美国章121法规中英文全文.docx

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1、03法规中英文全文Mitigation Strategies To Protect FoodAgainst Intentional AdulterationFood and Drug Administration, HHS.Action： Final ruleSummaryThe Food and Drug Administration (FDA or we) is issuing this final rule to require domestic andforeign food facilities that are required to register under the Fede

2、ral Food, Drug, and CosmeticAct (the FD&C Act) to address hazards that may be introduced with the intention to cause widescale public health harm. These food facilities are required to conduct a vulnerabilityassessment to identify significant vulnerabilities and actionable process steps and implemen

3、tmitigation strategies to significantly minimize or prevent significant vulnerabilities identified atactionable process steps in a food operation. FDA is issuing these requirements as part of ourimplementation of the FDA Food Safety Modernization Act (FSMA).DatesThis rule is effective July 26, 2016.

4、 See section VIII for compliance dates.Table of ContentsExecutive SummaryPurpose and Coverage of the RuleSummary of the Major Provisions of the RuleCosts and BenefitsI. BackgroundA. FDA Food Safety Modernization ActB. Proposed Rule on Intentional AdulterationC. Appendix 4 to Draft Risk AssessmentD.

5、Public CommentsII. Legal AuthorityA. Section 103 of FSMAB. Section 106 of FSMAC. Intrastate ActivitiesIII. General Comments on the Proposed RuleA. Comments on Overall Framework for the Regulatory ApproachB. One Set of Requirements Under Sections 418 and 420 of the FD&C ActC. Require Measures Only in

6、 the Event of a Credible ThreatD. General Comments on Implementation and ComplianceE. Comments on Requests for Additional ExemptionsF. Other General CommentsG. Other Issues Discussed in the Proposed RuleIV. Subpart A: Comments on Specific ProvisionsA. Revisions to Definitions Also Used in Section 41

7、5 Registration Regulations (21 CFRPart 1, Subpart H) and Section 414 Recordkeeping Regulations (21 CFR Part 1, SubpartJ)B. Other Definitions That We Proposed To Establish in Part 121C. Additional Definitions to Clarify Terms Not Defined in the Proposed RuleD. Comments Asking FDA to Establish Additio

8、nal Definitions or Otherwise Clarify TermsNot Defined in the RuleE. Proposed 121.5一ExemptionsV. Subpart C: Comments on Food Defense MeasuresA. Proposed 121.126Requirement for a Food Defense PlanB. Proposed 121,130Identification of Actionable Process StepsC. Proposed 121.135Focused Mitigation Strateg

9、ies for Actionable Process StepsD. Final 121.138一Mitigation Strategies Management ComponentsE. Proposed 121.140一MonitoringF. Proposed 121.145Corrective ActionsG. Proposed 121.150VerificationH. Proposed 121.160Training (Final 121.4)VI. Subpart D: Comments on Requirements Applying to Records That Must

10、 BeEstablished and MaintainedA. Proposed 121.301Records Subject to the Requirements of This Subpart DB. Proposed 121.305General Requirements Applying to RecordsC. Proposed 121.310Additional Requirements Applying to the Food Defense PlanD. Proposed 121.315一Requirements for Record RetentionE. Proposed

11、 121.320-Requirements for Official ReviewF. Proposed 121.325Public DisclosureG. Proposed 121.330Use of Existing RecordsVII. Subpart E: Comments on ComplianceProposed 121.401VIII. Effective and Compliance DatesIX. Executive Order 13175X. Final Regulatory Impact AnalysisXI. Paperwork Reduction Act of

12、1995XII. Analysis of Environmental ImpactXIII. FederalismXIV. ReferencesExecutive SummaryPurpose and Coverage of the RuleThis regulation implements three provisions of the FD&C Act, as amended by FSMA,that relate to the intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C.350g) ad

13、dresses intentional adulteration in the context of facilities that manufacture,process, pack, or hold food and are required to register under section 415 of the FD&CAct (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addressesintentional adulteration in the context of fruits and veget

14、ables that are raw agriculturalcommodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentionaladulteration in the context of high-risk foods and exempts farms except for farms thatproduce milk. FDA is implementing the intentional adulteration provisions in sections418, 419, and 420 o

15、f the FD&C Act in this rulemaking.The purpose of this rule is to protectfood from intentional acts of adulteration where there is an intent to cause wide scalepublic health harm. This rule applies to both domestic and foreign facilities that arerequired to register under section 415 of the FD&C Act. This rule establishes severalexemptions as follows:The rule does not apply to a very small business (i.e., a business, including anysubsidiaries or affiliates, averaging less than $10,000,000, adjusted for inflation, per year,during the 3-year period preceding the appl