO recommended that FDA revise its approach to comparability assessments in order to “enable the agency to leverage other countries’ oversight capacity and enforcement authority.” A comparability assessment consists of a review of a foreign country’s regulatory system for food safety to determine whether that system is sufficiently similar to the United States regulatory scheme to adequately protect food safety. A successful comparability assessment may result in the foreign country assuming greater responsibility for ensuring the safety of food imports into the United States. FDA is presently engaged in comparability pilot programs with New Zealand and Canada, but has indicated that it does not expect many countries to seek comparability because their overall food safety systems are not sufficiently similar.
The report explains that FDA’s current approach to comparability assessments focuses on a country’s food safety system in the aggregate, rather than a food safety system for a particular category of food. GAO argues that this approach unnecessarily limits the usefulness of comparability assessments because very few countries will have sufficiently comparable regulatory schemes for all food products. GAO points to the equivalence approach taken by USDA’s Food Safety Inspection Service (FSIS) and the European Union (EU) as “a more targeted approach to determine the safety of imported food by examining whether a country’s systems for ensuring the safety of a specific food product are equivalent.”
FDA responded, according to the report, by noting that it believes comparability assessments to be more efficient and effective when conducted for an entire food regulatory scheme, whereas third-party certification may be more appropriate when FDA is assessing a particular segment of a country’s food safety system. However, FDA indicated that it intends to seek public comment on its current comparability approach as it continues its efforts to implement FSMA.