In comments filed last week with the Food and Drug Administration, IDFA supported the agency's efforts to improve the safety of imported food under the new Food Safety Modernization Act. IDFA called foreign supplier verification "the crux" of the act's import-safety provisions and urged FDA to make it a top priority. IDFA also offered recommendations regarding third-party audits, mandatory import certifications and voluntary qualifying of importers.
FDA is accepting comments on different sections of the new act to gather input and encourage industry participation prior to its rulemaking process. IDFA will submit separate comments on preventive controls and compliance and enforcement later this year.
"IDFA supported passage of FSMA and recognizes that a robust food safety system is crucial for both public health and the success of our member companies," the comments stated. "We appreciate the need for enhanced import controls and stronger tools to evaluate foreign suppliers' compliance with U.S. regulations."
The Food Safety Modernization Act, which was signed into law in January, requires FDA to issue guidance and regulations that will help importers verify that foreign suppliers are meeting U.S. requirements for food safety. In the comments, IDFA asked FDA to specify performance objectives rather than specific methods of compliance because there is such a wide variety of importers and types of imported foods. Third-party auditors could be employed as one way to verify suppliers, IDFA said, adding that this would help smaller member companies that may not have the resources to audit their suppliers.
But IDFA disagreed with FDA's interpretation that third-party auditors would be required to notify FDA directly if they uncover "a condition that could cause or contribute to a serious risk to the public health." IDFA emphasized that Congress specifically limited FDA access to reports from consultative audits and noted that registered facilities are already required to notify FDA under the Reportable Food Registry.
Regarding mandatory import certifications, IDFA said FDA's authority should be tailored to situations involving known food-safety risks or scientific risk-based findings that show the foreign country cannot meet U.S. food-safety regulations. In addition, IDFA called for this process to remain revenue-neutral, with auditors reimbursing FDA only for the agency's processing costs.
IDFA also supported the implementation of the Voluntary Qualified Importer Program, saying it would allow FDA to focus resources on high-risk products and encourage foreign suppliers to gain third-party certification.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org.