The Food Safety Modernization Act (F.S.M.A.), signed into law by President Barack Obama on Jan. 4, established a framework for a robust approach to ensuring the safety of food imported into the United States.
“In two years, food processors and manufacturers will be required to verify that any imported ingredients or products are produced in compliance with U.S. laws and regulations,” said David Acheson, managing director, food and import safety, Leavitt Partners, Washington, in discussing the import aspect of the F.S.M.A. “As a result, companies will need to have new systems and processes in place to ensure they are sourcing ingredients and products from suppliers that meet U.S. requirements.”
Under Section 301 of the act, companies importing foods or food ingredients will be required to put into place a foreign supplier verification program to confirm the foods they import are produced in accordance with U.S. food laws, including the preventive measures newly required under the F.S.M.A. The act requires the Food and Drug Administration to issue not less than one year after enactment guidance to assist importers in developing foreign supplier verification programs. Companies must have the programs in place and operating within two years of enactment.
The act states verification activities under a foreign supplier verification program may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier and periodically testing and sampling shipments.
Records of an importer related to a foreign supplier verification program must be maintained for not less than two years and must be made available promptly to a representative of the Secretary of Health and Human Services (i.e. F.D.A.) upon request.
“Companies should start looking at their supply chain now and begin developing a verification program as it will be a challenge to get a system in place in time if they wait until the F.D.A. issues the regulation,” Dr. Acheson said. “Further, companies will need to ensure they stay current with new regulations as they are developed to be sure they are in the best position to be most responsive and stay out in front.”
Section 302 of the F.S.M.A. requires the Secretary of H.H.S., in consultation with the Secretary of Homeland Security, to establish within 18 months of enactment a program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such a program and meet its requirements. The F.D.A. was directed to establish a process for the issuance of a facility certification to accompany food offered for importation by importers participating in the voluntary program.
Eligibility in the voluntary program will be limited to importers offering food for importation from facilities that have been certified for providing such food.
The F.D.A. in reviewing applications for expedited importation was directed to consider the risk of the food to be imported based on factors such as the known safety risks of the food; compliance history of foreign suppliers used by the importer; the capability of the regulatory system of the country of export to ensure compliance with U.S. food safety standards for a designated food; the compliance of the importer with requirements of the foreign supplier verification program as specified in Section 301, and the potential risk for intentional adulteration of the food.
Section 303 of the F.S.M.A. specifies the F.D.A. may require, as a condition of granting admission of a food offered for importation into the United States, that an agency or representative of the government of the country from which the article of food originated or other accredited persons or entities provide certification or assurances that the article of food complies with the requirements of the act. The section indicates such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack or hold such food, or in such other form as the secretary may specify.
The F.D.A. must determine whether food safety programs, systems and standards in the country of origin are adequate to ensure the article of food is as safe as a similar article of food that is manufactured, processed, packed or held in the United States. In that connection, the F.S.M.A. directs the F.D.A. to develop a plan to help expand the technical, scientific and regulatory food safety capacity of foreign governments and their food industries from which food are exported to the United States.
An alternative to an agency of a foreign government providing certification of a food offered for importation into the United States would be an accredited private-sector, third-party auditor doing so. The act requires the F.D.A. to establish a process whereby such accreditation of third-party auditors is conferred and what requirements such auditors must meet.
“The provisions under Title III create multiple ways to ensure that food ingredients and product entering the United States are as safe as food produced in the United States,” Dr. Acheson said. “The foreign supplier verification program provides the first level of assurance by making importers accountable for the safety of the food products they introduce into the United States. The product/facility certification is a way to add an additional level of assurance for high risk products or countries/regions/territories by requiring that facilities exporting designated products have been inspected or audited by a third party for compliance. The voluntary qualified importer program creates an incentive to be a ‘good actor’ by providing expedited entry for firms who participate.”
While companies will have to devote additional resources to verifying the safety of foods they import, there are benefits from the F.S.M.A., including “greater confidence in the supply chain and a reduction in the risk of brand damage because of the increased accountability throughout the supply chain,” Dr. Acheson said.