Title 21

PART 117 SUBPART C

Subpart C - Hazard Analysis and Risk-Based Preventive Controls

• 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
• 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

21:2.0.1.1.16.3.1.1	SECTION 117.126	117.126 Food safety plan.
21:2.0.1.1.16.3.1.2	SECTION 117.130	117.130 Hazard analysis.
21:2.0.1.1.16.3.1.3	SECTION 117.135	117.135 Preventive controls.
21:2.0.1.1.16.3.1.4	SECTION 117.136	117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
21:2.0.1.1.16.3.1.5	SECTION 117.137	117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4).
21:2.0.1.1.16.3.1.6	SECTION 117.139	117.139 Recall plan.
21:2.0.1.1.16.3.1.7	SECTION 117.140	117.140 Preventive control management components.
21:2.0.1.1.16.3.1.8	SECTION 117.145	117.145 Monitoring.
21:2.0.1.1.16.3.1.9	SECTION 117.150	117.150 Corrective actions and corrections.
21:2.0.1.1.16.3.1.10	SECTION 117.155	117.155 Verification.
21:2.0.1.1.16.3.1.11	SECTION 117.160	117.160 Validation.
21:2.0.1.1.16.3.1.12	SECTION 117.165	117.165 Verification of implementation and effectiveness.
21:2.0.1.1.16.3.1.13	SECTION 117.170	117.170 Reanalysis.
21:2.0.1.1.16.3.1.14	SECTION 117.180	117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
21:2.0.1.1.16.3.1.15	SECTION 117.190	117.190 Implementation records required for this subpart.

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