FDA issues a proposed rule and draft guidance to implement its third-party accreditation program under FSMA.

  • The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for accrediting third parties to conduct food safety audits and issue certifications for facilities and food.  The Agency may use certifications:  (1) as a condition of entry for certain imported foods that FDA has determined to pose a food safety risk; and (2) to facilitate participation in the Voluntary Qualified Importer Program (VQIP), previously covered on this blog.  Participation in the accredited third-party audit/certification program is voluntary.  FDA issued a proposed rule to implement the program on July 29, 2013.  A final rule is anticipated in Fall 2015.  FSMA directs FDA to establish user fees to implement the third-party accreditation program and to develop Model Accreditation Standards that recognized accreditation bodies must use to qualify third-party auditors/certification bodies.
  • On July 23, 2015, FDA released a proposed rule to establish user fees to fund the Agency’s work in implementing the new third-party accreditation program.  The proposal indicates that four parties would be subject to user fees:
    1. Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
    2. Recognized accreditation bodies participating in the third-party accreditation program;
    3. Auditors/certification bodies submitting applications or renewal applications for direct accreditation; and
    4. Accredited auditors/certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party accreditation program.
  • The proposal would establish both application fees and annual fees to cover FDA’s costs in implementing the program.  FDA proposes to notify the public of the fee schedule annually prior to the beginning of the fiscal year for which the fees apply, and each fee schedule would be adjusted to account for inflation and improved estimates of the cost to FDA of performing relevant work for the upcoming year.  User fees would be non-refundable and no exemption or reduced fee exists for small businesses.  Non-payment of application fees would result in FDA deeming the applications to be incomplete.  Non-payment of annual fees would result in the suspension, and ultimately, revocation, of recognition/accreditation of previously recognized/accredited bodies.
  • Also on July 23, 2015, FDA released a draft guidance document intended to serve as the Model Accreditation Standards for the third-party accreditation program.  FDA considered various voluntary consensus standards and ultimately drew guidance from International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) ISO/IEC 17021:  Conformity Assessment — Requirements for bodies providing audit and certification management systems (2011) (ISO/IEC 17021:2011).  The draft guidance addresses topics such as capacity and competence; conflicts of interest; quality assurance; records procedures; and regulatory audit reports, and provides the Agency’s recommendations in each area.
  • Both the proposed rule and the notice of availability of the draft guidance are scheduled for publication in the Federal Register on July 24, 2015.  FDA will accept comments for 75 days after publication, i.e., until October 7, 2015.   Stakeholder comments will influence FDA’s implementation of the third-party accreditation program, which, in turn, will affect implementation of the VQIP and the Agency’s efforts to ensure the safety of the imported food supply.