• On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA).
  • Under FSMA, FDA established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals and that meet applicable FDA food safety requirements. As previously covered on this blog, the accreditation process includes a web-based application and user fee.
  • In fiscal year 2020, FDA will collect an initial application fee for accreditation bodies seeking recognition of $41,328, an annual fee for recognized accreditation bodies of $1,945, an annual fee for certification bodies accredited by a recognized accreditation body of $2,432, and an initial application fee for a certification body seeking direct accreditation from FDA of $41,328. The fee rates are effective October 1, 2019, and will remain in effect through September 30, 2020.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA or the Accredited Third-Party Certification Program.