Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Definition of Qualified Auditor; Announcement of Effective Date

The Food and Drug Administration is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of 17 September 2015.
In the Federal Register of 17 September 2015 (80 FR 55908), FDA published a final rule for "Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" (preventive controls for human food rule). In Section 117.3, FDA included the definition of a qualified auditor. In the definition, FDA provided examples of qualified auditors. Paragraph 2 of the definition reads "An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter". At the time the final rule published, paragraph 2 referred to a provision in a future final rule: "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications" (third-party certification rule). The preamble to the preventive controls for human food rule stated that FDA would publish a document in the Federal Register announcing the effective date of paragraph (2) once FDA finalized the third-party certification rule (80 FR 55908 at 55954).
The final third-party certification rule (80 FR 74569) published in the Federal Register on 27 November 2015, with an effective date of 26 January 2016. This document announces that the effective date for paragraph 2 in the definition of qualified auditor in Section 117.3 (80 FR 55098 at 56147) is 19 September 2016.
http://members.wto.org/crnattachments/2016/SPS/USA/16_4032_00_e.pdf