# Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Final rule; announcement of effective date.
**SUMMARY:**
The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the *Federal Register* of September 17, 2015.
**DATES:**
The effective date of paragraph (2) of the definition of qualified auditor in 21 CFR 117.3 and in 21 CFR 507.3, which published in the *Federal Register* of September 17, 2015 (80 FR 55908) and (80 FR 56170), is September 19, 2016.
**FOR FURTHER INFORMATION CONTACT:**
*For questions relating to Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food:* Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
*For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals:* Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246.
**SUPPLEMENTARY INFORMATION:**
In the *Federal Register* of September 17, 2015 (80 FR 55908), we 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 § 117.3, we included the definition of a qualified auditor. In the definition, we 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). In the preamble to the preventive controls for human food rule, we stated that we would publish a document in the *Federal Register* announcing the effective date of paragraph (2) once we finalized the third-party certification rule (80 FR 55908 at 55954).
In the *Federal Register* of September 17, 2015 (80 FR 56170), we published a final rule for “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (preventive controls for animal food rule). In § 507.3, we included the definition of a qualified auditor. In the definition, we 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). In the preamble to the preventive controls for animal food rule, we stated that we would publish a document in the *Federal Register* announcing the effective date of paragraph (2) once we 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 November 27, 2015, with an effective date of January 26, 2016. This document announces that the effective date for paragraph 2 in the definition of qualified auditor in § 117.3 (80 FR 55098 at 56147) and § 507.3 (80 FR 56170 at 56339) is September 19, 2016.
Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.