Updated: FDA Issues Guidance for Third-Party Certification Under FSMA | Practical Law

Updated: FDA Issues Guidance for Third-Party Certification Under FSMA | Practical Law

The Food and Drug Administration (FDA) has issued guidance for third-party certification of food safety audits under the Food Safety Modernization Act (FSMA). The final guidance contains standards for accreditation of third-party certification bodies as required under the final rule, Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.

Updated: FDA Issues Guidance for Third-Party Certification Under FSMA

Practical Law Legal Update w-004-9224 (Approx. 3 pages)

Updated: FDA Issues Guidance for Third-Party Certification Under FSMA

by Practical Law Commercial Transactions
Law stated as of 14 Dec 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has issued guidance for third-party certification of food safety audits under the Food Safety Modernization Act (FSMA). The final guidance contains standards for accreditation of third-party certification bodies as required under the final rule, Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.
This resource was updated on December 14, 2016 to reflect the Food and Drug Administration's (FDA) recent amendment to its regulations on accreditation of third-party certification bodies to conduct food safety audits and issue certifications (see User Fee Program).
On December 7, 2016, the FDA issued its final guidance on the third-party qualifications required to conduct food safety audits and issue food and facility certifications under the voluntary third-party certification program established under the Food Safety Modernization Act (FSMA).
The guidance is intended to be a companion document to the FDA's finale rule, Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, which became effective on January 26, 2016.
For more information on the FSMA, see Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Checklist and Practice Note, FSMA Regulation on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

User Fee Program

On December 14, 2016, the FDA issued a final rule to amend the agency's third-party certification regulations (Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program, 81 Fed. Reg. 90186 (Dec. 14, 2016)). This final rule provides for a reimbursement (user fee) program to assess fees for the work the FDA performs to establish and administer the third-party certification program under the FSMA.
This new final rule describes:
  • Who is subject to a user fee.
  • How the FDA computes user fees.
  • How the FDA notifies the public about annual fee rates.
  • How the FDA collects user fees.
  • The consequences for not paying a user fee.
This final rule becomes effective on January 13, 2017.