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On July 24, 2015, the U.S. Food and Drug Administration (FDA) published two documents to supplement its June 2013 proposed rule titled “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.”  The documents include:

  • A draft guidance to identify expected qualifications and standards for third-party auditors
  • A proposed rule to establish a user fee program to cover the costs of its third-party auditor accreditation program

Background

The Food Safety Modernization Act (FSMA) of 2011 directed FDA to establish a program for the accreditation of third-party auditors and certification bodies to conduct food safety audits and issue certifications of foreign food facilities and their products.  The 2013 rule  proposed eligibility requirements a company would have to meet in order to become a recognized accreditation body or an accredited certification body of eligible foreign entities.

Use of third-party auditors will be required for participation in the Voluntary Qualified Importer Program (VQIP).  Importers must obtain a food facility certification issued by a third-party auditor or certification body for each of their foreign suppliers of VQIP foods (foods approved for expedited U.S. entry under the VQIP).  Foreign suppliers must be re-certified annually.

The Draft Guidance

FDA’s draft guidance titled “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards” identifies FDA recommendations for qualifications a third-party auditor or certification body should have and standards they should meet.  According to FDA, once the guidance is finalized, it “will constitute the model accreditation standards referred to in section 808(b)(2)of the FD&C Act.”

Some examples of qualifications described in the guidance include that a third-party auditor or certification body must demonstrate that:

  • It has the authority to conduct onsite edits of eligible entities and review any relevant records of audited facilities.
  • It has adequate financial resources and numbers of personnel to fully implement its third-party auditor program.
  • Its audit agents have the relevant knowledge, skills, and experience to conduct effective audits.
  • It has implemented a written program for monitoring and assessing the performance of its staff.

See the guidance to view the entire list of qualifications and standards recommended by FDA.

The User Fees Proposed Rule

According to the proposed rule, the user fees will be decided based on an assessment of the time and resources required by FDA to establish and administer the third-party accreditation program. FDA tentatively concluded that the following groups should be charged user fees:

  • Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program
  • Certification bodies submitting applications or renewal applications for direct accreditation
  • Recognized accreditation bodies and accredited certification bodies participating in the third-party accreditation program subject to FDA monitoring activities

FDA plans to administer both application and annual user fees.  FDA’s estimated average costs are as follows:

  • Initial Applications: $35,850
  • Renewal Applications:  $18,853
  • Annual User fees: Between $1,982 and $2,250

These fees would be used to reimburse FDA for resources used when reviewing initial and renewal applications, as well as monitoring accreditation bodies and certification bodies.  FDA is requesting comments on whether additional user fees should be established to cover other costs (training new employees, maintaining an online list of recognized bodies, etc.) and if so, who the additional fees should be charged to.

FDA is expected to finalize its third-party accreditation rule by October 31, 2015.  Registrar Corp, an FDA consulting firm, stays up-to-date on U.S. FDA regulations and will continue to update industry as developments occur with FDA’s third-party accreditation rule and other upcoming FSMA rules.   For questions or assistance with U.S. FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177, or live help is available 24-hours a day at www.registrarcorp.com/livehelp.

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