The Accredited Third-Party Certification rule that FDA issued on November 27, 2015 establishes the framework, procedures, and requirements for the program.
An accreditation body recognized by FDA under this program could be a foreign government/agency or a private third party. Accreditation bodies assess third-party certification bodies for accreditation and monitor their performance.
Third-party certification bodies will be accredited under this program to conduct food safety audits and to certify that foreign food facilities, and the foods they produce, meet FDA food safety standards.
FDA issued two companion documents in December 2016. First, FDA issued a guidance to industry entitled, “Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards,” which contains FDA recommendations on third-party certification body qualifications. Second, FDA issued a final rule entitled, “Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program,” which provides for a user-fee program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program.
In June 2017 FDA launched a website where organizations can apply to be recognized as an Accreditation Body. Third-party certification bodies can seek accreditation after one or more FDA-recognized accreditation bodies begin accepting applications.
Once recognized by FDA, an accreditation body may begin accrediting third-party certification bodies that meet our program requirements.
