On July 26, 2013, FDA issued two new proposed regulations in accordance with section 301 of the Food Safety Modernization Act (FSMA): Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (1) and the Accreditation for Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (2). These new proposed rules follow two proposed rules issued by FDA on January 4, 2013: “Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The four proposed rules are designed to work together to strengthen food safety in the United States. Accordingly, the proposed rules will impact almost all companies selling food in the United States. In this article, Registrar Corp discusses how FDA’s Proposed Rule for Third-Party Auditors will likely affect the food and beverage industry. FDA proposes requirements for third-party auditors/certification bodies choosing to become accredited to conduct food safety audits and to issue food and facility certifications to eligible foreign entities under this FDA program. Food certification applies to most, but not all foods. For example, food certification typically does not apply to alcoholic beverages. FDA’s proposed rules would allow importers to use a report of a regulatory audit of an eligible foreign supplier to meet the verification requirements under proposed FSVP regulations. The FSVP proposed rule also would require importers to verify that hazards identified as reasonably likely to occur are being adequately controlled. Onsite auditing may be used to meet the requirements of this FSVP proposed rule. Further, facility certifications may be used in the future by FDA to help determine whether a facility is eligible to be a facility from which food may be offered for import under FDA’s proposal for the Voluntary Qualified Importer Program (VQIP).
