FDA Proposes Two New FSMA Rules
July 29, 2013
Washington — U.S. manufacturers will need to verify their international suppliers are meeting current U.S. food safety requirements and the FDA is developing standards that strengthen the quality and credibility of foreign third-party audits in two new proposed rules under the Food Safety Modernization Act (FSMA)
The NCA says it appreciates the FDA’s continued implementation of FSMA and is analyzing the proposed rules and will send a summary to its members at a later date.
Under the Foreign Supplier Verification Program (FSVP) food importers would require a compliance status review of the food and the potential foreign supplier and analyze the hazards associated with each of the foods. Verification activities could include onsite auditing and review of supplier food safety records.
Regardless of whether hazards are identified, manufacturers must maintain a list of foreign suppliers and establish written procedures for verification activities, the FDA reports. Importers would be required to reassess the effectiveness of their verification programs every three years, or sooner if they become aware of new hazards and must keep records of these and other activities. FSVP would also mandate importers obtain a Dun and Bradstreet Data Universal Numbering System number for their company to use when filing for entry with Customs and Border Protection.
The third-party accreditation rule would establish a program for verifying certification bodies to conduct food safety audits and issue certifications of foreign facilities. The administration says it will issue accreditation standards that would specify what qualifications a certification body must have.
The FDA is seeking public comment on the new laws at regulations.gov and will take them into consideration before it publishes a final rule.
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