Executive Summary 56,173 Purpose and Coverage of the Rule 56,173 Summary of the Major Provisions of the Rule 56,173 Costs and Benefits 56,175

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1 Executive Summary 56,173 Purpose and Coverage of the Rule 56,173 Summary of the Major Provisions of the Rule 56,173 Costs and Benefits 56,175 I. Background 56,176 A. FDA Food Safety Modernization Act 56,176 B. Stages in the Rulemaking for the Animal Food Preventive Controls Rule 56,177 C. Summary of the Major Provisions of Proposed Rule for Preventive Controls for Food for Animals 56,177 D. Draft Risk Assessment 56,178 E. Public Comments 56,178 II. Legal Authority 56,178 A. Current Good Manufacturing Practice Regulations 56,178 B. Hazard Analysis and Risk-Based Preventive Controls 56,179 III. General Comments on the Proposed Rule 56,180 IV. Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) 56,182 A. Definitions That Impact a Determination of Whether an Establishment Is a Farm 56,182 B. Proposed Revisions to the Definition of Farm 56,183 C. Proposed Revisions to Definitions of Harvesting, Holding, Manufacturing/Processing, Mixed-Type Facility, and Packing 56,184 D. Comments on Feed Mills Associated With Fully Vertically Integrated Farming Operations 56,184 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 56,185 VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities 56,185 A. Section 103(c)(1)(C) of FSMA 56,185 B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition 56,185 C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act 56,186 VII. Subpart A: Comments on Proposed Applicability and Status 56,186 A. Comments on Proposed 507.1(a) Applicability 56,186 B. Comments on Proposed 507.1(b) Prohibited Act 56,187 C. Comments on Proposed 507.1(c) Specific CGMP Requirements 56,187 D. Comments on Proposed 507.1(d) Human Food Facilities That Manufacture Animal Food 56,187 P.O. Box Cincinnati, OH Page 1 of 12

2 VIII. Subpart A: Comments on Proposed Definitions 56,187 A. Definitions We Proposed To Establish in Part ,188 B. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule 56,204 C. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule 56,206 IX. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Animal Food 56,206 A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Animal Food (Final 507.4(a), (b), and (d)) 56,207 B. Additional Requirements Applicable to Supervisory Personnel (Final 507.4(c)) 56,208 X. Subpart A: Comments on Proposed Exemptions 56,208 A. General Comments on the Proposed Exemptions 56,209 B. Proposed 507.5(a) Exemption for Facilities Not Required To Register Under Section 415 Regulations 56,209 C. Proposed 507.5(b) Exemption Applicable to Food Subject to 21 CFR part 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 56,210 D. Proposed 507.5(c) Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act 56,210 E. Proposed 507.5(d) Exemption Applicable to a Qualified Facility 56,211 F. Proposed 507.5(e) and (f) Exemptions Applicable to On-Farm Low-Risk Activity/Animal Food Combinations Conducted by a Small or Very Small Business 56,211 G. Proposed 507.5(g) Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Vegetables Intended for Further Distribution or Processing 56,213 H. Proposed 507.5(h) Exemption Applicable to the Holding or Transportation of One or More Raw Agricultural Commodities 56,214 I. Comments Requesting Additional Exemptions 56,215 XI. Subpart A: Comments on Proposed Requirements That Apply to a Qualified Facility 56,215 A. Comments on Submission of a Certification Statement 56,216 B. General Comments on Requirements That Apply to a Qualified Facility 56,217 C. Proposed 507.7(a) Documentation To Be Submitted 56,218 D. Proposed 507.7(b) Procedure for Submission 56,219 E. Proposed 507.7(c) Frequency of Determination and Submission 56,219 F. Proposed 507.7(d) Notification to Consumers (Final 507.7(e)) 56,220 G. Proposed 507.7(e) Records (Final 507.7(f)) 56,221 P.O. Box Cincinnati, OH Page 2 of 12

3 XII. Subpart A: Comments on Proposed Applicability of Part 507 to a Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food 56,221 XIII. Subpart A: Comments on Proposed Applicability of Part 507 to the Holding and Distribution of Human Food By-Products for Use as Animal Food 56,222 XIV. Subpart B: General Comments on Proposed Subpart B Current Good Manufacturing Practice 56,225 XV. Subpart B: Comments on Proposed Personnel 56,226 A. Proposed (a)(1) Personal Cleanliness (Final (b)(1)) 56,226 B. Proposed (a)(2) Hand Washing (Final (b)(2)) 56,226 C. Proposed (a)(3) Unsecured Jewelry and Other Objects (Final (b)(3)) 56,227 D. Proposed (a)(4) Storing Clothing and Personal Belongings (Final (b)(4)) 56,227 E. Proposed (a)(5) Taking Other Necessary Precautions (Final (b)(5)) 56,227 XVI. Subpart B: Comments on Proposed Plant and Grounds 56,227 A. Proposed (a) Grounds Surrounding an Animal Food Plant 56,227 B. Proposed (b)(1) Adequate Space Between Equipment, Walls, and Stored Materials 56,227 C. Proposed (b)(2) Dripping and Condensation 56,227 D. Proposed (b)(3) Ventilation 56,228 E. Proposed (b)(4) Lighting 56,228 F. Proposed (b)(5) Glass 56,228 G. Proposed (b)(6) Outdoor Storage 56,228 XVII. Subpart B: Comments on Proposed Sanitation 56,228 A. Proposed (a) Buildings 56,228 B. Proposed (b) Cleaning 56,228 C. Proposed (b)(1) Wet Cleaning 56,228 D. Proposed (b)(2) Wet Processing 56,229 E. Proposed (c) Cleaning Compounds and Sanitizing Agents 56,229 F. Proposed (d)(1) Toxic Materials 56,229 G. Proposed (d)(2) Identification, Use, and Storage of Toxic Materials 56,229 H. Proposed (e) Pest Control 56,229 I. Proposed (f) Trash and Garbage 56,230 XVIII. Subpart B: Comments on Proposed Water Supply and Plumbing 56,230 A. Proposed (a) Water Supply 56,230 B. Proposed (b) Plumbing 56,230 C. Proposed (c) Sewage 56,230 P.O. Box Cincinnati, OH Page 3 of 12

4 D. Proposed (d) Toilet Facilities 56,230 E. Proposed (e) Hand-Washing Facilities 56,230 XIX. Subpart B: Comments on Proposed Equipment and Utensils 56,231 A. Proposed (a)(1) Plant Equipment and Utensils 56,231 B. Proposed (a)(2) Design of Equipment and Utensils 56,231 C. Proposed (a)(3) Equipment Installation 56,231 D. Proposed (a)(4) Animal Food Contact Surfaces 56,231 E. Proposed (a)(5) Non-Animal Food Contact Equipment (Final (a)(1)) 56,231 F. Proposed (b) System Design and Construction 56,231 G. Proposed (c) Monitoring Cold Storage Temperatures 56,232 H. Proposed (d) Instruments 56,232 I. Proposed (e) Compressed Air 56,232 XX. Subpart B: Comments on Proposed Plant Operations 56,232 A. Proposed (a)(1) CGMPs 56,232 B. Proposed (a)(2) Identifying Contents of Containers 56,232 C. Proposed (a)(3) Labeling of Finished Product (Final (b)) 56,232 D. Proposed (a)(4) Animal Food Packaging Material (Final (a)(3)) 56,232 E. Proposed (a)(5) Responsibility for Overall Plant Cleanliness (Final (a)(4)) 56,232 F. Proposed (a)(6) Contamination Precautions (Final (a)(5)) 56,233 G. Proposed (a)(7) Testing Procedures (Final (a)(6)) 56,233 H. Proposed (a)(8) Contaminated Product (Final (a)(7)) 56,233 I. Proposed (a)(9) Protecting Against Contamination (Final (a)(8)) 56,233 J. Proposed (b)(1) Raw Materials and Ingredients 56,233 K. Proposed (b)(1)(i) Shipping Containers 56,233 L. Proposed (b)(1)(ii) Raw Materials 56,234 M. Proposed (b)(1)(iii) Raw Materials 56,234 N. Proposed (b)(2) Raw Materials Susceptible to Mycotoxins 56,234 O. Proposed (b)(3) Raw Materials and Rework (Final (b)(1)(iii)) 56,234 P. Proposed (b)(4) Frozen Raw Materials (Final (b)(3)) 56,234 Q. Proposed (c)(1) Appropriate Conditions for Animal Food 56,235 R. Proposed (c)(2) Control of Undesirable Microorganisms 56,235 S. Proposed (c)(3) Work-in-Process and Rework 56,235 T. Proposed (c)(4) Processing Steps 56,235 U. Proposed (c)(5) Processing Operations 56,235 V. Proposed (c)(6) Controlling Water Activity (aw) 56,235 W. Proposed (c)(7) Controlling ph 56,236 X. Proposed (c)(8) Ice 56,236 P.O. Box Cincinnati, OH Page 4 of 12

5 XXI. Subpart B: Comments on Proposed Holding and Distribution 56,236 A. Proposed (a) Holding and Distribution 56,236 B. Proposed (a)(1) Containers 56,236 C. Proposed (a)(2) Protection From Contamination 56,236 D. Proposed (a)(3) Labeling of Animal Food Held for Distribution (Final (b)) 56,237 E. Proposed (b) Shipping Containers (Final (c)) 56,237 F. Proposed (c) Returned Animal Food (Final (d)) 56,237 G. Proposed (d) Unpackaged Bulk Animal Food (Final (e)) 56,237 XXII. Subpart B: Comments on Proposed Holding and Distribution of Human Food By- Products for Use as Animal Food 56,237 A. Proposed (a) Contamination 56,237 B. Proposed (a)(1) Containers 56,238 C. Proposed (a)(2) Protection From Contamination 56,238 D. Proposed (a)(3) Labeling 56,238 E. Proposed (b) Shipping Containers 56,238 XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls 56,238 XXIV. Subpart C: Comments on Proposed Food Safety Plan 56,239 A. Proposed (a) Requirement for a Food Safety Plan 56,239 B. Proposed (b) Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual 56,241 C. Proposed (c) Contents of a Food Safety Plan 56,241 D. Proposed (d) Records 56,241 E. Comments on Potential Requirements for Submission of a Facility Profile to FDA 56,241 XXV. Subpart C: Comments on Proposed Hazard Analysis 56,242 A. Proposed (a) Requirement for a Written Hazard Analysis 56,242 B. Proposed (b) Hazard Identification 56,243 C. Proposed (c) and (d) Evaluation of Whether a Hazard Requires a Preventive Control 56,246 XXVI. Subpart C: Comments on Proposed Preventive Controls (Final ) 56,247 A. Proposed (a) Requirement To Identify and Implement Preventive Controls (Final (a)) 56,248 B. Proposed (b) Requirement for Written Preventive Controls (Final (b)) 56,248 C. Proposed (c)(1) Process Controls (Final (c)(1)) 56,248 D. Proposed (c)(2) Sanitation Controls (Final (c)(2)) 56,248 E. Proposed (c)(3) Supply-Chain Controls (Final (c)(3)) 56,249 P.O. Box Cincinnati, OH Page 5 of 12

6 F. Proposed (c)(4) Recall Plan (Final (c)(4)) 56,249 G. Proposed (c)(5) Other Controls (Final (c)(5)) 56,249 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 and ) 56,249 XXVIII. Subpart C: Comments on Proposed Recall Plan 56,253 A. Proposed (a) Requirement for a Written Recall Plan 56,253 B. Proposed (b) Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps 56,254 XXIX. Comments on Proposed Preventive Control Management Components 56,256 A. Proposed (a) Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification 56,256 B. Proposed (b) Applicability of Preventive Control Management Components to Supply-Chain Program 56,257 C. Proposed (c) Recall Plan is Not Subject to Preventive Control Management Components 56,257 XXX. Subpart C: Comments on Proposed Monitoring 56,257 A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls 56,258 B. Proposed (a) and (b) Flexibility in Requirements for Monitoring 56,258 C. Proposed (c) Records 56,259 XXXI. Subpart C: Comments on Proposed Corrective Actions and Corrections 56,259 A. Proposed (a)(1)(i) Requirement To Establish and Implement Corrective Action Procedures 56,260 B. Proposed (a)(2) Content of Corrective Action Procedures 56,261 C. Proposed (b) Corrective Action in the Event of an Unanticipated Problem 56,262 D. Proposed (c) Corrections 56,263 E. Proposed (d) Records 56,263 XXXII. Subpart C: Comments on Proposed Verification 56,263 A. Flexibility in Requirements for Verification 56,263 B. Proposed (a) Verification Activities 56,264 C. Proposed (b) Documentation of Verification Activities 56,264 D. Comments on Potential Requirements Regarding Complaints 56,264 XXXIII. Subpart C: Comments on Proposed Validation 56,265 A. Flexibility in the Requirements To Validate Preventive Controls 56,266 P.O. Box Cincinnati, OH Page 6 of 12

7 B. Proposed (b)(1) When Validation Must Be Performed and Role of Preventive Controls Qualified Individual in Validation 56,267 C. Proposed (b)(2) What Validation Must Include 56,268 D. Proposed (b)(3) Preventive Controls for Which Validation Is Not Required 56,268 XXXIV. Subpart C: Comments on Proposed Verification of Implementation and Effectiveness 56,269 A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness 56,269 B. Proposed (a)(1) Calibration 56,272 C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed (a)(2) and (b)(2)) and Environmental Monitoring (Proposed (a)(3) and (b)(3)) 56,272 D. Proposed (a)(2) Product Testing 56,274 E. Proposed (a)(3) Environmental Monitoring 56,275 F. Proposed (a)(4) Review of Records 56,275 G. Proposed (b) Written Procedures 56,276 XXXV. Subpart C: Comments on Proposed Reanalysis 56,278 A. Proposed (a) Circumstances Requiring Reanalysis 56,278 B. Proposed (b) Timeframe To Complete Reanalysis 56,279 C. Proposed (c) Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed 56,279 D. Proposed (d) Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual 56,279 E. Proposed (e) Reanalysis on the Initiative of FDA 56,279 XXXVI. Subpart C: Comments on Proposed Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food 56,280 A. Proposed (a) Modified Requirements for Unexposed Refrigerated Packaged Animal Food That Requires Time/Temperature Controls 56,280 B. Proposed (b) Records 56,282 XXXVII. Subpart C: Comments on Proposed Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor 56,282 A. Proposed (a) and (b) What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee 56,282 B. Proposed (c) Qualification Requirements 56,283 C. Proposed (d) Records 56,284 XXXVIII. Subpart C: Comments on Proposed Implementation Records 56,284 P.O. Box Cincinnati, OH Page 7 of 12

8 XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption 56,284 A. Proposed Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption 56,285 B. Proposed Issuance of an Order To Withdraw a Qualified Facility Exemption 56,286 C. Proposed Contents of an Order To Withdraw a Qualified Facility Exemption 56,287 D. Proposed Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption 56,288 E. Proposed Procedure for Submitting an Appeal 56,288 F. Proposed Procedure for Requesting an Informal Hearing 56,288 G. Proposed Requirements Applicable to an Informal Hearing 56,289 H. Proposed Reinstatement of a Qualified Facility Exemption That Was Withdrawn 56,289 I. Conforming Amendment to 21 CFR Part 16 56,290 J. Other Comments on the Withdrawal Provisions 56,290 XL. Subpart E: General Comments on Proposed Requirements Applicable to a Supply-Chain Program 56,290 XLI. Subpart E: Comments on Requirement To Establish and Implement a Supply-Chain Program 56,294 A. Requirement for a Written Supply-Chain Program (Final (a)(1) and (b)) 56,295 B. Circumstances That Do Not Require a Written Supply-Chain Program (Final (a)(2)) 56,296 C. Exemption for Animal Food Supplied for Research or Evaluation (Final (a)(3)) 56,297 D. Additional Requirements for Non-Suppliers (Final (c)) 56,297 E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed (a)(4) and (5)) 56,298 XLII. Subpart E: Comments on General Requirements for the Supply-Chain Program 56,298 A. Description of What the Supply-Chain Program Must Include (Final (a)) 56,299 B. Appropriate Supplier Verification Activities ((Final (b)) 56,299 C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final (c)) 56,301 D. Factors That Must Be Considered When Approving Suppliers and Determining Appropriate Supplier Verification Activities for Raw Materials and Other Ingredients (Final (d)) 56,301 E. Supplier Non-Conformance (Final (e)) 56,303 XLIII. Subpart E: New Requirement Specifying the Responsibilities of the Receiving Facility (Final ) 56,303 XLIV. Subpart E: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities 56,303 A. Using Approved Suppliers (Final ) 56,304 B. Determining Appropriate Verification Activities (Final ) 56,304 P.O. Box Cincinnati, OH Page 8 of 12

9 XLV. Subpart E: Comments on Conducting Supplier Verification Activities for Raw Materials and Other Ingredients 56,305 A. Requirement To Conduct One or More Supplier Verification Activities (Final (a)) 56,306 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 or Animals (Final (b)) 56,306 C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final (c)) 56,308 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 (d)) 56,309 E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final (e)) 56,310 F. Independence of Persons Who Conduct Supplier Verification Activities (Final (f)) 56,310 XLVI. Subpart E: Comments on Onsite Audit 56,310 A. Requirements Applicable to an Onsite Audit (Final (a) and (b)) 56,311 B. Substitution of Inspection by FDA or an Officially Recognized or Equivalent Food Safety Authority 56,312 C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of Section 808 of the FD&C Act 56,313 XLVII. Subpart E: Comments on Records Documenting the Supply-Chain Program 56,313 A. Applicability of the Recordkeeping Requirements of Subpart F (Final (a)) 56,315 B. Requirement To Review Records of the Supply-Chain Program (Final (b)) 56,315 C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final (c)(5)) 56,316 D. Documentation of the Conduct of an Onsite Audit (Final (c)(7)) 56,316 E. Documentation of Sampling and Testing (Final (c)(8)) 56,316 F. Documentation of Other Appropriate Supplier Verification Activity (Final (c)(10)) 56,317 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 (c)(13)) 56,317 XLVIII. Subpart F: Comments on Proposed New Recordkeeping Requirements 56,317 A. Proposed Records Subject to the Requirements of Subpart F and Requirements for Official Review 56,318 B. Proposed General Requirements Applying to Records 56,320 C. Proposed Additional Requirements Applying to the Food Safety Plan 56,321 D. Proposed Requirements for Record Retention 56,321 E. Proposed Use of Existing Records 56,322 F. Final Special Requirements Applicable to a Written Assurance 56,323 XLIX. Comments by Foreign Governments and Foreign Businesses 56,323 L. Editorial and Conforming Changes 56,324 P.O. Box Cincinnati, OH Page 9 of 12

10 LI. Comments on FSMA's Rulemaking Provisions 56,327 A. Comments on Section 418(m) of the FDA&C Act Regarding Modified Requirements for Facilities Solely Engaged in the Production of Food for Animals Other Than Man 56,327 B. Comments on Requirements in Section 418(n)(3) of the FD&C Act Regarding Content 56,327 LII. Comments on Proposed Conforming Amendments 56,328 LIII. Effective and Compliance Dates 56,328 A. Effective and Compliance Dates for Part ,328 B. Effective Dates for Conforming Amendments 56,330 C. Delayed Effective Dates for Provisions That Refer to the Forthcoming Rules for Produce Safety and Third-Party Certification 56,330 LIV. Compliance and Enforcement 56,330 LV. Executive Order ,331 LVI. Economic Analysis of Impacts 56,331 LVII. Analysis of Environmental Impact 56,331 LVIII. Paperwork Reduction Act of ,331 LIX. FederalismShow citation box 56,334 LX. References 56,334 Part 11- Electronic Records; Electronic Signatures 56,336 Part 16- Regulatory Hearing Before the Food and Drug Administration 56,336 Part 117- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food 56,337 Part 500- General 56,337 Part 507- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Animals 56,337 Subpart A- General Provisions 56,337 P.O. Box Cincinnati, OH Page 10 of 12

11 507.1 Applicability and status 56, Definitions 56, Qualifications of individuals who manufacture, process, pack, or hold animal food 56, Exemptions 56, Requirements that apply to a qualified facility 56, Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food 56, Applicability of this part to the holding and distribution of human food by-products for use as animal food animal food 56,342 Subpart B- Current Good Manufacturing Practice 56, Personnel 56, Plant and grounds 56, Sanitation 56, Water supply and plumbing 56, Equipment and utensils 56, Plant operations 56, Holding and distribution 56, Holding and distribution of human food by-products for use as animal food 56,344 Subpart C- Hazard Analysis and Risk-Based Preventative Controls 56, Food safety plan 56, Hazard analysis 56, Preventative controls 56, Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventative control 56, Provision of assurances required under (a)(2), (3), and (4) 56, Recall plan 56, Preventative control management components 56, Monitoring 56, Corrective actions and corrections 56, Verification 56, Validation 56, Verification of Implementation and effectiveness 56, Reanalysis 56, Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food 56, Requirements applicable to a preventative controls qualified individual and a qualified auditor 56, Implementation records required for this subpart 56,349 P.O. Box Cincinnati, OH Page 11 of 12

12 Subpart D- Withdrawal of a Qualified Facility Exemption 56, Circumstances that may lead FDA to withdraw a qualified facility exemption 56, Issuance of an order to withdraw a qualified facility exemption 56, Contents of an order to withdraw a qualified facility exemption 56, Compliance with, or appeal of, an order to withdraw a qualified facility exemption 56, Procedures for submitting an appeal 56, Procedures for requesting an informal hearing 56, Requirements applicable to an informal hearing 56, Presiding officer for an appeal and for an informal hearing 56, Timeframe for issuing a decision on an appeal 56, Revocation of an order to withdraw a qualified facility exemption 56, Final agency action 56, Reinstatement of a qualified facility exemption that was withdrawn 56,351 Subpart E- Supply-Chain Program 56, Requirement to establish and implement a supply-chain program 56, General requirements applicable to a supply-chain program 56, Responsibilities of the receiving facility 56, Using approved suppliers 56, Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) 56, Conducting supplier verification activities for raw materials and other ingredients 56, Onsite audit 56, Records documenting the supply-chain program 56,354 Subpart F- Requirements Applying to Records That Must Be Established and Maintained 56, Records subject to the requirements of this subpart 56, General requirements applying to records 56, Additional requirements applying to the food safety plan 56, Requirements for record retention 56, Use of existing records 56, Special requirements applicable to a written assurance 56, CFR Part ,360 Qualitative Risk Assessment of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability 56,360 P.O. Box Cincinnati, OH Page 12 of 12

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