Systems Recognition Assessment

“According to FDA officials, the agency expects a limited number of countries to seek comparability with the United States because, in part, most countries will not meet the FDA requirement that the foreign government‘s domestic and export food safety systems be comparable with the U.S. system for all their food products,” says a September 2012 report by the congressional Government Accountability Office (GAO). While some countries have “robust” export certification programs in place for certain food products, such as seafood, their overall food safety and domestic production systems may not be comparable with those of the U.S. “Such countries would be more suited to apply for accreditation as a third party rather than seek overall systems comparability,” FDA officials told GAO auditors.

FSMA requires FDA to establish a program for the Accreditation of Third-Party Auditors for foreign food facilities. In this, FDA will recognize accreditation bodies which, in turn, will accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food. A third-party auditor could be a foreign government, a foreign cooperative, or other third party as long as it has legal standing and meets other standards, such as for competency.

“FDA believes that comparability is a more efficient and appropriate tool for FDA to use in assessing whether a country‘s entire food safety system provides adequate assurances of comparable public health outcomes, and third-party certification is a more appropriate approach for FDA to use when assessing a particular segment of the food safety system,” says Jim R. Esquea, assistant secretary for legislation at the Department of Health and Human Services, FDA’s parent agency, in written comments to GAO.

GAO disagrees with FDA that the use of third parties is preferable to comparability assessments, noting that some foreign governments may object to being designated as a third party because of sovereignty issues. And then if they do agree to that designation, “there is a potential conflict of interest in having a government accreditation body accredit another government agency from the same country as a third party,” GAO says, raising questions of bias.

GAO would prefer that FDA utilize systems recognition even for specific foods or subsets of food. This would be more comprehensive than a third-party accreditation arrangement, and would produce advantages similar to those realized by the FDA’s Food Safety and Inspection Service (FSIS) and the E.U. from their use of stricter “equivalence” standards. “If FDA had a comparability assessment agreement with a foreign country, similar to an E.U. equivalence agreement, a foreign competent authority would address any identified problems and take regulatory actions across the supply chain, as necessary,” GAO says.

“Equivalence” is a much higher standard than “comparability.” When it comes to importing meat, poultry, and processed egg products into the U.S., FSIS evaluates whether a foreign country’s food regulatory system employs equivalent sanitary measures that provide the same level of protection against food hazards as is achieved domestically. As of October 2013, FSIS had approved 34 countries including Albania, Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Honduras, Hungary, Iceland, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Northern Ireland, Poland, Romania, San Marino, Spain, Sweden, and Uruguay.

“Trying to demonstrate equivalence for every food item would be impossible,” Dr. Acheson says of systems recognition. “So FDA is taking a different tack of seeing whether public health protections in the foreign country are similar to those in the U.S. This gives the FDA lee-way, but it is still a heavy lift and an onerous process.”

Getting Recognized

FDA has outlined a multistep process it will use for recognition. After a country requests systems recognition, FDA will review its compliance history, trade volume, number of admission refusals and reasons, import alerts, and other information. FDA will then review these findings with food safety officials in that country. If they want to proceed, the officials will be asked to complete an International Comparability Assessment Tool (ICAT) to evaluate the extent to which the country satisfies standards in 10 areas: The regulatory foundation; training programs; inspection program; program assessment/inspection audit program; food-related illness and outbreaks; compliance and enforcement; industry and community relations; program resources; international communication and harmonization; and laboratory support.