Vol. 80No. 180Part IIThursday,September 17, 2015Department of Health and Human ServicesFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 110,et al.Current Good Manufacturing Practice, Hazard Analysis, and Risk-BasedPreventive Controls for Human Food; Final RuleVerDate Sep201417:48 Sep 16, 2015Jkt 235001PO 00000Frm 00001Fmt 4717Sfmt 4717E:FRFM17SER2.SGM17SER2 tkelley on DSK3SPTVN1PROD with RULES255908Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and RegulationsDEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration21 CFR Parts 1, 11, 16, 106, 110, 114,117, 120, 123, 129, 179, and 211Docket No. FDA2011N0920Current Good Manufacturing Practice,Hazard Analysis, and Risk-BasedPreventive Controls for Human FoodAGENCY: Food and Drug Administration,HHS.ACTION: Final rule.SUMMARY: The Food and DrugAdministration (FDA or we) isamending our regulation for CurrentGood Manufacturing Practice InManufacturing, Packing, or HoldingHuman Food in two fundamental ways.First, we are modernizing the long-standing current good manufacturingpractice requirements. Second, we areadding requirements for domestic andforeign facilities that are subject to ourregulation for Registration of FoodFacilities to establish and implementhazard analysis and risk-basedpreventive controls for human food. Wealso are revising certain definitions inour regulation for Registration of FoodFacilities to clarify the scope of theexemption from registrationrequirements provided for farms and,in so doing, to clarify which domesticand foreign facilities are subject to therequirements for hazard analysis andrisk-based preventive controls forhuman food. We are taking this actionas part of our announced initiative torevisit the current good manufacturingpractice requirements since they werelast revised in 1986 and to implementnew statutory provisions in the FDAFood Safety Modernization Act. Therule is intended to build a food safetysystem for the future that makesmodern, science- and risk-basedpreventive controls the norm across allsectors of the food system.DATES: This rule is effective November16, 2015, except for the amendment topart 110 in instruction 13, which iseffective September 17, 2018 andparagraph (2) of the definition ofqualified auditor in 117.3, and 117.5(k)(2), 117.8, 117.405(a)(2),117.405(c), 117.410(d)(2)(ii), 117.430(d),117.435(d), 117.475(c)(2) and117.475(c)(13). FDA will publish adocument in the Federal Registerannouncing the effective dates ofparagraph (2) of the definition ofqualified auditor in 117.3, and 117.5(k)(2), 117.8, 117.405(a)(2),117.405(c), 117.410(d)(2)(ii), 117.430(d),117.435(d), 117.475(c)(2), and117.475(c)(13). See section LVI for thecompliance dates.FOR FURTHER INFORMATION CONTACT:Jenny Scott, Center for Food Safety andApplied Nutrition (HFS300), Food andDrug Administration, 5100 Paint BranchPkwy., College Park, MD 20740, 2404022166.SUPPLEMENTARY INFORMATION:Table of ContentsExecutive SummaryPurpose and Coverage of the RuleSummary of the Major Provisions of theRuleCosts and BenefitsI. BackgroundA. FDA Food Safety Modernization ActB. Stages in the Rulemaking for the HumanPreventive Controls RuleC. Summary of the Major Provisions ofProposed Human Preventive ControlsRuleD. Draft Risk AssessmentE. Definition of Retail FoodEstablishmentF. Public CommentsII. Legal AuthorityA. Changes to Current 21 CFR Part 1,Subparts H, I, and JB. Changes to Current 21 CFR Part 110C. Hazard Analysis and Risk-BasedPreventive ControlsD. Comments on Legal AuthorityIII. General Comments on the Proposed RuleIV. Comments on Proposed Revisions to theDefinitions in the Section 415Registration Regulations (21 CFR Part 1,Subpart H) and the Section 414Recordkeeping Regulations (21 CFR Part1, Subpart J)A. Definitions That Impact a Determinationof Whether an Establishment Is a FarmB. Proposed Revisions to the Definition ofFarmC. Proposed New Definition of HarvestingD. Proposed Revision to the Definition ofHoldingE. Proposed Revision to the Definition ofManufacturing/ProcessingF. Proposed New Definition of Mixed-TypeFacilityG. Proposed Revision to the Definition ofPackingV. Comments on the Organizing Principlesfor How the Status of a Food as a RawAgricultural Commodity or as aProcessed Food Affects the RequirementsApplicable to a Farm Under Sections 415and 418 of the FD&C ActVI. Rulemaking Required by Section 103(c) ofFSMA: On-Farm ActivitiesA. Section 103(c)(1)(C) of FSMAB. Comments on Qualitative RiskAssess