On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 90186) that establishes user fees for the agency’s accredited third-party certification rule. Finalized in November 2015 as part of the Food Safety Modernization Act (FSMA), the rule establishes a voluntary program for certification bodies to audit foreign food facilities and provide certification when their food safety controls are up to U.S. standards.
There are essentially three steps to the accredited third-party certification program:
- FDA recognizes accreditation bodies.
- Recognized accreditation bodies accredit qualified third-party certification bodies.
- Accredited certification bodies audit and issue certifications for foreign food facilities and their products.
For more information on the program requirements and use of certifications, read here.
FDA’s final rule establishes two types of user fees: application and annual.
Application fees apply to accreditation bodies applying for FDA recognition, recognized accreditation bodies applying for renewal, and to third-party certification bodies applying for direct accreditation from FDA or a renewal of their direct accreditation. The application fees are intended to cover the costs of FDA’s review and evaluation of initial and renewal applications. These fees must be submitted concurrently with an application and are non-refundable. Applications will be considered incomplete until payment is made.
Annual fees apply to recognized accreditation bodies. The annual fees also apply to accredited certification bodies, whether they were accredited directly through FDA or through an accreditation body. Annual fees are intended to cover the costs of FDA’s performance monitoring efforts. Annual fees must be paid within 30 days of receiving billing. Failure to pay FDA’s user fees may result in suspension or revocation of a participant’s recognition or accreditation.
The application fee for accreditation bodies applying for initial recognition in fiscal year (FY) 2017 will be $35,100 (81 FR 90363). This cost is slightly lower than the application fee estimated in the 2015 proposed rule. In the future, FDA will announce the fee schedule prior to the beginning of each FY.
Circumstances under which accredited third-party audits are required are likely to be rare. These audits are only required when a facility’s product is being imported to the US as a VQIP food and in the event that FDA issues a requirement for certification of a specific food due to safety concerns. In the case that your facility does require a third party audit, Registrar Corp offers a mock inspection service to help prepare. Registrar Corp’s Food Safety Specialists will inspect all aspects of your facility, from employee hygiene to equipment maintenance to recordkeeping. Our mock inspection service is also beneficial in preparing for a routine FDA inspection.
For questions regarding FDA’s accredited third-party certification program or other final FSMA rules, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.