21CFR117美国食品良好生产规范、危害分析和基于风险的预防控制措施Department of Health and Human Service

Vol. 80 No. 180 Part II Thursday, September 17, 2015 Department of Health and Human Services Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA–2011–N–0920] Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long- standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for ‘‘farms’’ and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system. DATES: This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of ‘‘qualified 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) and 117.475(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of ‘‘qualified 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), and 117.475(c)(13). See section LVI for the compliance dates. FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS–300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–2166. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Rule Summary of the Major Provisions of the Rule Costs and Benefits I. Background A. FDA Food Safety Modernization Act B. Stages in the Rulemaking for the Human Preventive Controls Rule C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule D. Draft Risk Assessment E. Definition of ‘‘Retail Food Establishment’’ F. Public Comments II. Legal Authority A. Changes to Current 21 CFR Part 1, Subparts H, I, and J B. Changes to Current 21 CFR Part 110 C. Hazard Analysis and Risk-Based Preventive Controls D. Comments on Legal Authority III. General Comments on the Proposed Rule IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J) A. Definitions That Impact a Determination of Whether an Establishment Is a ‘‘Farm’’ B. Proposed Revisions to the Definition of Farm C. Proposed New Definition of Harvesting D. Proposed Revision to the Definition of Holding E. Proposed Revision to the Definition of Manufacturing/Processing F. Proposed New Definition of Mixed-Type Facility G. Proposed Revision to the Definition of Packing V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm activities A. Section 103(c)(1)(C) of FSMA B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117) A. Title of Part 117 B. Proposed Revisions for Consistency of Terms C. Proposed Additions Regarding Allergen Cross-Contact D. Proposed Revisions for Consistency With the Definition of ‘‘Food’’ E. Proposed Revisions To Address Guidance in Current Part 110 F. Proposed Editorial Changes G. General Comments on Current Part 110 (Final Part 117) VIII. Subpart A: Comments on Proposed § 117.1—Applicability and Status A. Comments on Proposed § 117.1(a)— Applicability B. Comments on Proposed § 117.1(b)— Prohibited Act C. Comments on Proposed § 117.1(c)— Specific CGMP Requirements IX. Subpart A: Comments on Proposed § 117.3—Definitions A. Redesignation B. Definitions in Current Part 110 That We Proposed To Delete C. Definitions That We Proposed To Establish in Part 117 D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final § 117.4(a), (b), and (d)) B. Additional Requirements Applicable to Supervisory Personnel (Final § 117.4(c)) XI. Subpart A: Comments on Proposed § 117.5—Exemptions A. General Comments on the Proposed Exemptions B. Proposed § 117.5(a)—Exemption Applicable to a Qualified Facility C. Proposed § 117.5(b) and (c)— Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120) D. Proposed § 117.5(d)—Exemption Applicable to Food Subject to Part 113— Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers E. Proposed § 117.5(e)—Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement F. Proposed § 117.5(f)—Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act G. Proposed §§ 117.5(g) and (h)— Exemptions Applicable to On-Farm Low- Risk Activity/Food Combinations Conducted by a Small or Very Small Business H. Proposed § 117.5(i)—Exemption Related to Alcoholic Beverages I. Proposed § 117.5(j)—Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Vegetables Intended for Further Distribution or Processing J. Proposed § 117.5(k)—Exemption Applicable to Farms, Fishing Vessels, activities of ‘‘Farm Mixed-Type Facilities’’ Within the Definition of ‘‘Farm,’’ the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities K. Comments Requesting Additional Exemptions XII. Subpart A: Comments on Proposed § 117.7—Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food XIII. Subpart B: Comments on Proposed § 117.10—Personnel A. Management Responsibility for Requirements Applicable to Personnel B. Proposed § 117.10(a)—Disease Control C. Proposed § 117.10(b)—Cleanliness XIV. Subpart B: Comments on Proposed § 117.20—Plant and Grounds A. Proposed § 117.20(a)—Grounds B. Proposed § 117.20(b)—Plant Construction and Design XV. Subpart B: Comments on Proposed § 117.35—Sanitary Operations A. Proposed § 117.35(a)—General Maintenance B. Proposed § 117.35(b)—Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials C. Proposed § 117.35(c)—Pest Control D. Proposed § 117.35(d)—Sanitation of Food-Contact Surfaces E. Proposed § 117.35(d)(1)—Food-Contact Surfaces Used for Manufacturing/ Processing or Holding F. Proposed § 117.35(d)(2)—Wet Cleaning G. Proposed § 117.35(d)(3)—Single-Service Articles H. Proposed § 117.35(e)—Sanitation of Non-Food-Contact Surfaces I. Proposed § 117.35(f)—Storage and Handling of Cleaned Portable Equipment and Utensils XVI. Subpart B: Comments on Proposed § 117.37—Sanitary Facilities and Controls A. Proposed § 117.37(a)—Water Supply B. Proposed § 117.37(b)—Plumbing C. Proposed § 117.37(c)—Sewage Disposal D. Proposed § 117.37(d)—Toilet Facilities E. Proposed § 117.37(e)—Hand-Washing Facilities XVII. Subpart B: Comments on Proposed § 117.40—Equipment and Utensils A. Proposed § 117.40(a)—Design, Construction, Use, Installation, and Maintenance of Equipment and Utensils B. Proposed § 117.40(b)—Seams on Food- Contact Surfaces C. Proposed § 117.40(c)—Construction of Equipment D. Proposed § 117.40(d)—Holding, Conveying, and Manufacturing Systems E. Proposed § 117.40(e)—Freezer and Cold Storage Compartments F. Proposed § 117.40(f)—Accurate and Precise Instruments and Controls G. Proposed § 117.40(g)—Compressed Air or Other Gases XVIII. Subpart B: Comments on Proposed § 117.80(a)—General Processes and Controls A. Proposed § 117.80(a)(1)—Adequate Sanitation Principles B. Proposed § 117.80(a)(2)—Quality Control Operations C. Proposed § 117.80(a)(3)—Supervision of Overall Sanitation D. Proposed § 117.80(a)(4)—Production Procedures E. Proposed § 117.80(a)(5)—Chemical, Microbial, or Extraneous-Material Testing Procedures F. Proposed § 117.80(a)(6)—Contaminated Food XIX. Subpart B: Comments on Proposed § 117.80(b)—Processes and Controls for Raw Materials and Other Ingredients A. Proposed § 117.80(b)(1)—Inspection, Segregation and Handling of Raw Materials and Other Ingredients B. Proposed § 117.80(b)(2)—Levels of Microorganisms in Raw Materials and Other Ingredients C. Proposed § 117.80(b)(3)—Natural Toxins in Raw Materials and Other Ingredients D. Proposed § 117.80(b)(4)—Pests, Undesirable Microorganisms and Extraneous Materials in Raw Materials and Other Ingredients E. Proposed § 117.80(b)(5)—Holding Raw Materials, Other Ingredients, and Rework in Bulk F. Proposed § 117.80(b)(7)—Liquid or Dry Raw Materials and Other Ingredients G. Proposed § 117.80(b)(8)—Raw Materials and Other Ingredients That Are Food Allergens XX. Subpart B: Comments on Proposed § 117.80(c)—Manufacturing Operations A. Proposed § 117.80(c)(1)—Condition of Equipment, Utensils, and Finished Food Containers B. Proposed § 117.80(c)(2)—Conditions and Controls for Food Manufacturing, Processing, Packing, and Holding C. Proposed § 117.80(c)(3)—Food That Can Support the Rapid Growth of Undesirable Microorganisms D. Proposed § 117.80(c)(4)—Measures To Destroy or Prevent the Growth of Undesirable Microorganisms E. Proposed § 117.80(c)(5)—Work-in- Process and Rework F. Proposed § 117.80(c)(6)—Finished Food G. Proposed § 117.80(c)(7)—Equipment, Containers, and Utensils H. Proposed § 117.80(c)(8)—Metal or Other Extraneous Material I. Proposed § 117.80(c)(9)—Disposal of Adulterated Food, Raw Materials, and Other Ingredients J. Proposed § 117.80(c)(10)—Performing Manufacturing Steps K. Proposed § 117.80(c)(11)—Heat Blanching and Growth and Contamination by Thermophilic Microorganisms During Manufacturing Operations L. Proposed § 117.80(c)(12)—Batters, Breading, Sauces, Gravies, Dressings, and Other Similar Preparations M. Proposed § 117.80(c)(13)—Filling, Assembling, Packaging and Other Operations N. Proposed § 117.80(c)(14)—Food That Relies on the Control of Water Activity for Preventing the Growth of Undesirable Microorganisms O. Proposed § 117.80(c)(15)—Food That Relies on the Control of pH for Preventing the Growth of Undesirable Microorganisms P. Proposed § 117.80(c)(16)—Requirements for Ice Used in Contact With Food Q. Proposed Deletion of Current § 110.80(b)(17)—Food-Manufacturing Areas and Equipment XXI. Subpart B: Comments on Proposed § 117.93—Warehousing and Distribution XXII. Subpart B: Comments on Proposed § 117.110—Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls XXIV. Subpart C: Comments on Proposed § 117.126—Food Safety Plan A. Proposed § 117.126(a)(1)—Requirement for a Food Safety Plan B. Proposed § 117.126(a)(2)—Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual C. Proposed § 117.126(b)—Contents of a Food Safety Plan D. Proposed § 117.126(c)—Records E. Comments on Potential Requirements for Submission of a Facility Profile to FDA XXV. Subpart C: Comments on Proposed § 117.130—Hazard Analysis A. Proposed § 117.130(a)—Requirement for a Written Hazard Analysis B. Proposed § 117.130(b)—Hazard Identification C. Proposed § 117.130(c)—Evaluation of Whether a Hazard Requires a Preventive Control XXVI. Subpart C: Comments on Proposed § 117.135—Preventive Controls A. Proposed § 117.135(a)—Requirement To Identify and Implement Preventive Controls B. Proposed § 117.135(b)—Requirement for Written Preventive Controls C. Proposed § 117.135(c)(1)—Process Controls D. Proposed § 117.135(c)(2)—Food Allergen Controls E. Proposed § 117.135(c)(3)—Sanitation Controls F. Proposed § 117.135(c)(4)—Supply-Chain Controls G. Proposed § 117.135(c)(5)—Recall Plan H. Proposed § 117.135(c)(6)—Other Controls XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent in Charge of a Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control (Final §§ 117.136 and 117.137) XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan (Final § 117.139) A. Proposed § 117.137(a)—Requirement for a Written Recall Plan (Final § 117.139(a)) B. Proposed § 117.137(b)—Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps (Final § 117.139(b)) XXIX. Comments on Proposed § 117.140—Preventive Control Management Components A. Proposed § 117.140(a)—Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification B. Proposed § 117.140(b)—Applicability of Preventive Control Management Components to the Supply-Chain Program C. Proposed § 117.140(c)—Recall Plan is Not Subject to Preventive Control Management Components XXX. Subpart C: Comments on Proposed § 117.145—Monitoring A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls B. Proposed § 117.145(a)—Flexibility in Requirements for Monitoring C. Proposed § 117.145(b)—Records XXXI. Subpart C: Comments on Proposed § 117.150—Corrective Actions and Corrections A. Proposed § 117.150(a)(1)—Requirement To Establish and Implement Corrective Action Procedures B. Proposed § 117.150(a)(2)—Content of Corrective Action Procedures C. Proposed § 117.150(b)—Corrective Action in the Event of an Unanticipated Problem D. Proposed § 117.150(c)—Corrections E. Proposed § 117.150(d)—Records XXXII. Subpart C: Comments on Proposed § 117.155—Verification A. Flexibility in Requirements for Verification B. Proposed § 117.155(a)—Verification activities C. Proposed § 117.155(b)—Documentation of Verification Activities D. Comments on Potential Requirements Regarding Complaints XXXIII. Subpart C: Comments on Proposed § 117.160—Validation A. Flexibility in the Requirements To Validate Preventive Controls B. Proposed § 117.160(b)(1)—When Validation Must Be Performed and Role of the Preventive Controls Qualified Individual in Validation C. Proposed § 117.160(b)(2)—What Validation Must Include D. Proposed § 117.160(b)(3)—Preventive Controls for Which Validation Is Not Required XXXIV. Subpart C: Comments on Proposed § 117.165—Verification of Implementation and Effectiveness A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness B. Proposed § 117.165(a)(1)—Calibration C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed § 117.165(a)(2) and (b)(2)) and Environmental Monitoring (Proposed § 117.165(a)(3) and (b)(3)) D. Proposed § 117.165(a)(2)—Product Testing E. Proposed § 117.165(a)(3)— Environmental Monitoring F. Proposed § 117.165(a)(4)—Review of Records G. Proposed § 117.165(b)—Written Procedures XXXV. Subpart C: Comments on Proposed § 117.170—Reanalysis A. Proposed § 117.170(a)—Circumstances Requiring Reanalysis B. Proposed § 117.170(b)—Timeframe To Complete Reanalysis C. Proposed § 117.170(c)—Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed D. Proposed § 117.170(d)—Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual E. Proposed § 117.170(e)—Reanalysis on the Initiative of FDA XXXVI. Subpart C: Comments on Proposed § 117.180—Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor A. Proposed § 117.180(a) and (b)—What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee B. Proposed § 117.180(c)—Qualification Requirements C. Proposed § 117.180(d)—Records XXXVII. Subpart C: Comments on Proposed § 117.190—Implementation Records A. Proposed § 117.190(a)—List of Required Records B. Proposed § 117.190(b)—Applicability of Subpart F XXXVIII. Subpart D: Comments on Proposed § 117.201—Modified Requirements That Apply to a Qualified Facility A. Comments on Submission of a Certification Statement B. General Comments on Modified Requirements That Apply to a Qualified Facility C. Proposed § 117.201(a)—Documentation To Be Submitted D. Proposed § 117.201(b)—Procedure for Submission E. Proposed § 117.201(c)—Frequency of Determination and Submission F. Proposed § 117.201(d)—Notification to Consumers (Final § 117.201(e)) G. Proposed § 117.201(e)—Records (Final § 117.201(f)) XXXIX. Subpart D: Comments on Proposed § 117.206—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Food A. Proposed § 117.206(a)—Modified Requirements for Unexposed Refrigerated Packaged Food That Requires Time/Temperature Controls B. Proposed § 117.206(b)—Records XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption A. Proposed § 117.251—Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption B. Proposed § 117.254—Issuance of an Order To Withdraw a Qualified Facility Exemption C. Proposed § 117.257—Contents of an Order To Withdraw a Qualified Facility Exemption D. Proposed § 117.260—Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption E. Proposed § 117.264—Procedure for Submitting an Appeal F. Proposed § 117.267—Procedure for Requesting an Informal Hearing G. Proposed § 117.270—Requirements Applicable to an Informal Hearing H. Proposed § 117.287—Reinstatement of a Qualified Facility Exemption That Was Withdrawn I. Conforming Amendment to 21 CFR part 16 J. Other Comments on the Withdrawal Provisions XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements A. Proposed § 117.301—Records Subject to the Requirements of Subpart F B. Proposed § 117.305—General Requirements Applying to Records C. Proposed § 117.310—Additional Requirements Applying to the Food Safety Plan D. Proposed § 117.315—Requirements for Record Retention E. Proposed § 117.320—Requirements for Official Review F. Proposed § 117.325—Public Disclosure G. Proposed § 117.330—Use of Existing Records H. Final § 117.335—Special Requirements Applicable to a Written Assurance I. Other Comments on the Recordkeeping Requirements of Subpart F XLII. Subpart G: General Comments on Proposed Requirements for a Supply- Chain Program XLIII. Subpart G: Comments on Requirement To Establish and Implement a Supply- Chain Program A. Requirement for a Written Supply-Chain Program (Final § 117.405(a)(1) and (b)) B. Circumstances That Do Not Require a Written Supply-Chain Program (Final § 117.405(a)(2)) C. Exemption for Food Supplied for Research or Evaluation (Final § 117.405(a)(3)) D. Additional Requirements for Non- Suppliers (Final § 117.405(c)) E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed § 117.136(a)(4) and (5)) XLIV. Subpart G: Comments on General Requirements Applicable to a Supply- Chain Program A. Description of What the Supply-Chain Program Must Include (Final § 117.410(a)) B. Appropriate Supplier Verification Activities ((Final § 117.410(b)) C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(c)) D. Factors That Must Be Considered When Approving Suppliers and Determining Appropriate Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(d)) E. Supplier Non-Conformance (Final § 117.410(e)) XLV. Subpart G: New Requirement Specifying Responsibilities of the Receiving Facility (Final § 117.415) XLVI. Subpart G: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities A. Using Approved Suppliers (Final § 117.420) B. Determining Appropriate Verification activities (Final § 117.425) XLVII. Subpart G: Comments on Conducting Supplier Verification Activities for Raw Materials and Other Ingredients A. Requirement to Conduct One or More Supplier Verification Activities (Final § 117.430(a)) B. Requirement for an Onsite Audit as a Verification Activity When a Hazard Has a Reasonable Probability of Resulting in Serious Adverse Health Consequences or Death to Humans (Final § 117.430(b)) C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final § 117.430(c)) D. Alternative Verification Activity When the Supplier Is a Produce Farm That Is Not a ‘‘Covered Farm’’ for the Purposes of the Future Produce Safety Rule (Final § 117.430(d)) E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final § 117.430(e)) F. Independence of Persons Who Conduct Supplier Verification Activities (Final § 117.430(f)) XLVIII. Subpart G: Comments on Onsite Audit A. Requirements Applicable to an Onsite Audit (Final § 117.435(a) and (b)) B. Substitution of Inspection by FDA or an Officially Recognized or Equivalent Food Safety Authority C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of Section 808 of the FD&C Act XLIX. Subpart G: Comments on Records Documenting the Supply-Chain Program A. Applicability of the Recordkeeping Requirements of Subpart F (Final § 117.475(a)) B. Requirement To Review Records of the Supply-Chain Program (Final § 117.475(b)) C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final § 117.475(c)(5)) D. Documentation of the Conduct of an Onsite Audit (Final § 117.475(c)(7)) E. Documentation of Sampling and Testing (Final § 117.475(c)(8)) F. Documentation of Other Appropriate Supplier Verification Activity (Final § 117.475(c)(10)) G. Documentation of an Alternative Verification Activity for a Supplier That Is a Farm That Is Not a ‘‘Covered Farm’’ for the Purposes of the Future Produce Safety Rule (Final § 117.475(c)(13)) L. Holding Human Food By-Products Intended for Use in Animal Food LI. Comments by Foreign Governments and Foreign Businesses LII. Editorial and Conforming Changes LIII. Comments on FSMA’s Rulemaking Provisions A. Comments on Requirements in Section 418(n)(3) of the FD&C Act Regarding Content B. Comments on Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA LIV. Comments on Proposed Removal of 21 CFR part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food LV. Comments on Proposed Conforming Amendments LVI. Effective and Compliance Dates A. Effective and Compliance Dates for Part 117 B. Effective and Compliance Dates for Revisions to Part 1 C. Effective Dates for Conforming Amendments D. Delayed Effective Dates for Provisions That Refer to the Forthcoming Rules for Produce Safety and Third-Party Certification LVII. Compliance and Enforcement LVIII. Executive Order 13175 LIX. Economic Analysis of Impacts LX. Analysis of Environmental Impact LXI. Paperwork Reduction Act of 1995 LXII. Federalism LXIII. References Executive Summary Purpose and Coverage of the Rule This rule is part of FDA’s implementation of the FDA Food Safety Modernization Act (FSMA), which intends to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. This rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways. First, this rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk- based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food ‘‘facility.’’ This portion of the rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards, unless an exemption applies. Facilities must also monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions. Second, this rule modernizes FDA’s long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food. We have updated, revised, and otherwise clarified certain requirements within the CGMP regulations, which were last updated in 1986. Third, this rule clarifies the scope of the exemption for ‘‘farms’’ in FDA’s current food facility registration regulations and makes corresponding revisions to FDA’s current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls requirements established here. This final rule is the result of significant stakeholder engagement, beginning before the proposed rule. In response to extensive stakeholder input on the proposed rule, we revised key provisions in a supplemental notice of proposed rulemaking. After the supplemental notice of proposed rulemaking, we conducted even more outreach to the stakeholder community to ensure that the risk-based, preventive requirements in this final rule are practical and protective of public health. Summary of the Major Provisions of the Rule The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the rule establishes requirements for: ? A written food safety plan; ? Hazard analysis; ? Preventive controls; ? Monitoring; ? Corrective actions and corrections; ? Verification; ? Supply-chain program; ? Recall plan; and ? Associated records. We have added flexibility and clarity to these provisions in response to comments. Although there are similarities between these requirements of FSMA and the requirements of food safety systems known as Hazard Analysis and Critical Control Point (HACCP) systems, not every provision in FSMA is identical to the provisions of HACCP systems, and we have revised much of our terminology to distinguish FSMA’s requirements for hazard analysis and risk-based preventive controls from HACCP requirements. A facility subject to the rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether 继续阅读