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 507.1 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 54491 Cincinnati, OH 45254-0491 Page 1 of 12
VIII. Subpart A: Comments on Proposed 507.3 Definitions 56,187 A. Definitions We Proposed To Establish in Part 507 56,188 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 507.5 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 507.7 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 54491 Cincinnati, OH 45254-0491 Page 2 of 12
XII. Subpart A: Comments on Proposed 507.10 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 507.12 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 507.14 Personnel 56,226 A. Proposed 507.14(a)(1) Personal Cleanliness (Final 507.14(b)(1)) 56,226 B. Proposed 507.14(a)(2) Hand Washing (Final 507.14(b)(2)) 56,226 C. Proposed 507.14(a)(3) Unsecured Jewelry and Other Objects (Final 507.14(b)(3)) 56,227 D. Proposed 507.14(a)(4) Storing Clothing and Personal Belongings (Final 507.14(b)(4)) 56,227 E. Proposed 507.14(a)(5) Taking Other Necessary Precautions (Final 507.14(b)(5)) 56,227 XVI. Subpart B: Comments on Proposed 507.17 Plant and Grounds 56,227 A. Proposed 507.17(a) Grounds Surrounding an Animal Food Plant 56,227 B. Proposed 507.17(b)(1) Adequate Space Between Equipment, Walls, and Stored Materials 56,227 C. Proposed 507.17(b)(2) Dripping and Condensation 56,227 D. Proposed 507.17(b)(3) Ventilation 56,228 E. Proposed 507.17(b)(4) Lighting 56,228 F. Proposed 507.17(b)(5) Glass 56,228 G. Proposed 507.17(b)(6) Outdoor Storage 56,228 XVII. Subpart B: Comments on Proposed 507.19 Sanitation 56,228 A. Proposed 507.19(a) Buildings 56,228 B. Proposed 507.19(b) Cleaning 56,228 C. Proposed 507.19(b)(1) Wet Cleaning 56,228 D. Proposed 507.19(b)(2) Wet Processing 56,229 E. Proposed 507.19(c) Cleaning Compounds and Sanitizing Agents 56,229 F. Proposed 507.19(d)(1) Toxic Materials 56,229 G. Proposed 507.19(d)(2) Identification, Use, and Storage of Toxic Materials 56,229 H. Proposed 507.19(e) Pest Control 56,229 I. Proposed 507.19(f) Trash and Garbage 56,230 XVIII. Subpart B: Comments on Proposed 507.20 Water Supply and Plumbing 56,230 A. Proposed 507.20(a) Water Supply 56,230 B. Proposed 507.20(b) Plumbing 56,230 C. Proposed 507.20(c) Sewage 56,230 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 3 of 12
D. Proposed 507.20(d) Toilet Facilities 56,230 E. Proposed 507.20(e) Hand-Washing Facilities 56,230 XIX. Subpart B: Comments on Proposed 507.22 Equipment and Utensils 56,231 A. Proposed 507.22(a)(1) Plant Equipment and Utensils 56,231 B. Proposed 507.22(a)(2) Design of Equipment and Utensils 56,231 C. Proposed 507.22(a)(3) Equipment Installation 56,231 D. Proposed 507.22(a)(4) Animal Food Contact Surfaces 56,231 E. Proposed 507.22(a)(5) Non-Animal Food Contact Equipment (Final 507.22(a)(1)) 56,231 F. Proposed 507.22(b) System Design and Construction 56,231 G. Proposed 507.22(c) Monitoring Cold Storage Temperatures 56,232 H. Proposed 507.22(d) Instruments 56,232 I. Proposed 507.22(e) Compressed Air 56,232 XX. Subpart B: Comments on Proposed 507.25 Plant Operations 56,232 A. Proposed 507.25(a)(1) CGMPs 56,232 B. Proposed 507.25(a)(2) Identifying Contents of Containers 56,232 C. Proposed 507.25(a)(3) Labeling of Finished Product (Final 507.27(b)) 56,232 D. Proposed 507.25(a)(4) Animal Food Packaging Material (Final 507.25(a)(3)) 56,232 E. Proposed 507.25(a)(5) Responsibility for Overall Plant Cleanliness (Final 507.25(a)(4)) 56,232 F. Proposed 507.25(a)(6) Contamination Precautions (Final 507.25(a)(5)) 56,233 G. Proposed 507.25(a)(7) Testing Procedures (Final 507.25(a)(6)) 56,233 H. Proposed 507.25(a)(8) Contaminated Product (Final 507.25(a)(7)) 56,233 I. Proposed 507.25(a)(9) Protecting Against Contamination (Final 507.25(a)(8)) 56,233 J. Proposed 507.25(b)(1) Raw Materials and Ingredients 56,233 K. Proposed 507.25(b)(1)(i) Shipping Containers 56,233 L. Proposed 507.25(b)(1)(ii) Raw Materials 56,234 M. Proposed 507.25(b)(1)(iii) Raw Materials 56,234 N. Proposed 507.25(b)(2) Raw Materials Susceptible to Mycotoxins 56,234 O. Proposed 507.25(b)(3) Raw Materials and Rework (Final 507.25(b)(1)(iii)) 56,234 P. Proposed 507.25(b)(4) Frozen Raw Materials (Final 507.25(b)(3)) 56,234 Q. Proposed 507.25(c)(1) Appropriate Conditions for Animal Food 56,235 R. Proposed 507.25(c)(2) Control of Undesirable Microorganisms 56,235 S. Proposed 507.25(c)(3) Work-in-Process and Rework 56,235 T. Proposed 507.25(c)(4) Processing Steps 56,235 U. Proposed 507.25(c)(5) Processing Operations 56,235 V. Proposed 507.25(c)(6) Controlling Water Activity (aw) 56,235 W. Proposed 507.25(c)(7) Controlling ph 56,236 X. Proposed 507.25(c)(8) Ice 56,236 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 4 of 12
XXI. Subpart B: Comments on Proposed 507.27 Holding and Distribution 56,236 A. Proposed 507.27(a) Holding and Distribution 56,236 B. Proposed 507.27(a)(1) Containers 56,236 C. Proposed 507.27(a)(2) Protection From Contamination 56,236 D. Proposed 507.27(a)(3) Labeling of Animal Food Held for Distribution (Final 507.27(b)) 56,237 E. Proposed 507.27(b) Shipping Containers (Final 507.27(c)) 56,237 F. Proposed 507.27(c) Returned Animal Food (Final 507.27(d)) 56,237 G. Proposed 507.27(d) Unpackaged Bulk Animal Food (Final 507.27(e)) 56,237 XXII. Subpart B: Comments on Proposed 507.28 Holding and Distribution of Human Food By- Products for Use as Animal Food 56,237 A. Proposed 507.28(a) Contamination 56,237 B. Proposed 507.28(a)(1) Containers 56,238 C. Proposed 507.28(a)(2) Protection From Contamination 56,238 D. Proposed 507.28(a)(3) Labeling 56,238 E. Proposed 507.28(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 507.31 Food Safety Plan 56,239 A. Proposed 507.31(a) Requirement for a Food Safety Plan 56,239 B. Proposed 507.31(b) Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual 56,241 C. Proposed 507.31(c) Contents of a Food Safety Plan 56,241 D. Proposed 507.31(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 507.33 Hazard Analysis 56,242 A. Proposed 507.33(a) Requirement for a Written Hazard Analysis 56,242 B. Proposed 507.33(b) Hazard Identification 56,243 C. Proposed 507.33(c) and (d) Evaluation of Whether a Hazard Requires a Preventive Control 56,246 XXVI. Subpart C: Comments on Proposed 507.36 Preventive Controls (Final 507.34) 56,247 A. Proposed 507.36(a) Requirement To Identify and Implement Preventive Controls (Final 507.34(a)) 56,248 B. Proposed 507.36(b) Requirement for Written Preventive Controls (Final 507.34(b)) 56,248 C. Proposed 507.36(c)(1) Process Controls (Final 507.34(c)(1)) 56,248 D. Proposed 507.36(c)(2) Sanitation Controls (Final 507.34(c)(2)) 56,248 E. Proposed 507.36(c)(3) Supply-Chain Controls (Final 507.34(c)(3)) 56,249 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 5 of 12
F. Proposed 507.36(c)(4) Recall Plan (Final 507.34(c)(4)) 56,249 G. Proposed 507.36(c)(5) Other Controls (Final 507.34(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 507.36 and 507.37) 56,249 XXVIII. Subpart C: Comments on Proposed 507.38 Recall Plan 56,253 A. Proposed 507.38(a) Requirement for a Written Recall Plan 56,253 B. Proposed 507.38(b) Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps 56,254 XXIX. Comments on Proposed 507.39 Preventive Control Management Components 56,256 A. Proposed 507.39(a) Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification 56,256 B. Proposed 507.39(b) Applicability of Preventive Control Management Components to Supply-Chain Program 56,257 C. Proposed 507.39(c) Recall Plan is Not Subject to Preventive Control Management Components 56,257 XXX. Subpart C: Comments on Proposed 507.40 Monitoring 56,257 A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls 56,258 B. Proposed 507.40(a) and (b) Flexibility in Requirements for Monitoring 56,258 C. Proposed 507.40(c) Records 56,259 XXXI. Subpart C: Comments on Proposed 507.42 Corrective Actions and Corrections 56,259 A. Proposed 507.42(a)(1)(i) Requirement To Establish and Implement Corrective Action Procedures 56,260 B. Proposed 507.42(a)(2) Content of Corrective Action Procedures 56,261 C. Proposed 507.42(b) Corrective Action in the Event of an Unanticipated Problem 56,262 D. Proposed 507.42(c) Corrections 56,263 E. Proposed 507.42(d) Records 56,263 XXXII. Subpart C: Comments on Proposed 507.45 Verification 56,263 A. Flexibility in Requirements for Verification 56,263 B. Proposed 507.45(a) Verification Activities 56,264 C. Proposed 507.45(b) Documentation of Verification Activities 56,264 D. Comments on Potential Requirements Regarding Complaints 56,264 XXXIII. Subpart C: Comments on Proposed 507.47 Validation 56,265 A. Flexibility in the Requirements To Validate Preventive Controls 56,266 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 6 of 12
B. Proposed 507.47(b)(1) When Validation Must Be Performed and Role of Preventive Controls Qualified Individual in Validation 56,267 C. Proposed 507.47(b)(2) What Validation Must Include 56,268 D. Proposed 507.47(b)(3) Preventive Controls for Which Validation Is Not Required 56,268 XXXIV. Subpart C: Comments on Proposed 507.49 Verification of Implementation and Effectiveness 56,269 A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness 56,269 B. Proposed 507.49(a)(1) Calibration 56,272 C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed 507.49(a)(2) and (b)(2)) and Environmental Monitoring (Proposed 507.49(a)(3) and (b)(3)) 56,272 D. Proposed 507.49(a)(2) Product Testing 56,274 E. Proposed 507.49(a)(3) Environmental Monitoring 56,275 F. Proposed 507.49(a)(4) Review of Records 56,275 G. Proposed 507.49(b) Written Procedures 56,276 XXXV. Subpart C: Comments on Proposed 507.50 Reanalysis 56,278 A. Proposed 507.50(a) Circumstances Requiring Reanalysis 56,278 B. Proposed 507.50(b) Timeframe To Complete Reanalysis 56,279 C. Proposed 507.50(c) Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed 56,279 D. Proposed 507.50(d) Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual 56,279 E. Proposed 507.50(e) Reanalysis on the Initiative of FDA 56,279 XXXVI. Subpart C: Comments on Proposed 507.51 Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food 56,280 A. Proposed 507.51(a) Modified Requirements for Unexposed Refrigerated Packaged Animal Food That Requires Time/Temperature Controls 56,280 B. Proposed 507.51(b) Records 56,282 XXXVII. Subpart C: Comments on Proposed 507.53 Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor 56,282 A. Proposed 507.53(a) and (b) What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee 56,282 B. Proposed 507.53(c) Qualification Requirements 56,283 C. Proposed 507.53(d) Records 56,284 XXXVIII. Subpart C: Comments on Proposed 507.55 Implementation Records 56,284 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 7 of 12
XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption 56,284 A. Proposed 507.60 Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption 56,285 B. Proposed 507.62 Issuance of an Order To Withdraw a Qualified Facility Exemption 56,286 C. Proposed 507.65 Contents of an Order To Withdraw a Qualified Facility Exemption 56,287 D. Proposed 507.67 Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption 56,288 E. Proposed 507.69 Procedure for Submitting an Appeal 56,288 F. Proposed 507.71 Procedure for Requesting an Informal Hearing 56,288 G. Proposed 507.73 Requirements Applicable to an Informal Hearing 56,289 H. Proposed 507.85 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 507.105(a)(1) and (b)) 56,295 B. Circumstances That Do Not Require a Written Supply-Chain Program (Final 507.105(a)(2)) 56,296 C. Exemption for Animal Food Supplied for Research or Evaluation (Final 507.105(a)(3)) 56,297 D. Additional Requirements for Non-Suppliers (Final 507.105(c)) 56,297 E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed 507.37(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 507.110(a)) 56,299 B. Appropriate Supplier Verification Activities ((Final 507.110(b)) 56,299 C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final 507.110(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 507.110(d)) 56,301 E. Supplier Non-Conformance (Final 507.110(e)) 56,303 XLIII. Subpart E: New Requirement Specifying the Responsibilities of the Receiving Facility (Final 507.115) 56,303 XLIV. Subpart E: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities 56,303 A. Using Approved Suppliers (Final 507.120) 56,304 B. Determining Appropriate Verification Activities (Final 507.125) 56,304 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 8 of 12
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 507.130(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 507.130(b)) 56,306 C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final 507.130(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 507.130(d)) 56,309 E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final 507.130(e)) 56,310 F. Independence of Persons Who Conduct Supplier Verification Activities (Final 507.130(f)) 56,310 XLVI. Subpart E: Comments on Onsite Audit 56,310 A. Requirements Applicable to an Onsite Audit (Final 507.135(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 507.175(a)) 56,315 B. Requirement To Review Records of the Supply-Chain Program (Final 507.175(b)) 56,315 C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final 507.175(c)(5)) 56,316 D. Documentation of the Conduct of an Onsite Audit (Final 507.175(c)(7)) 56,316 E. Documentation of Sampling and Testing (Final 507.175(c)(8)) 56,316 F. Documentation of Other Appropriate Supplier Verification Activity (Final 507.175(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 507.175(c)(13)) 56,317 XLVIII. Subpart F: Comments on Proposed New Recordkeeping Requirements 56,317 A. Proposed 507.200 Records Subject to the Requirements of Subpart F and Requirements for Official Review 56,318 B. Proposed 507.202 General Requirements Applying to Records 56,320 C. Proposed 507.206 Additional Requirements Applying to the Food Safety Plan 56,321 D. Proposed 507.208 Requirements for Record Retention 56,321 E. Proposed 507.212 Use of Existing Records 56,322 F. Final 507.215 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 54491 Cincinnati, OH 45254-0491 Page 9 of 12
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 507 56,328 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 13175 56,331 LVI. Economic Analysis of Impacts 56,331 LVII. Analysis of Environmental Impact 56,331 LVIII. Paperwork Reduction Act of 1995 56,331 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 54491 Cincinnati, OH 45254-0491 Page 10 of 12
507.1 Applicability and status 56,337 507.3 Definitions 56,338 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food 56,340 507.5 Exemptions 56,340 507.7 Requirements that apply to a qualified facility 56,341 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food 56,342 507.12 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 56,337 507.14 Personnel 56,342 507.17 Plant and grounds 56,342 507.19 Sanitation 56,343 507.20 Water supply and plumbing 56,343 507.22 Equipment and utensils 56,343 507.25 Plant operations 56,344 507.27 Holding and distribution 56,344 507.28 Holding and distribution of human food by-products for use as animal food 56,344 Subpart C- Hazard Analysis and Risk-Based Preventative Controls 56,345 507.31 Food safety plan 56,345 507.33 Hazard analysis 56,345 507.34 Preventative controls 56,345 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventative control 56,346 507.37 Provision of assurances required under 507.35(a)(2), (3), and (4) 56,346 507.38 Recall plan 56,346 507.39 Preventative control management components 56,347 507.40 Monitoring 56,347 507.42 Corrective actions and corrections 56,347 507.45 Verification 56,347 507.47 Validation 56,348 507.49 Verification of Implementation and effectiveness 56,348 507.50 Reanalysis 56,348 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food 56,349 507.53 Requirements applicable to a preventative controls qualified individual and a qualified auditor 56,349 507.55 Implementation records required for this subpart 56,349 P.O. Box 54491 Cincinnati, OH 45254-0491 Page 11 of 12
Subpart D- Withdrawal of a Qualified Facility Exemption 56,350 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption 56,350 507.62 Issuance of an order to withdraw a qualified facility exemption 56,350 507.65 Contents of an order to withdraw a qualified facility exemption 56,350 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption 56,350 507.69 Procedures for submitting an appeal 56,350 507.71Procedures for requesting an informal hearing 56,351 507.73 Requirements applicable to an informal hearing 56,351 507.75 Presiding officer for an appeal and for an informal hearing 56,351 507.77 Timeframe for issuing a decision on an appeal 56,351 507.80 Revocation of an order to withdraw a qualified facility exemption 56,351 507.83 Final agency action 56,351 507.85 Reinstatement of a qualified facility exemption that was withdrawn 56,351 Subpart E- Supply-Chain Program 56,352 507.105 Requirement to establish and implement a supply-chain program 56,352 507.110 General requirements applicable to a supply-chain program 56,352 507.115 Responsibilities of the receiving facility 56,353 507.120 Using approved suppliers 56,353 507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) 56,353 507.130 Conducting supplier verification activities for raw materials and other ingredients 56,353 507.135 Onsite audit 56,354 507.175 Records documenting the supply-chain program 56,354 Subpart F- Requirements Applying to Records That Must Be Established and Maintained 56,355 507.200 Records subject to the requirements of this subpart 56,355 507.202 General requirements applying to records 56,355 507.206 Additional requirements applying to the food safety plan 56,355 507.208 Requirements for record retention 56,355 507.212 Use of existing records 56,356 507.215 Special requirements applicable to a written assurance 56,356 21 CFR Part 507 56,360 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 54491 Cincinnati, OH 45254-0491 Page 12 of 12